OSIREAL - Osimertinib RWE on EGFRm NSCLC in Spain
← catalyst calendarNCT06068049 · readout in 1,031 d
Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →.
Phase
—
Status
Recruiting
Study type
Observational
Enrollment
500estimated
Sites
26
Country
Spain
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-07-28 | actual | When the study began enrolling |
| Primary completion | 2029-06-15 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-06-15 | estimated | The whole study's end, after follow-up |
| First posted | 2023-10-05 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-22 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Non-small Cell Lung Cancer
Primary outcomes
what the primary-completion date above is the date OFTo evaluate the effectiveness of osimertinib in terms of median OS in patients with locally advanced or metastatic EGFRm NSCLC (Cohort 1).
measured 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).
measured 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).
measured 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).
measured From start of osimertinib treatment to death, assessed up to 3 years.
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