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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Withdrawn

Conditions: Non Small Cell Lung Cancer

Treatments: Diagnostic Test: Biopsy at Disease Progression; Diagnostic Test: Pre-Treatment Biopsy; Diagnostic Test: On-Treatment Biopsy; Diagnostic Test: Peripheral Blood-Based Studies

Study type: Observational

Funder types: Other

Identifiers

NCT03877250

19-030

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

Non Small Cell Lung Cancer (NSCLC)

Description:

Participants with pathologically confirmed newly diagnosed or recurrent advanced NSCLC that is PD-L1 high by immunohistochemistry

Treatment:

Diagnostic Test: Peripheral Blood-Based Studies

Diagnostic Test: On-Treatment Biopsy

Diagnostic Test: Pre-Treatment Biopsy

Diagnostic Test: Biopsy at Disease Progression