Clinical Trial of CD40L-Augmented TIL for Patients With EGFR, ALK, ROS1 or HER2-Driven NSCLC

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute

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)

Treatment groups

20 Participants
are divided into 1 treatment group