Tepotinib Phase II study in advanced lung cancer harboring MET exon 14 (METex14) skipping alterations and MET amplificatio

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 200

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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Updated 6/20/2016

Tepotinib Phase II study in advanced lung cancer harboring MET exon 14 (METex14) skipping alterations and MET amplificatio

Recruitment & Eligibility

Study & Design

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