Cadonilimab (AK104) Plus Chemotherapy as First-line Treatment in Non-squamous Non-Small Cell Lung Cancer (NSCLC) Patients With Programmed Cell Death Ligand 1 (PD-L1) Negative (ACHELOUS)
Carcinoma, Non-Small-Cell Lung
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring non-squamous Non-Small Cell Lung Cancer, Programmed Cell Death Ligand 1, cadonilimab
Eligibility Criteria
Inclusion Criteria: 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 Has no prior systemic therapy; (chemotherapy and/or radiotherapy is allowed as part of neoadjuvant/adjuvant therapy. Patients who have had recurrence or metastasis for more than 6 months from the end of neoadjuvant/adjuvant treatment would be enrolled) ECOG score 0-1 Patients must have at least one measurable lesion according to RECIST 1.1 Has adequate organ function Agree to provide tumour tissue samples for biomarker exploration (including but not limited to PD-L1 IHC or NGS testing) Voluntarily sign a written informed consent form Exclusion Criteria: 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 Women who are pregnant or lactating History of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonia requiring hormone therapy History of myocarditis, cardiomyopathy, and malignant arrhythmia Tumor compresses important surrounding organs (such as the esophagus) with accompanying symptoms, compressing the superior vena cava or invading the mediastinal vessels, heart, etc. Risk of bleeding, major hemoptysis, or with history of coagulation dysfunction Active autoimmune diseases that require systematic treatment within 2 years before enrollment History of Human Immunodeficiency Virus (HIV) With active hepatitis B infection With uncontrollable pleural effusion, pericardial effusion, or ascites that require repeated drainage
Sites / Locations
- Qian ChuRecruiting
Arms of the Study
Arm 1
Experimental
Experimental Arm
Patients will receive cadonilimab (10mg/kg) plus pemetrexed(500mg/m2) and carboplatin (AUC=5) every 3 weeks for 4 cycles, follwed with cadonilimab (10mg/kg) plus pemetrexed (500mg/m2) every 3 weeks as maintenance therapy.