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Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)
Bu çalışma, MET geninde değişiklikler (METex14 atlama değişiklikleri) taşıyan ileri evre küçük hücreli dışı akciğer kanseri (non-small cell lung cancer) olan hastalarda Tepotinib ilacını değerlendirmektedir. Çalışmaya, histolojik olarak doğrulanmış ileri veya metastatik hastalığı olan 18 yaş ve üzeri yetişkinler alınmıştır. Faz 2 aşamasında yürütülmektedir; şu an katılımcı almamakta ancak devam etmektedir (active, not recruiting).
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
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Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * Signed, written informed consent by participant or legal representative prior to any trial-specific screening procedure * Male or female, greater than or equal to (\>=) 18 years of age (or have reached the age of majority according to local laws and regulations) * Measurable disease confirmed by an independent review committee (IRC) in accordance with RECIST version 1.1 * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 * A female participant was eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: * Not a woman of childbearing potential OR * A woman of childbearing potential who agrees to use a highly effective contraception * A male participant must agree to use and to have their female partners of childbearing potential to use a highly effective contraception * Histologically or cytologically confirmed advanced (locally advanced or metastatic) NSCLC (all types including squamous and sarcomatoid) * Treatment naïve participant in first-line or pretreated participant with no more than 2 lines of prior therapy * Participants 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 Exclusion Criteria: * Participants with characterized Epidermal Growth Factor Receptor (EGFR) activating mutations that predict sensitivity to anti-EGFR-therapy * Participants with characterized Anaplastic Lymphoma Kinase (ALK) rearrangements that predict sensitivity to anti-ALK therapy * Participants with symptomatic brain metastases who are neurologically unstable * Any unresolved toxicity Grade 2 or more according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) from previous anticancer therapy * Need for transfusion within 14 days prior to the first dose of trial treatment * 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; * Participants who have brain metastasis as the only measurable lesion * Inadequate hematological, liver, renal, cardiac function * Prior treatment with other agents targeting the Hepatocyte Growth Factor c(HGF/c) -Met pathway * Hypertension uncontrolled by standard therapies (not stabilized to \< 150/90 mmHg) * Past or current history of neoplasm other than Non-small Cell Lung Cancer (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 * Medical history of difficulty swallowing, malabsorption, or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the test product * Major surgery within 28 days prior to Day 1 of trial treatment * Known infection with human immunodeficiency virus, or an active infection with hepatitis B or hepatitis C virus * Substance abuse, active infection, or other acute or chronic medical or psychiatric condition or laboratory abnormalities that might increase the risk associated with trial participation at the discretion of Investigators * Known hypersensitivity to any of the trial treatment ingredients * Legal incapacity or limited legal capacity * Any other reason that, in the opinion of the Principal Investigator, precludes the participant from participating in the trial * Participation in another clinical trial within the past 30 days