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

May 12, 2025 updated by: Memorial Sloan Kettering Cancer Center

Characterization of Mechanism of Response to PD-1 Blockade in NSCLC: A Pilot Study

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

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
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memoral Sloan Kettering Basking Ridge (Consent and Follow up)
      • Middletown, New Jersey, United States, 07748
        • Memoral Sloan Kettering Monmouth (Consent and Follow up)
      • Montvale, New Jersey, United States, 07645
        • Memorial Sloan Kettering Bergen (Consent and Follow up)
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Cancer Center @ Suffolk (Consent Only)
      • Harrison, New York, United States, 10604
        • Memoral Sloan Kettering Westchester (Consent & Follow Up)
      • New York, New York, United States, 10021
        • Memorial Sloan - Kettering Cancer Center (Consent and follow-up)

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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

Description

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

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 weeks

Collaborators and Investigators

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

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Wang Initiative in Lung Cancer Clinical Trials

Investigators

  • Principal Investigator: Matthew Hellmann, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

March 8, 2019

Primary Completion (Actual)

August 26, 2020

Study Completion (Actual)

August 26, 2020

Study Registration Dates

First Submitted

March 12, 2019

First Submitted That Met QC Criteria

March 14, 2019

First Posted (Actual)

March 15, 2019

Study Record Updates

Last Update Posted (Actual)

May 15, 2025

Last Update Submitted That Met QC Criteria

May 12, 2025

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

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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