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
Trial Parameters
Brief Summary
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.
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) meta