Evaluation of Tumor and Blood Immune Biomarkers in Resected Non-small Cell Lung Cancer
Completed
Conditions studied: Non-small Cell Lung Carcinoma
In brief
The hypothesis of this study is that functional tumor infiltrating lymphocyte (TIL) isolation from resected lung cancer specimens is feasible, allowing determination of tumor antigen-specific T cell reactivities. The primary objective of this study is to investigate the feasibility of isolating functional tumor infiltrating lymphocytes s(TILs) to determine tumor antigen-specific T cell re-activities in 30 resected lung tumor specimens. Successful isolation of TILs will be defined as collecting 1x10-6 viable, CD45+ mononuclear cells or greater from tumors containing \>/=1 gram of excess tissue. If successful isolation of TILs can be obtained from \>/= 66% of resected tumor specimens, the protocol will be considered feasible. The primary exploratory objective is to identify immunologic signatures that predict clinical outcomes from cytotoxic chemotherapy and/or immunotherapy.
Key facts
- Study ID
- NCT02848872
- Run by
- Duke University
- People needed
- 25
- Starts
- 2016-05-01
- Expected to finish
- 2019-04-02
- Last updated by the study team
- 2019-09-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Planned standard of care surgical resection, T > 3 cm or metastatic tumor >1 cm
- Age 18 or older
- Signed written ICF
- If neoadjuvant treatment is received, regimens containing either platinum-based chemotherapy or anti-PD1/PDL1 treatment will be allowed.
- Patients with metastatic disease undergoing tumor resection will be eligible if prior treatment has included systemic therapy of interest, including, but not limited to, anti-PD1/PDL agents.
You may not qualify if…
- Prisoners or subjects who are compulsorily detained for treatment of either psychiatric or physical (e.g. infectious) illness are not eligible.
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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