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

NCT03877250 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2025-05-15

No results posted yet for this study

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.

Conditions

  • Non Small Cell Lung Cancer

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Matthew Hellmann, MD · Memorial Sloan Kettering Cancer Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-08
Primary Completion
2020-08-26
Completion
2020-08-26

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03877250 on ClinicalTrials.gov