OncoMatch/Clinical Trials/NCT05681780
Clinical Trial of CD40L-Augmented TIL for Patients With EGFR, ALK, ROS1 or HER2-Driven NSCLC
Is NCT05681780 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for non small cell lung cancer.
Treatment: Tumor-infiltrating Lymphocytes (TIL) · Nivolumab · Cyclophosphamide · Fludarabine · Interleukin-2 (IL2) — To determine the effect of a special preparation of cells, called tumor-infiltrating lymphocytes (TIL) stimulated with CD40L, when given with the drug nivolumab, for patients with EGFR, ALK, ROS1, or HER2-genomically altered lung cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR activating genomic alteration within receptor tyrosine kinase domain
activating genomic alteration within either: EGFR, ALK, ROS1, or ERBB2 receptor tyrosine kinase domains
Required: ALK activating genomic alteration within receptor tyrosine kinase domain
activating genomic alteration within either: EGFR, ALK, ROS1, or ERBB2 receptor tyrosine kinase domains
Required: ROS1 activating genomic alteration within receptor tyrosine kinase domain
activating genomic alteration within either: EGFR, ALK, ROS1, or ERBB2 receptor tyrosine kinase domains
Required: HER2 (ERBB2) activating genomic alteration within receptor tyrosine kinase domain
activating genomic alteration within either: EGFR, ALK, ROS1, or ERBB2 receptor tyrosine kinase domains
Disease stage
Required: Stage IV
Metastatic disease required
Diagnosis of stage IV or recurrent non-small cell lung cancer (NSCLC)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy — NSCLC
Participants must have had disease progression after at least one prior line of systemic therapy for NSCLC, including appropriate prior targeted therapy for cases in which a targeted therapy is conventionally used for this genomic alteration
Cannot have received: anti-PD-1 therapy (nivolumab, pembrolizumab, cemplimumab, spartalizumab)
No prior PD-1...inhibitor treatment for metastatic NSCLC. Examples of inhibitors include: nivolumab, atezolizumab, pembrolizumab, avelumab, cemplimumab, spartalizumab, or durvalumab.
Cannot have received: anti-PD-L1 therapy (atezolizumab, avelumab, durvalumab)
No prior PD-1 or PD-L1 inhibitor treatment for metastatic NSCLC. Examples of inhibitors include: nivolumab, atezolizumab, pembrolizumab, avelumab, cemplimumab, spartalizumab, or durvalumab.
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL (transfusions permissible); ANC ≥ 1000/mm3; Platelet count ≥ 75,000/mm3 (no platelet transfusions for 7 days); Prothrombin Time ≤ 1.7x ULN unless on intended anticoagulant therapy
Kidney function
Serum creatinine ≤ 1.5x ULN, or ≥30 mL/min for participant with creatinine levels >1.5 × ULN
Liver function
Serum bilirubin ≤ 2.0x ULN, or ≤ 4.0x ULN if confirmed Gilbert's syndrome; AST/ALT ≤ 2.5x ULN unless liver metastases are present, in which case ≤ 5x ULN; Albumin ≥ 2.0 g/dl
Cardiac function
Mean QTc < 480 ms (Bazett's Correction)
Adequate normal organ and marrow function as defined below: ... Mean QT interval corrected for heart rate (QTc) ≥480 ms calculated from electrocardiograms (EKGs) using Bazett's Correction
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Moffitt Cancer Center · Tampa, Florida
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