Disease Registry on Patients With Advanced NSCLC Harboring METex14 Skipping Alterations (MOMENT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 700
- Locations
- 126
- Primary Endpoint
- Best Overall Response (BOR)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- 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
Arms & Interventions
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.
Outcomes
Primary Outcomes
Best Overall Response (BOR)
Time Frame: Through study completion, up to approximately 4.9 years
Overall Survival (OS)
Time Frame: Through study completion, up to approximately 4.9 years
Tumor Response According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1
Time Frame: Up to approximately 4.9 years
Number of Participants with Adverse Events (AEs)
Time Frame: Up to approximately 4.9 years
Number of Participants with Adverse Reactions (ARs)
Time Frame: Up to approximately 4.9 years
Secondary Outcomes
No secondary outcomes reported