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 (UmbREALung)

A Prospective, Observational, Real World Multi-cohort Study of Patients With Non-small Cell Lung Cancer (NSCLC) Initiating AstraZeneca (or Alliance Developed) Drugs

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.

Study Overview

• Status: Recruiting
• 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
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• France
  • Aix-en-Provence, France, 13100
    • Recruiting
    • Research Site
  • Angers, France, 49933
    • Recruiting
    • Research Site
  • Aurillac, France, 15000
    • Recruiting
    • Research Site
  • Auxerre, France, 89000
    • Recruiting
    • Research Site
  • Avignon, France, 84918
    • Recruiting
    • Research Site
  • Bezannes, France, 51430
    • Not yet recruiting
    • Research Site
  • Blois, France, 41016
    • Recruiting
    • Research Site
  • Bordeaux, France, 33000
    • Recruiting
    • Research Site
  • Bourg-en-Bresse, France, 01012
    • Recruiting
    • Research Site
  • Béziers, France, 34500
    • Not yet recruiting
    • Research Site
  • Caen, France, 14052
    • Not yet recruiting
    • Research Site
  • Carcassonne, France, 11010
    • Recruiting
    • Research Site
  • Chalon Sur Sa Ne, France, 71321
    • Recruiting
    • Research Site
  • Chambéry, France, 73000
    • Recruiting
    • Research Site
  • Châteauroux, France, 36019
    • Recruiting
    • Research Site
  • Créteil, France, 94000
    • Recruiting
    • Research Site
  • Dieppe, France, 76202
    • Recruiting
    • Research Site
  • Dinan, France, 22100
    • Recruiting
    • Research Site
  • Dreux, France, 28102
    • Recruiting
    • Research Site
  • Epagny METZ Tessy, France, 74370
    • Recruiting
    • Research Site
  • Fort de France Cedex, France, 97200
    • Recruiting
    • Research Site
  • Le Coudray, France, 28630
    • Recruiting
    • Research Site
  • Limoges, France, 87000
    • Recruiting
    • Research Site
  • Lyon, France, 69437
    • Recruiting
    • Research Site
  • Marseille, France, 13915
    • Recruiting
    • Research Site
  • Marseille, France, 13003
    • Recruiting
    • Research Site
  • Marseille, France, 13285
    • Recruiting
    • Research Site
  • Meaux, France, 77100
    • Recruiting
    • Research Site
  • Metz, France, 57000
    • Not yet recruiting
    • Research Site
  • Metz, France, 57070
    • Recruiting
    • Research Site
  • Mulhouse, France, 68100
    • Recruiting
    • Research Site
  • N MES, France, 30029
    • Recruiting
    • Research Site
  • Nancy, France, 54100
    • Recruiting
    • Research Site
  • Nantes, France, 44200
    • Recruiting
    • Research Site
  • Neuilly-sur-Seine, France, 92200
    • Recruiting
    • Research Site
  • Nice, France, 06000
    • Recruiting
    • Research Site
  • Perpignan, France, 66000
    • Recruiting
    • Research Site
  • Reims, France, 51726
    • Not yet recruiting
    • Research Site
  • Rouen, France, 76000
    • Not yet recruiting
    • Research Site
  • Saint-Brieuc, France, 22000
    • Recruiting
    • Research Site
  • Saint-Etienne, France, 42100
    • Recruiting
    • Research Site
  • Saint-Herblain, France, 44800
    • Recruiting
    • Research Site
  • Saint-Priest-en-Jarez, France, 42271
    • Not yet recruiting
    • Research Site
  • Strasbourg, France, 67000
    • Recruiting
    • Research Site
  • Suresnes, France, 92151
    • Recruiting
    • Research Site
  • Toulouse, France, 31076
    • Recruiting
    • Research Site
  • Troyes, France, 10000
    • Not yet recruiting
    • Research Site
  • Valenciennes, France, 59300
    • Recruiting
    • Research Site
  • Vandœuvre-lès-Nancy, France, 54519
    • Not yet recruiting
    • Research Site
  • Vannes, France, 56017
    • Recruiting
    • Research Site
  • Villefranche-sur-Saône, France, 69655
    • Recruiting
    • Research Site
  • Villeurbanne, France, 69100
    • Recruiting
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will be carried out with hospital and / or private clinics / hospitals (pulmonologist, medical oncologists) specialized in the treatment of patients with NSCLC in France and in Germany or any other participating countries afterwards.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Cohort 1 - Resectable; 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; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort A (resectable NSCLC)-Adjuvant rw DFS	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	3 years
Cohort A (resectable NSCLC)- Peri-operative rw EFS	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	3 years
Cohort B (unresectable NSCLC): median rwTFST	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	3 years
Cohort C (metastatic NSCLC) rw TFST	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	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response rates - all cohorts	Response is assessed via clinical or radiologic judgment or RECIST criteria	Response evaluation via patient's best response (PR, CR, SD, PD) and date of best response
Additional rw EFS (cohort A - Peri-operative)	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.	rw EFS and rates at 6 months, 1y, 3y, 5y (rwEFS6m, rwEFS1y, rwEFS3y, rwEFS5y)
Additional rwDFS (Cohort A- adjuvant)	rwDFS 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	rwDFS and rates at 6 months, 1y, 3y, 5y (rwDFS6m, rwDFS1y, rwDFS3y, rwDFS5y)
rwPFS (cohort B and C)	rwPFS defined as time from index date to progression (PD) or death due to any cause.	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	Early progressors (within 6 months) based on progression-free or recurrence-free survival	within 6 months
rwPFS2 (all cohorts)	rwPFS2 defined as time from index date to the earliest progression event subsequent to that used for the PFS endpoint or death due to any cause. Endpoints will be median time to second real-world progression (mrwPFS2) and rates	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)	Real-word distant progression-free (rwD-PFS) or distant recurrence-free survival (rwD-RFS), defined as the time from index date to an event of distant progression or distant recurrence or death due to any cause, whichever occurred first. Endpoints will be median time to second real world to the event and rates	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	Real-word locoregional recurrence-free survival (rwL-RFS), defined as the time from index date to an event of local progression or local recurrence or death due to any cause, whichever occurred first. Endpoints will be median time to event and rates	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	rw OS is defined as the time from the index date to death due to any cause, Real world median Endpoints will be median time to the event and rates	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	rwTTD is defined as the time from the index date (date of first administration of module-specific AZ-approved drug) to the date of last administration (+duration of the drug cycle, when applicable) or date of death (due to any cause). A patient who dies without reported treatment discontinuation will be considered to have discontinued on the date of death. For patients still receiving the selected drug at the end of follow-up, TTD will be censored on the last recorded day of ongoing treatment.	3 or 5 years
Real world time to next treatment (rwTTNT) - all cohorts	Real world time to next treatment (rwTTNT) as defined the period from the start of the treatment to the start of the next line of treatment. In the resectable cohort, local treatment will be considered as new treatment (surgery, radiotherapy) as occurring after a confirmation of progression. Endpoints will be median time to event and rates	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	Real world time to first subsequent local treatment (rwTFST-local treatment) as 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 local therapy (including supportive or curative RT or surgery) or the date of death (due to any cause)	3 or 5 years
rwTFST (systemic) - cohort A and B	rwTFST is defined as the time from the index date (date of first administration of module-specific AZ-approved drug) to the date of first subsequent systemic therapy or the date of death (due to any cause). For patients still receiving the module-specific approved drugs developed by AZ or as part of an AZ alliance at the end of follow-up, rwTFST will be censored on the last recorded day of ongoing treatment	3 or 5 years
Description of associated therapies	Associated therapies will comprise curative therapies for NSCLC, including surgery, radiotherapy (RT), associated chemotherapy and radiotherapy (CRT), as used to treat different stages of the disease in addition to the approved drugs developed by AZ or as part of an AZ alliance subject of the specific module. Outcomes related to this objective are specific to each stage of the disease and thus to each cohort. For resectable and unresectable NSCLC (cohort A and B), the treatment of the primitive tumor will include neoadjuvant treatment, curative treatment (surgery for cohort A and CRT for cohort B) and post-curative adjuvant or consolidation treatment. For mNSCLC (cohort C), the treatment will describe the line of systemic treatment received (including CT) and the supportive RT or surgery when applicable.	3 or 5 years

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2024
• Primary Completion (Estimated): June 30, 2032
• Study Completion (Estimated): June 30, 2032

Study Registration Dates

• First Submitted: December 6, 2024
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Actual): December 10, 2024

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: observational, real world study, RWE, non-small cell lung cancer, multi-cohort, Ambispective, Prospective, Retrospective, Durvalumab, Osimertinib
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: D4191R00060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No