NCT04923945已完成3 期
A Multi-center, Open-label, Phase IIIb Confirmatory Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of Savolitinib in Treating Locally Advanced or Metastatic NSCLC Patients With MET Exon 14mutations
Hutchison Medipharma Limited1 个研究点 分布在 1 个国家目标入组 203 人开始时间: 2021年8月19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
- 203
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR) evaluated by the Independent Review Committee (IRC) (RECIST 1.1 criteria)
研究概览
简要总结
Treating Non-small Cell Lung Cancer (NSCLC) Patients with MET exon 14mutations with Savolitinib
详细描述
This is a single-arm, multi-cohort, multi-center, open-label, phase IIIb clinical study. The objective is to evaluate the efficacy and safety of Savolitinib in the treatment of locally advanced or metastatic NSCLC patients with MET exon 14 mutations. The study involves a Screening Period, a Treatment Period and a Follow-up Period. There are 53 study sites initiated and enrolled 203 advanced or metastatic NSCLC patients with MET exon 14 mutations
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fully aware this study and signed the informed consent form in voluntary manner, and willing and able to comply with the study procedure;
- •Age ≥18 years;
- •Histologically diagnosed locally advanced or metastatic NSCLC with MET exon 14 mutation;
- •Cohort 1: disease progression or intolerable toxicity after previous therapy with platinum-based chemotherapeutic regimen (for the patients who have received platinum-based adjuvant chemotherapy/radiotherapy, neoadjuvant chemotherapy/radiotherapy previously or radical radiochemotherapy for progressive disease, if the disease progression occurred < 6 months after the end of the last therapy, the patient belongs to failure after the first-line therapy); Cohort 2: no any previous systematic antitumor therapy for advanced diseases; Cohort 3: no any previous systematic antitumor therapy for advanced diseases;
- •Having measurable lesions (in accordance with RECIST 1.1 criteria);
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1, or Karnofsky performance status ≥80;
- •Survival is expected to exceed 12 weeks;
- •Adequate functionality in bone marrow, liver, kidney
- •Able to take or swallow the drug orally.
- •Female patients of childbearing potential must agree to use effective contraceptive methods from screening period to 30 days after discontinuation of the study drug,The male patients whose sexual partners are women of childbearing age must use condom during sexual intercourse during the study and within 6 months after discontinuation of study drug;
排除标准
- •Having gene mutations sensitive to targeted drugs for EGFR, ALK and ROS1;
- •Previous anti-MET therapy (including but not limited to crizotinib, Onartuzumab, etc.)
- •Currently having other malignant tumors, or having other infiltrating malignant tumors in the past 5 years. Stage I malignant tumor after radical treatment for at least 3 years, except those considered by investigators to have small possibility of recurrence. Patients with radically treated carcinoma in situ (non-infiltrating) and skin cancer other than malignant melanoma can be enrolled;
- •Having received antitumor therapy (including chemotherapy, hormone therapy, biotherapy, immunotherapy or traditional Chinese medicine for antitumor indication) within 3 weeks prior to the start of study treatment, or having received treatment with small molecular tyrosine kinase inhibitors (e.g., EGFR-TKI) within 2 weeks prior to the start of study treatment;
研究组 & 干预措施
Savolitinib
Experimental
NSCLC
干预措施: Savolitinib (Drug)
结局指标
主要结局
Objective response rate (ORR) evaluated by the Independent Review Committee (IRC) (RECIST 1.1 criteria)
时间窗: through study completion, an average of 3 years
To evaluate the efficacy of Savolitinib in the treatment of locally advanced or metastatic NSCLC patients with MET exon 14 mutations
次要结局
- incidence of various adverse events (AE)(through study completion, an average of 3 years)
- Progression-free survival (PFS) (RECIST 1.1 criteria)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
3 期
Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCCPapillary Renal Cell CarcinomaNCT05043090AstraZeneca148
进行中（未招募）
3 期
Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLCNon-small Cell Lung CancerNCT05009836Hutchmed412
进行中（未招募）
3 期
Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib TreatmentCarcinomaNon-Small-Cell LungNCT05261399AstraZeneca341
终止
2 期
Savolitinib in Treating Patients With MET Amplified Metastatic or Unresectable Colorectal CancerColorectal CarcinomaMetastatic Colon AdenocarcinomaMetastatic Rectal AdenocarcinomaStage III Colon Cancer AJCC v8Stage III Rectal Cancer AJCC v8Stage IIIA Colon Cancer AJCC v8Stage IIIA Rectal Cancer AJCC v8Stage IIIB Colon Cancer AJCC v8Stage IIIB Rectal Cancer AJCC v8Stage IIIC Colon Cancer AJCC v8Stage IIIC Rectal Cancer AJCC v8Stage IV Colon Cancer AJCC v8Stage IV Rectal Cancer AJCC v8Stage IVA Colon Cancer AJCC v8Stage IVA Rectal Cancer AJCC v8Stage IVB Colon Cancer AJCC v8Stage IVB Rectal Cancer AJCC v8Stage IVC Colon Cancer AJCC v8Stage IVC Rectal Cancer AJCC v8Unresectable Colon AdenocarcinomaUnresectable Rectal AdenocarcinomaNCT03592641National Cancer Institute (NCI)5
已完成
2 期
Phase 2 Study of Study of Tesevatinib in Subjects With NSCLC and Brain or Leptomeningeal MetastasesLeptomeningeal MetastasesBrain MetastasesNon-Small Cell Lung CancerNCT02616393Kadmon Corporation, LLC36