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

NCT05504278 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2025-01-27

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-20
Primary Completion
2025-05-31
Completion
2027-07-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05504278 on ClinicalTrials.gov