NCT05504278

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not 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.

Detailed description

This Phase Ib/III study evaluates the efficacy and safety of IBI351 in combination with chemotherapy. There will be five cohorts of subjects, all of whom have KRAS G12C mutation and have advanced or metastatic NSCLC. Those five cohorts (A, B,C ,D and E) are treated with IBI351, IBI351+Sintilimab,IBI351+pemetrexed+cis-platinum/carboplatin,IBI351+Cetuximab, or IBI351+pemetrexed+cis-platinum/carboplatin respectively. IBI351 is an orally available small molecule inhibitor of KRAS G12C.

Conditions

• Advanced Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	IBI351	recommended dose, po
DRUG	Cetuximab	500mg/m\^2, Q2W, day1, i.v.
DRUG	pemetrexed	500mg/m\^2, Q3W, day1, i.v.
DRUG	Carboplatin	AUC=5, Q3W, day1, i.v.
DRUG	Sintilimab	200mg, Q3W, day1, i.v.
DRUG	cis-platinum	75mg/m\^2, Q3W, day1, i.v.

Timeline

• Start date: 2022-09-20
• Primary completion: 2025-05-31
• Completion: 2027-07-31
• First posted: 2022-08-17
• Last updated: 2025-01-27

Locations

1 site across 1 country: China