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New drug shows promise in lung cancer with brain spread

NCT ID NCT04603807

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This study tests whether a newer targeted drug, entrectinib, works better than the current standard drug, crizotinib, for people with advanced lung cancer that has a specific genetic change (ROS1). About 220 participants will take one of the two pills daily. The study focuses on how long the cancer stays under control, especially in patients whose cancer has spread to the brain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

217 people

The number who actually took part.

Started

Sep 2021

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, non-small-cell lung

Contacts and locations

Locations

  • Affiliated Hospital of Jining Medical University

    Jining, 272029, China

  • All India Institute Of Medical Sciences (AIIMS)

    New Delhi, National Capital Territory of Delhi, 110029, India

  • Amethyst Cluj

    Cluj County, 407280, Romania

  • Azienda Ospedaliera San Camillo Forlanini

    Rome, Lazio, 00152, Italy

  • Azienda Sanitaria Ospedaliera S Luigi Gonzaga

    Orbassano, Piedmont, 10043, Italy

  • Bangkok Metropolitan Administration Medical College and Vajira Hospital

    Wachira Phayaban, 10300, Thailand

  • CHRU Lille

    Lille, 59037, France

  • CHU Rennes - Hopital Pontchaillou

    Rennes, 35033, France

  • Centre Leon Berard

    Lyon, 69008, France

  • Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN

    Florianópolis, Santa Catarina, 88020-210, Brazil

  • Chulalongkorn Hospital

    Bangkok, 10330, Thailand

  • Clinical Hospital Centre Zagreb

    Zagreb, 10000, Croatia

  • Complejo Hospitalario Universitario A Coruña (CHUAC)

    A Coruña, 15006, Spain

  • Emergency County Clinical Hospital Ploiesti

    Ploieşti, Romania

  • Erasmus MC

    Rotterdam, 3015 GD, Netherlands

  • Faculty of Med. Siriraj Hosp.

    Bangkok, 10700, Thailand

  • Gazi University Medical Faculty, Oncology Hospital

    Ankara, 06500, Turkey (Türkiye)

  • Guangxi Cancer Hospital of Guangxi Medical University

    Nanning, 530021, China

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

    Berlin, 14165, Germany

  • Harbin Medical University Cancer Hospital

    Harbin, 150081, China

  • Health Pharma Professional Research

    Mexico City, Mexico CITY (federal District), 03100, Mexico

  • Hopital Larrey

    Toulouse, 31059, France

  • Hopital Nord AP-HM

    Marseille, 13015, France

  • Hopital Robert Schuman

    Vantoux, 57070, France

  • Hospitais Integrados da Gavea S/A

    Brasília, Federal District, 70390-140, Brazil

  • Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara, Jalisco, 44280, Mexico

  • Hospital Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Regional Universitario Carlos Haya

    Málaga, 29010, Spain

  • Hospital Sao Rafael - HSR

    Salvador, Estado de Bahia, 41253-190, Brazil

  • Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400, Brazil

  • Hospital del Mar

    Barcelona, 08003, Spain

  • Hotel Dieu de France

    Beirut, Lebanon

  • Hunan Cancer Hospital

    Changsha, 410013, China

  • IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST)

    Genoa, Liguria, 16132, Italy

  • IRCCS Istituto Oncologico Veneto (IOV)

    Padova, Veneto, 35128, Italy

  • Institut Bergonie

    Bordeaux, 33076, France

  • Institut Catala d Oncologia Hospital Duran i Reynals

    Barcelona, 08908, Spain

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000, Brazil

  • Jilin Cancer Hospital

    Changchun, 132013, China

  • Karolinska Universitetssjukhuset, Solna

    Stockholm, 171 76, Sweden

  • King Hussein Cancer Center

    Amman, 1269, Jordan

  • Liv Hospital Ankara

    Ankara, 06680, Turkey (Türkiye)

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

    Mumbai, Maharashtra, 400036, India

  • MVR Cancer Centre and Research Institute

    Kozhikode, Kerala, 673601, India

  • Mahamana Pandit Madan Mohan Malaviya Cancer Centre-TMC

    Varanasi, Uttar Pradesh, 221005, India

  • Metropolitan Hospital

    Athens, 185 47, Greece

  • NKI/AvL

    Amsterdam, 1066 CX, Netherlands

  • Oncocentro Serviços Médicos e Hospitalares Ltda

    Fortaleza, Ceará, 60130-241, Brazil

  • Oncoclinicas Rio de Janeiro S.A.

    Rio de Janeiro, 22250-905, Brazil

  • Pius-Hospital

    Oldenburg, 26121, Germany

  • Prapokklao Hospital

    Chanthaburi, 22000, Thailand

  • Shanghai Pulmonary Hospital

    Shanghai, 200433, China

  • Songklanagarind Hospital

    Songkhla, 90110, Thailand

  • Taihe Hospital of Hubei University of Medicine

    Shiyan, 442000, China

  • Tata Medical Center

    Kolkata, West Bengal, 700160, India

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120, China

  • The Second Xiangya Hospital of Central South University

    Changsha, 410011, China

  • UMC St Radboud

    Nijmegen, 6525 GA, Netherlands

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430048, China

  • Univerzitna nemocnica Bratislava

    Bratislava, 826 06, Slovakia

  • West China Hospital, Sichuan University

    Chengdu, 610041, China

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Other studies related to the condition(s) this trial covers.