Open-label Phase II Study of Repotrectinib in Frail and/or Elderly Patients With ROS1-rearranged Advanced Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are investigating the use of repotrectinib, a new-generation tyrosine-kinase inhibitor (TKI), in treating frail and/or elderly patients with advanced non-small cell lung cancer (NSCLC) that has a specific ROS1 gene rearrangement. This study addresses the need for new treatments as resistance to existing ROS1 inhibitors often develops, and frail or elderly patients are usually underrepresented in clinical trials. The trial is a national, multicenter, open-label, phase II study focusing on this patient group with limited treatment options. Participants in the study will receive repotrectinib at a dose of 160 mg twice daily until their disease progresses or they experience unacceptable side effects. The trial includes patients with stage III or IV NSCLC who are not eligible for local treatment. Both those who have never received ROS1 TKI therapy and those previously treated with such therapies may enroll under specific conditions. The study monitors treatment until progression or toxicity, without randomization or placebo control. Throughout the trial, participants will undergo regular assessments to evaluate tumor response and disease progression using established criteria like RECIST v1.1. Researchers will track a variety of outcomes, including objective response rate, progression-free survival, quality of life changes, and side effects. Monitoring will continue for up to seven years, with detailed subgroup analyses based on performance status and age. Safety and tolerability will be closely observed, and participants will be followed for disease symptoms and overall survival during and after treatment.

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