Evaluation of Tumor and Blood Immune Biomarkers in Resected Non-small Cell Lung Cancer (TOP 1502)

September 24, 2019 updated by: Duke University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
NSCLC patients
Resected patients

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At surgery (timepoint variable depending on pre-operative therapy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 2, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 2, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00069742

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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