This is a single arm, multi-center clinical trial. Target population is advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients with Programmed Cell Death Ligand 1 (PD-L1) negative, aiming to evaluate the efficacy and safety of the combination therapy of Cadonilimab and chemotherapy. Cadonilimab is a PD-1/CTLA-4 bi-specific antibody.
Patients with histologically/cytologically stage IIIB, IIIC, IV non-squamous Non-Small Cell Lung Cancer (NSCLC)
PD-L1 TPS<1%
Life expectancy more than 3 months
Without EGFR-sensitive mutation (19Exon del/21Exon L858R), ALK, ROS1 gene rearrangement or fusion
Histological examination with Small Cell Lung Cancer or squamous Non-Small Cell Lung Cancer
With active central nervous system (CNS) metastases confirmed by CT or MRI
With other malignancy within 3 years before enrollment
With severe infections within 4 weeks of the first dose of study treatment
Single group
Cadonilimab
DrugPatients receive cadonilimab (10mg/kg) every 3 weeks.
Pemetrexed
DrugPatients receive pemetrexed (500mg/m2) every 3 weeks.
Carboplatin
DrugPatients receive carboplatin (AUC=5) every 3 weeks for 4 cycles.
12-month progression-free-survival (PFS) rate
Rate of patients with complete/partial response at 12-month from enrollment
objective response rate (ORR)
objective response rate using RECIST 1.1 criteria
duration of response (DOR)
Time from the date of the first documented response (CR or PR) to the earliest date of disease progression (RECIST 1.1), or death due to any cause
disease control rate (DCR)
disease control rate using RECIST 1.1 criteria
time to response (TTR)
Time from the date of enrollment to the first documented response (CR or PR) (RECIST 1.1)
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