RecruitingPhase 1NCT05504278
Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation
An Open-label, Multi-center Phase Ib/III Study Evaluating the Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Enrollment
144 participants
Start Date
Sep 20, 2022
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria4
- 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.
Exclusion Criteria3
- 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.
Interventions
DRUGIBI351
recommended dose, po
DRUGCetuximab
500mg/m\^2, Q2W, day1, i.v.
DRUGpemetrexed
500mg/m\^2, Q3W, day1, i.v.
DRUGCarboplatin
AUC=5, Q3W, day1, i.v.
DRUGSintilimab
200mg, Q3W, day1, i.v.
DRUGcis-platinum
75mg/m\^2, Q3W, day1, i.v.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05504278
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