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NCT05376891 Clinical Trial

Met Non Small Cell Cancer Registry (MOMENT)

Cancer Clinical Trial

Official title:
Disease Registry on Patients With Advanced NSCLC Harboring METex14 Skipping Alterations (MOMENT)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05376891
Other study ID # MS200095_0050
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 4, 2022
Est. completion date March 31, 2027

Study information
Verified date February 2024
Source EMD Serono
Contact US Medical Information
Phone 888-275-7376
Email eMediUSA@emdserono.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this multi-national disease registry is to collect prospectively (with longitudinal follow-up) high-quality, standardized, and contemporaneous data to capture changes in the non-small cell lung cancer (NSCLC) treatment landscape and outcomes over time. The registry will capture data on participants; demographic, clinical characteristics (including biomarker data), treatment patterns, and effectiveness and safety outcomes for advanced NSCLC with mesenchymal-epithelial transition exon 14 (METex14) participants treated with systemic therapy.

Description:

This is a disease registry, which is an organized system using non-interventional methods to collect data on a patient population defined by a particular disease, exposure, or condition, and which is followed over time. Non-interventional means that after participants enrollment, participants will be treated according to the routine clinical treatment decision by the physician. The registry will not impose any treatment or procedure for participants.

Recruitment information / eligibility
Status Recruiting
Enrollment 700
Est. completion date March 31, 2027
Est. primary completion date March 31, 2027
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Participants who signed ICF - Participants with advanced stage (stages IIIB-IV) NSCLC (all histologies) and Confirmed METex14 skipping alterations (by valid assay) - Participants who are starting or are already being treated with systemic therapy Exclusion Criteria: - Participants who are enrolled in a clinical trial

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Austria Klinikum Klagenfurt Am Woerthersee Klagenfurt am Wörthersee
Austria Klinik Floridsdorf Wien
Belgium AZ Delta Roeselare
Belgium AZ Nikolaas Sint-Niklaas
Canada Ottawa Hospital General Campus Ottawa
Canada Princess Margaret Cancer Centre Toronto
Czechia FN Olomouc Olomouc
Czechia University Hospital Na Bulovce Praha 8
Finland University Hospital of Tampere Tampere
Finland Turun Yliopistollinen Keskussairaala Turku
France Centre Hospitalier de Cholet Cholet
France CHRU Lille Lille cedex
France Hôpital du Scorff Lorient
France Centre Leon Berard Lyon Cedex 08
France Hospital Tenon & University Paris 6 Paris
France Institut Curie - Centre de Lutte Contre le Cancer (CLCC) Paris Cedex 05
France CHU de Toulouse Hopital Larrey Toulouse
Germany Klinikum Chemnitz GmbH Chemnitz
Germany KKH Grosshansdorf GmbH Grosshansdorf
Germany Thoraxklinik-Heidelberg gGmbH Heidelberg
Germany Klinik Löwenstein GmbH Löwenstein
Israel Haemek Medical Center Afula
Israel Assuta Ashdod Medical Center Ashdod
Israel Bnei-Zion Medical Center Haifa
Israel Carmel Medical Center Haifa
Israel Rambam Medical Center - PPDS Haifa
Israel Shaare Zedek Medical Center Jerusalem
Israel Rabin Medical Center Oncology Beilinson Campus Petach Tikva
Israel Chaim Sheba Medical Center Ramat Gan
Israel Tel Aviv Sourasky Medical Center Tel Aviv
Italy Istituto Europeo di Oncologia Milano
Italy Istituto Nazionale Dei Tumori Milano
Italy AOU dell'Università degli Studi della Campania Luigi Vanvitelli Napoli
Italy I.F.O. Istituto Nazionale Tumori Regina Elena IRCCS Rome
Italy Azienda Sanitaria Ospedaliera S Luigi Gonzaga Torino
Italy Ospedale di Circolo Varese
Netherlands VU Medisch Centrum Amsterdam
Netherlands Universitair Medisch Centrum Groningen - Department of Medical Oncology Groningen
Netherlands Leiden University Medical Center Leiden
Portugal Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria Lisboa
Portugal Centro Hospitalar do Porto E.P.E. Hospital de Santo António Porto
Portugal Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS Porto Covo
Spain Clinica Tres Torres Barcelona
Spain Institut Universitari Dexeus-Quiron - Servei d oncologia medica - Institut Oncologic Dr. Rosell Barcelona
Spain Complejo Hospitalario Universitario Insular-Materno Infantil las Palmas de Gran Canaria
Spain Centro Integral Oncologico Clara Campa Madrid
Spain Centro Oncologico MD Anderson Madrid
Spain Hospital Regional Universitario de Malaga - Hospital General Malaga
Spain Hospidal Universitario Ntra. Sra. De Valme Sevilla
Spain Hospital Universitario Virgen Macarena Sevilla
Spain Hospital Universitari i Politecnic La Fe de Valencia Valencia
Sweden Universitetssjukhuset i Linköping Linköping
United Kingdom Bedford General Hospital Bedford
United Kingdom Birmingham Heartlands Hospital Birmingham
United Kingdom Royal Bournemouth Hospital Bournemouth
United Kingdom The Royal Marsden Hospital Chelsea
United Kingdom Royal Surrey County Hospital Guildford
United Kingdom Northwick Park Hospital Harrow
United Kingdom Clatterbridge Cancer Centre - Liverpool Liverpool
United Kingdom Charing Cross Hospital London
United Kingdom Preston Hospital Preston
United States The Ohio State University Wexner Medical Center Columbus Ohio
United States Holy Cross Health Fort Lauderdale Florida
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (2)
Lead Sponsor Collaborator
EMD Serono Research & Development Institute, Inc. Merck KGaA, Darmstadt, Germany

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Czechia,  Finland,  France,  Germany,  Israel,  Italy,  Netherlands,  Portugal,  Spain,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Best Overall Response (BOR) Through study completion, up to approximately 4.9 years
Primary Tumor Response According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 Up to approximately 4.9 years
Primary Overall Survival (OS) Through study completion, up to approximately 4.9 years
Primary Number of Participants with Adverse Events (AEs) Up to approximately 4.9 years
Primary Number of Participants with Adverse Reactions (ARs) Up to approximately 4.9 years
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