🏛️ 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: Review the eligibility criteria below.

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

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 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 ↗