EUCTR2016-001604-28-BG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
适应症
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
- •Phase Ib .Subjects are not eligible for Phase Ib if they fulfill any of the following exclusion criteria:
- •Cancer Related
- •1.Symptomatic metastasis of brain and/or CNS, uncontrolled with antiepileptics and requiring steroids, unless treated and stable without steroids for at least 10 days within 4 weeks prior to the first dose of trial treatment;
- •2.Any unresolved toxicity more than National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 4.0) Grade 2 from previous anticancer therapy;
- •3.Estimated life expectancy < 3 months;
- •4.Need for transfusion within 14 days prior to the first dose of trial treatment;
- •5.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.
- •Laboratory Values and Organ Function
- •1.Inadequate hematological function:Hemoglobin < 8.5 g/dLNeutrophils < 1.5 × 109/LPlatelets < 100 × 109/L
- •2.Inadequate liver function:Total bilirubin > 1.5 × upper limit of normal (ULN)Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 3 × ULN;
- •For subjects with liver metastases:Total bilirubin > 1.5 × ULNAST/ALT > 5 × ULN
- •3.Known pre-existing interstitial lung disease
- •4.Inadequate renal function:
- •6.Renal impairment as evidenced by serum creatinine ? 1.5 × ULN, or creatinine clearance (CrCl) < 60 mL/min calculated by the Cockcroft-Gault formula (24 hour CrCl might be requested by the investigator for confirmation, if calculated CrCl is < 60 mL/min. In such case, subjects with 24 hour CrCl < 60 mL/min should be excluded
- •5.Subjects who have ongoing medical history of acute pancreatitis and/or chronic pancreatitis, with concomitant elevated lipase and/or amylase, clinical symptoms, and/or imaging studies that are indicative of the diagnosis (subjects in mainland China only)
- •1.Impaired cardiac function
- •Left ventricular ejection fraction (LVEF) < 45% defined by echocardiography (a screening LVEF assessment without history of congestive heart failure [CHF] is not required)
- •Serious arrhythmia
- •Unstable angina pectoris
- •CHF New York Heart Association (NYHA) III and IV (Appendix E)
- •Myocardial infarction within the last 12 months prior to trial entry
- •Signs of pericardial effusion
- •2.Hypertension uncontrolled by standard therapies (not stabilized to <150/90 mmHg)
- •3.Contraindication to the administration of gefitinib
- •4.Medical history of liver fibrosis/cirrhosis
- •5.Past or current history of neoplasm other than NSCLC, except for curatively treated non melanoma skin cancer, in situ carcinoma of the cervix, or other cancer curatively treated and with no evidence of disease for at least 5 years;
- •6.Medical history of difficulty swallowing, malabsorption, or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product
- •7.Major surgery within 28 days prior to Day 1 of trial treatment
- •8.Known human immunodeficiency virus positivity
- •9.Substance abuse, active infection, or other acute or chronic medical or psychiatric condition or laboratory abnormalities that might increase the risk associated with study participation at the discretion of investigators
- •10.Female subjects who are pregnant or lactating, or men and women of reproductive potential not willing or not able to employ a highly effective method of birth control/contraception to prevent pregnancy until the end of study. A highly effecti
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