eligibility_summary
Inclusion: 18–70, driver‑mutant advanced/metastatic NSCLC post targeted + platinum chemo, resectable lesion >150 mm3 for TILs, residual measurable disease, ECOG 0–1, labs OK, contraception, 28‑day/5‑half‑life washout. Exclusion: >5 prior lines, recent trials/vaccines, uncontrolled CV/metabolic/hepatic disease, ILD/pulmonary disease or effusions, active infection (TB/HIV/viral hepatitis/syphilis), autoimmune on steroids, severe irAEs, prior allo transplant/cell therapy, symptomatic CNS mets unless stable, pregnant/nursing.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
NCT06473961 is an open-label, single-arm Phase Ib trial (China) testing GC101 autologous tumor-infiltrating lymphocyte (TIL) therapy in advanced/metastatic NSCLC. Intervention: Biological/cellular therapy—patient tumor is resected, TILs are expanded ex vivo, then infused after lymphodepletion, a low-dose anti–PD-1 monoclonal antibody (checkpoint inhibitor) follows. Mechanisms: TILs (primarily CD8+ and CD4+ T cells) recognize tumor-specific antigens via TCR–MHC and kill tumor cells, lymphodepletion supports TIL engraftment, PD-1 blockade reverses T-cell exhaustion, enhancing proliferation and cytotoxicity. Targets: tumor-reactive T cells, tumor cells presenting neoantigens, and the PD-1/PD-L1 immune checkpoint pathway in the tumor microenvironment.