EUCTR2016-001604-28-ES进行中（未招募）1 期
A Phase Ib/II Multicenter, Randomized, Open Label Trial to Compare Tepotinib(MSC2156119J) Combined with Gefitinib Versus Chemotherapy as Second-line Treatment in Subjects with MET Positive, Locally Advanced or Metastatic Non-smallCell Lung Cancer (NSCLC) Harboring EGFR Mutation and Having Acquired Resistance to Prior EGFR-Tyrosine Kinase Inhibitor (EGFR-TKI) Therapy - INSIGHT
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 入组人数
- 192
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •a) Histologically or cytologically confirmed advanced NSCLC, regardless of histology subtype, which failed on gefitinib for reasons other than toxicity or compliance;
- •b) Availability of a fresh or archived pretreatment tumor biopsy (excluding fine needle aspiration and cytology samples). For subjects who have had at least 1 prior anticancer treatment, a biopsy obtained between failure of the most recent anticancer treatment and enrollment is mandatory;
- •c) MET+ status, as determined by the central laboratory, i.e. c-Met overexpression as determined by immunohistochemistry (IHC) (i.e., IHC 2+ or IHC 3+);
- •d) Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- •a) Locally advanced or metastatic NSCLC other than predominantly squamous histology (confirmed by either histology or cytology);
- •b) Activating mutation of the EGFR receptor (documented, or as determined by the central laboratory);
- •c) Acquired resistance on first line EGFR-TKI therapy including gefitinib, erlotinib, icotinib, or afatinib;
- •d) EGFR T790M status (as determined by the central laboratory, using a validated PCR test);
- •T790M negative status for the randomized part T790M positive status for the single-arm cohort (mainland China sites only)
- •e) Availability of a fresh or archived tumor tissue (excluding fine needle aspiration and cytology samples) obtained between documentation of acquired resistance to EGFR-TKI therapy including gefitinib, erlotinib, icotinib, or afatinib and enrollment is mandatory;
- •f) MET+ status, as determined by the central laboratory, i.e. c-Met overexpression as determined by IHC (i.e., IHC 2+ or IHC 3+) and/or c-Met amplification and/or increased c-Met gene copy number (GCN), both determined by ISH;
- •g) ECOG PS of 0 or 1.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 112
排除标准
- •Exclusion Criteria (Phase Ib and Phase II)
- •a) Estimated life expectancy < 3 months;
- •b) Inadequate bone marrow, liver or renal functions;
- •c) Prior chemotherapy, biological therapy, radiation therapy, or
- •other investigational anticancer therapy (not including palliative
- •radiotherapy at focal sites) within 21 days prior to the first dose
- •of trial treatment (Phase Ib only);
- •d) Prior systemic anticancer treatment with chemotherapy or other
- •agents targeting the EGFR pathway excluding gefitinib,
- •erlotinib, icotinib, and afatinib for advanced NSCLC (one course
- •of chemotherapy regimen for [neo]adjuvant purpose, or one
- •course of chemoradiation for Stage IIIa disease is allowed)
- •(Phase II only).
研究者
相似试验
进行中（未招募）
1 期
Tepotinib with Gefitinib in Subjects with Locally Advanced or Metastatic NSCLC (INSIGHT)ocally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)MedDRA version: 20.0Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-001604-28-NLMerck KGaA156
撤回
2 期
A Phase Ib/II Multicenter, Randomized, Open Label Trial to Compare Tepotinib (MSC2156119J) Combined with Gefitinib Versus Chemotherapy as Second-line Treatment in Subjects with MET Positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation and Having Acquired Resistance to Prior EGFR-Tyrosine Kinase Inhibitor (EGFR-TKI) Therapy10038666Non-small cell lung cancerNL-OMON46330Merck2
进行中（未招募）
1 期
Tepotinib with Gefitinib in Subjects with Locally Advanced or Metastatic NSCLC (INSIGHT)ocally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)MedDRA version: 19.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-001604-28-SKMerck KGaA192
进行中（未招募）
1 期
Tepotinib with Gefitinib in Subjects with Locally Advanced or Metastatic NSCLC (INSIGHT)ocally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)MedDRA version: 19.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-001604-28-BGMerck KGaA192
进行中（未招募）
1 期
Tepotinib with Gefitinib in Subjects with Locally Advanced or MetastaticNSCLC (INSIGHT)ocally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)MedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-001604-28-ITMERCK KGAA192