A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2)
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
587actual
Sites
153
Countries
Argentina, Australia, Brazil +18
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 | 2019-07-02 | actual | When the study began enrolling |
| Primary completion | 2023-04-03 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-12-22 | estimated | The whole study's end, after follow-up |
| First posted | 2019-07-29 | actual | When this record first appeared on the registry |
| Results posted | 2024-08-06 | actual | When the sponsor posted results to the registry |
| Record updated | 2025-10-10 | 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
Interventions
- Drug: Osimertinib — also filed as AZD9291
- Drug: Pemetrexed/Carboplatin
- Drug: Pemetrexed/Cisplatin
Primary outcomes
what the primary-completion date above is the date OFAdverse Events Graded by Common Terminology Criteria for Adverse Event v5 (Safety Run-In Treatment Arms Only)
measured From first dose date to 28 days following last dose, up to 45 months
Progression-free Survival (PFS) (Randomized Component)
measured Up to approximately 33 months after the first patient is randomized (maximum follow up of 33.3 months)
Sensitivity Analysis for Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment (Randomized Component)
measured Up to approximately 33 months after the first patient is randomized (maximum follow up of 33.2 months).
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2021-08-26 · 1.6 MB · Prot_000.pdf
Statistical Analysis Planposted 2023-01-09 · 1.1 MB · SAP_002.pdf
Publications
- PMID 41104938 — linked by the registry
- PMID 40637621 — linked by the registry
- PMID 40311309 — linked by the registry
- PMID 38042525 — linked by the registry
- PMID 37937763 — linked by the registry
- PMID 34543864 — linked by the registry
- PMID 33610453 — linked by the registry
- PMID 33199228 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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