UmbREALung - A Retrospective and Prospective, Observational, Real World Multi-cohort Study of Patients With Non-small Cell Lung Cancer (NSCLC) Initiating Approved Drugs Developed by AZ or as Part of an AZ Alliance
A Prospective, Observational, Real World Multi-cohort Study of Patients With Non-small Cell Lung Cancer (NSCLC) Initiating AstraZeneca (or Alliance Developed) Drugs
AstraZeneca
300 participants
Dec 16, 2024
OBSERVATIONAL
Conditions
Summary
This is an ambispective, observational, multicenter and multicohort study, targeting patients with NSCLC initiating approved drugs developed by AZ or as part of an AZ alliance, in the participating countries, as monotherapy or in combination at any stage of disease. Three cohorts are designed, based on the stage of NSCLC (resectable, unresectable and metastatic). The multicohort study is modular in design. Specific modules will be set up separately to assess each new indication of drugs developed by AZ or as part of an AZ alliance once European marketing authorization (MA) has been granted and made available in the participating countries. Patients will be enrolled in the study if they have received (retrospective), receive (retrospective and prospective) or will receive (prospective) approved drugs developed by AZ or as part of an AZ alliance according to the eligibility criteria. Treatment plan and decision are made independently by each treating physician prior to inclusion in this study.
Eligibility
Inclusion Criteria4
- Adult patients (≥ 18 years old)
- Patients with histologically or cytologically proven NSCLC
- Patients initiated with approved drugs developed by AZ or as part of an AZ alliance at the time of the enrollment or within the previous three weeks.
- Informed patients who consent to participate in the study as per local regulations.
Exclusion Criteria4
- Patients participating in an interventional clinical trial for NSCLC\*
- \* with the exception on low-interventional studies (RIPH2) where the intervention does not involve the NSCLC treatment
- Patients already enrolled in another module of the cohort in UMBREALUNG
- Patients under safeguard of justice, curatorship or guardianship
Locations(40)
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NCT06726720