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

ConditionAdvanced Non-Small Cell Lung Cancer

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-75

SponsorInnovent Biologics (Suzhou) Co. Ltd.

About this trial

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

Qualifiers

Histologically confirmed diagnosis of nonsquamous NSCLC with KRAS G12C mutation

Unresectable or metastatic disease

Adequate organ function

Not received any systemic antitumor therapy for locally advanced or metastatic non-squamous NSCLC previously.

Disqualifiers

History of intestinal disease or major gastric surgery or inability to swallow oral medications

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

Active brain metastases.

Trial design

Treatments tested in this trial

IBI351
Cetuximab
pemetrexed
Carboplatin
Sintilimab
cis-platinum

Treatment groups

144 Participants

are divided into 5 treatment groups

Sponsors and collaborators

Innovent Biologics (Suzhou) Co. Ltd.

Lead sponsor

Source ClinicalTrials.gov