Study Stopped
The primary objectives have not been met due to no patient enrollment therefore, the PI is requesting to close the study at this time.
Analysis of Biopsy Specimens to Study Responses to PD-1 or PD-L1 Therapies
Characterization of Mechanism of Response to PD-1 Blockade in NSCLC: A Pilot Study
1 other identifier
observational
N/A
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2019
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 8, 2019
CompletedFirst Submitted
Initial submission to the registry
March 12, 2019
CompletedFirst Posted
Study publicly available on registry
March 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 26, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 26, 2020
CompletedMay 15, 2025
August 1, 2020
1.5 years
March 12, 2019
May 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants biopsied on-treatment and with newly diagnosed or recurrent PD-L1 advanced Non Small Cell Lung Cancer/NSCLC
24 weeks
Study Arms (1)
Non Small Cell Lung Cancer (NSCLC)
Participants with pathologically confirmed newly diagnosed or recurrent advanced NSCLC that is PD-L1 high by immunohistochemistry
Interventions
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.
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.
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.
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.
Eligibility Criteria
Participants with newly diagnosed or recurrent, PD-L1 high (\>50%) metastatic non-small cell lung cancer without prior PD-(L)1 therapy
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Memoral Sloan Kettering Basking Ridge (Consent and Follow up)
Basking Ridge, New Jersey, 07920, United States
Memoral Sloan Kettering Monmouth (Consent and Follow up)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Consent and Follow up)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center @ Suffolk (Consent Only)
Commack, New York, 11725, United States
Memoral Sloan Kettering Westchester (Consent & Follow Up)
Harrison, New York, 10604, United States
Memorial Sloan - Kettering Cancer Center (Consent and follow-up)
New York, New York, 10021, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Hellmann, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2019
First Posted
March 15, 2019
Study Start
March 8, 2019
Primary Completion
August 26, 2020
Study Completion
August 26, 2020
Last Updated
May 15, 2025
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will share
• 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.