Randomized Study Comparing 6 Months vs. 2 Years of Pembrolizumab Maintenance Treatment in Stage IV Non-Small Cell Lung Cancer After Chemotherapy and Pembrolizumab Induction

What this Trial Is About

Researchers are studying ways to reduce the duration of immunotherapy treatment in patients with advanced non-small cell lung cancer NSCLC who have their disease controlled after initial treatment. The study focuses on comparing a shorter immunotherapy maintenance period of 6 months to the usual 2 years to see if less treatment can still be effective. This phase II-III randomized study enrolls patients with stage IV NSCLC who have not received prior treatment for advanced disease. Participants will first receive a combination of chemotherapy and pembrolizumab for about 6 months, using specific chemotherapy drugs based on their cancer type. After this induction, patients showing disease control without severe side effects will be randomly assigned to one of two groups continuing pembrolizumab with or without pemetrexed for certain cancer types for up to 2 years or observation with or without pemetrexed. Researchers will monitor various factors including patient characteristics and tumor markers. During the study, participants will attend scheduled visits for treatment and monitoring, including imaging scans to measure tumor response and laboratory tests to check health status. Quality of life and survival will be tracked up to about 24 months after randomization. The study also collects data on side effects and progression-free survival to better understand the benefits and risks of shorter versus longer immunotherapy maintenance.

De-escalation Immunotherapy mAintenance Duration Trial for Stage IV Lung Cancer Patients With Disease Control After Chemo-immunotherapy Induction