OncoMatch/Clinical Trials/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
Is NCT06467500 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Cadonilimab (AK104) for non-small cell lung cancer.
Treatment: Cadonilimab (AK104) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR wild-type
Patients who tested negative for driver genes after genetic testing
Required: ALK wild-type
Patients who tested negative for driver genes after genetic testing
Required: ROS1 wild-type
Patients who tested negative for driver genes after genetic testing
Required: BRAF wild-type
Patients who tested negative for driver genes after genetic testing
Required: MET wild-type
Patients who tested negative for driver genes after genetic testing
Required: RET wild-type
Patients who tested negative for driver genes after genetic testing
Required: HER2 (ERBB2) wild-type
Patients who tested negative for driver genes after genetic testing
Required: KRAS wild-type
Patients who tested negative for driver genes after genetic testing
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anti-PD-1 therapy
Patients who have undergone previous systemic therapy and failed anti-PD-1/PD-L1 immunotherapy
Must have received: anti-PD-L1 therapy
Patients who have undergone previous systemic therapy and failed anti-PD-1/PD-L1 immunotherapy
Cannot have received: bispecific antibody
Previous treatment with bispecific antibodies
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5 × 10^9/L, platelet count ≥ 70 × 10^9/L, hemoglobin ≥ 80g/L (no transfusion or stimulating drugs within 7 days before screening)
Kidney function
Serum creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 45 mL/min (Cockcroft/Gault)
Liver function
Total serum bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN (no liver mets) or ≤ 5 × ULN (with liver mets)
Liver function: Total serum bilirubin ≤ 1.5 × ULN; ... ALT and AST ≤ 2.5 × ULN (no liver mets), ≤ 5 × ULN (with liver mets); Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 45 mL/min (Cockcroft/Gault); Blood routine: Absolute neutrophil count ≥ 1.5 × 10^9/L, platelet count ≥ 70 × 10^9/L; Hemoglobin ≥ 80g/L (no blood transfusion or use of hematopoietic stimulating drugs for correction within 7 days before screening)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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