NCT06467500

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Xin-Hua Xu · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Cadonilimab (AK104), China's first globally developed bispecific antibody targeting both PD-1 and CTLA-4, has demonstrated manageable safety and promising anti-tumor activity in female cervical cancer, esophageal squamous cell carcinoma, and hepatocellular carcinoma. However, there is currently no available data on the efficacy and safety of cadonilimab combined with monotherapy chemotherapy for treating advanced non-small cell lung cancer (NSCLC) with negative driver genes and previous immunotherapy failure. Therefore, this study aims to prospectively and openly evaluate the efficacy and safety of cadonilimab combined with monotherapy chemotherapy in treating patients with advanced NSCLC with negative driver genes and previous immunotherapy failure using a single-arm trial design. The goal is to provide a more effective and safe treatment option for these patients.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Cadonilimab (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

Timeline

• Start date: 2024-03-01
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2024-06-21
• Last updated: 2024-06-21

Locations

1 site across 1 country: China