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Analysis of Biopsy Specimens to Study Responses to PD-1 or PD-L1 Therapies

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ClinicalTrials.gov Identifier: NCT03877250
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Collaborator:
Wang Initiative in Lung Cancer Clinical Trials
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
The purpose of this study is to attempt to obtain an on-treatment biopsy in participants with non-small cell lung cancer who are receiving standard treatment with a drug that targets the PD-1 or PD-L1 protein.

Condition or disease Intervention/treatment
Non Small Cell Lung Cancer Diagnostic Test: Pre-Treatment Biopsy Diagnostic Test: On-Treatment Biopsy Diagnostic Test: Biopsy at Disease Progression Diagnostic Test: Peripheral Blood-Based Studies

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of Mechanism of Response to PD-1 Blockade in NSCLC: A Pilot Study
Actual Study Start Date : March 8, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Lung Cancer

Group/Cohort Intervention/treatment
Non Small Cell Lung Cancer (NSCLC)
Participants with pathologically confirmed newly diagnosed or recurrent advanced NSCLC that is PD-L1 high by immunohistochemistry
Diagnostic Test: Pre-Treatment Biopsy
Participants screened for participation will include those with a diagnosis of advanced NSCLC who have undergone a pre-treatment biopsy prior to start of therapy with a PD-(L)1 inhibitor or who are medically able to undergo a biopsy if (1) no pre-treatment biopsy has been obtained and (2) no PD-(L)1 inhibitor has been started.

Diagnostic Test: On-Treatment Biopsy
All participants who receive at least 1 dose of PD-(L)1 inhibitor will be referred for a biopsy. The biopsy should be obtained within 4 weeks of first on-treatment imaging (usually performed ~6-9 weeks after beginning therapy) and will be performed in participants regardless of radiologic response.

Diagnostic Test: Biopsy at Disease Progression
All participants who develop disease progression after initial response to PD-(L)1 blockade will be considered for an additional, optional biopsy. Biopsies at disease progression are often obtained per standard of care within 4 weeks of documented progression on imaging and prior to the initiation of further systemic therapy.

Diagnostic Test: Peripheral Blood-Based Studies
All participants will have peripheral blood obtained on Day 1 of cycles 1-4 (0, 3, 6, and 9 weeks). At each time point, peripheral blood sample will be collected pre-treatment and used for analysis of T cell subsets and TCR sequencing.




Primary Outcome Measures :
  1. Number of participants biopsied on-treatment and with newly diagnosed or recurrent PD-L1 advanced Non Small Cell Lung Cancer/NSCLC [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with newly diagnosed or recurrent, PD-L1 high (>50%) metastatic non-small cell lung cancer without prior PD-(L)1 therapy
Criteria

Inclusion Criteria:

  • Pathologically confirmed newly diagnosed or recurrent advanced Non Small Cell Lung Cancer/NSCLC that is PI-L1 high by immunohistochemistry (PD-L1 >/= 50%)
  • Intended treatment with a PD-(L)1 inhibitor
  • Age >/= 18 years
  • Karnofsky Performance Status >/= 70% and medically fit to undergo a biopsy procedure

Exclusion Criteria:

  • Any medical condition or any sites of disease that would preclude a biopsy
  • Pregnant or breastfeeding women
  • Cognitively impairment affecting ability to understand and provide informed consent
  • Prior PD-(L)1 blockade treatment
  • Chemotherapy within 6 months prior to enrollment

Information from the National Library of Medicine

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): NCT03877250


Contacts
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Contact: Matthew Hellmann, MD 646-888-4863 hellmanm@mskcc.org
Contact: Kathryn Arbour, MD 646-449-1775 arbourk@mskcc.org

Locations
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United States, New York
Memorial Sloan - Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Matthew Hellmann, MD    646-888-4863      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Wang Initiative in Lung Cancer Clinical Trials
Investigators
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Principal Investigator: Matthew Hellmann, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03877250     History of Changes
Other Study ID Numbers: 19-030
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: • Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Memorial Sloan Kettering Cancer Center:
PD-L1 High
19-030
Memorial Sloan Kettering Cancer Center

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases