Phase III Trial of Sacituzumab and Zimberelimab as Adjuvant Treatment for Stage IB-IIIA-IIIB(N2) Resected Non-Small Cell Lung Cancer Patients Without Pathological Complete Response

What this Trial Is About

Researchers are evaluating treatments for patients with non-small cell lung cancer (NSCLC) stages IB to IIIA-IIIB (N2) who have undergone surgery but did not achieve a complete pathological response after pre-surgery therapy. This open-label, phase III trial compares three different approaches to improve disease-free survival, which is the time from randomization until cancer returns, a new lung cancer develops, or death from any cause. The study also examines overall survival and safety of the treatments. Participants will be randomly assigned to one of three groups: one group will be observed without immunotherapy for 10 months, allowing chemotherapy as decided by doctors; the second group will receive immunotherapy with Zimberelimab administered intravenously every 21 days for 13 cycles; the third group will receive a combination of Sacituzumab Govitecan and Zimberelimab for 8 cycles followed by Zimberelimab alone for 5 cycles, also every 21 days. Treatment starts between 3 and 10 weeks after surgery, and the study includes patients with different PDL1 statuses. During the trial, participants will undergo assessments including PET-CT and brain CT scans to confirm no distant disease before randomization, regular monitoring of health status, and evaluation of disease recurrence or survival. Researchers will track adverse events for six months after treatment ends and explore biomarkers like ctDNA levels to understand treatment effects. The trial lasts approximately seven years, with two years for patient enrollment, one year of treatment, three years of follow-up, and additional time for study closure.

Study of Treatment With Sacituzumab and Zimberelimab for Patients With Lung Cancer Confined to the Chest and Previously Operated on Who Were Not Disease-free.