NCT05015608已完成3 期
Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Savolitinib + Osimertinib Versus Pemetrexed + Platinum in Treatment of Patients With NSCLC With MET Amplification
Hutchison Medipharma Limited1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2021年11月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
This study will look at how effective the study drug(Savolitinib combined with Osimertinib) versus Pemetrexed combined with platinum in treatment of patients with locally advanced or metastatic NSCLC with MET amplification after failure of the first-line EGFR inhibitor therapy.
详细描述
This is a multicenter, randomized, controlled, open, phase III clinical study to evaluate the clinical efficacy and safety of Savolitinib combined with Osimertinib in treatment of patients with locally advanced or metastatic NSCLC with MET amplification after failure of EGFR inhibitor therapy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fully aware this study and voluntary to sign the informed consent form, and willing and able to comply with the study procedure;
- •Age ≥ 18 and ≤75 years;
- •In accordance with the 8th Edition of TNM staging for lung cancers by International Association for the Study of Lung Cancer and American Joint Committee on Cancer, patients with histologically or cytologically confirmed unresectable and non-suitable for radical concurrent chemoradiotherapy, locally advanced or metastatic (stage IIIB, IIIC or IV) NSCLC;
- •EGFR sensitive mutations prior to the first-line EGFR-TKI therapy;
- •Radiologically documented disease progression after the first-line EGFR-TKI;
- •MET amplification after disease progression following the first-line therapy;
- •Having measurable lesions (in accordance with RECIST
- •1 criteria);
- •United States Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1;
- •Expected survival >12 weeks;
- •Adequate bone marrow reserve or organ function
- •Female patients of childbearing potential must agree to use effective contraceptive methods from screening period to 4 weeks after discontinuation of the study drug;
- •Male subjects should be willing to agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm. ;
- •Being able to take or swallow the drug orally.
排除标准
- •Patients with positive T790M mutations;
- •Previous treatment for c-MET;
- •Currently having other malignant tumors, or having other infiltrating malignant tumors in the past 5 years.;
- •Previous use of systematic antitumor therapy other than EGFR-TKI for advanced NSCLC;
- •Currently having received antiangiogenic therapy or traditional Chinese medicine with antitumor indication、extensive radiotherapy 、palliative local radiotherapy, a major surgery,or participated in other drug clinical trials and received corresponding tudy drug etc;
- •Currently receiving the potent CYP3A4 inducers or potent CYP1A2 inhibitors within two weeks prior to the start of study treatment;
- •Having not been sufficiently recovered from the toxicity and/or complication resulting from any interventional measure prior to the start of treatment;
- •Clinically significant active infection, including but not limited to tuberculosis, human immunodeficiency virus (HIV) infection (positive HIV1/2 antibody);
- •Active hepatitis B, or active hepatitis C;
- •Acute myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack;
- •Known cancerous thrombus or deep vein thrombosis or uncontrollable hypertension despite the use of drugs;
- •Mean resting corrected QT interval (QTcF) or Any important abnormality in rhythm;
- •Presence of meningeal metastases, spinal cord compression or active brain metastases prior to the start of study treatment;
- •Active gastrointestinal disease or other conditions significantly affecting the absorption, distribution, metabolism or excretion of oral study drug;
- •Lack of compliance with participation in this clinical study or inability to comply with the limitations and requirements of the study, as judged by investigators;
- •Known allergy to the active or inactive ingredient of Savolitinib or Osimertinib;
- •Previous history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis and any active interstitial lung disease;
- •Pregnant or breastfeeding women;
研究组 & 干预措施
Savolitinib + Osimertinib
Experimental
Savolitinib orally once per day (QD) + Osimertinib orally QD,21day cycles (every 3 weeks)
干预措施: Savolitinib + Osimertinib (Drug)
Pemetrexed combined with platinum
Active Comparator
Pemetrexed combined with platinumon on Day 1 of 21day cycles (every 3 weeks)
干预措施: Pemetrexed + Cisplatin /Carboplatin (Drug)
结局指标
主要结局
PFS
时间窗: 5 months after the last patient enrolled
Progression-free survival (PFS) using Investigator assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
次要结局
- Duration of Response (DoR)(5 months after the last patient enrolled)
- Overall survival (OS)(5 months after the last patient enrolled)
- The objective response rate of the tumor (ORR)(5 months after the last patient enrolled)
- PFS(5 months after the last patient enrolled)
- Safety and tolerability(5 months after the last patient enrolled)
- The disease control rate (DCR)(5 months after the last patient enrolled)
- Time to Response (TTR)(5 months after the last patient enrolled)
研究者
研究点 (1)
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