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 (NSCLC) With Negative Driver Genes and Failed Immunotherapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Objective Response Rate（ORR）
研究概览
简要总结
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.
详细描述
Cadonilimab (AK104), China's first globally developed bispecific antibody targeting both PD-1 and CTLA-4, has demonstrated manageable safety and promising anti-tumor activity in female cervical cancer, esophageal squamous cell carcinoma, and hepatocellular carcinoma. However, there is currently no available data on the efficacy and safety of cadonilimab combined with monotherapy chemotherapy for treating advanced non-small cell lung cancer (NSCLC) with negative driver genes and previous immunotherapy failure. Therefore, this study aims to prospectively and openly evaluate the efficacy and safety of cadonilimab combined with monotherapy chemotherapy in treating patients with advanced NSCLC with negative driver genes and previous immunotherapy failure using a single-arm trial design. The goal is to provide a more effective and safe treatment option for these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate in clinical research; Fully understand and be informed of this study and sign the informed consent form;
- •Age ≥ 18 and ≤ 75, male or female;
- •ECOG physical performance score of 0-2;
- •Patients with histologically confirmed squamous or non-squamous advanced non- small cell lung cancer (according to AJCC, 8th edition);
- •Patients who tested negative for driver genes after genetic testing;
- •Patients who have undergone previous systemic therapy and failed anti-PD-1/PD- L1 immunotherapy;
- •Presence of at least one measurable lesion as defined by Recist criteria 1.1;
- •Liver function: Total serum bilirubin ≤ 1.5 × ULN; For subjects without liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN, and for those with liver metastasis, ALT and AST ≤ 5 × ULN;
- •Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 45 mL/min (using the Cockcroft/Gault formula); Blood routine: Absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 70 × 109/L; Hemoglobin ≥ 80g/L (no blood transfusion or use of hematopoietic stimulating drugs for correction within 7 days before screening) with an expected lifespan of more than 3 months.
排除标准
- •ECOG physical performance score > 2;
- •Previous treatment with bispecific antibodies;
- •Participation in other clinical trials within 30 days prior to screening;
- •Tumor metastasis to the brain and/or leptomeninges;
- •History of other malignancies (excluding cervical carcinoma in situ or skin basal cell carcinoma that has been cured, and other malignancies that have been cured for more than 5 years);
- •Accompanied by other serious diseases, including but not limited to:
- •Difficult-to-control congestive heart failure (NYHA class III or IV), unstable angina, poorly controlled arrhythmia, uncontrolled moderate to severe hypertension (SBP > 160mmHg or DBP > 100mmHg);
- •Severe active infection;
- •Difficult-to-control diabetes (referring to large fluctuations in blood sugar despite standard insulin therapy and frequent blood glucose monitoring, affecting the patient's life and frequently causing hypotension);
- •Mental illness affecting informed consent and/or protocol compliance.
- •Allergy to the drugs used in this protocol or their ingredients;
- •Pregnant (confirmed by blood or urine HCG testing) or breastfeeding women, or subjects of reproductive age who are unwilling or unable to take effective contraceptive measures (applicable to both male and female subjects) until at least 6 months after the last experimental treatment;
- •Investigators consider it inappropriate to participate in this study;
- •Unwilling to participate in this study or unable to sign the informed consent form.
研究组 & 干预措施
Bispecific antibody plus Chemotherapy
干预措施: Cadonilimab (AK104) (Drug)
结局指标
主要结局
Objective Response Rate（ORR）
时间窗: approximately 24 months
The objective response rate (ORR) refers to the proportion of patients whose tumor shrinks by a certain percentage (generally 30%) and maintains this reduction for a certain period of time (generally 4 weeks).
次要结局
- Disease Control Rate (DCR)(approximately 24 months)
- Duration of Response (DoR)(approximately 24 months)
- Progression-free survival (PFS)(approximately 24 months)
- Overall Survival (OS)(approximately 24 months)
- Adverse event (AE)(approximately 24 months)
研究者
Xin-Hua Xu
professor
China Three Gorges University, Yichang, China