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.
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
No more than six prior lines of systemic therapy for NSCLC
No prior PD-1 or PD-L1 inhibitor treatment for metastatic NSCLC. Examples of inhibitors include: nivolumab, atezolizumab, pembrolizumab, avelumab, cemplimumab, spartalizumab, or durvalumab.
Participants with rapidly progressing tumors, as judged by the investigator
Active or prior documented autoimmune disease within the past 2 years. NOTE: Subjects with vitiligo, Grave's disease, limited site eczema, or limited site plaque psoriasis not requiring systemic treatment (within the past 2 years), or other autoimmune conditions which are not expected to recur, are allowed after approval from the medical monitor or PI
Single group
Tumor-infiltrating Lymphocytes (TIL)
Biological/VaccineTumor 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.
Nivolumab
DrugNivolumab (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.
Cyclophosphamide
DrugCyclophosphamide will be administered on days -7 and -6.
Fludarabine
DrugFludarabine will then be infused per institutional standard on Days -7 to -3.
Tumor-infiltrating Lymphocyte Therapy
Other interventionOn day 0, all patients will receive a dose infusion TIL cells.
Interleukin-2 (IL2)
DrugParticipants 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.
Adverse Events (AE)
To characterize the safety profile of CD40L-augmented TIL administered with nivolumab.
Objective Response Rate (ORR)
Proportion of patients with complete response + partial response (CR+PR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Duration of Response (DOR)
The time from the date of the first documentation of initial response (CR or PR) to the date of the first documentation of progressive disease (PD) or death due to any cause.
Overall Survival (OS)
The time length of patients living from the date of TIL infusion
Click on the lead sponsor to view all of their trials.
