RecruitingPhase 2NCT06341660

To Evaluate the Safety and Tolerability of Carbognilumab Combined With Chemotherapy as the First-line Treatment for Patients With KEAP1 Mutated Advanced or Postoperative Recurrent Non-small Cell Lung Cancer (NSCLC)

A Single-arm Pilot Study of Patients With Advanced or Postoperative Recurrent Non-small Cell Lung Cancer (NSCLC) With KEAP1 Mutation Treated With Carbonizumab Combined With Chemotherapy as the First-line Treatment


Sponsor

Guangzhou Institute of Respiratory Disease

Enrollment

30 participants

Start Date

May 25, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the safety and tolerability of carbognilumab combined with chemotherapy as first-line treatment in patients with KeAP1-mutated advanced or postoperative recurrent non-small cell lung cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new immunotherapy drug called carbognilumab combined with standard chemotherapy as a first-line treatment for patients with advanced lung cancer that has a specific genetic mutation (KEAP1/STK11) and cannot be treated with targeted therapies. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed advanced or recurrent non-small cell lung cancer - Your tumor has a STK11 mutation, confirmed by genetic testing - Your tumor does not have other mutations that have targeted treatments (e.g., EGFR, ALK, ROS1) - You have not yet received systemic treatment for advanced disease - Your organ function is adequate **You may NOT be eligible if...** - You have another targetable mutation with available treatment options - You have active autoimmune disease or are on immunosuppressive medications - You have uncontrolled brain metastases - You have serious heart, lung, or liver disease - You are pregnant or breastfeeding 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

DRUGcadonilimab

Cardunnilizumab: the recommended dose is 10mg/kg every 3 weeks on the first day of each cycle; Discontinuation of the drug may be considered if intolerable adverse reactions occur.


Locations(1)

The First Affiliated Hospital of Guangzhou Medical University

Guangdong, Guangzhou, China

View Full Details on ClinicalTrials.gov

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

Visit

NCT06341660


Related Trials