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)

AstraZeneca0 个研究点开始时间: 2014年9月10日最近更新: 2023年10月17日

试验速览

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•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

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