Study of Low-Dose Nivolumab With Chemotherapy Before Surgery for Stage IB-IIIA Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the effects of a low dose of neoadjuvant immunotherapy combined with platinum doublet chemotherapy in patients with stage IB-IIIA non-small cell lung cancer NSCLC. This phase 2 study aims to assess the major pathological response MPR rate and pathologic complete response pCR rate following this treatment approach. The study is led by Dr. Aline Fusco Fares and focuses on patients with specific tumor characteristics, including negative EGFR, ALK, and ROS1 expression and documented PD-L1 protein expression. Participants receive a combination of platinum-based neoadjuvant chemotherapy, which may include carboplatin with paclitaxel or pemetrexed, along with nivolumab administered at 0.3 mgkg every 21 days for three cycles. This treatment is given before surgery to reduce the tumor size and improve surgical outcomes. The study monitors responses within 2 to 3 months after treatment. During the trial, participants will undergo clinical assessments and laboratory tests to monitor tumor response and organ function. Researchers will evaluate outcomes such as major pathological response, complete pathological response, adverse events up to three months after treatment, event-free survival up to 60 months, and successful tumor removal R0 resection. Participants are followed closely throughout the treatment and evaluation periods to ensure safety and collect thorough data on treatment impact.

Efficacy Analysis of Neoadjuvant Treatment in Lung Cancer Using Low-dose Nivolumab Combined With Chemotherapy