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

Condition(s) studied

Study 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

Primary outcome measure(s)

• Cohort A (resectable NSCLC)-Adjuvant rw DFS — 3 years
  wDFS is defined as the time from the index date (date of first administration of module specific approved drugs developed by AZ or as part of an AZ alliance) to the date of first investigator-determined recurrence (local or distant) or death (due to any cause), whichever occurs first. A patient who dies without reported recurrence will be considered to have recurred on the date of death. For patients who remain alive and whose disease has not recurred, DFS will be censored on the date of last evaluable disease assessment
• Cohort A (resectable NSCLC)- Peri-operative rw EFS — 3 years
  rwEFS is defined as the time from the index date (date of first administration of module specific approved drugs developed by AZ or as part of an AZ alliance ) to the date of progression of the disease (PD) that precluded definitive surgery or discovered while attempting surgery, local or distant recurrence, or death (due to any cause), whichever occurs first. A patient who dies without reported recurrence will be considered to have event on the date of death. For patients who remain alive and who had no event, EFS will be censored on the date of last evaluable disease assessment
• Cohort B (unresectable NSCLC): median rwTFST — 3 years
  real-world time to first subsequent systemic therapy (rwTFST) is defined as the time from the index date (date of first administration of module-specific approved drugs developed by AZ or as part of an AZ alliance ) to the date of first subsequent systemic therapy or the date of death (due to any cause). For patients still receiving the module-specific AZ approved drug at the end of follow-up, rwTFST will be censored on the last recorded day of ongoing treatment
• Cohort C (metastatic NSCLC) rw TFST — 3 years
  real-world time to first subsequent systemic therapy (rwTFST) is defined as the time from the index date (date of first administration of module-specific approved drugs developed by AZ or as part of an AZ alliance ) to the date of first subsequent systemic therapy or the date of death (due to any cause). For patients still receiving the module-specific AZ approved drug at the end of follow-up, rwTFST will be censored on the last recorded day of ongoing treatment

Trial sites (70)

+ 30 more sites — see the full list on the official registry below.

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