AURA3

A Phase 3, Open Label, Randomized Study of AZD9291 versus Platinum-Based Doublet Chemotherapy for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor Receptor Gene (AURA3)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222601

Enrollment

Registered

2014-09-10

Start date

2014-09-17

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Non-Small Cell Lung Cancer

Interventions

investigational material(s) Generic name etc : AZD9291 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Subject with histologogically or cytologically documented NSCLC -Locally advanced or metastatic NSCLC -Radiological documentation of disease progression following 1st line EGFR TKI Treatment without any further treatment -Eligble to receive treatment wit the selected doublet chemotherapy -Central confirmation of T790M+ mutation status -World Health Organisation (WHO) performance status 0-1 -At least one lesion, not previously irradiated 18 Years and older, Japan patients aged at least 20 years

Exclusion criteria

Exclusion criteria: -Prior neo-adjuvant or adjuvant chemotherapy treatment within 6 months prior of starting 1st EGFR TKI treatment -Treatment with more than one prior line of treatment for advanced NSCLC -Treatment with an approved EGFR-TKI (e.g.,erlotinib,gefitinib,afatinib) within 8 days or approximately 5x half-life of the first dose of study treatment -Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment -Previous treatment with AZD9291, or a 3rd generation EGFR TKI For subjects who cross-over to AZD9291: -Once subjects on the platinum-based doublet chemotherapy arm are determined to have objective radiological progression according to RECIST 1.1 by the investigator and confirmed by independent central imaging review. -At least 14 days since last dose of platinum-based doublet chemotherapy

Design outcomes

Primary

Measure	Time frame
To assess the efficacy of AZD9291 compared with platinum-based doublet chemotherapy by assessment of Progression Free Survival (PFS).	—

Countries

Australia, Canada, China, France, Hong Kong, Hungary, Mexico, Netherlands, Russia, South Korea, Spain, Sweden, Taiwan, UK, USA

Contacts

Public ContactKazushige Hibi

Astrazeneka K.K

RD-clinical-information-Japan@astrazeneca.com+81-6-4802-3533

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026