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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

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Entrectinib
Crizotinib
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring ROS1 Non-small-cell lung

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically or cytologically-confirmed diagnosis of advanced or recurrent (Stage IIIB/C not amenable for radical treatment) or metastatic (Stage IV) NSCLC that harbors a documented ROS1 gene rearrangement.
  • 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:

  • 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
  • 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.

Sites / Locations

  • Oncoclinicas Rio de Janeiro S.A.Recruiting
  • Hospital de Cancer de Barretos
  • Instituto do Cancer do Estado de Sao Paulo - ICESP
  • Beijing Union Hospital
  • Jilin Cancer Hospital
  • Hunan Cancer Hospital
  • The Second Xiangya Hospital of Central South University
  • Sichuan Provincial Cancer Hospital
  • West China Hospital, Sichuan University
  • The First Affiliated Hospital of Guangzhou Medical University
  • Harbin Medical University Cancer Hospital
  • Affiliated Hospital of Jining Medical University
  • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
  • Guangxi Cancer Hospital of Guangxi Medical University
  • Shanghai Pulmonary Hospital
  • Taihe Hospital of Hubei University of Medicine
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Clinical Hospital Centre ZagrebRecruiting
  • Institut Bergonie; PneumologyRecruiting
  • CHRU LilleRecruiting
  • Centre Leon BerardRecruiting
  • Hopital Nord AP-HM
  • CHU Rennes - Hopital PontchaillouRecruiting
  • Hopital Larrey; PneumologieRecruiting
  • Hopital Robert Schuman; PneumologieRecruiting
  • Uoa Sotiria Hospital; OncologyRecruiting
  • Metropolitan HospitalRecruiting
  • University Hospital of Larissa;Department of Medical OncologyRecruiting
  • Euromedical General Clinic of Thessaloniki; Oncology DepartmentRecruiting
  • American Oncology InstituteRecruiting
  • All India Institute Of Medical Sciences (AIIMS)Recruiting
  • MVR Cancer Centre and Research InstituteRecruiting
  • Mumbai Oncocare CentreRecruiting
  • Mumbai Oncocare Center; Medical Oncology
  • Tata Medical Center; Department of Medical OncologyRecruiting
  • Postgraduate Institute of Medical Education and ResearchRecruiting
  • Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. PascaleRecruiting
  • IRCCS Istituto Regina Elena (IFO); Oncologia Medica B
  • Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1
  • IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica ARecruiting
  • Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia
  • Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed OncologiaRecruiting
  • ASST DI MONZA; Oncologia MedicaRecruiting
  • Azienda Sanitaria Ospedaliera S Luigi Gonzaga; SSD Oncologia Polomonare (II PAD. IV PIANO)Recruiting
  • Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco VascolareRecruiting
  • IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
  • King Hussein Cancer Center
  • Hospital Civil de Guadalajara Fray Antonio AlcaldeRecruiting
  • Health Pharma Professional ResearchRecruiting
  • Superare; Centro de InfusionRecruiting
  • Hospital Universitario; Dr. Jose E. GonzalezRecruiting
  • NKI/AvL
  • UMC St Radboud
  • Erasmus MCRecruiting
  • Amethyst Cluj; Medical OncologyRecruiting
  • Emergency County Clinical Hospital Ploiesti; Medical oncologyRecruiting
  • Centrul de Oncologie OncohelpRecruiting
  • AV Medical Ltd.Recruiting
  • Univerzitna nemocnica Bratislava; Oddelenie Klinickej Onkologie, Klinika Pneumologie A Ftizeologie
  • Vychodoslovensky onkologicky ustavRecruiting
  • Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de OncologiaRecruiting
  • Hospital del Mar; Servicio de Oncologia
  • Institut Catala d Oncologia Hospital Duran i ReynalsRecruiting
  • Hospital Ramon y Cajal; Servicio de OncologiaRecruiting
  • Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
  • Karolinska Universitetssjukhuset, Solna; Kliniska prövningsenheten Z:4:01Recruiting
  • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
  • Gazi University Medical Faculty, Oncology Hospital
  • Liv Hospital Ankara; Medical OncologyRecruiting
  • Ege Uni Medical Faculty Hospital; Oncology Dept
  • Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology DepartmentRecruiting
  • Ac?badem Maslak Hastanesi Büyükdere

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Entrectinib

Crizotinib

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Progression-free survival (PFS) in participants with central nervous system (CNS) metastases at baseline
PFS is defined as the time from randomization to the first documented disease progression (extracranial or intracranial) or death from any cause whichever occurs first determined by a blinded independent review committee (BIRC) using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).

Secondary Outcome Measures

Progression-free survival in the Central Nervous System (CNS-PFS)
CNS-PFS is defined as the time from randomization to the first documented disease progression in the CNS or death from any cause, whichever occurs first, as determined by the BIRC using RECIST v1.1
Overall response rate (ORR)
ORR is defined as the percentage of participants who attain Complete Response (CR) or Partial Response (PR) as assessed by the BIRC and the investigator per RECIST v1.1
Duration of response (DOR)
DOR is defined as the time from when response (CR or PR) is first documented to disease progression or death, whichever occurs first, as assessed by the BIRC and the investigator per RECIST v1.1
Progression-free survival (PFS)
PFS is defined as the time from randomization to the first documented disease progression (extracranial or intracranial) or death from any cause, whichever occurs first, as determined by the BICR and investigator using RECIST v1.1
Overall survival (OS)
OS is defined as the time from randomization to death from any cause
Percentage of participants with confirmed deterioration as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)
Percentage of participants with impact on lung cancer-specific symptoms assessed by the EORTC QLQ-LC13
Objective response rate in the CNS-ORR in participants with CNS metastases at baseline
CNS-ORR is defined as the percentage of participants who attain CR or PR for lesions in the CNS, as determined by the BIRC per RECIST v1.1
Duration of response in the CNS (CNS-DOR) in participants with CNS metastases at baseline
CNS-DOR is defined as the time from when a CNS response (CR or PR) is first documented to disease progression in the CNS, as determined by the BIRC per RECIST v1.1
Percentage of participants with Adverse Events and Serious Adverse Events and Adverse Events leading to dose modifications/interruptions, study drug withdrawal or death
Assessed by the investigator according to the NCI CTCAE v5.0

Full Information

First Posted
October 22, 2020
Last Updated
October 5, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT04603807
Brief Title
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
Official Title
Randomized, Open Label, Multicenter, Phase III Study of Entrectinib Versus Crizotinib in Patients With Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring ROS1 Gene Rearrangements With and Without Central Nervous System Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
December 1, 2027 (Anticipated)
Study Completion Date
December 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
Keywords
ROS1 Non-small-cell lung

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Entrectinib
Arm Type
Experimental
Arm Description
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.
Arm Title
Crizotinib
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Entrectinib
Intervention Description
Entrectinib will be self-administered orally at a dose of 600 mg (three 200 mg capsules per day) once daily with or without food.
Intervention Type
Drug
Intervention Name(s)
Crizotinib
Intervention Description
Crizotinib will be self-administered orally at a dose of 250 mg twice daily with or without food.
Primary Outcome Measure Information:
Title
Progression-free survival (PFS) in participants with central nervous system (CNS) metastases at baseline
Description
PFS is defined as the time from randomization to the first documented disease progression (extracranial or intracranial) or death from any cause whichever occurs first determined by a blinded independent review committee (BIRC) using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
Time Frame
Up to 7 years
Secondary Outcome Measure Information:
Title
Progression-free survival in the Central Nervous System (CNS-PFS)
Description
CNS-PFS is defined as the time from randomization to the first documented disease progression in the CNS or death from any cause, whichever occurs first, as determined by the BIRC using RECIST v1.1
Time Frame
Up to 7 Years
Title
Overall response rate (ORR)
Description
ORR is defined as the percentage of participants who attain Complete Response (CR) or Partial Response (PR) as assessed by the BIRC and the investigator per RECIST v1.1
Time Frame
Up to 7 Years
Title
Duration of response (DOR)
Description
DOR is defined as the time from when response (CR or PR) is first documented to disease progression or death, whichever occurs first, as assessed by the BIRC and the investigator per RECIST v1.1
Time Frame
Up to 7 Years
Title
Progression-free survival (PFS)
Description
PFS is defined as the time from randomization to the first documented disease progression (extracranial or intracranial) or death from any cause, whichever occurs first, as determined by the BICR and investigator using RECIST v1.1
Time Frame
Up to 7 years
Title
Overall survival (OS)
Description
OS is defined as the time from randomization to death from any cause
Time Frame
Up to 7 Years
Title
Percentage of participants with confirmed deterioration as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)
Time Frame
Up to 7 Years
Title
Percentage of participants with impact on lung cancer-specific symptoms assessed by the EORTC QLQ-LC13
Time Frame
Up to 7 Years
Title
Objective response rate in the CNS-ORR in participants with CNS metastases at baseline
Description
CNS-ORR is defined as the percentage of participants who attain CR or PR for lesions in the CNS, as determined by the BIRC per RECIST v1.1
Time Frame
Up to 7 Years
Title
Duration of response in the CNS (CNS-DOR) in participants with CNS metastases at baseline
Description
CNS-DOR is defined as the time from when a CNS response (CR or PR) is first documented to disease progression in the CNS, as determined by the BIRC per RECIST v1.1
Time Frame
Up to 7 Years
Title
Percentage of participants with Adverse Events and Serious Adverse Events and Adverse Events leading to dose modifications/interruptions, study drug withdrawal or death
Description
Assessed by the investigator according to the NCI CTCAE v5.0
Time Frame
Up to 7 Years
Other Pre-specified Outcome Measures:
Title
Change in the scores of EuroQol 5-Dimension Questionnaire, 5-level version (EQ-5D-5L)
Description
To evaluate health status utility scores of participants to inform pharmacoeconomic modeling using the EuroQol 5-Dimension Questionnaire (5-level version; EQ-5D-5L) index-based and visual analog scale (VAS) scores
Time Frame
Up to 7 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically-confirmed diagnosis of advanced or recurrent (Stage IIIB/C not amenable for radical treatment) or metastatic (Stage IV) NSCLC that harbors a documented ROS1 gene rearrangement. 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: 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: MO41552 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. and Canada)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Oncoclinicas Rio de Janeiro S.A.
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22250-905
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital de Cancer de Barretos
City
Barretos
State/Province
SP
ZIP/Postal Code
14784-400
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Beijing Union Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Jilin Cancer Hospital
City
Changchun
ZIP/Postal Code
132013
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Hunan Cancer Hospital
City
Changsha CITY
ZIP/Postal Code
410013
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
ZIP/Postal Code
410011
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Sichuan Provincial Cancer Hospital
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Withdrawn
Facility Name
West China Hospital, Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
ZIP/Postal Code
150081
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Affiliated Hospital of Jining Medical University
City
Jining
ZIP/Postal Code
272029
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
City
Nanjing City
ZIP/Postal Code
210008
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Guangxi Cancer Hospital of Guangxi Medical University
City
Nanning
ZIP/Postal Code
530021
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Taihe Hospital of Hubei University of Medicine
City
Shiyan
ZIP/Postal Code
442000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan City
ZIP/Postal Code
430023
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Clinical Hospital Centre Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Institut Bergonie; Pneumology
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Name
CHRU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Nord AP-HM
City
Marseille
ZIP/Postal Code
13015
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU Rennes - Hopital Pontchaillou
City
Rennes cedex 09
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Larrey; Pneumologie
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Robert Schuman; Pneumologie
City
Vantoux
ZIP/Postal Code
57070
Country
France
Individual Site Status
Recruiting
Facility Name
Uoa Sotiria Hospital; Oncology
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Individual Site Status
Recruiting
Facility Name
Metropolitan Hospital
City
Athens
ZIP/Postal Code
185 47
Country
Greece
Individual Site Status
Recruiting
Facility Name
University Hospital of Larissa;Department of Medical Oncology
City
Larissa
ZIP/Postal Code
411 10
Country
Greece
Individual Site Status
Recruiting
Facility Name
Euromedical General Clinic of Thessaloniki; Oncology Department
City
Thessaloniki
ZIP/Postal Code
546 45
Country
Greece
Individual Site Status
Recruiting
Facility Name
American Oncology Institute
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500019
Country
India
Individual Site Status
Recruiting
Facility Name
All India Institute Of Medical Sciences (AIIMS)
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Recruiting
Facility Name
MVR Cancer Centre and Research Institute
City
Kozhikode
State/Province
Kerala
ZIP/Postal Code
673601
Country
India
Individual Site Status
Recruiting
Facility Name
Mumbai Oncocare Centre
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400036
Country
India
Individual Site Status
Recruiting
Facility Name
Mumbai Oncocare Center; Medical Oncology
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400056
Country
India
Individual Site Status
Withdrawn
Facility Name
Tata Medical Center; Department of Medical Oncology
City
Kolkata
State/Province
WEST Bengal
ZIP/Postal Code
700160
Country
India
Individual Site Status
Recruiting
Facility Name
Postgraduate Institute of Medical Education and Research
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Individual Site Status
Recruiting
Facility Name
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Istituto Regina Elena (IFO); Oncologia Medica B
City
Roma
State/Province
Lazio
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1
City
Roma
State/Province
Lazio
ZIP/Postal Code
00152
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST DI MONZA; Oncologia Medica
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Sanitaria Ospedaliera S Luigi Gonzaga; SSD Oncologia Polomonare (II PAD. IV PIANO)
City
Orbassano
State/Province
Piemonte
ZIP/Postal Code
10043
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56124
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
King Hussein Cancer Center
City
Amman
ZIP/Postal Code
11941
Country
Jordan
Individual Site Status
Active, not recruiting
Facility Name
Hospital Civil de Guadalajara Fray Antonio Alcalde
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Health Pharma Professional Research
City
Cdmx
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
03100
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Superare; Centro de Infusion
City
Ciudad de México
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
06760
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Hospital Universitario; Dr. Jose E. Gonzalez
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Recruiting
Facility Name
NKI/AvL
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Individual Site Status
Active, not recruiting
Facility Name
UMC St Radboud
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Individual Site Status
Active, not recruiting
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Amethyst Cluj; Medical Oncology
City
Cluj County
ZIP/Postal Code
407280
Country
Romania
Individual Site Status
Recruiting
Facility Name
Emergency County Clinical Hospital Ploiesti; Medical oncology
City
Ploiesti
Country
Romania
Individual Site Status
Recruiting
Facility Name
Centrul de Oncologie Oncohelp
City
Timisoara
ZIP/Postal Code
300239
Country
Romania
Individual Site Status
Recruiting
Facility Name
AV Medical Ltd.
City
Sait-Petersburg Sankt Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
196006
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Univerzitna nemocnica Bratislava; Oddelenie Klinickej Onkologie, Klinika Pneumologie A Ftizeologie
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
Individual Site Status
Active, not recruiting
Facility Name
Vychodoslovensky onkologicky ustav
City
Kosice
ZIP/Postal Code
041 91
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
City
A Coruña
State/Province
LA Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital del Mar; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Institut Catala d Oncologia Hospital Duran i Reynals
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Ramon y Cajal; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
City
Malaga
ZIP/Postal Code
29011
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Karolinska Universitetssjukhuset, Solna; Kliniska prövningsenheten Z:4:01
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
City
Adana
ZIP/Postal Code
01230
Country
Turkey
Individual Site Status
Withdrawn
Facility Name
Gazi University Medical Faculty, Oncology Hospital
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Liv Hospital Ankara; Medical Oncology
City
Ankara
ZIP/Postal Code
06680
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ege Uni Medical Faculty Hospital; Oncology Dept
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Withdrawn
Facility Name
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ac?badem Maslak Hastanesi Büyükdere
City
Sar?yer/?stanbul
ZIP/Postal Code
34457
Country
Turkey
Individual Site Status
Withdrawn

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Learn more about this trial

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

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