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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry 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. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, Observational, Real World Multi-cohort Study of Patients With Non-small Cell Lung Cancer (NSCLC) Initiating AstraZeneca (or Alliance Developed) Drugs
Overview
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.
Primary outcome measures
- Cohort A (resectable NSCLC)-Adjuvant rw DFS [Time frame: 3 years]
- Cohort A (resectable NSCLC)- Peri-operative rw EFS [Time frame: 3 years]
- Cohort B (unresectable NSCLC): median rwTFST [Time frame: 3 years]
- Cohort C (metastatic NSCLC) rw TFST [Time frame: 3 years]
Secondary outcome measures (12)
- Response rates - all cohorts [Time frame: Response evaluation via patient's best response (PR, CR, SD, PD) and date of best response]
- Additional rw EFS (cohort A - Peri-operative) [Time frame: rw EFS and rates at 6 months, 1y, 3y, 5y (rwEFS6m, rwEFS1y, rwEFS3y, rwEFS5y)]
- Additional rwDFS (Cohort A- adjuvant) [Time frame: rwDFS and rates at 6 months, 1y, 3y, 5y (rwDFS6m, rwDFS1y, rwDFS3y, rwDFS5y)]
- rwPFS (cohort B and C) [Time frame: Endpoints will be median real-world Progression Free Survival (rwPFS) and rates at 6, 12, 18, 24, 36 months and 5 years (rwPFS6m, rwPFS12m, rwPF18m, rwPFS24m, rwPFS36m, rwPFS5y)]
- Early progressors-rates and characteristics of patients - all cohorts [Time frame: within 6 months]
- rwPFS2 (all cohorts) [Time frame: rwPFS2 and rates at 6, 12, 18, 24, 36 months and 5 years (rwPFS2-6m, rwPFS2-12m, rwPFS2-18m, rwD-RFS24m, rwPFS2-3y, rwPFS2-5y)]
- rwD-RFS or rwD-PFS ( cohort A and B) [Time frame: rwD-RFS and rates at 6, 12, 18, 24, 36 months and 5 years or rwD-PFS and rates at 6, 12, 18, 24, 36 months and 5 years]
- Real-word locoregional recurrence-free survival (rwL-RFS) - cohort A and B [Time frame: rwL-RFS and rates at 6, 12, 18, 24, 36 months and 5 years (rwL-RFS6m, rwL-RFS12m, rwL-RFS18m, rwL-RFSm, rwL-RFS3y,rrwL-RFS5y)]
- rwOS - all cohorts [Time frame: rwOS and rates at 6, 12, 18, 24, 36 months and 5 years (rwOS6m, rwOS12m, rwOS18m, rwOS24m, rwOS3y,rwOS5y)]
- Real world time to treatment discontinuation (rwTTD) - all cohorts [Time frame: 3 or 5 years]
- Real world time to next treatment (rwTTNT) - all cohorts [Time frame: rwTTNT and rates at 6 months, 1y, 3y,5y (rwTTNT6m, rwTTNT1y, rwTTNT3y,rwTTNTS5y)]
- Real world time to first subsequent local treatment (rwTFST-local treatment) all cohorts [Time frame: 3 or 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 52 centers
- Research Site — Aix-en-Provence
- Research Site — Angers
- Research Site — Aurillac
- Research Site — Auxerre
- Research Site — Avignon
- Research Site — Bezannes
- Research Site — Béziers
- Research Site — Blois
- … and 44 more centers
Identifiers
NCT: NCT06726720 · D4191R00060