Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation

Last updated: January 22, 2025
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

pemetrexed

Cetuximab

cis-platinum

Clinical Study ID

NCT05504278
CIBI351A301
  • Ages 18-75
  • All Genders

Study Summary

This Phase Ib/III study evaluates the efficacy and safety of IBI351 in combination with chemotherapy in advanced non-squamous NSCLC with KRAS G12C mutation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologically confirmed diagnosis of nonsquamous NSCLC with KRAS G12C mutation

  2. Unresectable or metastatic disease

  3. Adequate organ function

  4. Not received any systemic antitumor therapy for locally advanced or metastaticnon-squamous NSCLC previously.

Exclusion

Exclusion Criteria:

  1. History of intestinal disease or major gastric surgery or inability to swallow oralmedications

  2. Prior therapy with agents targeting KRAS G12C mutation (e.g., AMG 510).

  3. Active brain metastases.

Study Design

Total Participants: 144
Treatment Group(s): 7
Primary Treatment: pemetrexed
Phase: 1
Study Start date:
September 20, 2022
Estimated Completion Date:
July 31, 2027

Study Description

This Phase Ib/III study evaluates the efficacy and safety of IBI351 in combination with chemotherapy. There will be five cohorts of subjects, all of whom have KRAS G12C mutation and have advanced or metastatic NSCLC. Those five cohorts (A, B,C ,D and E) are treated with IBI351, IBI351+Sintilimab,IBI351+pemetrexed+cis-platinum/carboplatin,IBI351+Cetuximab, or IBI351+pemetrexed+cis-platinum/carboplatin respectively.

IBI351 is an orally available small molecule inhibitor of KRAS G12C.

Connect with a study center

  • Jilin Province Cancer Hospital

    Jilin, Changchun
    China

    Active - Recruiting

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