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

Innovent Biologics

Status and phase: Enrolling; Phase 1

Conditions: Advanced Non-Small Cell Lung Cancer

Treatments: Drug: Sintilimab; Drug: Carboplatin; Drug: cis-platinum; Drug: pemetrexed; Drug: IBI351; Drug: Cetuximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05504278

CIBI351A301

Details and patient eligibility

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.

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically confirmed diagnosis of nonsquamous NSCLC with KRAS G12C mutation
2. Unresectable or metastatic disease
3. Adequate organ function
4. Not received any systemic antitumor therapy for locally advanced or metastatic non-squamous NSCLC previously.

Exclusion criteria

1. History of intestinal disease or major gastric surgery or inability to swallow oral medications
2. Prior therapy with agents targeting KRAS G12C mutation (e.g., AMG 510).
3. Active brain metastases.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 5 patient groups

IBI351 in combination with pemetrexed and cis-platinum/carboplatin (the subject with PD-L1 TPS<1%)

Experimental group

Treatment:

Drug: IBI351

Drug: pemetrexed

Drug: cis-platinum

Drug: Carboplatin

IBI351 in combination with Cetuximab

Experimental group

Treatment:

Drug: Cetuximab

Drug: IBI351

IBI351 monotherapy

Experimental group

Treatment:

Drug: IBI351

IBI351 in combination with Sintilimab

Experimental group

Treatment:

Drug: IBI351

Drug: Sintilimab

IBI351 in combination with pemetrexed and cis-platinum/carboplatin(the subject with PD-L1 TPS 1-49%)

Experimental group

Treatment:

Drug: IBI351

Drug: pemetrexed

Drug: cis-platinum

Drug: Carboplatin