RecruitingPhase 2NCT06793813

Cadonilimab in Patients (Pts) with Advanced Non-small Cell Lung Cancer (NSCLC)

A Phase II Trial of Cadonilimab (PD-1/CTLA-4 Bispecific Antibody) in Combination with Bevacizumab and Docetaxel in Patients (pts) with Checkpoint Inhibitor (CPI)-experienced Advanced Non-small Cell Lung Cancer (NSCLC)

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

44 participants

Start Date

Jan 23, 2024

Study Type

INTERVENTIONAL

Conditions

Stage IVB Lung Cancer Non-Squamous

Summary

This phase II trial studies how well cadonilimab combined with Bevacizumab and docetaxel work in treating patients with non-squamous and stage IV non-small cell lung cancer. Cadonilimab, a PD-1/CTLA-4 bispecific antibody, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab can regulate tumor microenvironment. Docetaxel was used in standard of care chemotherapy for non-small cell lung cancer, work to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cadonilimab, bevacizumab and docetaxel together may work better in treating patients with non-squamous non-small lung cancer compared to standard of care.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests cadonilimab — a drug that blocks two immune checkpoint proteins at once (PD-1 and CTLA-4) — in people with advanced non-small cell lung cancer that has already been treated with immunotherapy and chemotherapy but has continued to grow. **You may be eligible if...** - You are 18 or older with advanced non-squamous lung cancer (Stage IIIB–IV) - You have already received at least one course of immunotherapy (PD-1/PD-L1 inhibitor) and chemotherapy with benefit - You do not have specific gene mutations for which targeted drugs are available (such as EGFR, ALK, ROS1) - Your overall health status is adequate (ECOG 0–1) **You may NOT be eligible if...** - Your cancer has one of the targetable mutations listed above - You have active brain metastases - You have serious autoimmune conditions or heart problems 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，bevacizumab，docetaxel

Patients receive Cadonilimab IV over 90 minutes on day 1. Patients also receive bevacizumab 7.5mg/kg IV on day 1 and docetaxel 60-75 mg/m2 IV over 60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Locations(1)

Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

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NCT06793813