Safety and Effectiveness of Personalized Tumor-Infiltrating Lymphocytes TIL Therapy Combined With Pembrolizumab for Advanced or Metastatic Lung Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a personalized immunotherapy combining autologous tumor-infiltrating lymphocytes TIL therapy with Pembrolizumab in patients with advanced or metastatic refractory lung cancer. This Phase III trial builds on the success of Lifileucel, the first FDA-approved TIL therapy for melanoma, by applying a similar approach to lung cancer, which typically has limited treatment options and poor prognosis. The study aims to determine how well this combined treatment can control the disease and improve patient quality of life. Patients undergo tumor sample collection to extract and expand their own TILs outside the body. Before TIL infusion, participants receive a lymphodepletion regimen with cyclophosphamide and fludarabine to prepare the body. After the TIL infusion, Interleukin-2 IL-2 is given to stimulate the immune cells. Pembrolizumab is administered intravenously before and after the TIL infusion and continued every six weeks for up to one year if the disease does not progress or if there is no unacceptable toxicity. Surgery is also scheduled on day 80 following initial treatments. During the study, participants are closely monitored for side effects and treatment reactions, with safety assessed over six months and efficacy evaluated up to 36 months using standard response criteria. Researchers will measure objective response rate, disease control rate, progression-free survival, overall survival, duration of response, and changes in quality of life. Follow-up visits will ensure ongoing assessment of participant health and treatment effects throughout the trial period.

TIL Therapy Combined With Pembrolizumab for Advanced or Metastatic Refractory Lung Cancer