Analysis of Biopsy Specimens to Study Responses to PD-1 or PD-L1 Therapies
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | 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.
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Outcome Measures
Primary Outcome Measures
- Number of participants biopsied on-treatment and with newly diagnosed or recurrent PD-L1 advanced Non Small Cell Lung Cancer/NSCLC [24 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Pathologically confirmed newly diagnosed or recurrent advanced Non Small Cell Lung Cancer/NSCLC that is PI-L1 high by immunohistochemistry (PD-L1 >/= 50%)
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Intended treatment with a PD-(L)1 inhibitor
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Age >/= 18 years
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Karnofsky Performance Status >/= 70% and medically fit to undergo a biopsy procedure
Exclusion Criteria:
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Any medical condition or any sites of disease that would preclude a biopsy
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Pregnant or breastfeeding women
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Cognitively impairment affecting ability to understand and provide informed consent
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Prior PD-(L)1 blockade treatment
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Chemotherapy within 6 months prior to enrollment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Memoral Sloan Kettering Basking Ridge (Consent and Follow up) | Basking Ridge | New Jersey | United States | 07920 |
| 2 | Memoral Sloan Kettering Monmouth (Consent and Follow up) | Middletown | New Jersey | United States | 07748 |
| 3 | Memorial Sloan Kettering Bergen (Consent and Follow up) | Montvale | New Jersey | United States | 07645 |
| 4 | Memorial Sloan Kettering Cancer Center @ Suffolk (Consent Only) | Commack | New York | United States | 11725 |
| 5 | Memoral Sloan Kettering Westchester (Consent & Follow Up) | Harrison | New York | United States | 10604 |
| 6 | Memorial Sloan - Kettering Cancer Center (Consent and follow-up) | New York | New York | United States | 10021 |
Sponsors and Collaborators
- Memorial Sloan Kettering Cancer Center
- Wang Initiative in Lung Cancer Clinical Trials
Investigators
- Principal Investigator: Matthew Hellmann, MD, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 19-030