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

PHASE2RecruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

March 1, 2024

Primary Completion Date

December 30, 2026

Study Completion Date

December 30, 2026

Conditions
Non-small Cell Lung Cancer
Interventions
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

Trial Locations (1)

443002

RECRUITING

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

All Listed Sponsors
lead

Xin-Hua Xu

OTHER