Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation
NCT05504278 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 144
Last updated 2025-01-27
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.
Conditions
Interventions
- DRUG
-
IBI351
recommended dose, po
- DRUG
-
500mg/m\^2, Q2W, day1, i.v.
- DRUG
-
pemetrexed
500mg/m\^2, Q3W, day1, i.v.
- DRUG
-
AUC=5, Q3W, day1, i.v.
- DRUG
-
Sintilimab
200mg, Q3W, day1, i.v.
- DRUG
-
cis-platinum
75mg/m\^2, Q3W, day1, i.v.
Sponsors & Collaborators
-
Innovent Biologics (Suzhou) Co. Ltd.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-09-20
- Primary Completion
- 2025-05-31
- Completion
- 2027-07-31
Countries
- China
Study Locations
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