Phase 3 Study Comparing THIO and Cemiplimab Combination Versus Chemotherapy as Third-Line Treatment for Advanced or Metastatic Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating THIO, a new small molecule that targets telomeres, combined with cemiplimab LIBTAYO in people with advanced or metastatic non-small cell lung cancer NSCLC who have received prior treatments. Cemiplimab is an immune checkpoint inhibitor approved for patients with high PD-L1 expression. The study explores whether giving THIO before cemiplimab can restore response to immunotherapy in those who have developed resistance or relapsed after first-line treatment. Participants will be randomly assigned to receive either THIO plus cemiplimab or a chemotherapy agent chosen by their doctor vinorelbine, gemcitabine, or docetaxel. In the experimental arm, THIO is given as three 30-minute intravenous infusions on days 1 to 3, followed by cemiplimab on day 5, repeated every three weeks. The chemotherapy arm follows standard dosing schedules for the selected drug every three weeks. This treatment continues as third-line therapy for advanced NSCLC. During the study, participants will have regular assessments including imaging to measure tumor response, laboratory tests to monitor organ function, and tracking of any side effects. The main outcome is overall survival within two years. Additional measures include disease control, duration of response, progression-free survival, and safety events. The trial spans multiple cycles of treatment with ongoing monitoring to evaluate these outcomes over a two-year period.

A Phase III Study With THIO + Cemiplimab vs Chemotherapy as 3rd Line Treatment in Advanced/Metastatic NSCLC