A Multicenter Randomized Open-Label Trial Evaluating ctDNA-Guided Interruption Versus Standard of Care Immune-Checkpoint Inhibitor (ICI) Therapy In Patients With Advanced / Metastatic Solid Tumors.

This is a multicenter, open-label, randomized (1:1) trial designed to evaluate whether ctDNA-guided interruption of immune-checkpoint inhibitor (ICI) therapy provides comparable survival to standard of care (SoC) continuous ICI therapy in patients with histologically confirmed advanced/metastatic non-small cell lung cancer (NSCLC), melanoma, microsatellite instability-high (MSI-High)/Deficient Mismatch Repair (dMMR) colorectal cancer (CRC), renal cell carcinoma (RCC) and other solid tumors. This study will be conducted in up to 100 sites.

NCT Number	NCT07689812
Lead Sponsor	Natera, Inc.
Conditions	NSCLC (Advanced Non-small Cell Lung Cancer), NSCLC (Non-small Cell Lung Cancer), NSCLC (Non-small Cell Lung Carcinoma), NSCLC, Melanoma (Skin Cancer), Melanoma (Skin) Stage IV, CRC, MSI High Colorectal Cancer +7 more
Enrollment	920 participants
Start Date	2026-12
Primary Completion	2033-12 (estimated)
Study Completion	2034-03 (estimated)
Updated on ClinicalTrials.gov	2026-08-04