CTIS2024-512003-39-00进行中（未招募）1 期
A Phase II, single-arm trial to investigate tepotinib in advanced (locally advanced or metastatic) non-small cell lung cancer with MET exon 14 (METex14) skipping alterations or MET amplification (VISION) - MS200095-0022
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 126
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1. Histologically or cytologically confirmed advanced (locally advanced or metastatic) NSCLC (all types including squamous and sarcomatoid);, 2. Treatment naive patients in first-line or pre-treated patients with no more than 2 lines of prior therapy, 3. Subjects with MET alterations, namely METex14 skipping alterations in plasma and/or tissue, as determined by the central laboratory or by an assay with appropriate regulatory status will, be enrolled into the trial. For these subjects, sufficient tumor tissue and/or plasma is requested to allow additional testing MET amplification only in plasma defined by a positive LBx test, as determined by the central laboratory or by an assay with appropriate regulatory status Based on the outcome of the interim analysis in 12 LBx selected subjects: MET amplification only in tissue defined by a positive TBx with a gain of at least 4 copies of the MET gene, as determined by the central laboratory or by an assay with appropriate regulatory status., 4. Signed, written informed consent by subject or legal representative prior to any trial-specific screening procedure;, 5. Male or female, = 18 years of age (or having reached the age of majority according to local laws and regulations, if the age of majority is > 18 years of age); [i.e., = 20 years of age in Japan]);, 6. Measurable disease in accordance with RECIST version 1.1;, 7. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1, 8. A female subjects is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a. Not a woman of childbearing potential as defined in Appendix VIII OR b. A woman of childbearing potential who agrees to use a highly effective contraception (i.e., methods with a failure rate of less than 1 % per year) as detailed in in Appendix VII of this protocol 2 weeks before start of first dose of study treatment, during the treatment period and for at least 4 weeks after the last dose of study treatment. Women of childbearing potential must have a negative pregnancy test (ß-HCG test in serum) prior to enrollment., 9. A male subject must agree to use and to have their female partners of childbearing potential to use a highly effective contraception (i.e., methods with a failure rate of less than 1 % per year) as detailed in Appendix VII of this protocol from the first dose of study treatment, during the treatment period and for at least 3 months after the last dose of study treatment and refrain from donating sperm during this period. Male subjects should always use a barrier method such as condom concomitantly.
排除标准
- •1. Subjects with characterized EGFR activating mutations that predict sensitivity to anti-EGFR-therapy, including, but not limited to exon 19 deletions and exon 21 alterations;, 10. 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 (for a full list of exlustion criteria please see the study protocol), 2. Subjects with characterized ALK rearrangements; that predict sensitivity to anti-ALK therapy, 3. Subjects with symptomatic brain metastases who are neurologically unstable, and/or have required an increase in steroid dose within 2 weeks and/or have received prior stereotactic radiosurgery/gamma knife within 2 weeks and/or other prior treatment for brain metastases within 4 weeks prior to the start of therapy. Subjects with leptomeningeal disease are ineligible;, 4. Any unresolved toxicity Grade 2 or more according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) from previous anticancer therapy;, 5. Need for transfusion within 14 days prior to the first dose of trial treatment;, 6. Prior chemotherapy, biological therapy, radiation therapy, hormonal therapy for anti-cancer purposes, targeted therapy, or other investigational anticancer therapy (not including palliative radiotherapy at focal sites) within 21 days prior to the first dose of trial treatment, 7. Subjects who have brain metastasis as the only measureable lesion, 8. Inadequate hematological, liver, renal, cardiac function, 9. Prior treatment with other agents targeting the HGF/c-Met pathway;
研究者
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