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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Jilin Province Cancer Hospital
RECRUITING
Jilin
Contact Information
Primary
Haiyan Zhu
haiyan.zhu@innoventbio.com
0512-69566088
Time Frame
Start Date: 2022-09-20
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 144
Treatments
Experimental: IBI351 in combination with pemetrexed and cis-platinum/carboplatin (the subject with PD-L1 TPS<1%)
Experimental: IBI351 in combination with Cetuximab
Experimental: IBI351 monotherapy
Experimental: IBI351 in combination with Sintilimab
Experimental: IBI351 in combination with pemetrexed and cis-platinum/carboplatin(the subject with PD-L1 TPS 1-49%)
Related Therapeutic Areas
Sponsors
Leads: Innovent Biologics (Suzhou) Co. Ltd.