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

Withdrawn

• Conditions: Non Small Cell Lung Cancer
• Interventions: Diagnostic Test: Pre-Treatment Biopsy; Diagnostic Test: On-Treatment Biopsy; Diagnostic Test: Biopsy at Disease Progression; Diagnostic Test: Peripheral Blood-Based Studies

• Registration Number: NCT03877250
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-03-08
• Study First Submitted: 2019-03-12
• Study First Submitted QC: 2019-03-14
• Study First Posted: 2019-03-15
• Status Verified: 2020-08
• Primary Completion: 2020-08-26
• Study Completion: 2020-08-26
• Last Update Submitted: 2020-08-27
• Last Update Posted: 2020-08-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non Small Cell Lung Cancer (NSCLC)	Pre-Treatment Biopsy	Participants with pathologically confirmed newly diagnosed or recurrent advanced NSCLC that is PD-L1 high by immunohistochemistry
Non Small Cell Lung Cancer (NSCLC)	Biopsy at Disease Progression	Participants with pathologically confirmed newly diagnosed or recurrent advanced NSCLC that is PD-L1 high by immunohistochemistry
Non Small Cell Lung Cancer (NSCLC)	On-Treatment Biopsy	Participants with pathologically confirmed newly diagnosed or recurrent advanced NSCLC that is PD-L1 high by immunohistochemistry
Non Small Cell Lung Cancer (NSCLC)	Peripheral Blood-Based Studies	Participants with pathologically confirmed newly diagnosed or recurrent advanced NSCLC that is PD-L1 high by immunohistochemistry

Primary Outcome Measures

Name	Time	Method
Number of participants biopsied on-treatment and with newly diagnosed or recurrent PD-L1 advanced Non Small Cell Lung Cancer/NSCLC	24 weeks

Trial Locations

Locations (6)

Memoral Sloan Kettering Monmouth (Consent and Follow up); 🇺🇸 Middletown, New Jersey, United States

Memoral Sloan Kettering Basking Ridge (Consent and Follow up); 🇺🇸 Basking Ridge, New Jersey, United States

Memoral Sloan Kettering Westchester (Consent & Follow Up); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center @ Suffolk (Consent Only); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Bergen (Consent and Follow up); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan - Kettering Cancer Center (Consent and follow-up); 🇺🇸 New York, New York, United States