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

Study Overview
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Brief Summary
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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.

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

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Diagnostic Test: Pre-Treatment Biopsy
* Diagnostic Test: On-Treatment Biopsy
* Diagnostic Test: Biopsy at Disease Progression
* Diagnostic Test: Peripheral Blood-Based Studies


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non Small Cell Lung Cancer (NSCLC)<br>Participants with pathologically confirmed newly diagnosed or recurrent advanced NSCLC that is PD-L1 high by immunohistochemistry | Diagnostic Test: Pre-Treatment Biopsy<br>* 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.<br>Diagnostic Test: On-Treatment Biopsy<br>* 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.<br>Diagnostic Test: Biopsy at Disease Progression<br>* 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.<br>Diagnostic Test: Peripheral Blood-Based Studies<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants biopsied on-treatment and with newly diagnosed or recurrent PD-L1 advanced Non Small Cell Lung Cancer/NSCLC |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PD-L1 High, 19-030, Memorial Sloan Kettering Cancer Center