A Phase 3, Open-Label, Randomized, Multi-Center Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon 20 Insertion Mutation
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 324
- 试验地点
- 305
- 主要终点
- Progression Free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1
研究概览
简要总结
This is a phase 3, open-label, randomized, multi-center study assessing the efficacy and safety of DZD9008 versus platinum-based doublet chemotherapy in participants with locally advanced or metastatic NSCLC with EGFR Exon20ins mutation, who are newly diagnosed or have not received prior systemic therapy in advanced stage.
Primary objective of this study is to assess the efficacy of DZD9008 versus platinum-based doublet chemotherapy using by BICR-assessed PFS per RECIST 1.1 as primary endpoint. Approximately 320 participants are estimated to be randomized into the study. Participants enrolled will be randomized to DZD9008 or platinum-based doublet chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged at least 18 years old (or per local regulatory/IRB requirement).
- •Histologically or cytologically confirmed diagnosis of non-squamous NSCLC, locally advanced (Stage IIIB and IIIC according to the 8th edition of the AJCC TNM staging criteria) or metastatic (Stage IV), not suitable for curative therapy.
- •Adequate tumor tissue available, for central laboratory confirmation of EGFR exon 20 insertion mutation
- •At least 1 measurable lesion per RECIST Version 1.1
- •Life expectancy ≥ 12 weeks
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •Adequate organ and hematologic function
排除标准
- •Prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC.
- •Spinal cord compression or leptomeningeal metastasis.
- •Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.
- •History of stroke or intracranial hemorrhage within 6 months before randomization.
- •As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses (i.e., hemophilia and Von Willebrand disease).
研究组 & 干预措施
Platinum-based Chemotherapy
干预措施: Pemetrexed+carboplatin (Drug)
sunvozertinib
干预措施: sunvozertinib (Drug)
结局指标
主要结局
Progression Free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1
时间窗: Up to approximately 34 months after the first participant is randomized
次要结局
- Overall Survival(Up to approximately 34 months after the first participant is randomized)