Phase 2 Study of Autologous LN-145 Tumor Infiltrating Lymphocyte Therapy for Metastatic Non-Small-Cell Lung Cancer

What this Trial Is About

This research aims to evaluate LN-145, an autologous tumor-infiltrating lymphocyte TIL therapy, in patients with metastatic non-small-cell lung cancer NSCLC. This phase 2, open-label, multi-cohort, non-randomized study involves patients with metastatic NSCLC, including those with varying PD-L1 tumor expression levels. The study excludes patients with certain genetic mutations and focuses on those with disease progression after prior therapies. The primary purpose is to assess treatment response and safety over time. Participants receive LN-145, which is produced by collecting a tumor sample to expand TILs outside the body. Before the infusion of LN-145, patients undergo a non-myeloablative lymphodepleting chemotherapy regimen including cyclophosphamide and fludarabine. After LN-145 infusion, patients are given IL-2 to support immune response. The study includes several cohorts based on tumor PD-L1 status, prior treatments, and other factors, with specific eligibility and treatment pathways for each. Throughout the study, participants are monitored for objective response rate and other outcomes up to 60 months. Assessments include disease progression evaluation, adverse event tracking, and biopsies. The study spans from screening through treatment and extended follow-up to evaluate long-term effects. Participants must meet performance and organ function criteria and agree to use effective birth control during and after treatment.

Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer