Evaluation of Tumor and Blood Immune Biomarkers in Resected Non-small Cell Lung Cancer

NCT02848872 | Completed

• 1 other identifier: Pro00069742
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-small Cell Lung Carcinoma

Keywords

Tumor-infiltrating lymphocytes (TILs)

Outcome Measures

Primary Outcomes (1)

• Quantity of functional tumor infiltrating lymphocytes (TILs) to determine tumor antigen-specific T cell re-activities.

  Successful isolation of TILs will be defined as collecting 1x10-6 viable, CD45+ mononuclear cells or greater from tumors containing \>/= 1 gm excess tissue in 30 resected lung tumor specimens.

  At surgery (timepoint variable depending on pre-operative therapy)

Study Arms (1)

NSCLC patients

Resected patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* Clinically suspected or pathologically documented NSCLC patients * Planned standard of care surgical resection, T \> 3 cm or metastatic tumor \>1 cm

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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Resected NSCLC specimens (excess)

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jeffrey Clarke, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: July 29, 2016
• Study Start: May 1, 2016
• Primary Completion: April 2, 2019
• Study Completion: April 2, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-05

Locations

US (1)