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

Phase 1RecruitingNCT05504278

Innovent Biologics (Suzhou) Co. Ltd.144 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

144

Conditions

Advanced Non-Small Cell Lung Cancer

Interventions

IBI351DRUG

recommended dose, po

CetuximabDRUG

500mg/m\^2, Q2W, day1, i.v.

pemetrexedDRUG

500mg/m\^2, Q3W, day1, i.v.

Carboplatin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Jilin Province Cancer Hospital

Jilin, Changchun, China

RECRUITING

Outcomes

Primary Outcomes

Number of participants with dose limiting toxicity

Number of participants with dose limiting toxicity in the dose escalation period

Time frame: 12 months

Evaluate clinical efficacy of IBI351 in combination with other therapeutic agents

Objective response rate per RECIST v1.1

Time frame: 24 months

Safety indicators during the introduction phase for IBI351 combination treatment :

Number of participants with Adverse events (AE), Treatment Emergent Adverse events (TEAE), treatment-related Adverse events (TEAE), TRAE) and the incidence of Serious Adverse events (SAE) (CTCAE v5.0 standard), with abnormal vital signs, abnormal physical exams, abnormal laboratory results and abnormal 12-lead electrocardiogram

Time frame: 24 months

Secondary Outcomes

Evaluate plasma peak concentration of IBI351

Cmax

Time frame: 12 months

Evaluate area under the plasma concentration-time curve (AUC) of IBI351

AUC

Time frame: 12 months

Evaluate terminal half-life (t1/2) of IBI351

t1/2

Time frame: 12 months

Evaluate clearance of IBI351 from the plasma

CL/F

Time frame: 12 months

Evaluate distribution of IBI351

V/F

Time frame: 12 months

Central Contacts

Haiyan Zhu

CONTACT

0512-69566088 haiyan.zhu@innoventbio.com

Data from ClinicalTrials.gov

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