An Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations

• Progression Free Survival (PFS) [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  To compare PFS between the treatment of AUY922 to comparators Pemetrexed or Docetaxel. PFS will be based on local investigator assessment per RECIST 1.1
  
  

• Overall Survival (OS) [ Time Frame: from randomization until death up to death ] [ Designated as safety issue: No ]
  OS is defined as the time from the date of randomization to date of death due to any cause. If a death has not been observed by the date of analysis cutoff, then OS will be censored at the date of last contact.
  
  
• Overall Response Rate (ORR) [ Time Frame: baseline, until disease progression up to 24 months ] [ Designated as safety issue: No ]
  ORR will be compared between treatment arms. The ORR will be based on local investigator assessment per RECIST 1.1
  
  
• Disease Control Rate (DCR) [ Time Frame: baseline, until disease progression up to 24 months ] [ Designated as safety issue: No ]
  Duration of DCR will be compared between treatment arms. The duration of DCR will be based on local investigator assessment per RECIST 1.1
  
  
• Time to Progression (TTP) [ Time Frame: baseline, until disease progression up to 24 months ] [ Designated as safety issue: No ]
  TTP will be compared between treatment arms. The TTP will be based on local investigator assessment per RECIST 1.1
  
  
• Duration of Response (DOR) [ Time Frame: baseline, until disease progression up to 24 months ] [ Designated as safety issue: No ]
  The DOR will be compared between treatment arms. The DOR will be based on local investigator assessment per RECIST 1.1
  
  
• Rate of Adverse Events (AEs) [ Time Frame: baseline, until disease progression up to 24 months ] [ Designated as safety issue: Yes ]
  To evaluate safety and tolerability of AUY922 compared to chemotherapy agents pemetrexed or docetaxel.
  
  
• Rate of serious Adverse events (SAEs) [ Time Frame: baseline, until disease progression up to 24 months ] [ Designated as safety issue: Yes ]
  To evaluate safety and tolerability of AUY922 compared to chemotherapy agents pemetrexed or docetaxel.
  
  
• Change in laboratory parameters [ Time Frame: baseline, until disease progression up to 24 months ] [ Designated as safety issue: Yes ]
  Changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), Dose interruptions, reductions and dose intensity.
  
  

The primary purpose of this study is to compare the efficacy of AUY922, when administered i.v. on a once-weekly schedule at 70 mg/m2, versus docetaxel or pemetrexed in adult patients with advanced NSCLC, whose tumors harbor EGFR activating mutations, and have developed resistance to EGFR TKI.