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
NCT ID: NCT04603807
Last Updated: 2026-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
220 participants
INTERVENTIONAL
2021-09-30
2028-06-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
Crizotinib
Crizotinib will be self-administered orally at a dose of 250 mg twice daily with or without food.
Interventions
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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.
Crizotinib
Crizotinib will be self-administered orally at a dose of 250 mg twice daily with or without food.
Eligibility Criteria
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Inclusion Criteria
* No prior treatment with a ROS1 tyrosine kinase inhibitor, chemotherapy or other systemic therapy for advanced or recurrent (Stage IIIB/C not amenable for radical treatment) or metastatic (Stage IV) NSCLC
* Prior radiotherapy is allowed if more than 14 days have elapsed between the end of treatment and randomization
* Measurable systemic disease according to RECIST v1.1
* Participants with measurable and non-measurable CNS lesions per RECIST v1.1, including leptomeningeal carcinomatosis
* Life expectancy of at least 12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
* Adequate hematologic, renal, liver functions
* Participants must have recovered from effects of any major surgery or significant traumatic injury at least 28 days before the first dose of study treatment
* Ability to swallow entrectinib and crizotinib intact without chewing, crushing, or opening the capsules
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of \<1% per year during the treatment period and for up to 5 weeks after the last dose of entrectinib or for at least 90 days after the last dose of crizotinib
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm.
Exclusion Criteria
* NCI-CTCAE v5.0 Grade 3 or higher toxicities due to any prior therapy (excluding alopecia, fatigue, nausea and lack of appetite), which have not shown improvement and are strictly considered to interfere with current study drug
* History of recent (within the past 3 months) symptomatic congestive heart failure or ejection fraction ≤ 50% observed during screening for the study
* History of prolonged corrected QTc interval
* Peripheral sensory neuropathy ≥ Grade 2
* Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis
* Previous malignancy within the past 3 years
* Incomplete recovery from any surgery prior to the start of study treatment
* Active GI disease (e.g., Crohn's disease, ulcerative colitis or short gut syndrome) or other malabsorption syndrome that would reasonably impact drug absorption
* History of prior therapy-induced pneumonitis
* Any condition (in the past 3 months) e.g., myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack, stroke, symptomatic bradycardia, or uncontrolled arrhythmias requiring medication
* Known active infections (bacterial, fungal or viral, including human immunodeficiency virus positive)
* History of hypersensitivity to any of the additives in the entrectinib and/or crizotinib drug formulations
* Pregnant or lactating women
* Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS)-related illness
* Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or the absorption of oral medications.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Oncocentro Serviços Médicos e Hospitalares Ltda
Fortaleza, Ceará, Brazil
Hospital Sao Rafael - HSR
Salvador, Estado de Bahia, Brazil
Hospitais Integrados da Gavea S/A
Brasília, Federal District, Brazil
Oncocentro Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
Ijuí, Rio Grande do Sul, Brazil
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN
Florianópolis, Santa Catarina, Brazil
Hospital de Cancer de Barretos
Barretos, São Paulo, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, Brazil
Oncoclinicas Rio de Janeiro S.A.
Rio de Janeiro, , Brazil
Beijing Union Hospital
Beijing, , China
Jilin Cancer Hospital
Changchun, , China
The Second Xiangya Hospital of Central South University
Changsha, , China
Hunan Cancer Hospital
Changsha, , China
West China Hospital, Sichuan University
Chengdu, , China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Affiliated Hospital of Jining Medical University
Jining, , China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, , China
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, , China
Shanghai Pulmonary Hospital
Shanghai, , China
Taihe Hospital of Hubei University of Medicine
Shiyan, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, , China
Clinical Hospital Centre Zagreb
Zagreb, , Croatia
Institut Bergonie
Bordeaux, , France
CHRU Lille
Lille, , France
Centre Leon Berard
Lyon, , France
Hopital Nord AP-HM
Marseille, , France
CHU Rennes - Hopital Pontchaillou
Rennes, , France
Hopital Larrey
Toulouse, , France
Hopital Robert Schuman
Vantoux, , France
HELIOS Klinikum Emil von Behring Klinik f.Pneumologie Onkologie u.Infektiologie
Berlin, , Germany
Universitaetsklinikum Giessen und Marburg GmbH
Giessen, , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Kliniken Maria Hilf
Mönchengladbach, , Germany
Pius-Hospital
Oldenburg, , Germany
Uoa Sotiria Hospital
Athens, , Greece
Metropolitan Hospital
Athens, , Greece
University Hospital of Larissa
Larissa, , Greece
Euromedical General Clinic of Thessaloniki
Thessaloniki, , Greece
American Oncology Institute
Hyderabad, Andhra Pradesh, India
MVR Cancer Centre and Research Institute
Kozhikode, Kerala, India
MOC Cancer Care & Research Centre (Unit of Cellcure Cancer Centre Pvt Ltd)
Mumbai, Maharashtra, India
All India Institute Of Medical Sciences (AIIMS)
New Delhi, National Capital Territory of Delhi, India
Mahamana Pandit Madan Mohan Malaviya Cancer Centre-TMC
Varanasi, Uttar Pradesh, India
Tata Medical Center
Kolkata, West Bengal, India
Postgraduate Institute of Medical Education and Research
Chandigarh, , India
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
Napoli, Campania, Italy
IRCCS Istituto Regina Elena (IFO)
Rome, Lazio, Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, Lazio, Italy
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST)
Genoa, Liguria, Italy
Irccs Istituto Europeo di Oncologia (IEO)
Milan, Lombardy, Italy
Asst Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, Italy
Asst Di Monza
Monza, Lombardy, Italy
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
Orbassano, Piedmont, Italy
Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello
Pisa, Tuscany, Italy
IRCCS Istituto Oncologico Veneto (IOV)
Padua, Veneto, Italy
King Hussein Cancer Center
Amman, , Jordan
Hotel Dieu de France
Beirut, , Lebanon
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico
Health Pharma Professional Research
Mexico City, Mexico CITY (federal District), Mexico
SUPERARE
Mexico City, Mexico CITY (federal District), Mexico
Hospital Universitario
Monterrey, Nuevo León, Mexico
NKI/AvL
Amsterdam, , Netherlands
UMC St Radboud
Nijmegen, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Amethyst Cluj
Cluj County, , Romania
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca
Cluj-Napoca, , Romania
Centrul de Oncologie Sfantul Nectarie
Craiova, , Romania
Emergency County Clinical Hospital Ploiesti
Ploieşti, , Romania
Centrul de Oncologie Oncohelp
Timișoara, , Romania
AV Medical Ltd.
Saint Petersburg, Sankt-Peterburg, Russia
Univerzitna nemocnica Bratislava
Bratislava, , Slovakia
Vychodoslovensky onkologicky ustav
Košice, , Slovakia
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, , Spain
Hospital del Mar
Barcelona, , Spain
Institut Catala d Oncologia Hospital Duran i Reynals
Barcelona, , Spain
Hospital Ramon y Cajal
Madrid, , Spain
Hospital Regional Universitario Carlos Haya
Málaga, , Spain
Karolinska Universitetssjukhuset, Solna
Stockholm, , Sweden
Chulalongkorn Hospital
Bangkok, , Thailand
Faculty of Med. Siriraj Hosp.
Bangkok, , Thailand
Prapokklao Hospital
Chanthaburi, , Thailand
Songklanagarind Hospital
Songkhla, , Thailand
Bangkok Metropolitan Administration Medical College and Vajira Hospital
Wachira Phayaban, , Thailand
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital
Adana, , Turkey (Türkiye)
Gazi University Medical Faculty, Oncology Hospital
Ankara, , Turkey (Türkiye)
Liv Hospital Ankara
Ankara, , Turkey (Türkiye)
Ege Uni Medical Faculty Hospital
Izmir, , Turkey (Türkiye)
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
Malatya, , Turkey (Türkiye)
Acıbadem Maslak Hastanesi Büyükdere
Sarıyer/İstanbul, , Turkey (Türkiye)
Medical Park Seyhan Hospital
Seyhan, , Turkey (Türkiye)
Countries
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Central Contacts
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Reference Study ID Number: MO41552 https://forpatients.roche.com/
Role: CONTACT
Other Identifiers
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2019-003859-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-507494-18-00
Identifier Type: CTIS
Identifier Source: secondary_id
MO41552
Identifier Type: -
Identifier Source: org_study_id
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