SKB264 Plus Glecirasib in Advanced KRAS G12C-Mutant NSCLC: A Phase II Study

This is a multicenter, single-arm, phase II (Simon two-stage) prospective interventional clinical study. The primary objective is to evaluate the efficacy and safety of SKB264 in combination with Glecirasib (a KRAS G12C inhibitor) as first-line treatment in patients with KRAS G12C-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). Specifically, the primary endpoint is the objective response rate (ORR) assessed by investigators per RECIST 1.1 to verify the core antitumor activity of the combination regimen. Secondary objectives include comprehensive evaluation of overall efficacy via disease control rate (DCR), duration of response (DoR), time to response (TTR), progression-free survival (PFS), and overall survival (OS). Safety will be monitored in accordance with NCI CTCAE 5.0, including the incidence and severity of adverse events (AEs) and serious adverse events (SAEs), to characterize the safety profile of the combination and the feasibility of dose modifications. This study aims to provide scientific evidence for the use of this combination regimen as first-line therapy for KRAS G12C-mutated advanced NSCLC and to explore a more optimal treatment option for this patient population.

NCT Number	NCT07670013
Lead Sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University Collaborators: Ruijin Hospital, The First Affiliated Hospital of University of Science and Technology of China, Affiliated Hospital of Jiaxing University, Huzhou Central Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Ningbo Medical Center Lihuili Hospital
Conditions	NSCLC
Enrollment	43 participants
Start Date	2026-04-01
Primary Completion	2028-01 (estimated)
Study Completion	2028-06 (estimated)
Updated on ClinicalTrials.gov	2026-07-07