EUCTR2015-005696-24-NLActive, not recruitingPhase 1
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) - VISIO
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Merck KGaA
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Histologically or cytologically confirmed advanced (Stage IIIB/IV) NSCLC (all histologies 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.
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 110
Exclusion Criteria
- •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;
- •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;
- •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)
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