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 (Jun 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
Treatments studied
Immunotherapy
Chemotherapy
Other
Cancer type
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05681780 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-PD-1 therapy, anti-PD-L1 therapy disqualifies patients from enrollment.
Does this trial require EGFR?
Yes, EGFR activating genomic alteration within receptor tyrosine kinase domain is a required biomarker for enrollment.
Does this trial require ALK?
Yes, ALK activating genomic alteration within receptor tyrosine kinase domain is a required biomarker for enrollment.
Does this trial require ROS1?
Yes, ROS1 activating genomic alteration within receptor tyrosine kinase domain is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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