A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
358actual
Sites
158
Countries
Austria, Brazil, Bulgaria +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 | 2020-12-16 | actual | When the study began enrolling |
| Primary completion | 2024-10-15 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-06-13 | estimated | The whole study's end, after follow-up |
| First posted | 2020-04-17 | actual | When this record first appeared on the registry |
| Results posted | 2026-06-05 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-06-05 | 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; TAGRISSO
- Drug: Cisplatin
- Drug: Carboplatin
- Drug: Placebo
- Drug: Pemetrexed
Primary outcomes
what the primary-completion date above is the date OFMajor Pathological Response (MPR) - IASLC Method
measured From date of randomization to an average of 12 weeks after the first dose
Major Pathological Response (MPR) - Chemotherapy Method
measured From date of randomization to an average of 12 weeks after the first dose
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2023-12-08 · 3.1 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-09-30 · 13.4 MB · SAP_001.pdf
Publications
- PMID 40454705 — linked by the registry
- PMID 40311309 — linked by the registry
- PMID 39732365 — linked by the registry
- PMID 34278827 — 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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