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A Phase III, Randomized, 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 (NeoADAURA)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502606-33-00
Acronym
D516AC00001
Enrollment
40
Registered
2024-05-14
Start date
2021-02-26
Completion date
Unknown
Last updated
2025-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with histologically or cytologically documented non-squamous NSCLC with completely resectable (Stage II - IIIB N2) disease

Brief summary

Major Pathological Response (MPR) (≤10% residual cancer cells in the main tumour, as assessed per central pathology laboratory post surgery)

Detailed description

Complete pathological Response (pCR) (absence of any residual cancer cells in the dissected tumour samples, including the main tumour and lymph nodes, assessed post-surgery); EFS; DFS; Downstaging; Overall Survival (OS), Change from baseline in Patient reported outcomes (ePRO), Concordance of EGFRm status between tumour tissue DNA and patientmatched plasma-derived ctDNA, Concordance of EGFR mutation status between the local and central cobas EGFR mutation test results from baseline tumour samples., PK plasma concentrations of osimertinib

Interventions

DRUGPEMETREXED
DRUGTAGRISSO 40 mg film-coated tablets
DRUGTAGRISSO 80 mg film-coated tablets
DRUGCARBOPLATIN
DRUGCISPLATIN
DRUGPLACEBO

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Major Pathological Response (MPR) (≤10% residual cancer cells in the main tumour, as assessed per central pathology laboratory post surgery)

Secondary

MeasureTime frame
Complete pathological Response (pCR) (absence of any residual cancer cells in the dissected tumour samples, including the main tumour and lymph nodes, assessed post-surgery); EFS; DFS; Downstaging; Overall Survival (OS), Change from baseline in Patient reported outcomes (ePRO), Concordance of EGFRm status between tumour tissue DNA and patientmatched plasma-derived ctDNA, Concordance of EGFR mutation status between the local and central cobas EGFR mutation test results from baseline tumour samples., PK plasma concentrations of osimertinib

Countries

Austria, Bulgaria, France, Germany, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026