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RECRUITING
NCT05504278
PHASE1

Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation

Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2022-09-20

Completion Date

2027-07-31

Last Updated

2025-01-27

Healthy Volunteers

No

Interventions

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.

Locations (1)

Jilin Province Cancer Hospital

Jilin, Changchun, China