Phase II Study of Tislelizumab With Chemotherapy Before Surgery for KRAS-Mutated Resectable Stage II-IIIBN2 Nonsquamous Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the pathological complete response in adults with resectable stage II to IIIB N2 KRAS-mutated nonsquamous non-small cell lung cancer. This Phase II study aims to assess the effectiveness and safety of combining tislelizumab with platinum-based doublet chemotherapy before surgery. The study focuses on participants who have not received prior lung cancer treatment and are eligible for curative surgical resection. Participants will receive tislelizumab administered by intravenous injection combined with platinum-based chemotherapy drugs such as cisplatin, carboplatin, or pemetrexed disodium, all given through IV infusion. The treatment is given in the perioperative period, meaning around the time of surgery, to evaluate its impact on tumor response and safety. The study follows a single-arm design, assessing the combination treatments effects without comparison to other treatments. Throughout the study, participants will be monitored for pathological complete response up to three months after completing neoadjuvant treatment. Additional outcomes include major pathological response, objective response rate, event-free survival, overall survival, and treatment-related side effects over up to three years. Participants will undergo medical assessments, imaging to measure lesions, organ function tests, and safety evaluations. The total duration of follow-up extends to three years to observe long-term treatment effects and survival outcomes.

Perioperative Tislelizumab for Resectable II-IIIB(N2) KRAS-mutated Nonsquamous Non-small Cell Lung Cancer