Sunvozertinib Combined With Chemotherapy for EGFRm + Locally Advanced or Metastasis NSCLC Patients After EGFR-TKI Treatment Failure：Phase I/II (WU-KONG36)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
To access the anti-tumor efficacy, safety and tolerability of Sunvozertinib combined with chemotherapy in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) sensitizing mutations who have progressed following standard TKI therapy.
详细描述
This study is a single arm study to access the anti-tumor efficacy, safety and tolerability of Sunvozertinib combined with chemotherapy in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) sensitizing mutations who have progressed following standard TKI therapy.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To provide a signed and dated, written informed consent.
- •80≥Age ≥ 18 years old
- •Histologically or cytologically confirmed non-squamous NSCLC with documented EGFR mutations from a local laboratory
- •EGFR-sensitive mutations including exon 19 deletion and exon 21 L858R mutated, and exon 20 T790M mutated.
- •Predicted life expectancy ≥ 12 weeks
- •EGFR-TKI resistance or intolerant to standard EGFR TKIs therapy.
- •No previous systemic chemotherapy for advanced or metastatic disease.
- •Adequate organ system function:
- •Patient must have measurable disease according to RECIST 1.
- •Patients with stable or pre-treated brain metastasis (BM) can be enrolled
排除标准
- •Spinal cord compression or meningeal metastasis
- •A history of malignant tumors within 2 years.
- •With known resistant mutations that have approved target therapy
- •Recover from AEs caused by previous treatment
- •A history of stroke or intracranial hemorrhage within 6 months prior to initial dosing.
- •Any severe or poorly controlled systemic disease per investigator's judgment active infections, including but not limited to hepatitis B (HBV), hepatitis C (HCV), and human immunodeficiency (HIV)
研究组 & 干预措施
Sunvozertinib combined with chemotherapy (Pemetrexed +platinum)
Sunvozertinib 200mg Quaquedie (QD) combined with chemotherapy (Pemetrexed +platinum)
干预措施: Sunvozertinib (Drug)
Sunvozertinib combined with chemotherapy (Pemetrexed +platinum)
Sunvozertinib 200mg Quaquedie (QD) combined with chemotherapy (Pemetrexed +platinum)
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Time from first dose to last dose, or up to 24 month
To assess sunvozertinib overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as the proportion of subjects who have a complete response (CR) or a partial response (PR)
次要结局
- Duration of Response (DoR)(Time from first subject dose to study completion, or up to 36 month)
- Progression-free survival (PFS)(Time from first subject dose to study completion, or up to 36 month)
- Overall survival (OS)(Time from first subject dose to study completion, or up to 36 month)
- Adverse events (AEs) according to CTCAE 5.0(From first dose until 28 days after the last dose, up to 24 month)
研究者
You Lu
Chair of Department of Thoracic Oncology
Sichuan University