Clinical trial NCT06726720: 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
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
Study type: OBSERVATIONAL
Overall 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
Keywords: observational, real world study, RWE, non-small cell lung cancer, multi-cohort, Ambispective, Prospective, Retrospective, Durvalumab, Osimertinib
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-12-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

Brief 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 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

Primary outcomes:
measure: Cohort A (resectable NSCLC)-Adjuvant rw DFS
timeFrame: 3 years
measure: Cohort A (resectable NSCLC)- Peri-operative rw EFS
timeFrame: 3 years
measure: Cohort B (unresectable NSCLC): median rwTFST
timeFrame: 3 years
measure: Cohort C (metastatic NSCLC) rw TFST
timeFrame: 3 years
Secondary outcomes:
measure: Response rates - all cohorts
timeFrame: Response evaluation via patient's best response (PR, CR, SD, PD) and date of best response
measure: Additional rw EFS (cohort A - Peri-operative)
timeFrame: rw EFS and rates at 6 months, 1y, 3y, 5y (rwEFS6m, rwEFS1y, rwEFS3y, rwEFS5y)
measure: Additional rwDFS (Cohort A- adjuvant)
timeFrame: rwDFS and rates at 6 months, 1y, 3y, 5y (rwDFS6m, rwDFS1y, rwDFS3y, rwDFS5y)
measure: rwPFS (cohort B and C)
timeFrame: 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)
measure: Early progressors-rates and characteristics of patients - all cohorts
timeFrame: within 6 months
measure: rwPFS2 (all cohorts)
timeFrame: 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)
measure: rwD-RFS or rwD-PFS ( cohort A and B)
timeFrame: 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
measure: Real-word locoregional recurrence-free survival (rwL-RFS) - cohort A and B
timeFrame: 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)
measure: rwOS - all cohorts
timeFrame: rwOS and rates at 6, 12, 18, 24, 36 months and 5 years (rwOS6m, rwOS12m, rwOS18m, rwOS24m, rwOS3y,rwOS5y)
measure: Real world time to treatment discontinuation (rwTTD) - all cohorts
timeFrame: 3 or 5 years
measure: Real world time to next treatment (rwTTNT) - all cohorts
timeFrame: rwTTNT and rates at 6 months, 1y, 3y,5y (rwTTNT6m, rwTTNT1y, rwTTNT3y,rwTTNTS5y)
measure: Real world time to first subsequent local treatment (rwTFST-local treatment) all cohorts
timeFrame: 3 or 5 years
measure: rwTFST (systemic) - cohort A and B
timeFrame: 3 or 5 years
measure: Description of associated therapies
timeFrame: 3 or 5 years
Other outcomes:
Locations:
city: Aix En Provence
country: France
facility: Research Site
city: Aurillac
country: France
facility: Research Site
city: Blois
country: France
facility: Research Site
city: Bordeaux
country: France
facility: Research Site
city: Carcassonne
country: France
facility: Research Site
city: Chalon Sur Sa Ne
country: France
facility: Research Site
city: Chambery
country: France
facility: Research Site
city: Creteil
country: France
facility: Research Site
city: Dieppe
country: France
facility: Research Site
city: Dinan
country: France
facility: Research Site
city: Le COUDRAY
country: France
facility: Research Site
city: Lyon
country: France
facility: Research Site
city: Meaux
country: France
facility: Research Site
city: Metz
country: France
facility: Research Site
city: Mulhouse
country: France
facility: Research Site
city: N Mes
country: France
facility: Research Site
city: Nancy
country: France
facility: Research Site
city: Nantes
country: France
facility: Research Site
city: Nice
country: France
facility: Research Site
city: Perpignan
country: France
facility: Research Site
city: St Brieuc
country: France
facility: Research Site
city: St Etienne
country: France
facility: Research Site
city: St Herblain
country: France
facility: Research Site
city: Toulouse
country: France
facility: Research Site
city: Troyes
country: France
facility: Research Site
city: Valenciennes
country: France
facility: Research Site
city: Vannes
country: France
facility: Research Site
city: Villeurbanne
country: France
facility: Research Site
Study officials:
References: