International Phase III Trial of Adding Adjuvant Durvalumab After Neoadjuvant Chemotherapy and Durvalumab in Patients With Stage IIB-IIIB Resectable Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are conducting an international, multicenter, open-label phase III trial to evaluate the addition of adjuvant durvalumab after neoadjuvant chemotherapy combined with durvalumab and surgery in patients with early-stage, operable non-small cell lung cancer NSCLC stages IIB to IIIB. The main goal is to see if giving durvalumab after surgery improves disease-free survival in patients who do not achieve complete pathological response after initial treatment. The treatment plan involves 3 to 4 cycles of neoadjuvant durvalumab combined with platinum-based doublet chemotherapy, followed by surgery to remove the tumor. After surgery, patients with complete R0 or microscopic residual R1 resection are randomly assigned to either receive adjuvant durvalumab given intravenously at 1500 mg every 4 weeks for up to 12 cycles or to be observed without additional treatment. Participants will be monitored regularly for about 60 months after randomization to assess disease-free survival and other outcomes such as overall survival, time to recurrence, and treatment toxicity. Assessments include imaging scans to check for metastatic disease, pathological review after surgery, and ongoing safety evaluations. Participants must attend scheduled visits and follow study procedures throughout the treatment and follow-up periods.

A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer.