Evaluation of Tumor and Blood Immune Biomarkers in Resected Non-small Cell Lung Cancer
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.
Checked against the public recordLast updated Sep 25, 2019 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- Duke University
- Interventions being studied
- Not specified
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * 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. Exclusion Criteria: * Prisoners or subjects who are compulsorily detained for treatment of either psychiatric or physical (e.g. infectious) illness are not eligible.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Duke University Medical CenterDurham, North Carolina
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 25, 2019. Always confirm current availability with the study team.