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

This Phase I/II study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) immunotherapy in patients with advanced or metastatic refractory lung cancer. Lifileucel (Amtagvi), the first FDA-approved TIL therapy, has demonstrated significant success in treating unresectable or metastatic melanoma by utilizing the patient's own immune cells to combat cancer. This study aims to apply a similar approach to lung cancer. TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody targeting the PD-1 receptor on T cells, will be administered to enhance the immune response. The primary endpoint is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and quality of life (QoL). This trial aims to offer a novel, personalized treatment option for patients with limited therapeutic alternatives.

NCT Number	NCT06538012
Lead Sponsor	Essen Biotech
Conditions	Lung Cancer, Lung Cancer Metastatic, Lung Cancer, Non-small Cell, Lung Cancer Recurrent
Enrollment	85 participants
Start Date	2024-08-20
Primary Completion	2026-09-10 (estimated)
Study Completion	2026-12-28 (estimated)
Updated on ClinicalTrials.gov	2024-10-15