Status:
RECRUITING
OSIREAL - Osimertinib RWE on EGFRm NSCLC in Spain
Lead Sponsor:
AstraZeneca
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
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...
Detailed Description
Cancer continues to be one of the leading causes of morbidity and mortality in the world. It is estimated that in the year 2020, approximately 18.1 million new cases of cancer in the world, and that t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Osimertinib treatment administration in a clinical trial setting.
Key Trial Info
Start Date :
July 28 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 15 2029
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06068049
Start Date
July 28 2023
End Date
June 15 2029
Last Update
December 19 2025
Active Locations (25)
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1
Research Site
Alicante, Spain
2
Research Site
Barcelona, Spain
3
Research Site
C Rdoba, Spain
4
Research Site
Girona, Spain