AZD9291 (Osimertinib) Versus Platinum-Based Doublet-Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Prior treatment

• Treatment with more than one prior line of treatment for advanced NSCLC
• 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
• 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

Lab values

• • Prior neo-adjuvant or adjuvant chemotherapy treatment within 6 months prior of starting 1st EGFR TKI treatment
• 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
• Previous treatment with Osimertinib, or a 3rd generation EGFR TKI
  • For subjects who cross-over to Osimertinib:

• Subjects with histologically or cytologically documented NSCLC.
• Locally advanced or metastatic NSCLC
• Radiological documentation of disease progression following 1st line EGFR TKI Treatment without any further treatment
• Eligible to receive treatment with the selected doublet-chemotherapy
• Central confirmation of T790M+ mutation status
• World Health Organization (WHO) performance status 0-1
• At least one lesion, not previously irradiated.