About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Tumor-infiltrating Lymphocytes (TIL)
- Nivolumab
- Cyclophosphamide
- Fludarabine
- Tumor-infiltrating Lymphocyte Therapy
- Interleukin-2 (IL2)