Clinical Trial of CD40L-augmented Tumor Infiltrating Lymphocytes (CD40L TIL) for Patients With Oncogene-Driven Advanced Non-Small Cell Lung Cancer (NSCLC)
H. Lee Moffitt Cancer Center and Research Institute
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age greater than or equal to 18 years * Diagnosis of stage IV or recurrent non-small cell lung cancer (NSCLC) with an activating genomic alteration within either: EGFR, ALK, ROS1, or ERBB2 receptor tyrosine kinase domains * ECOG performance status of 0 or 1 * Expected survival ≥ 4 months * 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, prior to initiating nivolumab trial therapy…
Interventions
- BiologicalTumor-infiltrating Lymphocytes (TIL)
Tumor harvest for TIL growth in the lab: A sample of the participant's tumor will be collected and sent to the lab for TIL growth. TIL will be prepared and cryopreserved.
- DrugNivolumab
Nivolumab (Opdivo®), 360 mg, IV infusion every 3 weeks prior to TIL infusion, and then after TIL infusion 480 mg ever 4 weeks for up to 12 months.
- DrugCyclophosphamide
Cyclophosphamide will be administered on days -7 and -6.
- DrugFludarabine
Fludarabine will then be infused per institutional standard on Days -7 to -3.
- OtherTumor-infiltrating Lymphocyte Therapy
On day 0, all patients will receive a dose infusion TIL cells.
- DrugInterleukin-2 (IL2)
Participants will receive IL-2 for up to 6 doses, based on participants tolerance and investigator judgement. This will be given after the infusion of the T-cells.
Location
- Moffitt Cancer CenterTampa, Florida