OncoMatch/Clinical Trials/NCT06538012
TIL Therapy Combined With Pembrolizumab for Advanced or Metastatic Refractory Lung Cancer
Is NCT06538012 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for lung cancer.
Treatment: Tumor Infiltrating Lymphocytes (TIL) · Cyclophosphamide · Fludarabine · Interleukin-2 · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Performance status
KARNOFSKY/ECOG 0–2
Karnofsky≥60% or ECOG score 0-2
Lab requirements
Blood counts
Absolute count of white blood cells≥2.5×10^9/L; Absolute count of neutropils≥1.5×10^9/L; Absolute count of lymphocytes ≥0.7×10^9/L; Platelet count≥100×10^9; hemoglobin≥90 g/L
Kidney function
Serum creatinine ≤1.5mg/dL (or ≤132.6μmol/L), or clearance rate≥50mL/min
Liver function
Serum ALT/AST ≤3×ULN (subjects with liver metastasis ≤3×ULN); Totol bilirubin≤1.5×ULN
Cardiac function
No significant cardiovascular anomalies (NYHA Grade III or IV CHF, low blood pressure, uncontrollable symptomatic coronary artery diseases, ejection fraction <35%, severe cardiac rhythm and conduction anomaly)
Hematology and Chemistry（within 7 days prior to enrollment）: Absolute count of white blood cells≥2.5×10^9/L; Absolute count of neutropils≥1.5×10^9/L; Absolute count of lymphocytes ≥0.7×10^9/L; Platelet count≥100×10^9; hemoglobin≥90 g/L; APTT ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days); INR ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days); Serum creatinine ≤1.5mg/dL(or ≤132.6μmol/L), or clearance rate≥50mL/min; Serum ALT/AST ≤3×ULN(subjects with liver metastasis ≤3×ULN); Totol bilirubin≤1.5×ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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