Brief description of trial (Data source: BASEC)
In dieser Studie wird untersucht, wie wirksam das Prüfpräparat (Tepotinib) das Wachstum und die Ausbreitung von Lungenkrebs stoppen kann. Diese Studie prüft auch eine Reihe anderer Dinge, einschliesslich der Sicherheit des Prüfpräparats und der Nebenwirkungen, wie das Prüfpräparat vom Körper verarbeitet wird oder wie das Prüfpräparat Ihre Lebensqualität beeinflusst. Bestandteil der Studie sind ausserdem freiwillige pharmakogenetische Forschungen. Die pharmakogenetische Forschung ist eine wichtige Methode, um die Rolle der Genetik bei Erkrankungen des Menschen zu verstehen. Es wird untersucht, wie Gene die Wirksamkeit von Medikamenten beeinflussen, weil Unterschiede in den Genen die Art und Weise verändern können, in der eine Person auf ein bestimmtes Medikament anspricht.
Health conditions investigated(Data source: BASEC)
Lungenkarzinom
Health conditions
(Data source: WHO)
Advanced (Stage IIIB/IV) Non-small Cell Lung Cancer (NSCLC) With MET Exon 14 (METex14) Skipping Alterations or MET Amplification
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Die Patienten erhalten einmal täglich 500 Milligramm (mg) Tepotinib Tabletten in Zyklen von 21 Tagen bis zum Fortschreiten der Krankheit, Tod oder bis unerwünschte Ereignisse (UE) auftreten, die zum Behandlungsabbruch oder zum Widerruf der Einwilligung führen.
Interventions
(Data source: WHO)
Drug: Tepotinib
Criteria for participation in trial
(Data source: BASEC)
• Vom Studienteilnehmer oder seinem gesetzlichen Betreuer unterzeichnete, schriftliche Einwilligungserklärung nach Aufklärung liegt vor, bevor eine studienspezifische Screeningmassnahme durchgeführt wird
• Männlich oder weiblich, mindestens (>=) 18 Jahre alt (bzw. volljährig laut geltenden nationalen Gesetzen)
• Messbare Erkrankung gemäss RECIST V 1.1
• Leistungsstatus laut Eastern Cooperative Oncology Group (ECOG) 0 oder 1
Exclusion criteria
(Data source: BASEC)
• Patienten mit beschriebenen epidermaler-Wachstumsfaktor-Rezeptor(EGFR)-aktivierenden Mutationen, die ein Ansprechen auf eine Anti-EGFR-Therapie vorhersagen
• Patienten mit beschriebenen Genumlagerungen der anaplastischen Lymphom-Kinase (ALK), die ein Ansprechen auf eine Anti-ALK-Therapie vorhersagen
• Aktive Hirnmetastasen
• Jegliche noch vorhandene Toxizität vom Grad 2 oder höher aus vorangegangener Krebstherapie gemäss der allgemeinen Terminologiekriterien für unerwünschte Ereignisse des nationalen Krebsinstituts (National Cancer Institute Common Terminology Criteria for Adverse Events, NCI-CTCAE)
• Notwendigkeit einer Transfusion innerhalb von 14 Tagen vor der ersten Dosis der Studienbehandlung
• Vorherige Chemotherapie, biologische Therapie, Strahlentherapie oder Hormontherapie gegen Krebs, zielgerichtete Therapie oder eine andere in der Erprobung befindliche Krebstherapie (gilt nicht für palliative Strahlentherapie am Beschwerdeort) innerhalb von 21 Tagen vor der ersten Dosis der Studienbehandlung
Inclusion/Exclusion Criteria
(Data source: WHO)
Inclusion Criteria:
- Signed, written informed consent by subject or legal representative prior to any
trial-specific screening procedure
- Male or female, greater than or equal to (>=) 18 years of age (or having 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 subject is 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 subject 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 patients in first-line or pretreated patients with no more than 2
lines of prior therapy
- 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
Exclusion Criteria:
- Subjects with characterized Epidermal Growth Factor Receptor (EGFR) activating
mutations that predict sensitivity to anti-EGFR-therapy
- Subjects with characterized Anaplastic Lymphoma Kinase (ALK) rearrangements that
predict sensitivity to anti-ALK therapy
- Subjects 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;
- Subjects 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
subject from participating in the trial
- Participation in another clinical trial within the past 30 days
-
Further information on trial
Date trial registered
Jul 29, 2016
Incorporation of the first participant
Sep 13, 2016
Recruitment status
Active, not recruiting
Academic title
(Data source: WHO)
A Phase II Single-arm Trial to Investigate Tepotinib in Advanced (Locally Advanced or Metastatic) Non-small Cell Lung Cancer With METex14 Skipping Alterations or MET Amplification (VISION)
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Data source: WHO)
Phase 2
Primary end point
(Data source: WHO)
Objective response as assessed by independent review committee
Secundary end point
(Data source: WHO)
Objective response assessed as per Investigator;Duration of response as assessed by independent review committee;Duration of response as assessed by investigator;Objective disease control as assessed by independent review committee;Objective disease control as assessed by investigator;Progression free survival as assessed by independent review committee;Progression free survival as assessed by investigator;Overall survival;Occurrence of Treatment emergent adverse event (TEAEs) and deaths;Percentage of subjects with of markedly abnormal clinical laboratory tests, vital signs, Electrocardiogram (ECG) and Eastern Cooperative Oncology Group Performance Status (ECOG PS);European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30);European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13);EuroQol Five Dimension Five Level Scale (EQ5D5L);Plasma concentrations of the drug;Number of subjects with markedly abnormal clinical laboratory tests (hematology and coagulation, biochemistry and urinalysis).
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Bern, Zurich
Countries
(Data source: WHO)
Austria, Belgium, China, France, Germany, Israel, Italy, Japan, Korea, Netherlands, Poland, Republic of, Spain, Switzerland, Taiwan, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Christian Britschgi
+41 44 255 21 57
christian.britschgi@usz.ch
Contact for general information
(Data source: WHO)
Medical Responsible;US Medical Information
EMD Serono Research & Development Institute, Inc, a business of Merck KGaA, Darmstadt, Germany
888-275-7376
eMediUSA@emdserono.com
Contact for scientific information
(Data source: WHO)
Medical Responsible;US Medical Information
EMD Serono Research & Development Institute, Inc, a business of Merck KGaA, Darmstadt, Germany
888-275-7376
eMediUSA@emdserono.com
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Kantonale
Ethikkommission Zürich
Date of authorisation by the ethics committee
13.03.2020
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2019-00299
Secondary ID (Data source: WHO)
2015-005696-24
MS200095-0022
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