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Met Non Small Cell Cancer Registry (MOMENT)

Sponsor
EMD Serono Research & Development Institute, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05376891
Collaborator
Merck KGaA, Darmstadt, Germany (Industry)
700
Enrollment
2
Locations
54
Anticipated Duration (Months)
350
Patients Per Site
6.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    700 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Disease Registry on Patients With Advanced NSCLC Harboring METex14 Skipping Alterations (MOMENT)
    Anticipated Study Start Date :
    Sep 28, 2022
    Anticipated Primary Completion Date :
    Mar 31, 2027
    Anticipated Study Completion Date :
    Mar 31, 2027

    Arms and Interventions

    Arm Intervention/Treatment
    Advanced Non-small Cell Lung Cancer with METex14 skipping alterations

    Participants diagnosed with advanced NSCLC and who receive available therapies in routine clinical practice setting will be part of this registry. Data will be collected routinely from the point of enrollment of a participants into the registry until death, loss to follow-up (drop-out), subsequent enrollment into a clinical trial, or end of data collection period for the registry.

    Outcome Measures

    Primary Outcome Measures

    1. Best Overall Response (BOR) [Through study completion, up to approximately 4.9 years]

    2. Tumor Response According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 [Up to approximately 4.9 years]

    3. Overall Survival (OS) [Through study completion, up to approximately 4.9 years]

    4. Number of Participants with Adverse Events (AEs) [Up to approximately 4.9 years]

    5. Number of Participants with Adverse Reactions (ARs) [Up to approximately 4.9 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Rockland Massachusetts United States 02370
    2 Research Site Darmstadt Germany

    Sponsors and Collaborators

    • EMD Serono Research & Development Institute, Inc.
    • Merck KGaA, Darmstadt, Germany

    Investigators

    • Study Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    EMD Serono Research & Development Institute, Inc.
    ClinicalTrials.gov Identifier:
    NCT05376891
    Other Study ID Numbers:
    • MS200095_0050
    First Posted:
    May 17, 2022
    Last Update Posted:
    Jul 28, 2022
    Last Verified:
    Jul 1, 2022
    Keywords provided by EMD Serono Research & Development Institute, Inc.
    Disease Registry
    METex14 Skipping Alterations

    Study Results

    No Results Posted as of Jul 28, 2022