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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03877250
• Other study ID #: 19-030
• Status: Withdrawn
• Start date: March 8, 2019
• Est. completion date: August 26, 2020

Study information

• Verified date: August 2020
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 26, 2020
• Est. primary completion date: August 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Memoral Sloan Kettering Basking Ridge (Consent and Follow up)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Cancer Center @ Suffolk (Consent Only)	Commack	New York
United States	Memoral Sloan Kettering Westchester (Consent & Follow Up)	Harrison	New York
United States	Memoral Sloan Kettering Monmouth (Consent and Follow up)	Middletown	New Jersey
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

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Wang Initiative in Lung Cancer Clinical Trials

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants biopsied on-treatment and with newly diagnosed or recurrent PD-L1 advanced Non Small Cell Lung Cancer/NSCLC		24 weeks

External Links

•   Memorial Sloan Kettering Cancer Center