Phase II Study of Single-Drug Chemotherapy with Immunotherapy in Elderly Patients 65 with Metastatic Non-Small Cell Lung Cancer

What this Trial Is About

Lung cancer is the leading cause of illness and death among men worldwide, with elderly patients aged 65 and older representing a growing portion of those affected. This research focuses on elderly patients with metastatic non-small cell lung cancer NSCLC to evaluate treatment options, as this age group has limited evidence guiding their care. The study aims to clarify whether single-drug chemotherapy combined with immunotherapy offers benefits similar to dual-drug chemotherapy with immunotherapy while reducing side effects. Participants receive single-drug chemotherapy plus immunotherapy tailored to the type of lung cancer. For squamous cell carcinoma, chemotherapy options include gemcitabine, paclitaxel, or vinorelbine combined with immunotherapy drugs such as Pembrolizumab, Penpulimab, Camrelizumab, Tislelizumab, Sintilimab, or sulgarizumab. For non-squamous NSCLC, paclitaxel or pemetrexed plus immunotherapy are used. This is a phase II clinical trial with one treatment group. During the study, researchers monitor participants for progression-free survival and objective response rate within 6 to 12 months, as well as overall survival and disease control up to 18 months. Assessments include imaging with enhanced CT scans and laboratory tests for blood counts and organ function. The study measures treatment efficacy, safety, and quality of life in elderly patients receiving first-line therapy for metastatic NSCLC.

Single-drug Chemotherapy Plus Immunotherapy in Metastatic Non-small Cell Lung Cancer Elderly Patients