Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)

Korábbi kezelés

• Participants with characterized Anaplastic Lymphoma Kinase (ALK) rearrangements that predict sensitivity to anti-ALK therapy
• 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;
• Prior treatment with other agents targeting the Hepatocyte Growth Factor c(HGF/c) -Met pathway
• Major surgery within 28 days prior to Day 1 of trial treatment

Más betegség

• Inadequate hematological, liver, renal, cardiac function
• 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
• Known infection with human immunodeficiency virus, or an active infection with hepatitis B or hepatitis C virus
• Known hypersensitivity to any of the trial treatment ingredients

Laborértékek

• Participants with characterized Epidermal Growth Factor Receptor (EGFR) activating mutations that predict sensitivity to anti-EGFR-therapy
• 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

Egyéb

• Participants with symptomatic brain metastases who are neurologically unstable
• Participants who have brain metastasis as the only measurable lesion
• 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

• 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