trialsTrialActive

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

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.

Also called: NeoADAURA

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.

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

Phase

Phase 3

Sponsor

AstraZeneca

Registry

Started

2020-12-16

Reported

2026

Enrolled

358 enrolled

Outcomes

In plain words

What these results mean for people, not percentages

358 enrolled

Major Pathological Response (MPR) - IASLC Methodprimarysurrogate endpoint

25.6 vs 24.8 out of 100 had no cancer left at surgery with Osimertinib + Chemo compared with Osimertinib; 0.8 more per 100.
Roughly one extra person helped for every 125 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
Other groups: Placebo + Chemo 1.7 of 100.

This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
These results apply to the people the trial enrolled: 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. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

358 enrolled.

Major Pathological Response (MPR) - IASLC Methodprimary

Osimertinib + Chemo25.6 of 100

n = 121

Osimertinib24.8 of 100

n = 117

Placebo + Chemo1.7 of 100

n = 120

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95% CI 18.1 to 34.4; Figures from the ClinicalTrials.gov results section (first posted 2026-06-05), not from a publication · 95% CI 17.3 to 33.6 · 95% CI 0.2 to 5.9

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Major Pathological Response (MPR) - IASLC Methodprimary	Osimertinib + Chemo	121	25.6%	-	-	link
	Osimertinib	117	24.8%
	Placebo + Chemo	120	1.7%

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cancers

Non-small-cell lung cancer Resectable stage I to III non-small-cell lung cancer Small-cell lung cancer

technologies

Small-molecule kinase inhibitors

drugs

ApprovedCytotoxic chemotherapy (platinum)

ApprovedCytotoxic chemotherapy (platinum)

Cisplatin · Platinol (generic)

ApprovedSmall-molecule kinase inhibitor (EGFR)

Osimertinib · Tagrisso

ApprovedCytotoxic (antifolate)

Pemetrexed · Alimta (and generics)

companies