Phase 2 Study of Reduced Dose Chemotherapy Plus Anti-PD-1 Immunotherapy as First Treatment in Vulnerable or Older Adults 70 with Advanced PD-L1 Under 50% Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are studying vulnerable or older adults aged 70 and above with recurrent or metastatic non-small cell lung cancer NSCLC that has a PD-L1 tumor proportion score TPS less than 50%. The study aims to evaluate how often treatment-related side effects cause patients to stop chemotherapy when receiving a reduced dose of chemotherapy combined with immunotherapy. This is a phase 2, single-arm, open-label study assessing safety and tolerability in this specific patient group. Participants with squamous cell NSCLC will receive carboplatin and paclitaxel chemotherapy every 21 days for 4 cycles, while those with non-squamous NSCLC will receive carboplatin and pemetrexed on the same schedule. Both groups will receive pembrolizumab immunotherapy every 21 days for up to 35 cycles or until disease progression or unacceptable side effects occur. The first 4 cycles include chemotherapy plus immunotherapy, followed by maintenance immunotherapy alone from cycle 5 onward. During the study, participants will be closely monitored for treatment side effects, response to therapy, survival outcomes, and quality of life at multiple time points up to several years. Researchers will collect data on adverse events, disease progression, and cancer symptoms through scans, lab tests, and questionnaires. The primary outcome is the rate of chemotherapy discontinuation due to side effects over up to two years of treatment. Secondary outcomes include response rates, overall survival, progression-free survival, and symptom changes up to five years.

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)