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

NCT06552234 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

  • NSCLC Stage IV
  • NSCLC, Stage III

Interventions

DRUG

Repotrectinib

Repotrectinib 160 mg BID, until progression or unacceptable toxicity

Sponsors & Collaborators

  • Groupe Francais De Pneumo-Cancerologie

    collaborator OTHER

  • Hospices Civils de Lyon

    collaborator OTHER

  • Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

    lead OTHER

Principal Investigators

  • Olivier BYLICKI, MD, PhD, PR · HIA Sainte Anne / Groupe Français d'Onco-Pneumologie

  • Laurent GREILLIER, MD, PhD, PR · AP-HM / Groupe Français d'Onco-Pneumologie

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2031-09-30
Completion
2031-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06552234 on ClinicalTrials.gov