Analysis of Biopsy Specimens to Study Responses to PD-1 or PD-L1 Therapies
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|ClinicalTrials.gov Identifier: NCT03877250|
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
|Condition or disease||Intervention/treatment|
|Non Small Cell Lung Cancer||Diagnostic Test: Pre-Treatment Biopsy Diagnostic Test: On-Treatment Biopsy Diagnostic Test: Biopsy at Disease Progression Diagnostic Test: Peripheral Blood-Based Studies|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Characterization of Mechanism of Response to PD-1 Blockade in NSCLC: A Pilot Study|
|Actual Study Start Date :||March 8, 2019|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03877250
|Contact: Matthew Hellmann, MDfirstname.lastname@example.org|
|Contact: Kathryn Arbour, MDemail@example.com|
|United States, New York|
|Memorial Sloan - Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10021|
|Contact: Matthew Hellmann, MD 646-888-4863|
|Principal Investigator:||Matthew Hellmann, MD||Memorial Sloan Kettering Cancer Center|