Clinical trial NCT05376891: Met Non Small Cell Cancer Registry (MOMENT)
Official title: Disease Registry on Patients With Advanced NSCLC Harboring METex14 Skipping Alterations (MOMENT)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Keywords: Disease Registry
METex14 Skipping Alterations
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
Collaborators: name: Merck KGaA, Darmstadt, Germany
First posted: 2022-05-17
Enrollment: 700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with advanced stage (stages IIIB-IV) NSCLC and confirmed METex14 skipping alterations who are initiating or already treated with a systemic therapy will be included.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Best Overall Response (BOR)
timeFrame: Through study completion, up to approximately 4.9 years
measure: Tumor Response According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1
timeFrame: Up to approximately 4.9 years
measure: Overall Survival (OS)
timeFrame: Through study completion, up to approximately 4.9 years
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to approximately 4.9 years
measure: Number of Participants with Adverse Reactions (ARs)
timeFrame: Up to approximately 4.9 years
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Holy Cross Health
state: Florida
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Klagenfurt am Wörthersee
country: Austria
facility: Klinikum Klagenfurt Am Woerthersee
city: Wien
country: Austria
facility: Klinik Floridsdorf
city: Roeselare
country: Belgium
facility: AZ Delta
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
city: Ottawa
country: Canada
facility: Ottawa Hospital General Campus
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
city: Olomouc
country: Czechia
facility: FN Olomouc
city: Praha 8
country: Czechia
facility: University Hospital Na Bulovce
city: Tampere
country: Finland
facility: University Hospital of Tampere
city: Turku
country: Finland
facility: Turun Yliopistollinen Keskussairaala
city: Cholet
country: France
facility: Centre Hospitalier de Cholet
city: Lille cedex
country: France
facility: CHRU Lille
city: Lorient
country: France
facility: Hôpital du Scorff
city: Lyon Cedex 08
country: France
facility: Centre Leon Berard
city: Paris Cedex 05
country: France
facility: Institut Curie - Centre de Lutte Contre le Cancer (CLCC)
city: Paris
country: France
facility: Hospital Tenon & University Paris 6
city: Toulouse
country: France
facility: CHU de Toulouse Hopital Larrey
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz GmbH
city: Grosshansdorf
country: Germany
facility: KKH Grosshansdorf GmbH
city: Heidelberg
country: Germany
facility: Thoraxklinik-Heidelberg gGmbH
city: Löwenstein
country: Germany
facility: Klinik Löwenstein GmbH
city: Afula
country: Israel
facility: Haemek Medical Center
city: Ashdod
country: Israel
facility: Assuta Ashdod Medical Center
city: Haifa
country: Israel
facility: Bnei-Zion Medical Center
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center - PPDS
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center Oncology Beilinson Campus
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Milano
country: Italy
facility: Istituto Nazionale Dei Tumori
city: Napoli
country: Italy
facility: AOU dell'Università degli Studi della Campania Luigi Vanvitelli
city: Rome
country: Italy
facility: I.F.O. Istituto Nazionale Tumori Regina Elena IRCCS
city: Torino
country: Italy
facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga
city: Varese
country: Italy
facility: Ospedale di Circolo
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen - Department of Medical Oncology
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria
city: Porto Covo
country: Portugal
facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto E.P.E. Hospital de Santo António
city: Barcelona
country: Spain
facility: Clinica Tres Torres
city: Barcelona
country: Spain
facility: Institut Universitari Dexeus-Quiron - Servei d oncologia medica - Institut Oncologic Dr. Rosell
city: las Palmas de Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario Insular-Materno Infantil
city: Madrid
country: Spain
facility: Centro Integral Oncologico Clara Campa
city: Madrid
country: Spain
facility: Centro Oncologico MD Anderson
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga - Hospital General
city: Sevilla
country: Spain
facility: Hospidal Universitario Ntra. Sra. De Valme
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
city: Linköping
country: Sweden
facility: Universitetssjukhuset i Linköping
city: Bedford
country: United Kingdom
facility: Bedford General Hospital
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: Chelsea
country: United Kingdom
facility: The Royal Marsden Hospital
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
city: Harrow
country: United Kingdom
facility: Northwick Park Hospital
city: Liverpool
country: United Kingdom
facility: Clatterbridge Cancer Centre - Liverpool
city: London
country: United Kingdom
facility: Charing Cross Hospital
city: Preston
country: United Kingdom
facility: Preston Hospital
Study officials:
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: