AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy.
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
682actual
Sites
238
Countries
Australia, Belgium, Brazil +22
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 | 2015-10-21 | actual | When the study began enrolling |
| Primary completion | 2022-04-11 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-01-31 | estimated | The whole study's end, after follow-up |
| First posted | 2015-07-29 | estimated | When this record first appeared on the registry |
| Results posted | 2021-07-27 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-03-30 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Stage IB-IIIA Non-small Cell Lung Carcinoma
Interventions
- Drug: AZD9291 80 mg/40 mg
- Drug: Placebo AZD9291 80 mg/40 mg
- Drug: Open-label AZD9291 80 mg/40 mg
Primary outcome
what the primary-completion date above is the date OFAssess the Efficacy of AZD9291 Compared to Placebo as Measured by Disease Free Survival (DFS).
measured Up to approximately 5 years after the first patient is randomized (maximum follow up of 70 months)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2023-08-09 · 3.4 MB · Prot_002.pdf
Statistical Analysis Planposted 2020-06-23 · 3.5 MB · SAP_001.pdf
Publications
- PMID 33596365 — reports results
- PMID 40311309 — linked by the registry
- PMID 40097663 — linked by the registry
- PMID 38340108 — linked by the registry
- PMID 37390376 — linked by the registry
- PMID 37272535 — linked by the registry
- PMID 37236398 — linked by the registry
- PMID 36720083 — linked by the registry
- PMID 36534268 — linked by the registry
- PMID 35012927 — linked by the registry
- PMID 34740861 — linked by the registry
- PMID 34723634 — linked by the registry
- PMID 32955177 — linked by the registry
- PMID 29789220 — 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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