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

NCT07670013 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2026-07-07

No results posted yet for this study

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 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.

Conditions

Interventions

DRUG

SKB264

4 mg/kg intravenously every 2 weeks

DRUG

Goleirex

600 mg orally once daily

Sponsors & Collaborators

  • Ruijin Hospital

    collaborator OTHER

  • The First Affiliated Hospital of University of Science and Technology of China

    collaborator OTHER

  • Affiliated Hospital of Jiaxing University

    collaborator OTHER

  • Huzhou Central Hospital

    collaborator OTHER

  • Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

    collaborator OTHER

  • Ningbo Medical Center Lihuili Hospital

    collaborator OTHER_GOV

  • Second Affiliated Hospital, Zhejiang University, School of Medicine

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2028-01-31
Completion
2028-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07670013 on ClinicalTrials.gov