Nivolumab and Tumor Infiltrating Lymphocytes (TIL) in Advanced Non-Small Cell Lung Cancer (NCT03215810) | Clinical Trial Compass
CompletedPhase 1
Nivolumab and Tumor Infiltrating Lymphocytes (TIL) in Advanced Non-Small Cell Lung Cancer
United States20 participantsStarted 2017-10-11
Plain-language summary
Investigators plan to study the safety, side effects, and benefits of tumor-infiltrating lymphocytes (TILs) when they are given with the drug nivolumab. Nivolumab is a type of immunotherapy - a drug that is used to boost the ability of the immune system to fight cancer, infection, and other diseases.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \>18 years
* Able to understand and give written informed consent
* Confirmed or suspected diagnosis of stage IV or recurrent non-small cell lung cancer (NSCLC). For suspected NSCLC, diagnosis must be histologically or cytologically confirmed prior to start of nivolumab treatment. Neuroendocrine cancers, or mixed neuroendocrine features in \>10% of tumor cells, are excluded.
* Tumor deemed accessible by metastasectomy (TIL harvest) which expects to yield \>1.5 cm\^3 of resectable tumor amount.
* Measurable disease, even after resection of applicable lesion for TIL harvest. Defined as ≥1 lesion that is ≥10 mm in one dimension by CT scan, MRI, or calipers on clinical exam.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Expected survival \> 6 months
* Patients with activating Epidermal Growth Factor Receptor (EGFR) mutation or Anaplastic Lymphoma Kinase (ALK) rearrangement which is expected to be responsive to available tyrosine kinase inhibitor therapy, must have been previously treated with an applicable tyrosine kinase inhibitor.
* Adequate normal organ and marrow function in an assessment performed within 7 days (+ 3 day window) of enrollment, defined as: Hemoglobin ≥ 9.0 g/dL; Absolute neutrophil count (ANC) ≥ 1.0 x 10\^9/L (\> 1000 per mm\^3); Platelet count ≥ 100 x 10\^9/L (\>100,000 per mm\^3); Prothrombin Time (PT) and Partial Thromboplastin Time (PTT) ≤ 1.5x the institutional upper limit of normal (ULN), (This will…
What they're measuring
1
Rate of Dose Limiting Toxicity (DLT)
Timeframe: Up to 40 months
Trial details
NCT IDNCT03215810
SponsorH. Lee Moffitt Cancer Center and Research Institute