Cancer
Conditions
Keywords
Disease Registry, METex14 Skipping Alterations
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.
Interventions
None listed
Sponsors
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best Overall Response (BOR) | Through study completion, up to approximately 4.9 years |
| Tumor Response According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 | Up to approximately 4.9 years |
| Overall Survival (OS) | Through study completion, up to approximately 4.9 years |
| Number of Participants with Adverse Events (AEs) | Up to approximately 4.9 years |
| Number of Participants with Adverse Reactions (ARs) | Up to approximately 4.9 years |
Countries
Austria, Belgium, Canada, Czechia, France, Germany, Israel, Italy, Netherlands, Portugal, Spain, Sweden, United Kingdom, United States
Contacts
CONTACTUS Medical Information
CONTACTCommunication Center
STUDY_DIRECTORMedical Responsible
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Outcome results
None listed