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

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.

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	NSCLC Stage IV, NSCLC, Stage III
Enrollment	30 participants
Start Date	2024-10-01
Primary Completion	2031-09 (estimated)
Study Completion	2031-09 (estimated)
Updated on ClinicalTrials.gov	2026-07-07