# A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-S

Source: https://onco.cc/trials/nct04351555/  
OnCo record `nct04351555` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Osimertinib, Cisplatin, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.

## Summary

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 is a phase 3 interventional study registered as NCT04351555 by AstraZeneca, with 358 participants enrolled, started 2020-12-16 and due to reach its primary completion in 2024-10-15. Interventions recorded: Osimertinib, Cisplatin, Carboplatin, Placebo, Pemetrexed. Conditions listed: Non-Small Cell Lung Cancer. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-22
- Also known as: NeoADAURA
- Tags: ctgov-ingest
- Registry id: NCT04351555
- Phase: 3
- Setting: A Phase III, Randomised, Controlled, Multi-center, 3-Arm Study of Neoadjuvant Osimertinib as Monotherapy or in Combination With Chemotherapy Versus Standard of Care Chemotherapy Alone for the Treatment of Patients With Epidermal Growth Factor Receptor Mutation Positive, Resectable Non-small Cell Lung Cancer
- Sponsor: AstraZeneca
- Enrolled: 358
- Outcomes: Major Pathological Response (MPR) - IASLC Method: Osimertinib + Chemo 25.6% vs Osimertinib 24.8% vs Placebo + Chemo 1.7%

## Sources

- ClinicalTrials.gov NCT04351555: https://clinicaltrials.gov/study/NCT04351555

## Connected records

- cancers: [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Resectable stage I to III non-small-cell lung cancer](https://onco.cc/cancers/resectable-nsclc/), [Small-cell lung cancer](https://onco.cc/cancers/sclc/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- drugs: [Carboplatin](https://onco.cc/drugs/carboplatin/), [Cisplatin](https://onco.cc/drugs/cisplatin/), [Osimertinib](https://onco.cc/drugs/osimertinib/), [Pemetrexed](https://onco.cc/drugs/pemetrexed/)
- companies: [AstraZeneca](https://onco.cc/companies/astrazeneca/)

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