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Tumor-infiltrating Lymphocytes (TIL)

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

  • RegistryNCT05681780
  • PhasePhase 1
  • StatusRecruiting
  • ConditionNon Small Cell Lung Cancer
  • SponsorH. Lee Moffitt Cancer Center and Research Institute
How Tumor-infiltrating Lymphocytes (TIL) works1 min

The drug

What is being tested.

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.

On day 0, all patients will receive a dose infusion TIL cells.

The study

How the trial runs.

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.

Live record on ClinicalTrials.gov →

Eligibility

Who the study is looking for.

  • 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
  • Measurable disease, not including any lesion that is used for TIL harvest, prior to initiation of nivolumab trial therapy

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.

How these trials work: what Phase 1 actually is · common questions Not clinical evidence.

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