The Phase II IOV-LUN-202 trial is an open-label, multicenter, non-randomised cohort study evaluating the autologous tumor-infiltrating lymphocyte therapy LN-145 in adults with metastatic non-small-cell lung cancer (NSCLC) lacking EGFR, ALK or ROS1 driver mutations. The primary objective is to assess the objective response rate (ORR) per RECIST 1.1. Eligible patients are adults with documented radiographic progression following at least one line of systemic therapy including an immune checkpoint inhibitor plus platinum-based chemotherapy. Screening excludes the presence of EGFR, ALK and ROS1 driver mutations. Treatment is delivered in sequence: a non-myeloablative lymphodepleting preparative regimen followed by LN-145 infusion and IL-2 administration in non-randomised cohorts. Key secondary endpoints include duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and the safety profile.
This study investigates an adoptive cell therapy – autologous tumor-infiltrating lymphocytes (TIL), drug name LN-145 – in adults with metastatic non-small-cell lung cancer (NSCLC). The aim is to evaluate how effective this treatment may be in patients whose disease progressed after prior immunotherapy plus chemotherapy. Eligible participants have stage IV NSCLC without EGFR, ALK or ROS1 driver mutations. The molecular status of these driver mutations is confirmed absent at screening. Treatment is administered in non-randomised cohorts: patients receive lymphodepleting chemotherapy, followed by infusion of LN-145 and subsequent IL-2. Key secondary objectives include objective response rate, duration of response and overall survival.
