Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation
Recruiting · NCT05504278 · Interventional (participants receive a specific treatment) · Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- Jilin Province Cancer Hospital - Jilin City, Changchun, China