AURA3
- Conditions
- on-Small Cell Lung Cancer
- Registration Number
- JPRN-jRCT2080222601
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- Not specified
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
-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method