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

RECRUITINGPhase 1Sponsored by Innovent Biologics (Suzhou) Co. Ltd.
Actively Recruiting
PhasePhase 1
SponsorInnovent Biologics (Suzhou) Co. Ltd.
Started2022-09-20
Est. completion2025-05-31
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted

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

Age: 18 Years – 75 YearsHealthy volunteers accepted
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 metastatic non-squamous NSCLC previously.

Exclusion Criteria:

1. History of intestinal disease or major gastric surgery or inability to swallow oral medications
2. Prior therapy with agents targeting KRAS G12C mutation (e.g., AMG 510).
3. Active brain metastases.

Conditions3

Advanced Non-Small Cell Lung CancerCancerLung Cancer

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