Safety and Feasibility of Preoperative Sintilimab with Bevacizumab and Chemotherapy for Locally Advanced Resectable Non-Small Cell Lung Cancer

What this Trial Is About

This research aims to study locally advanced and resectable non-small cell lung cancer (NSCLC), focusing on improving treatment outcomes beyond the current standard of neoadjuvant chemotherapy followed by surgery. The trial investigates the safety and feasibility of combining sintilimab, an immune checkpoint inhibitor targeting PD-1, with bevacizumab, an anti-angiogenesis drug targeting VEGF, along with chemotherapy before surgery. This approach is based on prior evidence of these drugs' activity in advanced NSCLC and aims to enhance treatment effects in earlier disease stages. Participants will receive four cycles of sintilimab (200 mg intravenously) and bevacizumab (15 mg/kg intravenously) every three weeks, alongside four cycles of carboplatin and pemetrexed chemotherapy given on the same schedule. Surgery is planned within four to six weeks after completing this preoperative treatment. A chest CT scan will be done after the second treatment cycle to check for disease progression; if progression is detected, surgery will be performed without the last two treatment cycles. During the study, researchers will closely monitor safety by tracking treatment-related adverse events of grade 3 or higher from the start of treatment until surgery or up to 90 days after the last preoperative dose. They will also assess treatment feasibility, radiologic response, and major pathological response after surgery. The full participation period includes the preoperative treatment phase and follow-up assessments up to about five months, aiming to determine if this combined treatment approach is suitable for further study.

Preoperative Sintilimab Combined With Bevacizumab and Chemotherapy for Resectable Non-Small Cell Lung Cancer