RecruitingPhase 2NCT06315010

REPotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain mEtastasis

A Phase II Study Assessing Safety and Efficacy of REPotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain mEtastasis (REPOSE Study)


Sponsor

MedSIR

Enrollment

20 participants

Start Date

Jun 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

REPOSE is a phase II clinical trial exploring the safety and efficacy of repotrectinib in patients with non-small cell lung cancer (NSCLC) characterized by the presence of brain metastasis (BM) and whose tumors have mutated ROS proto-oncogene 1, receptor tyrosine kinase (ROS1) gene.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating repotrectinib — a targeted drug — specifically in patients with ROS1-positive non-small cell lung cancer (NSCLC) who have active brain metastases. ROS1 is a genetic mutation that drives some lung cancers, and repotrectinib is designed to cross the blood-brain barrier and attack cancer cells in both the lungs and brain. **You may be eligible if...** - You are 18 years or older - You have non-small cell lung cancer confirmed by biopsy with a ROS1 gene rearrangement (ROS1-positive) - You have active brain metastases (cancer that has spread to the brain), with or without symptoms - Immediate surgery or radiation to the brain is not required right now - You are able to swallow capsules whole **You may NOT be eligible if...** - Your lung cancer does not have a ROS1 mutation - You require immediate brain surgery or radiation for your brain metastases - You have serious organ dysfunction or other medical conditions that prevent safe treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRepotrectinib

Repotrectinib is administered orally in capsule form, with each capsule containing size 0 hard gelatin 40 mg of the active compound in bottles containing 30 capsules. Repotrectinib is administered orally in the form of capsules. The capsules are taken by mouth and swallowed intact (without chewing, crushing, or opening) with water or another suitable liquid.


Locations(16)

Medizinische Universität Graz

Graz, Austria

Medical University of Vienna

Vienna, Austria

Ludwig-Maximilians-University Munich

München, Germany

Hospital de Vinalopó

Elche, Alicante, Spain

Hospital Universitari Sant Joan de Reus

Reus, Tarragona, Spain

Hospital General Universitario Dr. Balmis

Alicante, Spain

Hospital de Cruces

Barakaldo, Spain

UOMI Cancer Center

Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Institut Català d' Oncologia Girona (ICO)

Girona, Spain

Hospital Universitario de León

León, Spain

Hospital Lucus Agusti

Lugo, Spain

Hospital Beata María Ana

Madrid, Spain

Hospital Universitario Vithas Madrid La Milagrosa

Madrid, Spain

Complejo Hospitalario Universitario de Santiago (CHUS)

Santiago de Compostela, Spain

Hospital Clínico Universitario de Valencia

Valencia, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06315010


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