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RECRUITING
NCT07670013
PHASE2

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

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

Summary

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 lucankizumab (SKB264) in combination with golelixir (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.

Official title: A Multicenter, Single-Arm, Phase II (Simon Two-Stage) Study of Lucankizumab (SKB264) Plus Goleirex (KRAS G12C Inhibitor) as First-Line Treatment for KRAS G12C-Mutated Advanced NSCLC

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

43

Start Date

2026-04-01

Completion Date

2028-06

Last Updated

2026-06-25

Healthy Volunteers

No

Conditions

Interventions

DRUG

SKB264

4 mg/kg intravenously every 2 weeks

DRUG

Goleirex

600 mg orally once daily

Locations (1)

2nd Affiliated Hospital, School of Medicine

Hangzhou, Zhejiang, China