RecruitingPhase 2NCT06467500

A Prospective, Open-label, Single-center, Single-arm Phase II Clinical Study of Cadonilimab (AK104) Combined With Monotherapy Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer With Negative Driver Genes and Failed Immunotherapy

A Prospective, Open-label, Single-center, Single-arm Phase II Clinical Study of Cadonilimab (AK104) Combined With Monotherapy Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With Negative Driver Genes and Failed Immunotherapy

Sponsor

Xin-Hua Xu

Enrollment

48 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer

Summary

The aim of evaluating the efficacy and safety of cadonilimab combined with monotherapy chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) with negative driver genes who have failed previous immunotherapy is to provide a more effective and safe treatment option for these patients.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This phase II study is testing whether combining the immunotherapy drug cadonilimab with a single chemotherapy agent can help patients with advanced non-small cell lung cancer (NSCLC) that has stopped responding to standard immunotherapy. **You may be eligible if...** - You are between 18 and 75 years old - You have histologically confirmed advanced or metastatic NSCLC (squamous or non-squamous) - Your cancer tested negative for driver gene mutations (EGFR, ALK, etc.) - You have previously received and failed an anti-PD-1/PD-L1 immunotherapy - You have at least one measurable lesion **You may NOT be eligible if...** - Your cancer has driver gene mutations (like EGFR or ALK) - You have not previously received immunotherapy 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 (AK104)

Subjects participated in a study where they received cadonilimab intravenously at 6mg/kg every two weeks, prepared in 100mL of normal saline (0.9% NaCl), with a final concentration range of 0.2-5.0mg/mL. The infusion solution must be used within 4 hours of preparation. Treatment continued until disease progression (PD), unacceptable toxicity, or 24 months, whichever came first. Patients who investigators deemed could still benefit from cadonilimab post-PD were allowed continued treatment. Chemotherapy regimens were selected by investigators based on prior medication use, including gemcitabine, pemetrexed, docetaxel, albumin-bound paclitaxel, or vinorelbine as second- or third-line therapy

Locations(1)

Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University

Yichang, China

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NCT06467500

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