🏛️ Verified NIH Record • Updated 2026-08-12

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 (NCT04603807)

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

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Hoffmann-La Roche

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (12 items) and avoid the listed exclusions (17 items).

Location: Oncocentro Serviços Médicos e Hospitalares Ltda — Fortaleza, Ceará

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (61 Sites)

Showing the first 25 of 61 sites.

  • Oncocentro Serviços Médicos e Hospitalares Ltda — Fortaleza, Ceará
  • Hospital Sao Rafael - HSR — Salvador, Estado de Bahia
  • Hospitais Integrados da Gavea S/A — Brasília, Federal District
  • Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN — Florianópolis, Santa Catarina
  • Hospital de Cancer de Barretos — Barretos, São Paulo
  • Instituto do Cancer do Estado de Sao Paulo - ICESP — São Paulo, São Paulo
  • Oncoclinicas Rio de Janeiro S.A. — Rio de Janeiro,
  • Jilin Cancer Hospital — Changchun,
  • The Second Xiangya Hospital of Central South University — Changsha,
  • Hunan Cancer Hospital — Changsha,
  • West China Hospital, Sichuan University — Chengdu,
  • The First Affiliated Hospital of Guangzhou Medical University — Guangzhou,
  • Harbin Medical University Cancer Hospital — Harbin,
  • Affiliated Hospital of Jining Medical University — Jining,
  • Guangxi Cancer Hospital of Guangxi Medical University — Nanning,
  • Shanghai Pulmonary Hospital — Shanghai,
  • Taihe Hospital of Hubei University of Medicine — Shiyan,
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan,
  • Clinical Hospital Centre Zagreb — Zagreb,
  • Institut Bergonie — Bordeaux,
  • CHRU Lille — Lille,
  • Centre Leon Berard — Lyon,
  • Hopital Nord AP-HM — Marseille,
  • CHU Rennes - Hopital Pontchaillou — Rennes,
  • Hopital Larrey — Toulouse,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗