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

Study acronym: REPOROS
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. 6 versions Re-verified since Nov 19, 2025, no change to tracked fieldsv5-v10
  2. Site details revised at 10 of 20 sitesv4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2024 to Oct 1, 2024
    • Site details revised at 20 of 20 sites
    v3
  4. Start date: Sep 1, 2024 to Oct 2024
    • Primary and study completion dates: Aug 1, 2031 to Sep 2031
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06552234
Lead Sponsor Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Collaborators: Groupe Francais De Pneumo-Cancerologie, Hospices Civils de Lyon
Conditions
(from sponsor)		 NSCLC Stage IV, NSCLC, Stage III
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov