Repotrectinib Treatment in Frail or Elderly Patients with Advanced ROS1-Positive NSCLC A Phase II Study

What this Trial Is About

Researchers are evaluating repotrectinib, a new-generation tyrosine-kinase inhibitor TKI, in frail and elderly patients with advanced non-small cell lung cancer NSCLC that has ROS1 gene rearrangements. ROS1 rearrangements are rare and account for 1-2% of NSCLC cases but are linked to responses to ROS1 inhibitors like crizotinib and entrectinib. However, resistance to these treatments can develop, and evidence is limited in frail or elderly populations often excluded from trials. Participants will receive repotrectinib at a dose of 160 mg twice daily until disease progression or unacceptable side effects occur. The study is national, multicenter, open label, and non-randomized, including frail patients with performance status 2 or higher andor those aged 70 years or older. Treatment is given in first or any line for stage III or IV NSCLC patients with ROS1 rearrangements. During the study, participants will be regularly assessed for tumor response, progression-free survival, overall survival, quality of life, and treatment side effects using established criteria up to seven years. Tumor measurements will follow RECIST v1.1 guidelines, and safety monitoring will include adverse event tracking. The study involves ongoing evaluations until progression, death, or new treatment introduction, with detailed subgroup analyses based on age and performance status.

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