RecruitingPhase 2NCT06552234

Phase II Efficacy Study of Repotrectinib in Frail and/or Elderly Patients With ROS1-rearranged Advanced NSCLC

Open-label Phase II Efficacy Study of Repotrectinib in Frail (PS ≥2) and/or Elderly Patients With ROS1-rearranged Advanced NSCLC


Sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Enrollment

30 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

ROS1 rearrangements are rare, accounting for only 1-2% of NSCLC cases, but have been associated with response to ROS1 inhibitors, such as crizotinib and entrectinib. However, many patients develop resistance to the tyrosine-kinase inhibitors (TKIs), creating a need for new treatments. Repotrectinib is a new-generation TKI designed against ROS1 or NTRK rearranged malignancies (Drilon 2018). Early phase clinical data support activity of repotrectinib in patients with NSCLC harboring such gene rearrangements (TRIDENT-1 study), but there are limited evidence in frail populations, such as poor performance status patients and/or elderly patients, who are classically excluded from clinical trials or underrepresented. The present study aims to assess the activity and tolerability of repotrectinib in frail (PS ≥2) and/or elderly patients with ROS1-rearranged advanced NSCLC.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase II trial is testing repotrectinib in elderly or frail patients with advanced non-small cell lung cancer (NSCLC) whose tumors carry a specific genetic change called a ROS1 rearrangement. Repotrectinib is a targeted drug designed to block the abnormal ROS1 protein that drives cancer growth. **You may be eligible if...** - You are 18 or older AND either aged 70+ or have limited daily function (ECOG performance status 2 or higher) - Your lung cancer has been confirmed to have a ROS1 gene rearrangement by a molecular test - You have at least one measurable tumor on imaging - You are in otherwise reasonable health with adequate blood, liver, and kidney function **You may NOT be eligible if...** - You have another active cancer within 2 years - You have active hepatitis B or C, active tuberculosis, or HIV - You have significant heart disease or had a recent heart attack or stroke - You are pregnant or breastfeeding - You are currently in another therapeutic clinical trial 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 160 mg BID, until progression or unacceptable toxicity


Locations(20)

CH Aix-en-Provence

Aix-en-Provence, Bouches Du Rhône, France

AP-HM

Marseille, Bouches Du Rhône, France

HIA Sainte Anne

Toulon, Var, France

CHU Angers

Angers, France

CHU Bordeaux

Bordeaux, France

CHU Brest

Brest, France

Centre François Baclesse

Caen, France

CH Chambéry

Chambéry, France

Hôpitaux civils de Colmar

Colmar, France

CHI Créteil

Créteil, France

CHD Vendée

La Roche-sur-Yon, France

CHRU Lille

Lille, France

CHU Limoges

Limoges, France

Hospices Civils de Lyon

Lyon, France

CH Cornouaille

Quimper, France

CHU Rennes

Rennes, France

CHU Rouen

Rouen, France

Hôpital Foch

Suresnes, France

CHU Toulouse

Toulouse, France

Hôpitaux Nord-Ouest

Villefranche-sur-Saône, France

View Full Details on ClinicalTrials.gov

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NCT06552234


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