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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06467500 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior bispecific antibody disqualifies patients from enrollment.
Does this trial require EGFR?
Yes, EGFR wild-type is a required biomarker for enrollment.
Does this trial require ALK?
Yes, ALK wild-type is a required biomarker for enrollment.
Does this trial require ROS1?
Yes, ROS1 wild-type is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages