Study of Modified Si Jun Zi Tang with Chemotherapy and Immunotherapy for Treating Resectable Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the addition of Modified Si Jun Zi Tang, a traditional Chinese medicine formula known for strengthening the spleen, to the standard perioperative treatment of chemotherapy and immunotherapy for patients with resectable or potentially resectable non-small cell lung cancer NSCLC. This Phase 2 trial aims to assess whether this combination improves surgery success rates, tumor response, and safety compared to standard treatment alone. The study also explores 1-year and 2-year disease-free survival after surgery and collects biological samples to identify tumor markers related to treatment outcomes and side effects. Participants are randomly assigned to one of two groups one receives Modified Si Jun Zi Tang combined with chemotherapy albumin-bound paclitaxel or pemetrexed plus carboplatin and PD1 monoclonal antibody, while the other receives standard chemotherapy and PD1 monoclonal antibody without the traditional medicine. Surgery is performed if feasible after neoadjuvant treatment. Following surgery, participants continue their assigned treatments, with the traditional medicine group receiving Modified Si Jun Zi Tang plus PD1 antibody, and the control group receiving only PD1 antibody, for up to one year. During the study, participants undergo assessments including surgery evaluation approximately 2-4 months after starting treatment, tumor response measurement about 6 weeks after two treatment cycles, and continuous monitoring for adverse reactions throughout treatment and up to one year after surgery. Researchers will also track disease-free survival at one and two years post-surgery. Biological sample collection supports analysis of tumor markers. Overall, participants are followed closely to evaluate treatment effects, safety, and long-term outcomes.

Efficacy and Safety of Modified Si Jun Zi Tang in Perioperative NSCLC Treatment