A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases

PHASE3RecruitingINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

September 30, 2021

Primary Completion Date

June 26, 2028

Study Completion Date

June 26, 2028

Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
DRUG

Entrectinib

Entrectinib will be self-administered orally at a dose of 600 mg (three 200 mg capsules per day) once daily with or without food.

DRUG

Crizotinib

Crizotinib will be self-administered orally at a dose of 250 mg twice daily with or without food.

Trial Locations (91)

1269

ACTIVE_NOT_RECRUITING

King Hussein Cancer Center, Amman

10000

RECRUITING

Clinical Hospital Centre Zagreb, Zagreb

10043

RECRUITING

Azienda Sanitaria Ospedaliera S Luigi Gonzaga, Orbassano

10300

RECRUITING

Bangkok Metropolitan Administration Medical College and Vajira Hospital, Wachira Phayaban

10330

RECRUITING

Chulalongkorn Hospital, Bangkok

10700

RECRUITING

Faculty of Med. Siriraj Hosp., Bangkok

13015

ACTIVE_NOT_RECRUITING

Hopital Nord AP-HM, Marseille

14165

RECRUITING

HELIOS Klinikum Emil von Behring Klinik f.Pneumologie Onkologie u.Infektiologie, Berlin

15006

RECRUITING

Complejo Hospitalario Universitario A Coruña (CHUAC), A Coruña

16132

ACTIVE_NOT_RECRUITING

IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST), Genoa

20141

WITHDRAWN

Irccs Istituto Europeo di Oncologia (IEO), Milan

20162

RECRUITING

Asst Grande Ospedale Metropolitano Niguarda, Milan

20246

RECRUITING

Universitätsklinikum Hamburg-Eppendorf, Hamburg

20900

WITHDRAWN

Asst Di Monza, Monza

22000

RECRUITING

Prapokklao Hospital, Chanthaburi

26121

RECRUITING

Pius-Hospital, Oldenburg

28034

RECRUITING

Hospital Ramon y Cajal, Madrid

29010

ACTIVE_NOT_RECRUITING

Hospital Regional Universitario Carlos Haya, Málaga

31059

ACTIVE_NOT_RECRUITING

Hopital Larrey, Toulouse

33076

ACTIVE_NOT_RECRUITING

Institut Bergonie, Bordeaux

34457

WITHDRAWN

Ac?badem Maslak Hastanesi Büyükdere, Sar?yer/?stanbul

35033

RECRUITING

CHU Rennes - Hopital Pontchaillou, Rennes

35100

WITHDRAWN

Ege Uni Medical Faculty Hospital, Izmir

35128

ACTIVE_NOT_RECRUITING

IRCCS Istituto Oncologico Veneto (IOV), Padua

35392

RECRUITING

Universitaetsklinikum Giessen und Marburg GmbH, Giessen

41063

RECRUITING

Kliniken Maria Hilf, Mönchengladbach

44280

RECRUITING

Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara

WITHDRAWN

Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department, Malatya

56124

WITHDRAWN

Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello, Pisa

57070

RECRUITING

Hopital Robert Schuman, Vantoux

59037

ACTIVE_NOT_RECRUITING

CHRU Lille, Lille

64460

RECRUITING

Hospital Universitario, Monterrey

69008

RECRUITING

Centre Leon Berard, Lyon

80131

RECRUITING

Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale, Napoli

90110

RECRUITING

Songklanagarind Hospital, Songkhla

100730

WITHDRAWN

Beijing Union Hospital, Beijing

110029

RECRUITING

All India Institute Of Medical Sciences (AIIMS), New Delhi

132013

ACTIVE_NOT_RECRUITING

Jilin Cancer Hospital, Changchun

150081

ACTIVE_NOT_RECRUITING

Harbin Medical University Cancer Hospital, Harbin

160012

WITHDRAWN

Postgraduate Institute of Medical Education and Research, Chandigarh

199034

WITHDRAWN

AV Medical Ltd., Saint Petersburg

200433

ACTIVE_NOT_RECRUITING

Shanghai Pulmonary Hospital, Shanghai

200542

RECRUITING

Centrul de Oncologie Sfantul Nectarie, Craiova

210008

WITHDRAWN

Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing

221005

RECRUITING

Mahamana Pandit Madan Mohan Malaviya Cancer Centre-TMC, Varanasi

272029

ACTIVE_NOT_RECRUITING

Affiliated Hospital of Jining Medical University, Jining

300239

WITHDRAWN

Centrul de Oncologie Oncohelp, Timișoara

400015

RECRUITING

Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca, Cluj-Napoca

400036

ACTIVE_NOT_RECRUITING

MOC Cancer Care & Research Centre (Unit of Cellcure Cancer Centre Pvt Ltd), Mumbai

407280

RECRUITING

Amethyst Cluj, Cluj County

410011

ACTIVE_NOT_RECRUITING

The Second Xiangya Hospital of Central South University, Changsha

410013

ACTIVE_NOT_RECRUITING

Hunan Cancer Hospital, Changsha

430048

ACTIVE_NOT_RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan

442000

ACTIVE_NOT_RECRUITING

Taihe Hospital of Hubei University of Medicine, Shiyan

500019

WITHDRAWN

American Oncology Institute, Hyderabad

510120

ACTIVE_NOT_RECRUITING

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou

530021

ACTIVE_NOT_RECRUITING

Guangxi Cancer Hospital of Guangxi Medical University, Nanning

610041

ACTIVE_NOT_RECRUITING

West China Hospital, Sichuan University, Chengdu

673601

ACTIVE_NOT_RECRUITING

MVR Cancer Centre and Research Institute, Kozhikode

700160

RECRUITING

Tata Medical Center, Kolkata

60130-241

RECRUITING

Oncocentro Serviços Médicos e Hospitalares Ltda, Fortaleza

41253-190

RECRUITING

Hospital Sao Rafael - HSR, Salvador

70390-140

ACTIVE_NOT_RECRUITING

Hospitais Integrados da Gavea S/A, Brasília

30360-680

WITHDRAWN

Oncocentro Belo Horizonte, Belo Horizonte

98700-000

WITHDRAWN

Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda, Ijuí

88020-210

RECRUITING

Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN, Florianópolis

14784-400

ACTIVE_NOT_RECRUITING

Hospital de Cancer de Barretos, Barretos

01246-000

ACTIVE_NOT_RECRUITING

Instituto do Cancer do Estado de Sao Paulo - ICESP, São Paulo

22250-905

COMPLETED

Oncoclinicas Rio de Janeiro S.A., Rio de Janeiro

115 27

RECRUITING

Uoa Sotiria Hospital, Athens

185 47

RECRUITING

Metropolitan Hospital, Athens

411 10

WITHDRAWN

University Hospital of Larissa, Larissa

546 45

RECRUITING

Euromedical General Clinic of Thessaloniki, Thessaloniki

00144

ACTIVE_NOT_RECRUITING

IRCCS Istituto Regina Elena (IFO), Rome

00152

ACTIVE_NOT_RECRUITING

Azienda Ospedaliera San Camillo Forlanini, Rome

Unknown

RECRUITING

Hotel Dieu de France, Beirut

RECRUITING

Emergency County Clinical Hospital Ploiesti, Ploieşti

03100

ACTIVE_NOT_RECRUITING

Health Pharma Professional Research, Mexico City

06760

WITHDRAWN

SUPERARE, Mexico City

1066 CX

ACTIVE_NOT_RECRUITING

NKI/AvL, Amsterdam

6525 GA

ACTIVE_NOT_RECRUITING

UMC St Radboud, Nijmegen

3015 GD

ACTIVE_NOT_RECRUITING

Erasmus MC, Rotterdam

826 06

RECRUITING

Univerzitna nemocnica Bratislava, Bratislava

040 01

WITHDRAWN

Vychodoslovensky onkologicky ustav, Košice

08003

RECRUITING

Hospital del Mar, Barcelona

08908

ACTIVE_NOT_RECRUITING

Institut Catala d Oncologia Hospital Duran i Reynals, Barcelona

171 76

RECRUITING

Karolinska Universitetssjukhuset, Solna, Stockholm

01250

WITHDRAWN

Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital, Adana

06500

ACTIVE_NOT_RECRUITING

Gazi University Medical Faculty, Oncology Hospital, Ankara

06680

ACTIVE_NOT_RECRUITING

Liv Hospital Ankara, Ankara

01140

RECRUITING

Medical Park Seyhan Hospital, Seyhan

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY