A Multicenter, Randomized, Open-label, Phase III Study to Compare the Efficacy and Safety of YL202 and Docetaxel in Patients With Locally Advanced or Metastatic EGFR Sensitive Mutation Non-Squamous Non-Small Cell Lung Cancer
概览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 440
- 试验地点
- 2
- 主要终点
- Overall Survival (OS)
概览
简要总结
Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to evaluate YL202 monotherapy versus Docetaxel in participants with locally advanced or metastatic non-squamous NSCLC with EGFR mutation who have failed to EGFR-TKI therapy and platinum-based chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •Males or females aged ≥18 to ≤75 years at the time of signing the ICF
- •Histologically or cytologically confirmed diagnosis of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with documented EGFR Exon 19 deletion or Exon21 L858R mutation.
- •Received one prior epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy in the locally advanced, or metastatic setting, either as monotherapy or in combination with other agents; Received one prior platinum based chemotherapy in the locally advanced, or metastatic setting, either prior to TKI, in combination with TKI, or after TKI therapy.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to
- •At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated.
- •Central nervous system (CNS) metastasis, these should be clinically asymptomatic or stable after definitive treatment.
- •Current, historical, or suspected interstitial lung disease (ILD)/pneumonitis.
排除标准
- •Histologically or cytologically confirmed presence of small cell lung cancer, neuroendocrine carcinoma, and carcinosarcoma components or squamous cell carcinoma components of more than 10%;
- •Other malignancies within 5 years prior to the first dose;
- •History of (noninfectious) interstitial lung disease (ILD) and current ILD
- •Prior HER3-targeted therapy; Prior treatment with any drug therapy targeting topoisomerase I inhibitor, including antibody-drug conjugates (ADCs);
- •Pregnant or lactating women;
研究组 & 干预措施
YL202
干预措施: YL202 (Drug)
Docetaxel
干预措施: Docetaxel (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to Approximately 36 Months
OS is defined as the time from randomization to the event of death from any cause.
Title: Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)
时间窗: Up to Approximately 36 Months
PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by BICR or death from any cause, whichever occurs earlier.
次要结局
- Progression-Free Survival assessed by Investigator(Up to Approximately 36 Months)
- Overall response rate（ORR）assessed by BICR(Up to Approximately 36 Months)
- Characterize Pharmacokinetics parameter Ctrouph trough concentration(Up to Approximately 12 Months)