A Phase II Clinical Study of Cadonilimab in Combination With Chemotherapy as First-Line Treatment for PD-L1 Negative Advanced Non-Small Cell Lung Cancer
The goal of this clinical trial is to investigate the efficacy, safety and tolerability of PD-1/CTLA-4 inhibitor (Cadonilimab) combination with chemotherapy as first-line treatment for PD-L1 negative advanced non small cell lung cancer patients. And also explore the potential biomarkers for predicting the efficacy of PD-1/CTLA-4 inhibitor for advanced non small cell lung cancer.
• Written informed consent must be obtained before implementing any trial-related procedures;
• Aged 18-80 years;
• Expected survival of more than 3 months;
• The investigator confirms the presence of at least one measurable lesion according to RECIST 1.1 criteria;
• Wild-type EGFR/ALK;
• Patients with locally advanced (stage IIIb/IIIc), metastatic, or recurrent (stage IV) NSCLC confirmed by histology or cytology, who are not eligible for curative surgery and cannot undergo definitive radiotherapy/chemotherapy, according to the 8th edition of the TNM staging classification by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer;
• PD-L1 expression in tumor tissue with Tumor Proportion Score (TPS) \< 1%;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
• No prior systemic anti-tumor treatment for advanced/metastatic disease; patients who have previously received platinum-based adjuvant chemotherapy/radiotherapy, neoadjuvant chemotherapy/radiotherapy, or curative radiotherapy for advanced disease and experienced disease progression more than 6 months after the last treatment can participate in this study;
• Adequate hematologic function, defined as absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L, platelet count \>= 100 x 10\^9/L, hemoglobin \>= 90 g/L (without transfusion history within 7 days);
• Adequate liver function, defined as total bilirubin level \<= 1.5 times the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels \<= 2.5 times ULN in all patients, or \<= 5 times ULN in patients with liver metastases;
• Adequate renal function, defined as serum creatinine \<= 1.5 times ULN;
• Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) \<= 1.5 times ULN; for subjects receiving anticoagulant therapy, INR/PT should be within the range planned by the anticoagulant;
• Women of childbearing potential must have a negative pregnancy test within 7 days before starting treatment, and must use reliable contraceptive measures (such as intrauterine device, contraceptive pills, and condoms) during the trial and for 30 days after the end of the trial; male subjects of reproductive potential must use condoms for contraception during the trial and for 30 days after the end of the trial;
• Willingness to comply with regular follow-up visits and trial requirements.