Phase 2 Study of PD-1 Antibody with Platinum-based Chemotherapy for Locally Advanced Non-small Cell Lung Cancer Evaluating Chemoimmunotherapy Followed by Surgery or Radiotherapy

What this Trial Is About

Researchers are studying locally advanced non-small cell lung cancer NSCLC that cannot be removed by surgery initially. The trial evaluates whether adding surgery after chemoimmunotherapy improves survival and safety compared to chemoimmunotherapy followed by radiotherapy or continued non-surgical therapy. This is an open-label, randomized, phase 2 trial sponsored by Shanghai Pulmonary Hospital, China. Participants receive four cycles of chemoimmunotherapy with serplulimab a PD-1 antibody combined with platinum-based doublet chemotherapy including nab-paclitaxel or pemetrexed plus carboplatin. Patients whose tumors shrink enough to become operable are randomly assigned to surgery or radiotherapy. Those with tumors still unresectable after chemoimmunotherapy continue non-surgical treatments in oncology. During the study, patients undergo imaging tests to confirm tumor status, and assessments include event-free survival measured up to 30 months. Additional outcomes such as response rate, progression-free survival, disease-free survival, overall survival, safety events, and quality of life are monitored over up to 60 months. Researchers also track adverse events and lung function, with follow-up visits scheduled regularly to evaluate health and treatment effects throughout the study period.

Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung Cancer