Phase II Study of IPH5201 and Durvalumab with Chemotherapy for Early-Stage Resectable Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining IPH5201 and durvalumab with standard chemotherapy as a neoadjuvant pre-surgery treatment for patients with resectable early-stage non-small cell lung cancer NSCLC, specifically stages II to IIIA or IIIB with PD-L1 expression of 1% or higher. This phase II, open-label, single-arm multicenter study includes two cohorts, with Cohort 2 currently enrolling patients receiving the combination before surgery. Participants will receive IPH5201, durvalumab, and standard chemotherapy before surgery. In Cohort 1, patients also receive adjuvant treatment with IPH5201 and durvalumab after surgery. The study treatment involves neoadjuvant therapy aimed at improving outcomes before surgery, with Cohort 2 focusing on patients expressing PD-L1 at 1% or more. During the study, participants will be monitored for pathological complete response approximately 16 weeks after the first dose and adverse events up to 90 days after the last dose. Additional assessments include event-free survival, disease-free survival, surgical outcomes, major pathological response, objective response rate, and overall survival up to about two years. Researchers will also study pharmacokinetics and antibody responses during approximately four months of adjuvant treatment, with follow-up visits to assess safety and treatment effects over time.

IPH5201 and Durvalumab in Patients With Resectable Non-Small Cell Lung Cancer (MATISSE)