RecruitingPhase 2NCT06331650

A Single-arm Pilot Study of First-line Treatment With Carbognilumab Combined With Chemotherapy in Patients With STK11-mutated Advanced or Postoperative Recurrent Non-small Cell Lung Cancer


Sponsor

Guangzhou Institute of Respiratory Disease

Enrollment

30 participants

Start Date

Aug 9, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the safety and tolerability of carbognilumab combined with chemotherapy as the first-line treatment for patients with STK11 mutated advanced or postoperative recurrent non-small cell lung cancer (NSCLC).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of a new immunotherapy drug called carbognilumab together with standard chemotherapy as a first-line treatment for people with advanced non-small cell lung cancer (NSCLC) that carries a mutation in a gene called STK11. STK11-mutated lung cancers typically don't respond well to standard immunotherapy, and researchers are exploring whether this combination can overcome that resistance. **You may be eligible if:** - You are between 18 and 75 years old - You have been diagnosed with advanced or recurrent NSCLC confirmed by biopsy or cytology - Your tumor has an STK11 gene mutation detected by genetic testing (NGS) - Your tumor does not have other treatable driver mutations (such as EGFR, ALK, ROS1, etc.) - You have not yet received systemic (whole-body) cancer treatment for your advanced disease, OR you completed adjuvant/neoadjuvant treatment more than 12 months ago - You have at least one measurable tumor lesion on imaging **You may NOT be eligible if:** - Your tumor has other driver mutations that have approved targeted therapies - You have already received immunotherapy or systemic cancer therapy for advanced disease - You have had recent anticancer treatment with less than a 4-week gap - You have unresolved significant side effects from previous treatments 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.

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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

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NCT06331650


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