Non-small Cell Lung CarcinomaTOP 1502NCT02848872
Evaluation of Tumor and Blood Immune Biomarkers in Resected Non-small Cell Lung Cancer
An observational study of Non-small Cell Lung Carcinoma, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Carcinoma
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 2 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Clinically suspected or pathologically documented NSCLC patients * Planned standard of care surgical resection, T > 3 cm or metastatic tumor >1 cm
Who may be able to join
- 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.
Who cannot join
- Prisoners or subjects who are compulsorily detained for treatment of either psychiatric or physical (e.g. infectious) illness are not eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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.
Read the 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.
- Conditions
- Non-small Cell Lung Carcinoma
- Keywords
- Tumor-infiltrating lymphocytes (TILs)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NSCLC patients | Resected patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At surgery (timepoint variable depending on pre-operative therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startMay 2016
- Primary completion2 Apr 2019
- Study completion2 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Clarke, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848872
- Sponsor's protocol ID
- Pro00069742
- Acronym
- TOP 1502
- Status last verified
- May 2019
- First submitted
- 26 May 2016
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tumor and Blood Immune Biomarkers in Resected Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02848872
- Acronym / sponsor ID
- TOP 1502 / Pro00069742
- Conditions
- Non-small Cell Lung Carcinoma
- Keywords
- Tumor-infiltrating lymphocytes (TILs)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- 2 Apr 2019 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 29 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NSCLC patients | – | –Resected patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Clinically suspected or pathologically documented NSCLC patients * Planned standard of care surgical resection, T > 3 cm or metastatic tumor >1 cm
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Prisoners or subjects who are compulsorily detained for treatment of either psychiatric or physical (e.g. infectious) illness are not eligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Clarke, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Carcinoma, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.