Carcinoma, Non-Small-Cell LungPhase 3NCT04603807
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
A Phase 3 study testing Entrectinib and Crizotinib in people with Carcinoma, Non-Small-Cell Lung, run by Hoffmann-La Roche at 61 sites in 18 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Entrectinib and Crizotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 61 sitesin 18 countries
- Study dates
- 30 Sep 2021to 29 Jan 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
61 sites in 18 countries.
61 sites in 18 countries
China11 sites
Jilin Cancer Hospital
Changchun, 132013
The Second Xiangya Hospital of Central South University
Changsha, 410011
Hunan Cancer Hospital
Changsha, 410013
West China Hospital, Sichuan University
Chengdu, 610041
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510120
Harbin Medical University Cancer Hospital
Harbin, 150081
Affiliated Hospital of Jining Medical University
Jining, 272029
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, 530021
Shanghai Pulmonary Hospital
Shanghai, 200433
Taihe Hospital of Hubei University of Medicine
Shiyan, 442000
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430048
Brazil7 sites
Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400
Hospitais Integrados da Gavea S/A
Brasília, Federal District, 70390-140
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN
Florianópolis, Santa Catarina, 88020-210
Oncocentro Serviços Médicos e Hospitalares Ltda
Fortaleza, Ceará, 60130-241
Oncoclinicas Rio de Janeiro S.A.
Rio de Janeiro, 22250-905
Hospital Sao Rafael - HSR
Salvador, Estado de Bahia, 41253-190
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, 01246-000
France7 sites
Institut Bergonie
Bordeaux, 33076
CHRU Lille
Lille, 59037
Centre Leon Berard
Lyon, 69008
Hopital Nord AP-HM
Marseille, 13015
CHU Rennes - Hopital Pontchaillou
Rennes, 35033
Hopital Larrey
Toulouse, 31059
Hopital Robert Schuman
Vantoux, 57070
India5 sites
Tata Medical Center
Kolkata, West Bengal, 700160
MVR Cancer Centre and Research Institute
Kozhikode, Kerala, 673601
MOC Cancer Care & Research Centre (Unit of Cellcure Cancer Centre Pvt Ltd)
Mumbai, Maharashtra, 400036
All India Institute Of Medical Sciences (AIIMS)
New Delhi, National Capital Territory of Delhi, 110029
Mahamana Pandit Madan Mohan Malaviya Cancer Centre-TMC
Varanasi, Uttar Pradesh, 221005
Spain5 sites
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, 15006
Hospital del Mar
Barcelona, 08003
Institut Catala d Oncologia Hospital Duran i Reynals
Barcelona, 08908
Hospital Ramon y Cajal
Madrid, 28034
Hospital Regional Universitario Carlos Haya
Málaga, 29010
Thailand5 sites
Chulalongkorn Hospital
Bangkok, 10330
Faculty of Med. Siriraj Hosp.
Bangkok, 10700
Prapokklao Hospital
Chanthaburi, 22000
Songklanagarind Hospital
Songkhla, 90110
Bangkok Metropolitan Administration Medical College and Vajira Hospital
Wachira Phayaban, 10300
Italy4 sites
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST)
Genoa, Liguria, 16132
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
Orbassano, Piedmont, 10043
IRCCS Istituto Oncologico Veneto (IOV)
Padova, Veneto, 35128
Azienda Ospedaliera San Camillo Forlanini
Rome, Lazio, 00152
Netherlands3 sites
NKI/AvL
Amsterdam, 1066 CX
UMC St Radboud
Nijmegen, 6525 GA
Erasmus MC
Rotterdam, 3015 GD
Germany2 sites
HELIOS Klinikum Emil von Behring Klinik f.Pneumologie Onkologie u.Infektiologie
Berlin, 14165
Pius-Hospital
Oldenburg, 26121
Mexico2 sites
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, 44280
Health Pharma Professional Research
Mexico City, Mexico CITY (federal District), 03100
Romania2 sites
Amethyst Cluj
Cluj County, 407280
Emergency County Clinical Hospital Ploiesti
Ploieşti
Turkey (Türkiye)2 sites
Gazi University Medical Faculty, Oncology Hospital
Ankara, 06500
Liv Hospital Ankara
Ankara, 06680
About this study
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
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.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Entrectinib, Crizotinib
- Keywords
- ROS1 Non-small-cell lung
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntrectinibDrug
Entrectinib will be self-administered orally at a dose of 600 mg (three 200 mg capsules per day) once daily with or without food.
CrizotinibDrug
Crizotinib will be self-administered orally at a dose of 250 mg twice daily with or without food.
| Study group | Role | What they receive |
|---|---|---|
| Entrectinib | Experimental | 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. Receives: Drug: Entrectinib |
| Crizotinib | Active comparator | 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. Receives: Drug: Crizotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 7 years
Secondary outcomes (10)
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
Measured: Up to 7 Years
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
Measured: Up to 7 Years
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
Measured: Up to 7 Years
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
Measured: Up to 7 years
Overall survival (OS)
OS is defined as the time from randomization to death from any cause
Measured: Up to 7 Years
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)
Measured: Up to 7 Years
Percentage of participants with impact on lung cancer-specific symptoms assessed by the EORTC QLQ-LC13
Measured: Up to 7 Years
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
Measured: Up to 7 Years
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
Measured: Up to 7 Years
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
Measured: Up to 7 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start30 Sep 2021
- Primary completion30 Sep 2026 (estimated)
- Study completion29 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603807
- Sponsor's protocol ID
- MO41552
- Other IDs
- 2019-003859-11, 2023-507494-18-00, 2023, 2019
- Status last verified
- Aug 2026
- First submitted
- 22 Oct 2020
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04603807
- Acronym / sponsor ID
- MO41552
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- ROS1 Non-small-cell lung
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 29 Jan 2028 (estimated)
- First posted
- 27 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Entrectinib | Experimental | Drug: EntrectinibParticipants 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. |
| Crizotinib | Active comparator | Drug: CrizotinibParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EntrectinibEntrectinib will be self-administered orally at a dose of 600 mg (three 200 mg capsules per day) once daily with or without food. | Drug | Entrectinib |
| CrizotinibCrizotinib will be self-administered orally at a dose of 250 mg twice daily with or without food. | Drug | Crizotinib |
Primary outcome
Progression-free survival (PFS) in participants with central nervous system (CNS) metastases at baseline
Time frame: Up to 7 years
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).
10 secondary outcomes
Progression-free survival in the Central Nervous System (CNS-PFS)
Time frame: Up to 7 Years
Overall response rate (ORR)
Time frame: Up to 7 Years
Duration of response (DOR)
Time frame: Up to 7 Years
Progression-free survival (PFS)
Time frame: Up to 7 years
Overall survival (OS)
Time frame: Up to 7 Years
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
Percentage of participants with impact on lung cancer-specific symptoms assessed by the EORTC QLQ-LC13
Time frame: Up to 7 Years
Objective response rate in the CNS-ORR in participants with CNS metastases at baseline
Time frame: Up to 7 Years
Duration of response in the CNS (CNS-DOR) in participants with CNS metastases at baseline
Time frame: Up to 7 Years
Percentage of participants with Adverse Events and Serious Adverse Events and Adverse Events leading to dose modifications/interruptions, study drug withdrawal or death
Time frame: Up to 7 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
61 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Entrectinib and Crizotinib in people with Carcinoma, Non-Small-Cell Lung, run by Hoffmann-La Roche at 61 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in China, Brazil, France, India, Spain and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) in participants with central nervous system (CNS) metastases at baseline (time frame: Up to 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.