title: A Phase 2 Trial of Pembrolizumab (MK-3475) in Combination With Platinum Doublet Chemotherapy and Radiotherapy for Participants With Unresectable, Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC) (KEYNOTE-799).

summary: This is a trial in adult participants with unresectable, locally advanced, Stage III non-small cell lung cancer (NSCLC) treated with pembrolizumab in combination with platinum doublet chemotherapy and standard thoracic radiotherapy followed by pembrolizumab monotherapy. The primary hypothesis of the trial is that within each platinum doublet chemotherapy cohort, the percentage of participants who develop Grade 3 or higher pneumonitis is ≤10%.

ReferenceType: result

ReferenceCitation: Jabbour SK, Lee KH, Frost N, Breder V, Kowalski DM, Pollock T, Levchenko E, Reguart N, Martinez-Marti A, Houghton B, Paoli JB, Safina S, Park K, Komiya T, Sanford A, Boolell V, Liu H, Samkari A, Keller SM, Reck M. Pembrolizumab Plus Concurrent Chemoradiation Therapy in Patients With Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer: The Phase 2 KEYNOTE-799 Nonrandomized Trial. JAMA Oncol. 2021 Jun 4. doi: 10.1001/jamaoncol.2021.2301. [Epub ahead of print]

name: Department of Radiation Oncology, Rutgers Cancer Institute of New Jersey, Rutgers Robert Wood Johnson Medical School, Rutgers University, New Brunswick

family: Jabbour

full_name: Salma K. Jabbour

given: Salma K.

name: Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, South Korea

family: Lee

full_name: Ki Hyeong Lee

given: Ki Hyeong

name: Department of Infectious Diseases and Respiratory Medicine, Charité–Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany

family: Frost

full_name: Nikolaj Frost

given: Nikolaj

name: N.N. Blokhin Russian Cancer Research Center, Moscow, Russia

family: Breder

full_name: Valeriy Breder

given: Valeriy

name: The Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland

family: Kowalski

full_name: Dariusz M. Kowalski

given: Dariusz M.

name: Northeastern Health System, Tahlequah, Oklahoma

family: Pollock

full_name: Theodore Pollock

given: Theodore

name: N.N. Petrov National Medical Research Center of Oncology, St Petersburg, Russia

family: Levchenko

full_name: Evgeny Levchenko

given: Evgeny

name: Thoracic Oncology Unit, Department of Medical Oncology, IDIBAPS, Hospital Clínic, Barcelona, Spain

family: Reguart

full_name: Noemi Reguart

given: Noemi

name: Vall d’Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d’Hebron, Barcelona, Spain

family: Martinez-Marti

full_name: Alex Martinez-Marti

given: Alex

name: Mid North Coast Cancer Institute, Port Macquarie Base Hospital, Port Macquarie, New South Wales, Australia

family: Houghton

full_name: Baerin Houghton

given: Baerin

name: Radiotherapie, Clinique Clairval, Marseille, France

family: Paoli

full_name: Jean-Baptiste Paoli

given: Jean-Baptiste

name: Medical Oncology, Republican Dispensary of Tatarstan Ministry of Healthcare, Kazan, Russia

family: Safina

full_name: Sufia Safina

given: Sufia

name: Division of Hematology/Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea

family: Park

full_name: Keunchil Park

given: Keunchil

name: Hematology/Medical Oncology, Parkview Cancer Institute, Fort Wayne, Indiana

family: Komiya

full_name: Takefumi Komiya

given: Takefumi

name: Sanford Health, Sioux Falls, South Dakota

family: Sanford

full_name: Amy Sanford

given: Amy

name: Ballarat Health Services, Ballarat, Victoria, Australia

family: Boolell

full_name: Vishal Boolell

given: Vishal

family: Liu

full_name: Hong Liu

given: Hong

family: Samkari

full_name: Ayman Samkari

given: Ayman

family: Keller

full_name: Steven M. Keller

given: Steven M.

name: LungenClinic, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany

family: Reck

full_name: Martin Reck

given: Martin

journal_name: JAMA Oncology

oa_colors: green hybrid

evidence: open (via free pdf)

title: Pembrolizumab Plus Concurrent Chemoradiation Therapy in Patients With Unresectable, Locally Advanced, Stage III Non–Small Cell Lung Cancer

location_country:
United States
France
Poland
Australia
Russian Federation
New Zealand
Spain
Germany
United Kingdom
Korea, Republic of

location_facility: Osrodek Badan Klinicznych przy Szpitalu Specjalistycznym ( Site 0802)

location_facility: Clinica Universitaria de Navarra ( Site 1102)

location_facility: Bethanien Krankenhaus Moers ( Site 0406)

location_facility: Augusta-Kranken-Anstalt Bochum ( Site 0401)

location_facility: Royal Free NHS Foundation Trust ( Site 1200)

location_facility: National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0904)

location_facility: Institut de Cancerologie Gustave Roussy ( Site 0305)

location_facility: St Joseph Heritage Healthcare ( Site 1403)

location_facility: Hospital Universitario Virgen Macarena ( Site 1103)

location_facility: Institut du Cancer de Montpellier ( Site 0300)

location_facility: Blacktown Hospital Western Sydney Local Health District ( Site 0204)

location_facility: LungenClinic Grosshansdorf GmbH ( Site 0408)

location_facility: UMass Memorial Medical Center ( Site 1417)

location_facility: Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0404)

location_facility: Katholisches Marienkrankenhaus gGmbH ( Site 0411)

location_facility: Southampton General Hospital ( Site 1204)

location_facility: Hospital Clinic de Barcelona ( Site 1100)

location_facility: Southern Medical Day Care Centre ( Site 0201)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0800)

location_facility: Leeds Teaching Hospitals NHS Trust ( Site 1209)

location_facility: Universitatsklinikum Mannheim GmbH ( Site 0413)

location_facility: Blokhin National Medical Oncology ( Site 0902)

location_facility: Chungbuk National University Hospital ( Site 1003)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0910)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 1422)

location_facility: North Shore University Health System ( Site 1413)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0811)

location_facility: St. Francis Cancer Treatment Center ( Site 1421)

location_facility: Szpital Wojewodzki w Koszalinie im. Mikolaja Kopernika ( Site 0813)

location_facility: Hospital Universitari Vall d Hebron ( Site 1101)

location_facility: Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 0812)

location_facility: MNCCI Port Macquarie Base Hospital ( Site 0200)

location_facility: Charite Universitaetsmedizin Berlin - Campus-Virchow-Klinikum ( Site 0414)

location_facility: C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 0302)

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 0903)

location_facility: Sanford Cancer Center Oncology Clinic ( Site 1434)


ReferenceType: derived

ReferenceCitation: Chung HC, Bang YJ, S Fuchs C, Qin SK, Satoh T, Shitara K, Tabernero J, Van Cutsem E, Alsina M, Cao ZA, Lu J, Bhagia P, Shih CS, Janjigian YY. First-line pembrolizumab/placebo plus trastuzumab and chemotherapy in HER2-positive advanced gastric cancer: KEYNOTE-811. Future Oncol. 2021 Feb;17(5):491-501. doi: 10.2217/fon-2020-0737. Epub 2020 Nov 10.

name: Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, 03722, South Korea

family: Chung

full_name: Hyun Cheol Chung

given: Hyun Cheol

sequence: first

name: Seoul National University College of Medicine, Seoul, 03080, South Korea

family: Bang

full_name: Yung-Jue Bang

given: Yung-Jue

sequence: additional

name: Yale Cancer Center, Smilow Cancer Hospital, New Haven, CT 06510, USA

family: S Fuchs

full_name: Charles S Fuchs

given: Charles

name: Cancer Center of People's Liberation Army, Nanjing, 210002, China

family: Qin

full_name: Shu-Kui Qin

given: Shu-Kui

name: Osaka University, Suita, Osaka, 565-0871, Japan

family: Satoh

full_name: Taroh Satoh

given: Taroh

name: National Cancer Center Hospital East, Kashiwa, 277-8577, Japan

family: Shitara

full_name: Kohei Shitara

given: Kohei

name: Vall d'Hebron University Hospital & Institute of Oncology, Barcelona, 08035, Spain

family: Tabernero

full_name: Josep Tabernero

given: Josep

name: University Hospitals Gasthuisberg Leuven & KU Leuven, Leuven, 03001, Belgium

family: Van Cutsem

full_name: Eric Van Cutsem

given: Eric

family: Alsina

full_name: Maria Alsina

given: Maria

name: Department of Medical Oncology, Merck & Co., Inc., Kenilworth, NJ 07033, USA

family: Cao

full_name: Zhu Alexander Cao

given: Zhu Alexander

family: Lu

full_name: Jia Lu

given: Jia

family: Bhagia

full_name: Pooja Bhagia

given: Pooja

family: Shih

full_name: Chie-Schin Shih

given: Chie-Schin

name: Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA

family: Janjigian

full_name: Yelena Y Janjigian

given: Yelena Y

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Future Oncology

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: Yonsei University Medical Library - YUHSpace

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
LIRIAS (KU Leuven)
PubMed Central
ir.ymlib.yonsei.ac.kr

repositories_institution: Yonsei University Medical Library - YUHSpace

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

design_allocation: Randomized

intervention_type: Drug

status: Active, not recruiting

study_start_date_type: Actual

study_type: Interventional

lead_sponsor: Merck Sharp & Dohme Corp.

enrollment_type: Anticipated

primary_purpose: Treatment

location_country:
Italy
Brazil
Chile
Guatemala
Spain
Germany
France
Japan
Poland
Israel
Ireland
Australia
Russian Federation
New Zealand
China
Turkey
United States
United Kingdom
Korea, Republic of
Ukraine

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1807)

location_facility: Hospital General Universitario de Elche ( Site 1404)

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 2606)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0301)

location_facility: Universitaetsklinikum Carl Gustav Carus der Technischen Univ ( Site 1001)

location_facility: The First Affiliated Hospital of Xiamen University ( Site 2431)

location_facility: Universitaetsklinikum Leipzig AOeR ( Site 1007)

location_facility: Hospital de Caridade de Ijui ( Site 0202)

location_facility: Fujian Provincial Cancer Hospital ( Site 2418)

location_facility: IBCC - Instituto Brasileiro de Controle do Cancer ( Site 0204)

location_facility: University of Miami Sylvester Comprehensive Cancer Center - Plantation ( Site 0026)

location_facility: Royal Marsden NHS Foundation Trust ( Site 1512)

location_facility: Trakya Universitesi Tip Fakultesi ( Site 2015)

location_facility: Manor Hospital Walsall England ( Site 1515)

location_facility: Centro Regional de Sub Especialidades Medicas SA ( Site 0502)

location_facility: Kumamoto University Hospital ( Site 2601)

location_facility: St Petersburg City Clinical Oncology Dispensary ( Site 1812)

location_facility: Beth Israel Deaconess Medical Center ( Site 0070)

location_facility: Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0902)

location_facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 2112)

location_facility: Medical Center Asklepion LLC ( Site 2115)

location_facility: Hospital Nossa Senhora da Conceicao ( Site 0203)

location_facility: Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 8000)

location_facility: Malatya Inonu Universitesi Tip Fakultesi Hastanesi ( Site 2009)

location_facility: The First Hospital Of Jilin University ( Site 2402)

location_facility: The Cancer Institute Hospital of JFCR ( Site 2610)

location_facility: Osaka General Medical Center ( Site 2624)

location_facility: IEO Istituto Europeo di Oncologia ( Site 1105)

location_facility: Medical Centre LLC Oncolife ( Site 2103)

location_facility: Blokhin National Medical Oncology ( Site 1805)

location_facility: Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 2012)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1801)

location_facility: Fudan University Shanghai Cancer Center ( Site 2424)

location_facility: Southeastern Regional Medical Center, Inc. ( Site 0058)

location_facility: UC Irvine Medical Center/Chao Family Comprehensive Cancer Center ( Site 0050)

location_facility: A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1103)

location_facility: Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi ( Site 2006)

location_facility: Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 1708)

location_facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0201)

location_facility: Hiroshima City Hiroshima Citizens Hospital ( Site 2625)

location_facility: Clinic of National Cancer Institute ( Site 2104)

location_facility: Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2106)

location_facility: National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 26

location_facility: Leningrad Regional Oncology Center ( Site 1800)

location_facility: CEPON - Centro de Pesquisas Oncologicas ( Site 0200)

location_facility: Seattle Cancer Care Alliance ( Site 0038)

location_facility: Ninewells Hospital and Medical School ( Site 1504)

location_facility: St Georges University Hospitals NHS Foundation Trust. ( Site 1500)

location_facility: Seoul National University Hospital ( Site 2703)

location_facility: City Clinical Hosp.4 of DCC ( Site 2102)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0302)

location_facility: Soroka University Medical Center ( Site 1603)

location_facility: Severance Hospital Yonsei University Health System ( Site 2700)

location_facility: Hospital Universitario Quiron Madrid ( Site 1407)

location_facility: Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum ( Site 1026)

location_facility: Kobe City Medical Center General Hospital ( Site 2614)

location_facility: Minnesota Oncology Hematology, PA ( Site 8001)

location_facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0045)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 2105)

location_facility: Instituto Nacional del Cancer ( Site 0303)

location_facility: Universita Magna Graecia di Catanzaro ( Site 1107)

location_facility: Harbin Medical University Cancer Hospital ( Site 2407)

location_facility: Dana-Farber Cancer Institute [Boston, MA] ( Site 0010)

location_facility: Midwestern Regional Medical Center, Inc. ( Site 0059)

location_facility: Dolnoslaskie Centrum Onkologii. ( Site 1712)

location_facility: Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0071)

location_facility: Zhongshan Hospital affiliated to Fudan University ( Site 2401)

location_facility: Instituto do Cancer do Ceara ( Site 0208)

location_facility: Ospedale Civile Spirito Santo ( Site 1104)

location_facility: Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1715)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 2615)

location_facility: University of Texas MD Anderson Cancer Center ( Site 0001)

location_facility: Klinikum rechts der Isar der Technischen Universitaet ( Site 1027)

location_facility: Niigata Cancer Center Hospital ( Site 2622)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 2609)

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2017)

location_facility: University College London Hospital NHS Foundation Trust ( Site 1508)

location_facility: Peking Union Medical College Hospital ( Site 2419)

location_facility: National Cancer Center Hospital East ( Site 2605)

location_facility: Hospital Universitario Marques de Valdecilla ( Site 1405)

location_facility: Tallaght University Hospital ( Site 1513)

location_facility: Memorial Sloan-Kettering Cancer Center ( Site 0017)

location_facility: Innere Medizin I, Universitaetsklinikum Tuebingen ( Site 1020)

location_facility: MI Odessa Regional Oncological Centre ( Site 2108)

location_facility: Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 2000)

location_facility: Kyiv City Clinical Oncology Centre ( Site 2110)

location_facility: Kansai Medical University Hospital ( Site 2618)

location_facility: C.H.R.U. de Brest - Hopital Morvan ( Site 0913)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 2607)

location_facility: Gunma Prefectural Cancer Center ( Site 2602)

location_facility: Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0025)

location_facility: Hospital Universitario Ramon y Cajal ( Site 1400)

location_facility: Xiangya Hospital Central-South University ( Site 2426)

location_facility: MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2101)

location_facility: Ibaraki Prefectural Central Hospital ( Site 2611)

location_facility: The First Affiliated Hospital.Zhejiang University ( Site 2408)

location_facility: Southern Medical Day Care Centre ( Site 2207)

location_facility: Fifth Medical Center of CPLA General Hospital ( Site 2415)

location_facility: Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2114)

location_facility: Medizinische Hochschule Hannover ( Site 1019)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

location_facility: Aichi Cancer Center Hospital ( Site 2617)

location_facility: Hopital Jean Minjoz Besancon ( Site 0901)

location_facility: Osaka International Cancer Institute ( Site 2613)

location_facility: Hadassah Ein Kerem Medical Center ( Site 1604)

location_facility: Uniwersytecki Szpital Kliniczny im. J. M. Radeckiego we Wroclawiu ( Site 1705)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2001)

location_facility: Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1410)

location_facility: Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2011)

location_facility: National Cancer Center Hospital ( Site 2612)

location_facility: Clinica Universidad Catolica del Maule ( Site 0305)

location_facility: Hospital Universitario Central de Asturias ( Site 1402)

location_facility: Hospital General Universitari Vall d Hebron ( Site 1401)

location_facility: Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1815)

location_facility: Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1710)

location_facility: Azienda Ospedaliero - Universitaria Policlinico di Modena ( Site 1102)

location_facility: Podolsky City Clinical Hospital ( Site 1817)

location_facility: Washington University School of Medicine ( Site 0040)

location_facility: The Christie Hospital NHS Foundation Trust ( Site 1503)

location_facility: Chaim Sheba Medical Center. ( Site 1607)

location_facility: CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0205)

location_facility: Centro Investigación del Cáncer James Lind ( Site 0300)

location_facility: Edith Wolfson Medical Center ( Site 1605)

location_facility: Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 0065)

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 1709)

location_facility: Sanford Hematology Oncology-Sioux Falls SD ( Site 0004)

location_facility: Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2430)

ipd_sharing: Yes

study_completion_date_type: Anticipated

title: A Phase III, Randomized, Double-blind Trial Comparing Trastuzumab Plus Chemotherapy and Pembrolizumab With Trastuzumab Plus Chemotherapy and Placebo as First-line Treatment in Participants With HER2 Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (KEYNOTE 811)

summary: The study will compare the efficacy and safety of pembrolizumab plus trastuzumab in combination with standard of care (SOC) chemotherapy versus trastuzumab in combination with SOC chemotherapy in participants with HER2-positive gastric cancer. The primary hypotheses of the study are that pembrolizumab plus trastuzumab in combination with chemotherapy is superior to trastuzumab plus chemotherapy in terms of 1) progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), and 2) overall survival (OS).


status: Terminated

lead_sponsor: Sanofi

enrollment_type: Actual

location_country:
Italy
United States
Switzerland
Netherlands
Spain
Germany
France
Japan
Israel
Hungary
Belgium
Argentina
Australia
Russian Federation
Estonia
Canada
United Kingdom

location_facility:
Investigational Site Number 5280008
Investigational Site Number 3800001
Investigational Site Number 3800005
Investigational Site Number 8400003
Investigational Site Number 2760004
Investigational Site Number 3800003
Investigational Site Number 1240001
Investigational Site Number 8260002
Investigational Site Number 3920003
Investigational Site Number 8260007
Investigational Site Number 8400009
Investigational Site Number 6430004
Investigational Site Number 2500002
Investigational Site Number 2760007
Investigational Site Number 8400022
Investigational Site Number 0360003
Investigational Site Number 2760003
Investigational Site Number 3920001
Investigational Site Number 5280004
Investigational Site Number 8260003
Investigational Site Number 7240002
Investigational Site Number 2760009
Investigational Site Number 2500003
Investigational Site Number 3760004
Investigational Site Number 6430008
Investigational Site Number 8260004
Investigational Site Number 2500014
Investigational Site Number 7560001
Investigational Site Number 3800004
Investigational Site Number 0560003
Investigational Site Number 2500015
Investigational Site Number 2760001
Investigational Site Number 3760001
Investigational Site Number 3800002
Investigational Site Number 6430003
Investigational Site Number 3920005
Investigational Site Number 6430001
Investigational Site Number 5280007
Investigational Site Number 7240008
Investigational Site Number 5280005
Investigational Site Number 7560002
Investigational Site Number 2500011
Investigational Site Number 1240007
Investigational Site Number 0360001
Investigational Site Number 2500004
Investigational Site Number 2760002
Investigational Site Number 7240005
Investigational Site Number 7240007
Investigational Site Number 0560001
Investigational Site Number 8400006
Investigational Site Number 3480001
Investigational Site Number 5280002
Investigational Site Number 8400025
Investigational Site Number 2760008
Investigational Site Number 3920002
Investigational Site Number 7240004
Investigational Site Number 0320001
Investigational Site Number 0360004
Investigational Site Number 0320005
Investigational Site Number 2500010
Investigational Site Number 8400002
Investigational Site Number 3800008
Investigational Site Number 0320003
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Investigational Site Number 2500016
Investigational Site Number 1240010
Investigational Site Number 1240003
Investigational Site Number 7240001
Investigational Site Number 8260001
Investigational Site Number 3760002
Investigational Site Number 8400015
Investigational Site Number 8400011
Investigational Site Number 6430002
Investigational Site Number 0320002
Investigational Site Number 2330001
Investigational Site Number 3760005
Investigational Site Number 3760003
Investigational Site Number 8400005
Investigational Site Number 8400014
Investigational Site Number 1240005
Investigational Site Number 8260009
Investigational Site Number 5280003
Investigational Site Number 0360002
Investigational Site Number 2500005

ipd_sharing: No

study_completion_date_type: Actual

type: EudraCT Number

type: Other Identifier

source: euctr

title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica

summary:
Primary Objective:

To evaluate the efficacy of KEVZARA (sarilumab) in patients with polymyalgia rheumatica (PMR) as assessed by the proportion of subjects with sustained remission for sarilumab with a shorter corticosteroid (CS) tapering regimen as compared to placebo with a longer CS tapering regimen.

Secondary Objectives:

To demonstrate the efficacy of sarilumab in patients with polymyalgia rheumatica compared to placebo, in combination with a CS taper with regards to:
Clinical responses (such as components of sustained remission, disease remission rates, time to first disease flare) over time.
Cumulative CS (including prednisone) exposure.
To assess the safety (including immunogenicity) and tolerability of sarilumab in patients with PMR.
To measure sarilumab serum concentrations in patients with PMR.
To assess the effect of sarilumab in reducing glucocorticoid toxicity as measured by the composite glucocorticoid toxicity index (GTI) questionnaire.

lead_sponsor_type: industriel

status_simplified: Unknown


location_country:
Finland
Australia
Belgium
Russian Federation
Denmark
Croatia
France
Argentina
Canada
Slovenia
Sweden
Switzerland
Netherlands
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Israel
Spain
Estonia

location_facility:
Investigational Site Number 5280008
Investigational Site Number 3800009
Investigational Site Number 2460001
Investigational Site Number 7240013
Investigational Site Number 2760003
Investigational Site Number 7240016
Investigational Site Number 8260006
Investigational Site Number 2460002
Investigational Site Number 3800006
Investigational Site Number 2500008
Investigational Site Number 7050001
Investigational Site Number 3800004
Investigational Site Number 5280005
Investigational Site Number 1910001
Investigational Site Number 2500004
Investigational Site Number 3480001
Investigational Site Number 0560005
Investigational Site Number 0360006
Investigational Site Number 8400029
Investigational Site Number 6200002
Investigational Site Number 7240015
Investigational Site Number 8260001
Investigational Site Number 7240011
Investigational Site Number 2500007
Investigational Site Number 0320002
Investigational Site Number 3760003
Investigational Site Number 8400014
Investigational Site Number 8400028
Investigational Site Number 8400007
Investigational Site Number 8400012
Investigational Site Number 3800001
Investigational Site Number 3800005
Investigational Site Number 3800003
Investigational Site Number 6430004
Investigational Site Number 8400022
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Investigational Site Number 2500003
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Investigational Site Number 6430005
Investigational Site Number 2330001
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Investigational Site Number 2500005
Investigational Site Number 3760007
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Investigational Site Number 2760004
Investigational Site Number 0360007
Investigational Site Number 2760007
Investigational Site Number 8400024
Investigational Site Number 3760004
Investigational Site Number 0400001
Investigational Site Number 5280001
Investigational Site Number 6200003
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Investigational Site Number 6430003
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Investigational Site Number 1240007
Investigational Site Number 2760002
Investigational Site Number 6430006
Investigational Site Number 8400006
Investigational Site Number 0320001
Investigational Site Number 0360005
Investigational Site Number 8260008
Investigational Site Number 1240003
Investigational Site Number 8260011
Investigational Site Number 8400011
Investigational Site Number 6430002
Investigational Site Number 8400005
Investigational Site Number 8400027
Investigational Site Number 1240001
Investigational Site Number 0400002
Investigational Site Number 2500002
Investigational Site Number 6200004
Investigational Site Number 0360003
Investigational Site Number 7240014
Investigational Site Number 8260003
Investigational Site Number 6200001
Investigational Site Number 8260004
Investigational Site Number 2080003
Investigational Site Number 6430001
Investigational Site Number 8400020
Investigational Site Number 6200005
Investigational Site Number 2500001
Investigational Site Number 7560002
Investigational Site Number 8260005
Investigational Site Number 0560001
Investigational Site Number 7240009
Investigational Site Number 2500009
Investigational Site Number 8400025
Investigational Site Number 7240010
Investigational Site Number 2080002
Investigational Site Number 3760006
Investigational Site Number 8400017
Investigational Site Number 3760002
Investigational Site Number 3760005
Investigational Site Number 1240005
Investigational Site Number 0360002

title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sarilumab in Patients With Giant Cell Arteritis

summary:
Primary Objective:

To evaluate the efficacy of sarilumab in patients with giant cell arteritis (GCA) as assessed by the proportion of patients with sustained remission for sarilumab compared to placebo, in combination with a corticosteroid (CS) tapering course.

Secondary Objective:

To demonstrate the efficacy of sarilumab in patients with GCA compared to placebo, in combination with CS taper with regards to:
Clinical responses (such as responses based on disease remission rates, time to first disease flare) over time.
Cumulative CS (including prednisone) exposure.
To assess the safety (including immunogenicity) and tolerability of sarilumab in patients with GCA.
To measure sarilumab serum concentrations in patients with GCA.
To assess the effect of sarilumab on sparing glucocorticoid toxicity as measured by glucocorticoid toxicity index (GTI).


title: PONENTE: A Multicenter, Open-label, Phase 3b Efficacy and Safety Study of Benralizumab 30 mg Administered Subcutaneously to Reduce Oral Corticosteroid Use in Adult Patients With Severe Eosinophilic Asthma on High Dose Inhaled Corticosteroid Plus Long-acting β2 Agonist and Chronic Oral Corticosteroid Therapy

acronym: PONENTE

summary: This is a study designed to evaluate efficacy and safety of Benralizumab in reducing the Oral Corticosteroid (OCS) use in adult patients with severe asthma who are receiving OCS with or without additional asthma controller medications.

ReferenceCitation: Menzies-Gow A, Gurnell M, Heaney LG, Corren J, Bel EH, Maspero J, Harrison T, Jackson DJ, Price D, Lugogo N, Kreindler J, Burden A, de Giorgio-Miller A, Padilla K, Martin UJ, Garcia Gil E. Oral corticosteroid elimination via a personalised reduction algorithm in adults with severe, eosinophilic asthma treated with benralizumab (PONENTE): a multicentre, open-label, single-arm study. Lancet Respir Med. 2021 Oct 4. pii: S2213-2600(21)00352-0. doi: 10.1016/S2213-2600(21)00352-0. [Epub ahead of print] Erratum in: Lancet Respir Med. 2021 Oct 22;:.

family: Menzies-Gow

full_name: Andrew Menzies-Gow

given: Andrew

family: Gurnell

full_name: Mark Gurnell

given: Mark

family: Heaney

full_name: Liam G Heaney

given: Liam G

family: Corren

full_name: Jonathan Corren

given: Jonathan

family: Bel

full_name: Elisabeth H Bel

given: Elisabeth H

family: Maspero

full_name: Jorge Maspero

given: Jorge

family: Harrison

full_name: Timothy Harrison

given: Timothy

family: Jackson

full_name: David J Jackson

given: David J

family: Price

full_name: David Price

given: David

family: Lugogo

full_name: Njira Lugogo

given: Njira

family: Kreindler

full_name: James Kreindler

given: James

family: Burden

full_name: Annie Burden

given: Annie

family: de Giorgio-Miller

full_name: Alex de Giorgio-Miller

given: Alex

family: Padilla

full_name: Kelly Padilla

given: Kelly

family: Martin

full_name: Ubaldo J Martin

given: Ubaldo J

family: Garcia Gil

full_name: Esther Garcia Gil

given: Esther

journal_name: The Lancet Respiratory Medicine

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Menzies-Gow A, Corren J, Bel EH, Maspero J, Heaney LG, Gurnell M, Wessman P, Martin UJ, Siddiqui S, Garcia Gil E. Corticosteroid tapering with benralizumab treatment for eosinophilic asthma: PONENTE Trial. ERJ Open Res. 2019 Sep 25;5(3). pii: 00009-2019. doi: 10.1183/23120541.00009-2019. eCollection 2019 Jul.

apc_source: doaj

full_name: Elisabeth H. Bel

given: Elisabeth H.

repository_institution: Queen's University Belfast - Research Portal

evidence: oa repository (via OAI-PMH title and first author match)

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

location_country:
Italy
United States
Brazil
Sweden
Mexico
Germany
France
Poland
Belgium
Argentina
Russian Federation
Spain
Denmark
Canada
United Kingdom
Taiwan
Colombia


location_country:
Italy
Brazil
United States
Sweden
Hong Kong
Mexico
Spain
Germany
France
Japan
Israel
Australia
China
Canada
United Kingdom
Korea, Republic of
Taiwan

acronym: Pemetrexed+Platinum Chemotherapy with/ without MK-3475 in TKI-resistant EGFR-mutated Tumors in NSCLC

location_facility: Kaiser Permanente Northwest ( Site 0037)

location_facility: White Plains Hospital Center for Cancer Care ( Site 0014)

location_facility: Froedtert Hospital & the Medical College of Wisconsin ( Site 0041)

location_facility: Florence Nightingale Krankenhaus ( Site 0912)

location_facility: Kanazawa University Hospital ( Site 0617)

location_facility: Memorial Sloan Kettering Cancer Center-Rockerfeller Patient Pavilion ( Site 0049)

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 1911)

location_facility: Barking Havering and Redbridge University Hospitals NHS Trust Queen s Hospital ( Site 1004)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 1903)

location_facility: Osaka International Cancer Institute ( Site 0611)

location_facility: Hopital Jean Minjoz Besancon ( Site 0805)

location_facility: Chungbuk National University Hospital ( Site 0404)

location_facility: Birmingham Heartlands Hospital ( Site 1002)

location_facility: Taipei Medical University Shuang Ho Hospital ( Site 0508)

location_facility: Gachon University Gil Medical Center ( Site 0408)

location_facility: Istituto Europeo di Oncologia ( Site 1303)

location_facility: Centre Georges Francois Leclerc ( Site 0809)

location_facility: National Hospital Organization Nagoya Medical Center ( Site 0608)

location_facility: Hospitalo Univ. Germans Trias i Pujol ( Site 1100)

location_facility: St. Joseph Heritage Healthcare ( Site 0003)

location_facility: Medizinische Fakultaet Carl Gustav Carus der TU Dresden ( Site 0907)

location_facility: Hong Kong Integrated Oncology Centre ( Site 0304)

location_facility: Complejo Hospitalario Carlos Haya de Malaga ( Site 1107)

location_facility: Providence Portland Medical Center ( Site 0097)

location_facility: Oaxaca Site Management Organization SC ( Site 2001)

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 0618)

location_facility: Universita Campus Bio-Medico di Roma ( Site 1304)

location_facility: Hospital Universitario 12 de Octubre ( Site 1103)

location_facility: University of Texas Southwestern Medical Center at Dallas ( Site 0035)

location_facility: National Cancer Center Hospital ( Site 0603)

location_facility: Ospedale San Vincenzo di Taormina ( Site 1302)

location_facility: Kansai Medical University Hospital ( Site 0606)

location_facility: Hospital Universitari Vall d Hebron ( Site 1106)

location_facility: Xiangya Hospital of Central South University ( Site 0710)

location_facility: Centre D Oncologie de Gentilly ( Site 0810)

location_facility: Emily Couric Clinical Cancer Center ( Site 0020)

location_facility: Taichung Veterans General Hospital ( Site 0504)

location_facility: C.H.U. de Tours - Hopital Bretonneau ( Site 0806)

location_facility: UC Irvine Medical Center/Chao Family Comprehensive Cancer Center ( Site 0092)

location_facility: Robert Bosch Krankenhaus Klinik Schillerhoehe ( Site 0904)

location_facility: Changhua Christian Hospital ( Site 0509)

location_facility: St James s University Hospital ( Site 1008)

location_facility: Princess Margaret Cancer Centre ( Site 0104)

location_facility: Kaohsiung Chang Gung Memorial Hospital ( Site 0507)

location_facility: Hong Kong United Oncology Centre ( Site 0306)

location_facility: North Shore University Health System ( Site 0030)

location_facility: The First Affiliated Hospital of Anhui Medical University ( Site 0721)

location_facility: Taipei Veterans General Hospital ( Site 0501)

location_facility: Cedars-Sinai Medical Center ( Site 0070)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 0502)

location_facility: Hospital de Clinicas de Porto Alegre ( Site 1905)

location_facility: Hospital de la Santa Creu i Sant Pau ( Site 1102)

location_facility: Instituto Jaliscience de Cancerologia ( Site 2000)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 0616)

location_facility: Sahlgrenska Universitetssjukhuset ( Site 1502)

location_facility: Linkopings Universitetssjukhus ( Site 1504)

location_facility: Siouxland Regioinal Cancer Center dba June E. Nylen Cancer Center ( Site 0065)

location_facility: Instituto Nacional de Cancerologia. ( Site 2007)

location_facility: Sunnybrook Health Sciences, Odette Cancer Centre ( Site 0102)

location_facility: Klinikum Wuerzburg Mitte gGmbH ( Site 0901)

location_facility: Sir Run Run Shaw Hospital School of Medicine, Zhejiang University ( Site 0715)

location_facility: IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 1305)

location_facility: Okayama University Hospital ( Site 0614)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 0602)

location_facility: New York Oncology Hematology P.C ( Site 8000)

location_facility: Seoul National University Hospital ( Site 0402)

location_facility: Aichi Cancer Center Hospital ( Site 0612)

location_facility: AOU San Luigi Gonzaga di Orbassano ( Site 1300)

location_facility: Azienda Ospedaliero Universitaria Careggi ( Site 1301)

location_facility: University College London Hospitals NHS Foundation Trust ( Site 1006)

location_facility: Universitaetsklinikum Muenster ( Site 0906)

location_facility: Saint Lukes Hospital of Kansas City ( Site 0060)

location_facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 0717)

location_facility: Sussex University Hospitals ( Site 1003)

location_facility: Karolinska Universitetssjukhuset Solna ( Site 1500)

location_facility: The First Affiliated Hospital.Zhejiang University ( Site 0713)

location_facility: Southdale Cancer Care, University of Minnesota Medical Center- Edina ( Site 0048)

location_facility: Chelsea & Westminster Hospital ( Site 1001)

location_facility: Universitaetsklinikum Mannheim ( Site 0911)

location_facility: National Cheng Kung University Hospital ( Site 0506)

location_facility: The Affiliated Tumour Hospital of Harbin Medical University ( Site 0706)

location_facility: Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0701)

location_facility: Hosp. Clinicas da Fac. de Medicina de Ribeirao Preto - USP ( Site 1912)

location_facility: William Osler Health System ( Site 0100)

location_facility: National Cancer Center Hospital East ( Site 0601)

location_facility: Seoul National University Bundang Hospital ( Site 0405)

location_facility: Hualien Tzu Chi Medical Center-Hospital ( Site 0510)

location_facility: Zhongshan Hospital Fudan University ( Site 0712)

location_facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 0709)

location_facility: Liga Norte Riograndense Contra o Cancer ( Site 1909)

location_facility: Peking Union Medical College Hospital ( Site 0703)

location_facility: National Taiwan University Hospital ( Site 0500)

location_facility: National Taiwan University Hospital Hsin-Chu Branch ( Site 0511)

location_facility: Hospital Universitario Virgen Macarena ( Site 1104)

location_facility: CHU Caen Service de Pneumologie ( Site 0804)

location_facility: Skanes Universitetssjukhus Lund ( Site 1503)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 0621)

location_facility: The First Hospital of Jilin University ( Site 0702)

location_facility: China Medical University Hospital ( Site 0505)

location_facility: Southwest Hospital, The Third Military Medical University ( Site 0725)

location_facility: Wakayama Medical University Hospital ( Site 0613)

location_facility: Azienda Ospedaliera dei Colli V. Monaldi ( Site 1306)

location_facility: Fujita Health University Hospital ( Site 0619)

location_facility: The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0406)

location_facility: Chaim Sheba Medical Center. ( Site 1700)

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1904)

location_facility: Parkland Health & Hospital System ( Site 2102)

location_facility: Niigata Cancer Center Hospital ( Site 0610)

location_facility: Hospital de Caridade de Ijui ( Site 1907)

type: Registry Identifier

title: A Randomized, Double-Blind, Phase 3 Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in TKI-resistant EGFR-mutated Tumors in Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) Participants (KEYNOTE-789)

summary:
The purpose of this study is to evaluate the efficacy and safety of pemetrexed plus platinum chemotherapy (carboplatin or cisplatin) with or without pembrolizumab (MK-3475; KEYTRUDA®) in the treatment of adults with the following types of tyrosine kinase inhibitor (TKI)-resistant, epidermal growth factor receptor (EGFR)-mutated, metastatic non-squamous non-small cell lung cancer (NSCLC) tumors: 1) TKI-failures (including osimertinib [TAGRISSO®] failure) with T790M-negative mutation tumors, 2) T790M-positive mutation tumors with prior exposure to osimertinib, and 3) first-line osimertinib failure regardless of T790M mutation status.

The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy has superior efficacy compared to saline placebo plus chemotherapy in terms of: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review, and 2) Overall Survival (OS). This study will be considered to have met its success criteria if the combination of pembrolizumab plus chemotherapy is superior to saline placebo plus chemotherapy in terms of PFS or OS.

status_simplified: Ongoing


ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Austria
Brazil
Switzerland
Spain
Germany
France
Bulgaria
Czechia
Israel
Japan
Norway
Poland
Argentina
Australia
Belgium
Portugal
Turkey
United States
Taiwan

location_facility:
Oregon Health and Science University
University of Chicago Medical Center
Novartis Investigative Site
Dana Farber Cancer Institute

title: A Phase III, Randomized, Double-blind Study of Chemotherapy With Daunorubicin or Idarubicin and Cytarabine for Induction and Intermediate Dose Cytarabine for Consolidation Plus Midostaurin (PKC412) or Chemotherapy Plus Placebo in Newly Diagnosed Patients With FLT-3 Mutation Negative Acute Myeloid Leukemia (AML)

summary:
The purpose of this study is to confirm the preliminary evidence from early clinical trials that midostaurin may provide clinical benefit not only to AML patients with the FLT3-mutations but also in FLT3-MN (SR<0.05) AML (FLT3 mutant to wild type signal ratio below the 0.05 clinical cut-off).

This study will evaluate the efficacy and safety of midostaurin in combination with daunorubicin or idarubicin and cytarabine for induction and intermediate-dose cytarabine for consolidation, and midostaurin single agent post-consolidation therapy in newly diagnosed patients with FLT3-MN (SR<0.05) AML.


title: Phase III Multicenter Open-Label Randomized Trial to Evaluate Efficacy and Safety of CPI-613® (Devimistat) in Combination With High Dose Cytarabine and Mitoxantrone (CHAM) Compared to High Dose Cytarabine and Mitoxantrone (HAM) Therapy and Control Sub-groups: Combination of Mitoxantrone, Etoposide and Cytarabine (MEC) and Combination of Fludarabine, Cytarabine, and Filgrastim (FLAG) in Older Patients (≥ 50 Years) With Relapsed/Refractory Acute Myeloid Leukemia (AML)

summary: A Phase III study to evaluate the safety and efficacy of CPI-613® (devimistat) in combination with High Dose Cytarabine and Mitoxantrone in comparison with high dose Cytarabine and Mitoxantrone and control sub-groups: combination of Mitoxantrone, Etoposide and Cytarabine (MEC) and combination of Fludarabine, Cytarabine, and Filgrastim (FLAG) in older patients with relapsed/refractory Acute Myeloid Leukemia. CPI-613® (devimistat) targets the altered energy metabolism and processes for production of ATP and essential bio-intermediates unique to and characteristic of most cancer cell types. The addition of CPI-613® (devimistat) to high dose cytarabine and mitoxantrone (CHAM) will improve the complete remission (CR) rate in patients 50 years or older with relapsed or refractory AML when compared to HAM alone or other control sub groups.

ipd_sharing: Undecided

lead_sponsor: Rafael Pharmaceuticals Inc.

location_country:
Austria
Germany
France
Poland
Australia
Belgium
Spain
United States
Korea, Republic of

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: University of Iowa-Holden Cancer Care Center

location_facility: Institut Catala d'Oncologia (ICO) - Hospital Universitari Germans Trias i Pujol

location_facility: Centre Hospitalier Universitaire Grenoble Hopital Michalon

location_facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center

location_facility: University of Texas - Southwestern Medical Center

location_facility: Centre Hospitalier de Versailles - Hôpital André Mignot

location_facility: Service d'Hématologie Clinique, Hôpital Avicenne-APHP-Université Paris

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: Uniwersyteckie Centrum Kliniczne Klinika Hematologii i Transplantologii

location_facility: Chao Family Comprehensive Cancer Center (University of California Irvine)


title: A Randomized, Open-label, Phase 3 Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Subjects With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL).

summary: The purpose of this study is to assess progression-free survival (PFS) from treatment with ibrutinib plus venetoclax (I+VEN) compared with obinutuzumab plus chlorambucil (G-Clb) as assessed by an Independent Review Committee (IRC).

lead_sponsor: Janssen Research & Development, LLC

location_country:
United States
Sweden
Netherlands
France
Czechia
Poland
Israel
Belgium
Russian Federation
Spain
Turkey
Denmark
Canada
United Kingdom

location_facility: Barking Havering and Redbridge University Hospitals NHS Trust

location_facility: Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie

location_facility: Centre Hospitalier Universitaire de Reims, Hôpital Robert Debré

location_facility: St.-Petersburg Clinical Research Institute of Hematology and Transfusiology

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

location_facility: Nizhniy Novgorod Region Clinical Hospital

location_facility: Ankara Universitesi Tip Fakültesi Ibn-i Sina Hastanesi

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

location_facility: Hospital Clinico Universitario Salamanca

location_facility: CIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-Rosemont

location_facility: S.P. Botkin Moscow City Clinical Hospital

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

location_facility: Hopital Haut Leveque Service Maladie Du Sang

location_facility: FSBIFederal Centre of Heart, Blood and Endocrinology named after V.A.Almazov MoH of the RF

location_facility: Karolinska Universitetssjukhuset Solna, Centrum för Hematologi, Stockholm

location_facility: Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni

location_facility: Rigshospitalet Copenhagen University Hospital

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka,


title: A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With Completely Resected Stage IB (Tumors Equal to or Larger Than 4cm) to Stage IIIA Anaplastic Lymphoma Kinase Positive Non-Small Cell Lung Cancer

summary:
This randomized, active-controlled, multicenter, open-label, Phase III study is designed to investigate the efficacy and safety of alectinib compared with platinum-based in the adjuvant setting. Participants in the experimental arm will receive alectinib at 600 mg orally twice daily (BID) taken with food for 24 months.

Participants in the control arm will receive one of the protocol specified platinum based chemotherapy regimens for 4 cycles. Following treatment completion, participants will be followed up for their disease until disease recurrence. At the time of disease recurrence, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier.

status: Recruiting

lead_sponsor: Hoffmann-La Roche

location_country:
North Macedonia
Greece
Romania
Australia
Russian Federation
Denmark
Taiwan
Ukraine
Spain
France
Japan
Poland
Thailand
Korea, Republic of
South Africa
Saudi Arabia
Singapore
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Bosnia and Herzegovina
Lebanon
Israel
Belarus
Egypt
Kazakhstan
Turkey
Latvia

location_facility: Chemotherapy SI Dnipropetrovsk MA of MOHU

location_facility: Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology

location_facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

location_facility: Vinnytsia Regional Clinical Oncology Dispensary; Department of Chemotherapy

location_facility: University Clinical Center Tuzla; Clinic for Pulmonary Diseases

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc; Oddzial onkologii z pododdzialem chemioterapii

location_facility: Almaty Cancer Hospital; Chemotherapy department

location_facility: A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii

location_facility: Brüderkrankenhaus St. Josef Paderborn, Klinik für Hämatologie/Onkologie

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: Private Health Organization Acibadem Sistina Hospital

location_facility: Sureyyapasa Göğüs Hastalıkları ve Göğüs Cerrahisi Egitim ve Araştırma Hastanesi; Göğüs Hastalıkları

location_facility: PHI University Clinic of Radiotherapy and Oncology; Malignant diseases of thorax

location_facility: Az. Osp. Monaldi; 1 Pneumologia Oncologica

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: Izmir Suat Seren Chest Diseases and Surgery Research Hospital

location_facility: Hetenyi Geza County Hospital; Onkologiai Kozpont

location_facility: Prof Dr I Chiricuta Institute of Oncology; Oncology Department

location_facility: Royal Preston Hospital; Lancashire Clinical Research Facility

location_facility: Hospital Universitario Donostia: Oncology Service

location_facility: Maharaj Nakorn Chiang Mai Hospital; Department of Medicine

location_facility: Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica

location_facility: Scientific Research Oncology Institute named after N.N. Petrov; Oncology

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Hospital Universitari i Politecnic La Fe; Oncologia

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Healthcare Institution "Gomel Regional Clinical Oncologic Dispensary"

location_facility: Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia

location_facility: University Clinical Centre of the Republic of Srpska; Clinic for Pulmonary Diseases

location_facility: Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico

location_facility: P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept

location_facility: University of Pecs; 1St Department of Medicine

location_facility: Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

location_facility: Gdanski Uniwersytet Medyczny; Katedra i Klinika Onkologii i Radioterapii

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Azienda Ospedaliera San Camillo Forlanini - Unità Operativa Complessa di Pneumologia Oncologica 1

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Medical Radiological Research Centre Rams; Dept. of Radiotherapy & Chemotherapy of Hemoblastosis

location_facility: CHUC - Unidade de Pneumologia Oncológica; Hospital de Dia de Oncologia Edificio Sao Jeronimo

location_facility: Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH

location_facility: The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)

location_facility: Clinic of Oncology, University Clinical Center Sarajevo

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Medipol University MF; Oncology Department

location_facility: Institut Gustave Roussy; Pathologie Thoracique

location_facility: Institutul Oncologic Prof. Dr. Alexandru Trestioreanu; Oncologie Medicala II

location_facility: Hopital Bichat Claude Bernard; Oncologie Serv.

location_facility: Cairns Base Hospital; Cancer Care Centre

location_facility: National Cancer Centre; Medical Oncology

location_facility: Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Chonnam National University Hwasun Hospital

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Kazakh Scientific Research Institution Of Oncology and Radiology; Chemotherapy department

location_facility: Municipal Clinical Emergency Hospital Timisoara; Medical Oncology Clinic

location_facility: Kasr Eieny Uni Hospital; Oncology (Nemrock)

location_facility: Hospital Pulido Valente; Servico de Pneumologia

location_facility: FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

location_facility: Dr. Abdurrahman Yurtarslan Oncology Hospital; 2nd Oncology Clinic

location_facility: HM Sanchinarro - CIOCC; Servicio de Oncologia

location_facility: King Faisal Specialist Hospital & Research Centre; Oncology

location_facility: Multidisciplinary medical center; Chemotherapy department

location_facility: National Cancer Institute MOH of Ukraine

location_facility: A.O. Istituti Ospitalieri - Cremona; S.C. Oncologia

location_facility: Minsk City Clinical Oncologic Dispensary

location_facility: American University of Beirut - Medical Center

location_facility: Ege Uni Medical Faculty Hospital; Oncology Dept

location_facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Hôpital d'Instruction des Armées de Sainte Anne; Service de Pneumologie

location_facility: Irccs Ospedale San Raffaele;Oncologia Medica

location_facility: Healthcare Institution Grodno University Hospital; Regional Oncologic Dispensary

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Seoul National University Bundang Hospital

location_facility: The Affiliated Hospital of Xuzhou Medical University

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II; Oddz. Klin. Chir. Klatki Piersiowej i Onkol.

location_facility: First Affiliated Hospital of Soochow University

location_facility: Ufuk University Dr. Rıdvan Ege Health Research and Implementation Hospital; Oncology Departmant

location_facility: National Hospital Organization Himeji Medical Center

location_facility: Dolnoslaskie Centrum Chorob Pluc we Wroclawiu

location_facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University

location_facility: Samodzielny Publiczny Szpital Wojewodzki im. Jana Bozego w Lublinie; Oddzial Chorob Pluc i Gruzlicy

location_facility: State Inst N.N. Alexandrov Republican Scientific & Practical Centre of Oncology & Medical Radiology

location_facility: CHVNG/E_Unidade 1; Servico de Pneumologia

location_facility: Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology

location_facility: Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie

location_facility: National Hospital Organization Yamaguchi - Ube Medical Center

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

location_facility: Vitebsk Regional Clinical Oncology Dispensary

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

location_facility: Sunshine Coast University Hospital; The Adem Crosby Centre

location_facility: Chang Gung Memorial Foundation - Kaohsiung

location_facility: Chang Gung Medical Foundation - Linkou; Chest Dept

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Semmelweis Egyetem, AOK, Pulmonologiai Klinika

location_facility: Azienda Osp. Univ di Modena; Dept Onc & Hem

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología

location_facility: Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica

location_facility: Riga East Clinical University Hospital Latvian Oncology Centre

location_facility: Fujian Medical University Union Hospital

location_facility: General Hospital "G.Papanikolaou"; Pulmonogy Clinic

location_facility: MI of Zaporizhzhia Regional Council Zaporizhzhia Regional Clinical Oncology Dispensary; Thoracic

location_facility: RCI Sumy Regional Clinical Oncological Dispensary

location_facility: Charite - Universitätsmedizin Berlin; Campus Virchow-Klinikum, Med. Klinik m. S. Infekt und Pneumo

location_facility: Ankara Ataturk Chest Diseases Training and Research Hospital


location_country:
Belgium
Australia
Russian Federation
Taiwan
Ukraine
India
France
Japan
Poland
Thailand
Canada
Korea, Republic of
South Africa
Hungary
China
Portugal
United States
Germany
United Kingdom
Italy
Brazil
Spain
Turkey

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale; S.C. Oncol. Medica Testa-Collo e Sarcoma

location_facility: Gustave Roussy Cancer Campus; Radiotherapie

location_facility: Miami Cancer Institute of Baptist Health, Inc.

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter.

location_facility: Hopital Timone Adultes; Oncologie Medicale Et Usp

location_facility: Orszagos Onkologial Intezet; Onkologiai Osztaly X

location_facility: China Medical University Hospital;Oncology and Hematology Office Critical Care Center, 14H

location_facility: Municipal Noncommercial Institution Regional Center of Oncology

location_facility: Taichung Veterans General Hospital; Radiation Oncology

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

location_facility: Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowotworów Głowy i Szyi

location_facility: ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department

location_facility: Tianjin Medical University General Hospital

location_facility: Asst Santi Paolo E Carlo; Unita Operativa Di Oncologia Medica

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy

location_facility: Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia

location_facility: GVI Oncology Outeniqua Unit; GVI Oncology Outeniqua Unit

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet

location_facility: Songklanagarind Hospital; Department of Oncology

location_facility: Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia

location_facility: Lviv State Oncology Regional Treatment and Diagnostic Centre; Department of hemotherapy

location_facility: Klinikum d. Uni. München; Campus Großhadern; Klinik und Poliklinik f. Strahlenthera. und Radioonko

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Winship Cancer Institute of Emory University

location_facility: Dr. Abdurrahman Yurtarslan Oncology Hospital; 2nd Oncology Clinic

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi; Ic Hastaliklari Anabiim Dali

location_facility: Vinnytsya Regional Clinical Oncology Dispensary

location_facility: Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: P.A. Herzen Oncological Inst. ; Oncology

location_facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Universitätsmedizin Rostock, Klinik und Poliklinik für Strahlentherapie; Zentrum für Radiologie

location_facility: University of California San Diego Medical Center; Moores Cancer Center

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Gazi University Medical Faculty, Oncology Hospital

location_facility: Ivano-Frankivsk Regional Oncology Center

location_facility: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: The Oncology Centre; Haematology - Radiation Oncology

location_facility: FSAI Treatment and rehabilitation Centre Ministry of Health; Clinical research and chemotherapy.

location_facility: Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde

location_facility: Tomsk scientific research institute of oncology SO RAMN, PAD; Pathological

location_facility: Cleveland Clinic; Taussig Cancer Institute

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: BHI of Omsk region Clinical Oncology Dispensary

location_facility: First MSMU n.a. Sechenov Univercity Hospital 1; Plastic surgery

location_facility: CENTRE LEON BERARD; Département d'Hématologie et d'Oncologie

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: National Taiwan University Hospital; Oncology

location_facility: Kyiv City Clinical Oncological Center, Day Hospital Department for Oncological patients

location_facility: National Cheng Kung University Hospital; Oncology

location_facility: Division of Hematology and Oncology, Taipei Veterans General Hospital

location_facility: Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia

location_facility: Sverdlovsk Regional Oncology Dispensary; Chemotherapy

location_facility: Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: IPO de Coimbra; Servico de Oncologia Medica

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori;S.S. Trattamento MedicoTumori dellaTesta e delCollo

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: Aberdeen Royal Infirmary; Medical Oncology Dept

location_facility: Main Military Clinical Hospital named after N.N. Burdenko

location_facility: Universitätsklinikum Bonn; Med. Klinik und Poliklinik III; Hämatologie, Onkologie und Rheumatologie

location_facility: Tata Memorial Hospital; Dept of Medical Oncology

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Ospedale Umberto I ASL di Ravenna Presidio Ospedaliero di Lugo

location_facility: Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: Novosibirsk Regional Oncological Dispancer

title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab (Anti-Pd-L1 Antibody) as Adjuvant Therapy After Definitive Local Therapy in Patients With High-Risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck

summary: This study will evaluate the efficacy and safety of atezolizumab compared with placebo as adjuvant therapy after definitive local therapy in patients with high-risk locally advanced squamous cell carcinoma of the head and neck (SCCHN)


title: Randomized, Double-Blind, Placebo-Controlled, Three-Arm, 12-Month, Safety and Efficacy Study of TRx0237 Monotherapy in Subjects With Alzheimer's Disease Followed by a 12-Month Open-Label Treatment

summary: The purpose of this study is to determine the safety and efficacy of TRx0237 16 mg/day and 8 mg/day in the treatment of subjects with Alzheimer's Disease compared to placebo. In addition, an open-label, delayed-start phase is included to demonstrate a disease-modifying effect of TRx0237.

lead_sponsor: TauRx Therapeutics Ltd

location_country:
Italy
United States
France
Poland
Belgium
Spain
Canada
United Kingdom

location_facility: Azienda Ospedaliera San Gerardo - Clinica Neurologica

location_facility: Georgia Neurology and Sleep Medicine Associates

location_facility: L&C Professional Medical Research Institute

location_facility: Ospedale San Giovanni Calibita Fatebenefratelli

location_facility: IRCCS Centro S. Giovanni di Dio Fatebenefratelli

location_facility: Istituto Neurologico Casimiro Mondino, IRCCS

location_facility: NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis

location_facility: Josephson Wallack Munshower Neurology P.C.

location_facility: Alzheimer's Research and Treatment Center

location_facility: Hospital Universitario QuironSalud Madrid

location_facility: University of Perugia, Ospedale S.M. della Misericordia

location_facility: Emerald Coast Center for Neurological Disorders

location_facility: Clinica Neurologica Santa Maria della Misericordia

location_facility: CRC Gerontopole Cite de la Sante, Hôpital La Grave

location_facility: Miami Dade Medical Research Institute, LLC

location_facility: Neuro-Behavioral Clinical Research, Inc.

location_facility: Centro de salud de San Juan, Unidad de Investigación Neurociencias


intervention_type: Other

lead_sponsor: Celgene

location_country:
Finland
Romania
Belgium
Australia
Russian Federation
Denmark
Taiwan
Ukraine
Spain
Croatia
France
Poland
Norway
Argentina
Moldova, Republic of
Canada
Korea, Republic of
Saudi Arabia
Switzerland
Bulgaria
Ireland
Germany
United States
United Kingdom
Italy
Bosnia and Herzegovina
Mexico
Czechia
Israel
Belarus
Turkey
Latvia

location_facility: University Hospital Centre Zagreb, Clinic of Internal Diseases

location_facility: Hospital Privado Centro Medico de Cordoba

location_facility: Universidad Nacional De Rosario - Hospital Provincial Del Centenario

location_facility: Instituto Tecnológico y de Estudios Superiores de Monterrey

location_facility: Children's Center for Digestive Healthcare

location_facility: General Hospital "Prim.dr. Abdulah Nakas"

location_facility: Salve Limited Liability Company Limited Partnership, Outpatient Clinic

location_facility: Medical Center of Far-Eastern Federal University

location_facility: Dr. Carol Davila Central Military Emergency Clinical Hospital

location_facility: Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi

location_facility: Krajská nemocnice Pardubice, Kožní oddelení

location_facility: Advanced Research for Health Improvement

location_facility: SPb SBIH City Hospital of Saint Martyr Elizaveta

location_facility: Centre Hospitalier Intercommunal de Creteil

location_facility: University of Calgary Health - The Gastrointestinal Research Group (GIRG)

location_facility: Public City Clinical Hospital of Emergency Medical Care

location_facility: Kornel Gibinski Independent Public Central Clinical Hospital in Katowice

location_facility: Budget Institution of the Khanty-Mansiysk Autonomous Okrug - Ugra Surgut Regional Clinical Hospital

location_facility: University of Oklahoma Health Sciences Center

location_facility: Azienda Socio Sanitaria Territoriale (ASST) di Monza

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: University Clinical Centre of the Republic of Srpska

location_facility: Primorsky Regional Clinical Hospital No.1

location_facility: Biopharma Informatic Inc. Research Center

location_facility: Interdisciplinary Crohn Colitis Center Rhein Main

location_facility: University Hospital Southampton NHS Foundation Trust - Southampton General Hospital

location_facility: VA Northern California Health Care System

location_facility: University College London Hospitals NHS Foundation Trust - University College Hospital

location_facility: Santa Familia Centrum Badan, Profilaktyki i Leczenia

location_facility: Brigham and Women's Hospital - Crohn's and Colitis Center

location_facility: Goztepe Prof. Dr. Suleyman Yalcin City Hospital

location_facility: Sart Tilman Hospital Department of Gastroenterology and Hepatology

location_facility: London Health Sciences Centre, University Hospital

location_facility: Integrated University Hospital Santa Maria della Misericordia of Udine

location_facility: Poltava M.V. Sklifosovskyi Regional Clinical Hospital under Poltava Regional Council

location_facility: Rush University Medical Center - University Cardiovascular Surgeons

location_facility: ACIBADEM City Clinic Medical Center Bregalnitsa

location_facility: Korea University Medical Center - Korea University Ansan Hospital

location_facility: Ivano-Frankivsk Central City Clinical Hospital

location_facility: Toronto Digestive Disease Associates Inc

location_facility: Clinical and Diagnostic Center with an outpatient department under the Presidential Executive Office

location_facility: CHU de Dijon Bourgogne - Hopital Francois Mitterand

location_facility: Targu Mures County Emergency Clinical Hospital

location_facility: Maternal Pediatric and Adolescent Healthcare Centre

location_facility: Penn State Milton S Hershey Medical Center

location_facility: Centro de Investigacion Clinica Acelerada (CICA) S.C.

location_facility: V.T. Zaitsev Institute of General and Emergency Surgery

location_facility: "Sf. Arhanghel Mihail" Municipal Clinical Hospital

location_facility: Federal Siberian Research and Clinical Center

location_facility: Univerisity Polyclinic Foundation Agostino Gemelli

location_facility: Texas Digestive Disease Consultants - Southlake

location_facility: University of Florida Health Endocrinology - Medical Specialties - Medical Plaza

location_facility: The Center for Gastrointestinal Disorders

location_facility: H-T. Medical Center Sp. z o.o. LLC Limited Partnership

location_facility: Craiova County Emergency Clinical Hospital

location_facility: Ok Clinic Medical Center within International Institute of Clinical Trials, LLC

location_facility: Universitair Ziekenhuis Leuven, Campus Gasthuisberg

location_facility: Hospital Christus Muquerza del Parque S.A. de C.V.

location_facility: Republican Clinical Hospital, Department of Colorectal Surgery

location_facility: Center of Diagnosis and Treatment Provita

location_facility: Practice for Gastroenterology and Internal Medicine

location_facility: Washington University School of Medicine

location_facility: Multiprofile Hospital for Active Treatment Medline

location_facility: SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego

location_facility: Humanitas Research Hospital - Humanitas Mirasole S.p.A

location_facility: Gastroenterology Associates Of Central Georgia LLC

location_facility: Maggiore Polyclinic Hospital, IRCCS Ca' Granda

location_facility: Seoul National University Bundang Hospital

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Bucharest University Emergency Hospital, Department of Internal Medicine II

location_facility: Irkutsk State Medical Academy of Postgraduate Education

location_facility: Palo Alto Center-Palo Alto Medical Foundation Research Institute

location_facility: Clinical Hospital Center Sestre milosrdnice Clinic of Internal Diseases

location_facility: Atlanta Gastroenterology Associates, LLC

location_facility: University Hospital of the Canary Islands (HUC) La Laguna

location_facility: Ternopil City Public Emergency Medical Care Hospital

location_facility: Bulent Ecevit Universitesi Uygulama ve Arastirma Hastanesi

location_facility: GASTROMED Kopon, Zmudzinski and Partners Specialist Centre for Gastroenterology and Endoscopy, Spe

location_facility: University Polyclinic Hospital G. Martino

location_facility: P. Stradins Clinical University Hospital

location_facility: Si Institute Of Gastroenterology Of Namsu Dept Of Stomach And Duodenum Diseases

location_facility: Ankara University Medical Faculty Cebeci Hospital

location_facility: University Hospital Germans Trias i Pujol

location_facility: Vitebsk Regional Clinical Specialized Center

location_facility: Samara Station Railway Clinical Hospital under OAO Russian Railways

location_facility: Harry Perkins Medical Research Institute, Fiona Stanley Hospital

location_facility: Provincial Specialist Hospital in Olsztyn

location_facility: University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia

location_facility: Riga East Clinical University Hospital clinic Gailezers

location_facility: "Sfanta Treime" Clinical Municipal Hospital

location_facility: Carolinas HealthCare System Digestive Health

location_facility: Bezmialem Foundation University Medical Faculty

location_facility: Clinical Hospital of the Ministry of Health, Department of Endoscopic Surgery

location_facility: Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital

location_facility: Soukroma Gastroenterologicka ambulance a endoskopie

location_facility: Centro Regiomontano de Estudios Clinicos Roma SC.

location_facility: Vinnytsia M.I. Pyrohov Regional Clinical Hospital

location_facility: Penn State University Milton S Hershey Medical Center

location_facility: Instituto Medico de la Fundacion Estudios Clinicos

location_facility: Vancouver Hospital Gastrointestinal Research Unit The Gordon and Leslie Diamond Centre

location_facility: Investigacion Biomedica para el desarrollo de Farmacos, S.A. de C.V.

location_facility: Research Associates of South Florida LLC

location_facility: Asheville Gastroenterology Associates, P.A.

location_facility: Bat Yamon Medical Center, Clalit Medical Services

location_facility: Cleveland Clinic - Taussig Cancer Institute

location_facility: Institut klinicke a experimentalni mediciny

location_facility: University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD

location_facility: Moscow Clinical Scientific and Practical Center

location_facility: Queen Fabiola Children's University Hospital

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED

title: Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease

summary: This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.


lead_sponsor: Allergan

location_country:
Malaysia
Romania
Australia
Belgium
Russian Federation
Denmark
Ukraine
India
France
Poland
Thailand
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Saudi Arabia
Philippines
Bulgaria
Singapore
Hungary
Puerto Rico
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Spain
Latvia

acronym:
Diabetic Gastroparesis Study with Randomized-withdrawal Period

 Étude de la gastroparésie diabétique avec une période d'arrêt randomisée

location_facility: ClinTrial Medical Center, Pulmonology Department

location_facility: DRRI-Vinnytsia National Pirogov Memorial Medical University

location_facility: Texas Tech University Health Sciences, Center Division of Gastroenterology

location_facility: Faculty of Medicine, Siriraj Hospital, Mahidol University

location_facility: Mysore Medical College & Research Institute

location_facility: SU" Clinic of medical academy" of SI "Dnepropetrovsk medical cacadamy of MoH of Ukraine"

location_facility: Unidad de Investigacion Clinica Cardiometabolica de Occidente, S.C.

location_facility: Long Island Gastrointestinal Research Group LLP

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Woodholme Gastroenterology Associates, P.A.

location_facility: Moscow Regional Research Clinical Institute named by MF Vladimirski

location_facility: Family Practice Center of Wadsworth, Inc. DBA New Venture Medical Research

location_facility: Medical Center Asklepion - Humane Medicine Research EOOD

location_facility: Premier Clinical Research d.b.a. STAT Research

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: Scientific Institute of Clinical and Experimental Lymphology

location_facility: State Budgetary Healthcare Institution Of Arkhangelsk Region Suvorova 1

location_facility: Synexus Merseyside Dedicated Research Centre

location_facility: IRCCS S.Matteo Hospital Foundation, University of Pavia

location_facility: Indiana University Health University Hospital

location_facility: Centro Especializado en Investigacion Clinica S.C.

location_facility: Regional Public Organization "Chernivtsi Regional Endocrinology Center"

location_facility: Municipal Institution City Hospital No. 7

location_facility: Centro de Investigacion Cardiometabolica de Aguascalientes SA de CV

location_facility: Cabinet Medical De Nutritie Si Boli Metabolice Dr. Nicoleta

location_facility: Azienda Ospedaliera Rilievo Nazionale Alta Specialita (ARNAS) Garibaldi

location_facility: Synexus Helderberg Clinical Research Centre

location_facility: Clinical Endocrinology of SI "V.Danilevsky Institute for endocrine pathology problems National Academy of Medical sciences of Ukraine"

location_facility: Instituto Catarinense de Endocrinologia e Diabetes (ICED)

location_facility: 6th City Clinical Hospital, c. Zaporizhzhia

location_facility: Mid Essex Hospital Services NHS Trust Broomfield Hospital

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Municipal nonprofit entity "Chernigiv city hospital #2" of Chernigiv municipal council, therapeutic department

location_facility: Nizhegorodsky Regional Clinical Hospital named after N. A. Semashko

location_facility: Gruppo Humanitas - Humanitas Research Hospital

location_facility: Universitätsklinikum Giessen und Marburg GmbH

location_facility: Diabetes and Endocrinology Consultants, PC

location_facility: Centro de Atención e Investigación en Factores de Riesgo Car

location_facility: Hospices Civils de Lyon - Hôpital Edouard Herrriot

location_facility: S.P.Medical College & Group of Hospitals Bikaner

location_facility: Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

location_facility: North-Western State Medical University named after I. I. Mechnikov

location_facility: Municipal Institution-Zaporizhzhia Regional Clinical Hospital

location_facility: Southern Illinois University School of Medicine

location_facility: Centre Hospitalier de l'Universite de Montreal - CHUM

location_facility: Synexus North Tees Clinical Research Centre

location_facility: Ivano-Frankivsk National Medical University

location_facility: Oddzial Gastroenterologii Mazowieckie Centrum Rehabilitacji Stocer sp. Z o.o.

location_facility: Policlinico Gemelli, Divisione di Endocrinologia e Malattie del Metabolismo

location_facility: Diabetesinstitut Heidelberg c-o St. Josefskrankenhaus

location_facility: State Institution Ukrainian State Research Institute of Medical and Social Problems of Disability of the Ministry of Health of Ukraine

location_facility: University Emergency Militare Central Dr.Carol Davila

location_facility: University of Iowa Hospitals and Clinics

location_facility: Communal Institution "Odesa Regional Clinical Hospital", Out-patient department

location_facility: Kyiv municipal clinical endocrinological center

location_facility: FSBI National medical endocrinology research centre

location_facility: Carolina Digestive Health Associates, PA

location_facility: Dr. Anil K. Gupta Medicine Professional Corporation

location_facility: First Department of Medicine, University of Szeged

location_facility: Gastroenterology Associates of Western Michigan

location_facility: M. S. Ramaiah medical College and Hospitals

location_facility: Instituto Privado de Investigaciones Clínicas de Córdoba

location_facility: Surat Institute of Digestive Sciences Hospitals

location_facility: New Orleans Research Institute - Metropolitan Gastroenterology Associates

location_facility: Vinnytsia Regional Clinical highly specialized Endocrinology Centre

location_facility: University Malaya Medical Centre, Lembah Pantai

location_facility: Gastroenterology Associates of Fairfield County, P.C.

location_facility: Madras Medical College & Rajiv Gandhi Govt. General Hospital

location_facility: Gastroenterology Centers of the Midsouth

location_facility: Saint-Petersburg City Pokrovskaya Hospital

location_facility: Synexus Clinical Research, US, Santa Rosa

location_facility: Synexus Polska Sp. z o.o. Oddzial w Lodzi

location_facility: Szpital Uniwestytetu Medycznego w Bialymstoku

location_facility: Centro Universitario de Investigacion en Farmacologia Clinic

location_facility: Hospital Universitario "Dr. José E. González" UANL

location_facility: Instytut Medycyny Wsi im. Witolda Chodzki w Lublinie

location_facility: Chopda Medicare & Research Centre Pvt.Ltd, Magnum Heart Institute

location_facility: Gastroenterology Consultants of Southwest Virginia, Inc.

location_facility: Connecticut Clinical Research Foundation

location_facility: Grant Medical Foundation Ruby Hall Clinic

location_facility: S.R. Kalla (SRK) Memorial Gastro & General Hospital

location_facility: Royal Victoria Infirmary: Clinical Research Facility

location_facility: San Juan De Dios Educational Foundation, Inc.

location_facility: Sanggye Paik Hospital, Inje University College of Medicine

location_facility: Kumudini Devi Diabetes Research Center; Ramdevrao Hospital

location_facility: Digestive & Liver Disease Center of San Antonio, PLLC

location_facility: Dr. Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre - Gasterentrology

location_facility: Synexus Hexham Dedicated Research Centre

location_facility: Digestive Health Specialist of the South East

location_facility: Municipal Institution of Sumy Regional Council Sumy Regional Clinical Hospital

location_facility: Torrance Clinical Research Institute, Inc.

location_facility: City Hospital #1, department of endocrinology, c. Mykolayiv

location_facility: Kyiv Railway Clinical Hospital No-2 of Branch of Healthcare Center of the PJSC Ukrainian Railway , Endocrynology Department

location_facility: Troy Gastroenterology, PC dba Center for Digestive Health

location_facility: Rocky Mountain Diabetes and Osteoporosis Center, PA

location_facility: Morales Vargas Centro de Investigación S.C. (Consultorio ane

location_facility: Specjalistyczny Gabinet Neurologiczny Marta Banach

location_facility: Instituto de Pesquisa Clinica de Campinas

location_facility: Instituto de Diabetes Obesidad y Nutricion SC

location_facility: Toronto Western Hospital, University Health Network

location_facility: The Liver Institute at Methodist Dallas Medical Center

location_facility: Diabetes & Endocrinology Associates of Stark County, Inc.

location_facility: Hospital Clinico Universitario San Carlos

location_facility: Instituto de Investigaciones Clinicas de Rosario

location_facility: CIDIM - Centro Integral de Diagnóstico por Imágenes Marchegian

location_facility: Unidad de Investigación Clínica en Medicina S.C.

location_facility: Universita degli Studi di Napoli Federico II

location_facility: Professional Research Network of Kansas, LLC

location_facility: Clinical Research Consultants of Atlanta

location_facility: Medical Center of the Limited Liability Company "Health Clinic", nt oMedical Clinical Research Center

location_facility: Fundacion Centro de Investigaciones Clinicas CARDIOMET

location_facility: Núcleo de Pesquisa Clínica do Rio Grande do Sul

location_facility: Centro de Investigaciones Medicas Mar del Plata

location_facility: Victoria Hospital Bangalore Medical College and Research Institute

location_facility: Municipal nonprofit entity of Kharkiv municipal council

location_facility: Lifecare Clinic and Research Centre - Internal Med/Diabetology

location_facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie

location_facility: Synexus Lancashire Dedicated Research Centre

location_facility: Cotton-O'Neil Clinical Research Center - Digestive Health

location_facility: University of North Carolina at Chapel Hill

location_facility: West Visayas State University Medical Center

location_facility: Markhot Ferenc Oktatokorhaz es Rendelointezet

location_facility: University of Texas Health Science Center at Houston

location_facility: M.V. Hospital for Diabetes & Diabetes Research Centre

location_facility: Kindred Medical Institute for Clinical Trials, LLC

location_facility: Institute of Endocrinology and Metabolism im. V. P. Komisarenka NAMS Ukraine

location_facility: Diacon Hospital and research Center - Diabetology

location_facility: The Ohio State University, Wexner Medical Center

location_facility: Centro Especializado en Diabetes, Obesidad y Prevencion de E - Endocrinology

location_facility: Clinical Applications Laboratories, Inc.

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: Hospital Universitário João de Barros Barreto

location_facility: Houston Endoscopy and Research Center, Inc.

location_facility: Universita' Di Salerno- Aou Ruggi D'aragona

location_facility: NYU Winthrop Hospital, Clinical Trials Center

location_facility: Centro de Investigación y Atención de Diabetes - Endocrinología y Nutrición

location_facility: Pauls Stradins Clinical University Hospital, Endokrinologijas nodala

location_facility: Clinical Research of South Nevada - CROSN

location_facility: Instituto de Estudos e Pesquisas Clinicas do Ceara IEP/CE - Oncology

location_facility: Family Medical Associates, Research Department

location_facility: Frederick Gastroenterology Associates, PA an Elligo Health Research Site

location_facility: Odessa Railway Clinical Hospital of Branch of HC JSC Ukrzaliznytsia, Odessa National Medical University

location_facility: Cardinal Internal Medicine Associates, PC

location_facility: Polyclinic of medical services and rehabilitation department of State Joint-Stock Holding Company Artem, day-patient unit

location_facility: Communal Institution Kherson City Clinical Hospital

location_facility: University of Florida, College of Medicine Dept. of Gastroenterology

location_facility: NZOZ Vita Diabetica - Malgorzata Buraczyk

location_facility: L.T.Malaya Therapy National Institute of the National Academy of Medical Sciences of Ukraine

location_facility: Instituto de Hematologia y Medicina Clinica Dr. Ruben Davoli

location_facility: Synexus Manchester Clinical Research Centre

location_facility: Medical Research Center of Connecticut, LLC

location_facility: Regional muniRegional municipal institution "Chernivtsi's regional clinical hospital", gastroenterological department, Higher state educational establishment of Ukraine "Bukovinian state medical university", department of internal medicine and infectious

location_facility: Ivano-Frankivsk Central City Clinical Hospital

location_facility: Kryvyi Rih City Hospital #3 of Dnipropetrovsk Regional Council

location_facility: Wingate Institute of Neurogastroenterology and Barts Health Trust and the Royal London Hospital

location_facility: Universitair Ziekenhuis Antwerpen, Gastro-Enterologie,

location_facility: National Diabetes and Obesity Research Institute - Gen1 Research

location_facility: Synexus Polska sp.z.o.o oddzial Czestochowa

location_facility: B. J. Government Medical College and Sassoon General Hospitals

location_facility: Hospital Universitario Principe de Asturias

location_facility: Limited Liability Company "Medical Center "Salutem"

location_facility: Private Small-Scale Enterprise Medical Centre Pulse

location_facility: Clinica Mayo de Urgencias Medicas Cruz Blanca SRL

location_facility: Powiatowe Centrum Medyczne w Wolowie Sp. z o.o.

location_facility: Biopharma Informatic Inc., Research Center

location_facility: Synexus Clinical Research US - Cincinnati

location_facility: Limited Liability Company "Medical and Diagnostic Center "ADONIS Plus", outpatient department, c. Kyiv

location_facility: Municipal nonprofit entity "Vinnytsia's city clinical hospital #1", gastroenterological department, Vinnytsia National Pirogov Memorial Medical University, department of propedeutics of internal medicine, c. Vinnytsia

location_facility: Millitary-medical Academy, department of hospital therapy

location_facility: Maffei Centro Medico-Investigacion Clinica Aplicada

location_facility: Centro Cardiovascular Colombiano Clínica Santa María

location_facility: Metropolitan Gastroenterology Group PC, Chevy Chase Clinical Research

location_facility: MultiCare Institute for Research & Innovation

location_facility: Methodist Physicians Clinic Diabetes and Endocrine Specialists

location_facility: Capital Diabetes and Endocrine Associates

location_facility: Toronto Digestive Disease Associates, Inc.

location_facility: Baylor College of Medicine Medical Center

location_facility: Synexus Polska Sp. z o.o.Oddzial w Poznaniu

location_facility: Apollo Hospitals International Limited - Diabetologist

title: A 46-week, Double-blind, Placebo-controlled, Phase 3 Study With a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients With Diabetic Gastroparesis

summary: A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.


title: RATIONALE-208: A Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients With Previously Treated Hepatocellular Unresectable Carcinoma

summary: This is a Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Participants with Previously Treated Hepatocellular Unresectable Carcinoma.

lead_sponsor: BeiGene

location_country:
Italy
Spain
Poland
France
China
Germany
United Kingdom
Taiwan

location_facility: Chiayi Chang Gung Memorial Hospital of the Chang Gung Medical Foundation

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

location_facility: Shanghai Cancer Hospital, Fudan University

location_facility: Hospital Universitario HM Madrid Sanchinarro

location_facility: The Second Hospital of Anhui Medical Hospital

location_facility: Nanfang Hospital of Southern Medical University

location_facility: Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

location_facility: Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

location_facility: The First affiliated hospital of Nanchang University

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: Fujian Medical University Union Hospital

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Chinese PLA General Hospital Medical School of Chinese PLA

location_facility: Harbin Medical University Cancer Hospital

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: Groupe Hospitalier Sud - Hôpital Haut Lévêque

location_facility: Tianjin Medical University Cancer Institute & Hospital


title: A Two-Part Randomized, Phase 3 Study of Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in First-line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

summary:
The primary objectives of this study are:

Part 1: To compare the overall survival (OS) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus platinum-based doublet chemotherapy in the first-line treatment of patients with advanced squamous or nonsquamous non-small cell lung cancer (NSCLC) with tumors expressing PD-L1 in <50% of tumor cells.

Part 2: To compare the OS of cemiplimab/chemo-f with placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression.

The key secondary objectives are:

Part 1: To compare the progression-free survival (PFS) and objective response rate (ORR) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC and tumors expressing PD-L1 in <50% of tumor cells.

Part 2: To compare the PFS and ORR of cemiplimab/chemo-f versus placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression.

lead_sponsor: Regeneron Pharmaceuticals

location_country:
Italy
Austria
Thailand
France
Czechia
Greece
Lithuania
Georgia
Malaysia
Ireland
Poland
Romania
Russian Federation
China
Slovakia
Turkey
United States
Korea, Republic of
Ukraine

location_facility:
Regeneron Research Site #2
Regeneron Research Site #1
Regeneron Research Site 1
Regeneron Reserach Site
Regeneron Research Site
Regeneron research Site