A Randomized, Open-Label, Controlled, Multicenter Phase III Study of Camrelizumab Combined With Apatinib Mesylate or Camrelizumab Alone Versus Platinum-based Chemotherapy for First-line Treatment in Subjects With PD-L1 Positive Relapsed or Advanced NSCLC
试验速览
- 阶段
- 3 期
- 入组人数
- 762
- 主要终点
- Progression Free Survival (PFS) assessed by Independent review committee (IRC)
研究概览
简要总结
The study is being conducted to evaluate the efficacy and safety of Camrelizumab (200mg,q2w) combined with Apatinib(250mg qd) in subjects with PD-L1 positive relapsed or advanced non-small cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have recurrent or advanced (Stage IIIB-IV) non-small cell lung cancer confirmed by histology or cytology.
- •No prior systemic treatment. Subjects who have received prior neo-adjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment free interval of at least 6 months from randomization since the last chemotherapy cycle.
- •Subjects should not have a previously detected activating Epidermal Growth Factor Receptor (EFGR) mutation or Anaplastic Lymphoma Kinase (ALK) fusion oncogene.
- •Subjects must have measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria;
- •Freshly acquired samples or archived specimens within 6 months before randomization must be provided.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
排除标准
- •Radiologically confirmed central squamous cell carcinoma.
- •Untreated central nervous system metastases (such as brain or meningeal metastases).
- •Pleural effusion, pericardial effusion, or ascites with clinical symptoms that need drainage
- •Past or present with idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, tissue pneumonia (eg bronchitis, occlusive vasculitis), drug-induced pneumonia, active pneumonia during CT screening, or objective evidence of severe impairment of lung function
- •Subjects with an active, known or suspected autoimmune disease. Patients with type I diabetes who are receiving a stable dose of insulin, hypothyroidism who only needs hormone replacement therapy, and skin diseases (such as eczema, vitiligo, or psoriasis) that do not require systemic treatment and do not have acute deterioration within 1 year before the screening period, are allowed.
- •Subjects with suspected active tuberculosis should be examined for chest X-rays, sputum, and ruled out by clinical signs and symptoms.
- •Uncontrolled Cardiac Symptoms or Diseases.
- •Subjects with high blood pressure who cannot be controlled well with antihypertensive drugs (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
- •Arterial / venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, occurred within the first 6 months of randomization.
- •Subjects who have previously received anti-PD-1 / PD-L1 monoclonal antibody, anti-cytotoxic T lymphocyte antigen-4 monoclonal antibody, or vascular endothelial growth factor receptor (VEGFR) small molecule inhibitor therapy.
研究组 & 干预措施
Camrelizumab 200mg + Apatinib Mesylate 250mg
Camrelizumab 200mg q2w ivgtt+ Apatinib Mesylate 250mg once daily po qd
干预措施: Camrelizumab 200mg (Biological)
Pemetrexed/Paclitaxel injection+ Carboplatin
For non-squamous NSCLC: Pemetrexed disodium for injection + Carboplatin; For squamous NSCLC: Paclitaxel injection + Carboplatin
干预措施: Carboplatin (Drug)
Camrelizumab 200mg + Apatinib Mesylate 250mg
Camrelizumab 200mg q2w ivgtt+ Apatinib Mesylate 250mg once daily po qd
干预措施: Apatinib Mesylate 250mg (Drug)
Camrelizumab 200mg
Camrelizumab 200mg q2w ivgtt
干预措施: Camrelizumab 200mg (Biological)
Pemetrexed/Paclitaxel injection+ Carboplatin
For non-squamous NSCLC: Pemetrexed disodium for injection + Carboplatin; For squamous NSCLC: Paclitaxel injection + Carboplatin
干预措施: Pemetrexed disodium for injection (Drug)
Pemetrexed/Paclitaxel injection+ Carboplatin
For non-squamous NSCLC: Pemetrexed disodium for injection + Carboplatin; For squamous NSCLC: Paclitaxel injection + Carboplatin
干预措施: Paclitaxel injection (Drug)
结局指标
主要结局
Progression Free Survival (PFS) assessed by Independent review committee (IRC)
时间窗: up to 2 years
Progression Free Survival, defined as the time from randomization to the first occurrence of disease progression as determined by IRC with use of Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or death from any cause, whichever occurs first.
Overall survival
时间窗: up to 2 years
Overall survival is the time interval from the date of randomization to death due to any reason or lost of follow-up
次要结局
- Time to Treatment Failure(Up to 2 years)
- Disease Control Rate(At the time point of every 6 weeks，up to 2 years)
- Adverse Events and Serious Adverse Events(from the first drug administration to within 90 days for the last Camrelizumab dose)
- PFS assessed by investigator(up to 2 years)
- Objective Response Rate(At the time point of every 6 weeks，up to 2 years)
- Duration of Response(Up to 2 years)