OSIREAL - Osimertinib RWE on EGFRm NSCLC in Spain
OSIREAL
An Ambispective, Non-interventional, Multiple Cohort Study to Assess the Management of Osimertinib Treatment in Patients With EGFRm Non-small Cell Lung Cancer Under Real-world Conditions in Spain
1 other identifier
observational
500
1 country
25
Brief Summary
Lung cancer (LC) is the tumor responsible for the highest mortality worldwide. Lung adenocarcinoma is the major subtype of lung cancer and represents the deadliest human cancer, affecting current-, ex-, and even non-smokers. Osimertinib is indicated as monotherapy for the first-line (1L) treatment of adult patients with locally advanced or metastatic NSCLC with activating mutations in the EGFR, for the treatment of adult patients with EGFR T790M mutation-positive locally advanced or metastatic NSCLC, for the adjuvant treatment of adult patients with NSCLC stages IB-IIIA after complete resection of the tumor that has activating mutations of the EGFR, for the treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 substitution mutation and whose disease has not progressed during or following platinum-based chemoradiation therapy, and in combination with pemetrexed and platinum-based chemotherapy for the 1L treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 substitution mutations. The FLAURA trial showed that treatment with osimertinib significantly prolongs PFS and improves overall survival (OS) compared to standard EGFR tyrosine kinase inhibitors. The results of the ADAURA study showed a reduction in the risk of recurrence or death by 83% in stages II to IIIA, and in 80% in stages IB-IIIA. Additionally, osimertinib demonstrated a highly statistically significant improvement in DFS and HRQoL was maintained. The FLAURA2 trial showed that 1L treatment with osimertinib-chemotherapy led to significantly longer progression-free survival than osimertinib monotherapy among patients with EGFR mutated (EGFRm) advanced NSCLC. The LAURA trial showed that treatment with osimertinib after chemoradiotherapy resulted in significantly longer PFS than placebo among patients with unresectable stage III EGFRm NSCLC. To date, there are no real-world data on osimertinib either in 1L treatment in locally advanced or metastatic EGFRm NSCLC nor as adjuvant treatment, in early stages of cancer, regarding effectiveness, adherence, treatment exposure and quality of life (QoL), among others, and in particular for the use of osimertinib in subpopulations less represented in pivotal trials such as elderly or patients with uncommon EGFR mutations. Furthermore, the duration of treatment in real life in Spain is also a gap, as it appears to be longer than in clinical trials, which means that there are patients who are treated beyond progression. Therefore, this observational ambispective study based on real-world data aims to provide data on osimertinib use as adjuvant treatment in adult patients diagnosed with stages IB-IIIA EGFRm NSCLC, in 1L treatment in patients with locally advanced or metastatic EGFRm NSCLC, as consolidation treatment in patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy, and in combination with pemetrexed and platinum-based chemotherapy in patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution. Specifically, the study will focus on patient characteristics, adherence, treatment exposure, administration, survival, quality of life, effectiveness and safety providing insights into osimertinib use in daily practice for patients with EGFRm NSCLC, where there are current evidence gaps.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2023
Longer than P75 for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2023
CompletedStudy Start
First participant enrolled
July 28, 2023
CompletedFirst Posted
Study publicly available on registry
October 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 15, 2029
April 30, 2026
April 1, 2026
5.9 years
July 26, 2023
April 29, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
To evaluate the effectiveness of osimertinib in terms of median OS in patients with locally advanced or metastatic EGFRm NSCLC (Cohort 1).
\- Overall survival (OS) measured as median time from start of osimertinib treatment to death. The primary measure of interest is median OS and corresponding 95% confidence interval.
From start of osimertinib treatment to death, assessed up to 6 years
To evaluate the effectiveness of osimertinib in terms of 4-year rwDFS rate in patients with stages IB-IIIA EGFRm NSCLC (Cohort 2).
The primary measure of interest is the 4-year real world disease-free survival rate and corresponding 95% confidence interval. \- 4-year real world disease-free survival rate for Cohort 2. (i.e., percentage of patients with clinical or radiological recurrence or death from any cause in the absence of disease recurrence 4 years after the start of osimertinib treatment, as evaluated by the treating physician according to standard clinical practice).
From start of osimertinib treatment to death, assessed up to 4 years.
To evaluate the effectiveness of osimertinib in combination with pemetrexed and platinum-based chemotherapy in terms of 3-year OS in adult patients with advanced NSCLC whose tumours have EGFRm exon 19 deletions or exon 21 (L858R) substitution (Cohort 3).
The primary measure of interest is 3-year overall survival rate and corresponding 95% confidence interval. \- 3-year OS rate for Cohort 3 (i.e., percentage of patients alive 3 years after the start of osimertinib treatment).
From start of osimertinib treatment to death, assessed up to 3 years.
To evaluate the effectiveness of osimertinib (median rwPFS) in patients with locally advanced, unresectable NSCLC with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations whose disease is stable during or after platinum-based CRT (Cohort 4).
\- Real World Progression-free survival (rwPFS) defined as the median time from start of osimertinib treatment to clinical/radiological progression or death from any cause, in the absence of progression, as evaluated by the treating physician according to standard clinical practice. The primary measure of interest is median rwPFS and corresponding 95% confidence interval.
From start of osimertinib treatment to death, assessed up to 3 years.
Secondary Outcomes (7)
To further evaluate the effectiveness of osimertinib in terms of rwPFS in patients with locally advanced or metastatic EGFRm NSCLC (Cohort 1).
From start of osimertinib to clinical/radiological progression or death from any cause, whichever came first, assesed up to 6 years
To further evaluate the effectiveness of osimertinib in terms of rwDFS rates and OS in patients with stages IB-IIIA EGFRm NSCLC (Cohort 2).
From start of osimertinib to clinical/radiological recurrence or death from any cause, whichever came first, assesed up to 4 years
To further evaluate the effectiveness of osimertinib in combination with pemetrexed and platinum-based CT in terms of rwPFS and OS, in patients with advanced NSCLC whose tumours have EGFRm exon 19 deletions or exon 21 (L858R) substitution (Cohort 3).
From start of osimertinib to clinical/radiological progression or death from any cause, whichever came first, assesed up to 3 years.
To further evaluate the effectiveness of osimertinib in terms of CNS PFS, rwTTDM and 3-year OS (Cohort 4).
From start of osimertinib to clinical/radiological progression or death from any cause, whichever came first, assessed up to 3 years.
To describe the characteristics of osimertinib treatment administration for EGFRm NSCLC.
During osimertinib treatment, assessed up to 6 years in cohort 1 and up to 3 years in cohorts 2, 3 & 4.
- +2 more secondary outcomes
Other Outcomes (8)
To describe the effectiveness, safety and use of healthcare resources of osimertinib monotherapy in patients with locally advanced or metastatic EGFRm NSCLC (Cohort 1) who have uncommon EGFR mutations.
rwPFS from start of treatment initiation until disease progression or death; OS from treatment initiation until death from any cause.
To describe the effectiveness, safety and use of healthcare resources of osimertinib monotherapy in elderly patients (>65 and >75 years) with locally advanced or metastatic EGFRm NSCLC (Cohorts 1, 3 & 4).
rwPFS from start of treatment initiation until disease progression or death; OS from treatment initiation until death from any cause.
To evaluate patient reported outcomes and experience measures (PROMs and PREMs) in EGFRm NSCLC patients treated with Osimertinib as adjuvant treatment (only applicable to cohort 2).
SATMED-Q, SF-36: at study inclusion and every 6 months. ADAQ: at study inclusion and every week during on osimertinib treatment, an average of 3 years.
- +5 more other outcomes
Study Arms (4)
Cohort 1
Patients diagnosed with locally advanced or metastatic NSCLC with activating EGFR mutations that received first line treatment with osimertinib (FLAURA regimen).
Cohort 2
Patients with stage IB-IIIA NSCLC after complete tumour resection that has activating mutations in the EGFR (deletion of exon 19 or substitution of exon 21 \[L858R\]) that received adjuvant treatment with osimertinib (ADAURA regimen).
Cohort 3
Patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, that received osimertinib in combination with pemetrexed and platinum-based chemotherapy for the first- line treatment (FLAURA2 regimen).
Cohort 4
Patients with locally advanced, unresectable NSCLC treated with osimertinib, whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy (LAURA regimen).
Eligibility Criteria
The study population will include all adult EGFRm NSCLC patients receiving osimertinib according to SmPC.
You may qualify if:
- Female or male patients, treated with osimertinib
- Age ≥ 18 years at starts of osimertinib treatment (i.e., index date).
- Patients histologically diagnosed with EGFRm NSCLC (before index date):
- Patients with first-line treatment with EGFRm locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy (Cohort 1).
- Patients with stage IB-IIIA whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, after complete tumor resection (Cohort 2).
- Patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, that received osimertinib in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment (Cohort 3).
- Patients with locally advanced, unresectable NSCLC treated with osimertinib, whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy (cohort 4).
- Provision of informed consent (for alive patients). Deceased patients who met the selection criteria when they started treatment with osimertinib could also be included in the study.
You may not qualify if:
- Osimertinib treatment administration in a clinical trial setting.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (25)
Research Site
Alicante, Spain
Research Site
Barcelona, Spain
Research Site
C Rdoba, Spain
Research Site
Girona, Spain
Research Site
Gran Canaria, Spain
Research Site
Granada, Spain
Research Site
Ja N, Spain
Research Site
L Rida, Spain
Research Site
La Coru A, Spain
Research Site
León, Spain
Research Site
M Laga, Spain
Research Site
Madrid, Spain
Research Site
Murcia, Spain
Research Site
Ourense, Spain
Research Site
Palma, Spain
Research Site
Sabadell, Spain
Research Site
Salamanca, Spain
Research Site
Santa Cruz de Tenerife, Spain
Research Site
Santander, Spain
Research Site
Santiago de Compostela, Spain
Research Site
Seville, Spain
Research Site
Valencia, Spain
Research Site
Valladolid, Spain
Research Site
Vigo, Spain
Research Site
Zaragoza, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2023
First Posted
October 5, 2023
Study Start
July 28, 2023
Primary Completion (Estimated)
June 15, 2029
Study Completion (Estimated)
June 15, 2029
Last Updated
April 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org.