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

AstraZeneca

Status: Enrolling

Conditions: 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

Study type: Observational

Funder types: Industry

Identifiers

NCT06726720

D4191R00060

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

300 participants in 3 patient groups

Cohort 1 - Resectable

Description:

Ambispective, observational, study of patients with non-small cell lung cancer initiating approved drugs developed by AZ or as part of an AZ alliance in resectable NSCLC

Cohort 2 - Unresectable

Description:

Ambispective, observational, study of patients with non-small cell lung cancer initiating approved drugs developed by AZ or as part of an AZ alliance in Unresectable NSCLC

Cohort 3 - Metastatic

Description:

Ambispective, observational, study of patients with non-small cell lung cancer initiating approved drugs developed by AZ or as part of an AZ alliance in Metastatic NSCLC