RecruitingPhase 1NCT05504278

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


Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Enrollment

144 participants

Start Date

Sep 20, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called IBI351 — which targets a specific mutation in cancer cells called KRAS G12C — combined with chemotherapy in patients with advanced non-squamous non-small cell lung cancer. KRAS G12C is a genetic "on-switch" that drives cancer growth; IBI351 is designed to block it. **You may be eligible if...** - You have confirmed non-squamous non-small cell lung cancer with a KRAS G12C mutation - Your cancer is unresectable (cannot be surgically removed) or has spread - You have not received any prior systemic treatment for your advanced lung cancer - Your organ function is adequate **You may NOT be eligible if...** - You have had prior treatment targeting KRAS G12C - You have active brain metastases - You have had major stomach surgery or cannot swallow oral medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGIBI351

recommended dose, po

DRUGCetuximab

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

DRUGpemetrexed

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

DRUGCarboplatin

AUC=5, Q3W, day1, i.v.

DRUGSintilimab

200mg, Q3W, day1, i.v.

DRUGcis-platinum

75mg/m\^2, Q3W, day1, i.v.


Locations(1)

Jilin Province Cancer Hospital

Jilin, Changchun, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05504278


Related Trials