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

Overview

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.

Full Title of Study: “Characterization of Mechanism of Response to PD-1 Blockade in NSCLC: A Pilot Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 26, 2020

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.

Arms, Groups and Cohorts

  • Non Small Cell Lung Cancer (NSCLC)
    • Participants with pathologically confirmed newly diagnosed or recurrent advanced NSCLC that is PD-L1 high by immunohistochemistry

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Memorial Sloan Kettering Cancer Center
  • Collaborator
    • Wang Initiative in Lung Cancer Clinical Trials
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Matthew Hellmann, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.