Phase II Study of Neoadjuvant Sintilimab, Bevacizumab, Pemetrexed, and Carboplatin Followed by Surgery in Adults with Unresectable Stage III Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating a treatment approach for patients with unresectable stage III non-small cell lung cancer NSCLC that combines neoadjuvant IBI308, bevacizumab, pemetrexed, and carboplatin followed by surgery. This approach is being studied because current combined chemoradiotherapy offers limited prognosis, and surgery may provide a chance for cure. IBI308 is a humanized anti-PD-1 monoclonal antibody being assessed for its role in this treatment. The study involves giving participants four cycles of neoadjuvant therapy every 21 days. During each cycle, IBI308 is given as a 200 mg intravenous infusion, bevacizumab is administered at 15 mgkg, pemetrexed is injected intravenously at 500 mgm, and carboplatin is dosed intravenously based on serum concentration. Surgery is scheduled at least 21 days after completing the neoadjuvant therapy. Participants will be closely monitored through the neoadjuvant treatment and surgery phases. Researchers will assess the resectability rate within three months and track perioperative complications for two years. The study includes blood tests and performance status evaluations to ensure safety and adherence. Overall participation involves treatment cycles, surgery, and follow-up assessments extending over multiple years.

Neoadjuvant IBI308, Bevacizumab, Plus Pemetrexed and Carboplatin Followed by Surgery in Unresectable Stage III NSCLC