Study of CD40L-Enhanced Tumor-Infiltrating Lymphocytes with Nivolumab for Advanced Non-Small Cell Lung Cancer with EGFR, ALK, ROS1, or HER2 Changes

What this Trial Is About

Researchers are evaluating the effects of a special preparation of immune cells called tumor-infiltrating lymphocytes TIL that are stimulated with CD40L. These cells are given together with the drug nivolumab to patients who have advanced non-small cell lung cancer NSCLC with specific genetic changes in EGFR, ALK, ROS1, or HER2. This phase 1 clinical trial aims to explore how this combination works for these patients whose cancer has progressed after previous treatments. Participants will receive an infusion of nivolumab every three weeks before receiving chemotherapy with cyclophosphamide and fludarabine to prepare the body for TIL therapy. On day 0, they will be given an infusion of the prepared TIL cells followed by up to six doses of interleukin-2 IL-2 to support the immune response. Afterward, nivolumab infusions continue every four weeks for up to 12 months. The study focuses on this combined treatment approach and its administration schedule. During the study, participants will be closely monitored for side effects up to 18 months. Researchers will also assess how the cancer responds to treatment, the duration of any response, and overall survival for up to five years. The study involves tumor sampling to grow TIL cells, blood tests, physical exams, imaging scans, and other assessments to track health and treatment effects. The total participation time will vary, with ongoing follow-up to evaluate long-term outcomes and safety.

Clinical Trial of CD40L-Augmented TIL for Patients With EGFR, ALK, ROS1 or HER2-Driven NSCLC