Evaluation of Tumor and Blood Immune Biomarkers in Resected Non-small Cell Lung Cancer (TOP 1502)
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|ClinicalTrials.gov Identifier: NCT02848872|
Recruitment Status : Recruiting
First Posted : July 29, 2016
Last Update Posted : May 11, 2018
|Condition or disease|
|Non-small Cell Lung Carcinoma|
Investigating tumor infiltrating lymphocytes in Non-small Cell Lung Cancer (NSCLC) is of clinical importance for multiple reasons. Cellular, antigen, and cytokine profiles associated with favorable clinical outcomes after therapy are currently lacking in lung cancer, and these results may lead to the development of clinically important prognostic and predictive biomarkers. Additionally, by determining the specific cell types and antigen targets of effector cells in the microenvironment, strategies can be devised to alter mechanisms regulating tumor immune tolerance. These data may ultimately enable future, novel combinational approaches of anti-tumor therapies through early phase clinical trials designed to improve clinical outcomes for patients with lung cancer. Finally, by correlating immunologic profiles with clinical outcomes (including pathologic response and progression free survival), signatures can be derived to help predict benefit from cytotoxic chemotherapy for patients receiving these treatments.
This study will plan to enroll a total of 30 patients. This number will consist of a combination of early stage NSCLC patients receiving no neoadjuvant therapy, standard neoadjuvant cytotoxic chemotherapy, or immune checkpoint therapy as well as patients with metastatic disease undergoing tumor resection that have received prior systemic therapy of interest, including but not limited to anti-PD1/PDL agents.
Standard diagnostic and staging work up will be performed, including pathologic/histologic diagnosis of cancer. Patients will receive therapy as deemed appropriate by their treating physician as per standard clinical care or as part of a clinical cancer trial. There is no randomization nor stratification. Patients will not receive any information about the assays/research performed as these are for research purposes only.
Data from patients will be extracted from medical records and images. Data elements that will be extracted include the following: age, sex, tumor histology and stage, chemotherapy regimens and immune-modulating therapy dose and schedule, disease response (outcomes).
Tumor specimen samples will be collected at the time of definitive surgical resection of tumor. After the specimen has been processed for margin status and the frozen section assessment of the specimen is complete, a specimen of excess tumor (at least 1gm) will be released and acquired by the tumor immunology correlative science staff for isolation of tumor infiltrating lymphocytes for purposes of this protocol with any remaining tissue to be processed by the Duke Biorepository staff if the subject has consented to biobanking. For those subjects that decline participation in this biorepository tissue will be processed as outlined above.
Blood will be collected prior to surgery to assess activated CD8+ T cells with specificity against tumor antigens and CD4 and CD8 functional memory.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Evaluation of Tumor and Blood Immune Biomarkers in Resected Non-small Cell Lung Cancer|
|Actual Study Start Date :||May 2016|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||February 2021|
- Quantity of functional tumor infiltrating lymphocytes (TILs) to determine tumor antigen-specific T cell re-activities. [ Time Frame: At surgery (timepoint variable depending on pre-operative therapy) ]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.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848872
|Contact: Candice F Singletary, MA||919 email@example.com|
|Contact: Melody Torain, BS||919 firstname.lastname@example.org|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Candice Singletary, MA 919-668-6719 email@example.com|
|Principal Investigator:||Jeffrey Clarke, MD||Duke University|