eligibility_summary
Eligibility: 16–90, histologic lung cancer (primary/relapsed/metastatic), life >3 mo, KPS≥60 or ECOG 0–2, failed/no standard therapy, ≥1 evaluable lesion and lesion/effusion for TIL harvest, adequate counts/coagulation/renal/hepatic function, no surgery/biopsy contraindication, contraception, off anti-cancer therapy ≥28 d, consent/compliance. Exclude: steroids >15 mg/d or autoimmune Rx, FEV1<2 L/DLCO<40%, major cardiac disease, HIV/HBV/HCV/syphilis, active infection, recent therapy, severe irAE/unresolved AEs, pregnancy/lactation, prior organ/allo-SCT or dialysis, other serious illness.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Phase I/II, single-arm trial in advanced/metastatic refractory lung cancer testing: 1) Autologous tumor-infiltrating lymphocytes (TIL) adoptive cell therapy—patient tumor-derived T cells expanded ex vivo to recognize and kill cancer cells. 2) Pembrolizumab (Keytruda), a monoclonal antibody immune checkpoint inhibitor that blocks PD-1 on T cells to restore/augment antitumor activity. Conditioning includes cyclophosphamide (alkylating agent) and fludarabine (purine analog) for lymphodepletion to improve TIL engraftment, plus aldesleukin (IL-2), a cytokine, to expand/activate infused T cells. Targets/pathways: tumor-specific cytotoxic T cells, PD-1/PD-L1 axis, and suppression of regulatory/suppressive cells in the tumor microenvironment. Primary endpoint: ORR.