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

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

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.

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