Study Comparing Reduced-Dose Carboplatin-Doublet Chemotherapy Plus Cemiplimab Versus Cemiplimab Alone in Older and Frail Patients With Metastatic Non-Small Cell Lung Cancer and Low PD-L1 Levels

What this Trial Is About

Researchers are evaluating treatment options for older and frail patients aged 70 and above with metastatic non-small cell lung cancer NSCLC who have PD-L1 expression below 50%. This study focuses on comparing reduced-dose chemotherapy combined with cemiplimab against cemiplimab alone. The goal is to find a treatment that is both effective and better tolerated in this vulnerable group, who often face greater risks of side effects and poor tolerance to standard-dose chemotherapy. This randomized, open-label phase II trial assigns participants to one of two groups one receives reduced-dose platinum-doublet chemotherapy plus cemiplimab, and the other receives cemiplimab alone. The chemotherapy regimens vary slightly depending on cancer histology and are given every three weeks for four cycles, followed by maintenance cemiplimab treatment for up to two years or until disease progression or unacceptable side effects. Participants who experience disease progression may be eligible to switch to the combination therapy. Participants undergo regular assessments including CT scans and CNS imaging every 6 to 12 weeks, quality of life questionnaires, and geriatric-specific tests such as hand-grip strength at set intervals during treatment and follow-up. Researchers measure progression-free survival, overall survival, tumor response, treatment side effects, and patient-reported outcomes to evaluate treatment effectiveness and safety. The study aims to improve treatment decisions for older patients often excluded from clinical trials, ensuring their quality of life and functional status are considered.

Reduced-dose Carboplatin-doublet-chemotherapy + Cemiplimab vs Cemiplimab Monotherapy in Treatment Naive Older and Frail Patients With Metastatic NSCLC With PD-L1 <50%