This website uses cookies that help the website function and that help us understand how you interact with it. Please read our privacy policy for more information.
The study will compare the efficacy and safety of entrectinib with crizotinib in participants with advanced or metastatic ROS1 non-small cell lung cancer (NSCLC). The participants will self-administer oral entrectinib or crizotinib as described in the protocol and local prescribing information. Treatments will continue until progressive disease, unacceptable toxicity, death, or withdrawal from the study, whichever occurs first.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04603807 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Hoffmann-La Roche |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Clinical Trials |
Principal Investigator Affiliation | Hoffmann-La Roche |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Brazil, China, Croatia, France, Germany, Greece, India, Italy, Jordan, Lebanon, Mexico, Netherlands, Romania, Russian Federation, Slovakia, Spain, Sweden, Thailand, Turkey |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Carcinoma, Non-Small-Cell Lung |
Experimental: Entrectinib
Participants will be enrolled to receive 600 mg entrectinib orally once daily until progressive disease, unacceptable toxicity, death, or withdrawal from the study, whichever occurs first.
Active Comparator: Crizotinib
Participants will be enrolled to receive 250 mg crizotinib orally twice daily until progressive disease, unacceptable toxicity, death, or withdrawal from the study, whichever occurs first.
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.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Hospital Sao Rafael - HSR
Salvador, Bahia, 41253-190
Status
Recruiting
Address
Oncocentro Serviços Médicos e Hospitalares Ltda
Fortaleza, Ceará, 60130-241
Status
Active, not recruiting
Address
Hospitais Integrados da Gavea S/A
Brasilia, Distrito Federal, 70390-140
Status
Withdrawn
Address
Oncocentro Belo Horizonte
Belo Horizonte, Minas Gerais, 30360-680
Status
Withdrawn
Address
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
Ijui, Rio Grande Do Sul, 98700-000
Status
Recruiting
Address
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN
Florianopolis, Santa Catarina, 88020-210
Status
Active, not recruiting
Address
Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400
Status
Active, not recruiting
Address
Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo, São Paulo, 01246-000
Status
Completed
Address
Oncoclinicas Rio de Janeiro S.A.
Rio de Janeiro, , 22250-905
Status
Withdrawn
Address
Beijing Union Hospital
Beijing, , 100730
Status
Active, not recruiting
Address
Jilin Cancer Hospital
Changchun, , 132013
Status
Active, not recruiting
Address
Hunan Cancer Hospital
Changsha City, , 410013
Status
Active, not recruiting
Address
The Second Xiangya Hospital of Central South University
Changsha, , 410011
Status
Active, not recruiting
Address
West China Hospital, Sichuan University
Chengdu, , 610041
Status
Active, not recruiting
Address
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, , 510120
Status
Active, not recruiting
Address
Harbin Medical University Cancer Hospital
Harbin, , 150081
Status
Active, not recruiting
Address
Affiliated Hospital of Jining Medical University
Jining, , 272029
Status
Completed
Address
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing City, , 210008
Status
Active, not recruiting
Address
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, , 530021
Status
Active, not recruiting
Address
Shanghai Pulmonary Hospital
Shanghai, , 200433
Status
Active, not recruiting
Address
Taihe Hospital of Hubei University of Medicine
Shiyan, , 442000
Status
Active, not recruiting
Address
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan City, , 430023
Status
Recruiting
Address
Clinical Hospital Centre Zagreb
Zagreb, , 10000
Status
Active, not recruiting
Address
Institut Bergonie
Bordeaux, , 33076
Status
Active, not recruiting
Address
CHRU Lille
Lille, , 59037
Status
Recruiting
Address
Centre Leon Berard
Lyon, , 69008
Status
Active, not recruiting
Address
Hopital Nord AP-HM
Marseille, , 13015
Status
Recruiting
Address
CHU Rennes - Hopital Pontchaillou
Rennes cedex 09, , 35033
Status
Active, not recruiting
Address
Hopital Larrey
Toulouse, , 31059
Status
Recruiting
Address
Hopital Robert Schuman
Vantoux, , 57070
Status
Recruiting
Address
HELIOS Klinikum Emil von Behring Klinik f.Pneumologie Onkologie u.Infektiologie
Berlin, , 14165
Status
Recruiting
Address
Universitaetsklinikum Giessen und Marburg GmbH
Gießen, , 35392
Status
Recruiting
Address
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , 20246
Status
Recruiting
Address
Kliniken Maria Hilf
Mönchengladbach, , 41063
Status
Recruiting
Address
Pius-Hospital
Oldenburg, , 26121
Status
Recruiting
Address
Uoa Sotiria Hospital
Athens, , 115 27
Status
Recruiting
Address
Metropolitan Hospital
Athens, , 185 47
Status
Recruiting
Address
University Hospital of Larissa
Larissa, , 411 10
Status
Recruiting
Address
Euromedical General Clinic of Thessaloniki
Thessaloniki, , 546 45
Status
Withdrawn
Address
American Oncology Institute
Hyderabad, Andhra Pradesh, 500019
Status
Recruiting
Address
All India Institute Of Medical Sciences (AIIMS)
New Delhi, Delhi, 110029
Status
Active, not recruiting
Address
MVR Cancer Centre and Research Institute
Kozhikode, Kerala, 673601
Status
Active, not recruiting
Address
MOC Cancer Care & Research Centre (Unit of Cellcure Cancer Centre Pvt Ltd)
Mumbai, Maharashtra, 400036
Status
Recruiting
Address
Mahamana Pandit Madan Mohan Malaviya Cancer Centre-TMC
Varanasi, Uttar Pradesh, 221005
Status
Recruiting
Address
Tata Medical Center
Kolkata, WEST Bengal, 700160
Status
Withdrawn
Address
Postgraduate Institute of Medical Education and Research
Chandigarh, , 160012
Status
Recruiting
Address
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
Napoli, Campania, 80131
Status
Active, not recruiting
Address
IRCCS Istituto Regina Elena (IFO)
Roma, Lazio, 00144
Status
Active, not recruiting
Address
Azienda Ospedaliera San Camillo Forlanini
Roma, Lazio, 00152
Status
Active, not recruiting
Address
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST)
Genova, Liguria, 16132
Status
Withdrawn
Address
Irccs Istituto Europeo di Oncologia (IEO)
Milano, Lombardia, 20141
Status
Recruiting
Address
Asst Grande Ospedale Metropolitano Niguarda
Milano, Lombardia, 20162
Status
Withdrawn
Address
Asst Di Monza
Monza, Lombardia, 20900
Status
Recruiting
Address
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
Orbassano, Piemonte, 10043
Status
Withdrawn
Address
Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello
Pisa, Toscana, 56124
Status
Active, not recruiting
Address
IRCCS Istituto Oncologico Veneto (IOV)
Padova, Veneto, 35128
Status
Active, not recruiting
Address
King Hussein Cancer Center
Amman, , 1269
Status
Recruiting
Address
Hotel Dieu de France
Beirut, ,
Status
Recruiting
Address
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, 44280
Status
Active, not recruiting
Address
Health Pharma Professional Research
Cdmx, Mexico CITY (federal District), 03100
Status
Withdrawn
Address
SUPERARE
Ciudad de México, Mexico CITY (federal District), 06760
Status
Recruiting
Address
Hospital Universitario
Monterrey, Nuevo LEON, 64460
Status
Active, not recruiting
Address
NKI/AvL
Amsterdam, , 1066 CX
Status
Active, not recruiting
Address
UMC St Radboud
Nijmegen, , 6525 GA
Status
Active, not recruiting
Address
Erasmus MC
Rotterdam, , 3015 GD
Status
Recruiting
Address
Amethyst Cluj
Cluj County, , 407280
Status
Recruiting
Address
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca
Cluj Napoca, , 400015
Status
Recruiting
Address
Centrul de Oncologie Sfantul Nectarie
Craiova, , 200542
Status
Recruiting
Address
Emergency County Clinical Hospital Ploiesti
Ploiesti, ,
Status
Recruiting
Address
Centrul de Oncologie Oncohelp
Timisoara, , 300239
Status
Withdrawn
Address
AV Medical Ltd.
Sankt-peterburg, Leningrad, 199034
Status
Recruiting
Address
Univerzitna nemocnica Bratislava
Bratislava, , 826 06
Status
Withdrawn
Address
Vychodoslovensky onkologicky ustav
Košice, , 040 01
Status
Active, not recruiting
Address
Hospital del Mar
Barcelona, , 08003
Status
Active, not recruiting
Address
Institut Catala d Oncologia Hospital Duran i Reynals
Barcelona, , 08908
Status
Recruiting
Address
Complejo Hospitalario Universitario A Coruña (CHUAC)
La Coruna, , 15006
Status
Recruiting
Address
Hospital Ramon y Cajal
Madrid, , 28034
Status
Active, not recruiting
Address
Hospital Regional Universitario Carlos Haya
Malaga, , 29010
Status
Recruiting
Address
Karolinska Universitetssjukhuset, Solna
Stockholm, , 171 76
Status
Recruiting
Address
Chulalongkorn Hospital
Bangkok, , 10330
Status
Recruiting
Address
Faculty of Med. Siriraj Hosp.
Bangkok, , 10700
Status
Recruiting
Address
Prapokklao Hospital
Chanthaburi, , 22000
Status
Recruiting
Address
Songklanagarind Hospital
Songkhla, , 90110
Status
Recruiting
Address
Bangkok Metropolitan Administration Medical College and Vajira Hospital
Wachira Phayaban, , 10300
Status
Withdrawn
Address
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital
Adana, , 01250
Status
Active, not recruiting
Address
Gazi University Medical Faculty, Oncology Hospital
Ankara, , 06500
Status
Active, not recruiting
Address
Liv Hospital Ankara
Ankara, , 06680
Status
Withdrawn
Address
Ege Uni Medical Faculty Hospital
Izmir, , 35100
Status
Withdrawn
Address
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
Malatya, , 44280
Status
Withdrawn
Address
Ac?badem Maslak Hastanesi Büyükdere
Sar?yer/?stanbul, , 34457
Status
Recruiting
Address
Medical Park Seyhan Hospital
Seyhan, , 01140