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.
The IOV-LUN-202 study is an international Phase II trial investigating a novel type of cell therapy for advanced lung cancer. In this study, a patient's own immune cells (TILs) are harvested from their tumor, expanded in a laboratory, and then infused back into the patient (as LN-145) to specifically attack the cancer. The primary goal is to evaluate the effectiveness of this one-time treatment in patients whose disease has progressed despite previous standard therapies. Eligible participants are adults with metastatic non-small cell lung cancer that does not carry specific genetic alterations such as EGFR, ALK, or ROS1. Following a preparatory chemotherapy regimen, participants receive the cell infusion followed by an immune-boosting medication. Throughout the study, researchers closely monitor how well the tumor responds and assess the overall safety of the therapy.
