This is a prospective, non-randomized, pilot study. The target population is adults ≥18 years of age with metastatic non-small cell lung cancer that have completed at least 85% of planned doses of pembrolizumab in the first line setting. For the purpose of calculating 85%, we will consider 400mg pembrolizumab every 6 weeks equal to 2 cycles of 200mg pembrolizumab every 21 days. The study will be conducted at various LCI locations; external sites may be added in the future. Subjects will have blood for ctDNA and immune markers collected at baseline, and every 3 months for up to 6 months. Blood will be collected at disease progression if it occurs prior to 6 months, ensuring that the collection occurs prior to start of subsequent anti-cancer therapy. We will also collect data from standard of care CT scans every 3 months for up to 6 months or until disease progression. In patients undergoing standard of care biopsies, a portion of tumor tissue will be obtained and tested for tumor mutations. Archived tumor tissue collected pre-immunotherapy (if available) will also be tested.
The purpose of this study is to examine the association between ctDNA/immune biomarkers and disease progression in patients who completed at least 85% of planned doses of pembrolizumab monotherapy or pembrolizumab-combination chemotherapy for mNSCLC.