InDuRanS: neoadjuvant immunochemotherapy followed by surgery or definitive chemoradiotherapy and consolidation durvalumab in resectable and borderline resectable stage IIB–IIIA/B non-small-cell lung cancer

Background The optimal integration of surgery and definitive chemoradiotherapy (CRT) following modern neoadjuvant immunochemotherapy in stage IIB–IIIA/B non-small-cell lung cancer (NSCLC) remains controversial. Although immune checkpoint inhibitors have substantially improved outcomes in both resectable and unresectable disease, prospective randomized data directly comparing surgery and definitive CRT after neoadjuvant immunochemotherapy are lacking. Methods InDuRanS is a prospective, multicenter, randomized, open-label phase II trial conducted in Germany. Patients with (borderline) resectable stage IIB–IIIA/B (N2) NSCLC receive three cycles of neoadjuvant immunochemotherapy with durvalumab plus platinum–paclitaxel. Patients with persistent resectability are randomized 1:1 to surgery or definitive CRT. Both treatment arms receive consolidation durvalumab for up to 12 months. The primary endpoint is 2-year event-free survival in 158 randomized patients. Key secondary endpoints include progression-free survival, overall survival, safety and tolerability, health-related quality of life, and an extensive exploratory translational research program. Discussion InDuRanS is the first randomized trial to directly compare surgery versus definitive CRT within a contemporary multimodal treatment sequence incorporating both neoadjuvant and consolidation immunotherapy in stage IIB–IIIA/B NSCLC. Its results are expected to help define optimal local treatment strategies in an evolving therapeutic landscape. InDuRanS is currently active and open to enrollment as of April 2025, with primary completion anticipated in 2028 (NCT06810609).