AUY922 in NSCLC patients with EGFR mutations after TKI treatment

• Research type

  Research Study

• Full title

  A multicenter, open-label, randomized phase II study to evaluate the efficacy of AUY922 vs pemetrexed or docetaxel in NSCLC patients with EGFR mutations who have progressed on prior EGFR TKI treatment

• IRAS ID

  111335

• Contact name

  Samreen Ahmed

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2012-001050-25

• ISRCTN Number

  N/A

• Research summary

  The goal of this study is to find out if AUY922, a new investigational drug has any effect in patients with non small cell lung cancer (NSCLC) who have a specific mutation in the EGFR gene. We know from laboratory research that AUY922 can block the activity of an enzyme called ATPase. ATPase is involved when cells divide. Blocking it may stop cancer cells growing. About 300 People'so far with various cancers have been treated with AUY922. In this trial, researchers will compare AUY922 with the chemotherapy drugs docetaxel or pemetrexed. The aims of the trial are to:?½ See if AUY922 helps people with NSCLC who failed previous TKI therapy ?½ Find out more about AUY922 and what happens to it in the body ?½ Learn more about the side effects Patients will be randomly assigned to either receive AUY922 or chemotherapy. The standard chemotherapy agents in this study will be docetaxel or pemetrexed. It will be the study doctor??s decision to choose between docetaxel or pemetrexed. Both docetaxel and pemetrexed are standard treatments for treating this type of cancer. Patients will continue to receive study treatment as long as they are benefiting from the treatment and their cancer is not growing. About 120 patients will join this study from different countries. Patients will visit the study hospital between 3 and 5 times every cycle (three weeks) for routine check-ups and they will have scans every 6 weeks to determine the tumour status. Because the safety and efficacy profile of AUY922 has not yet been established, access to this investigational compound is available only through carefully controlled and monitored clinical trials. Because of uncertainty of clinical trials, there is no guarantee that AUY922 will ever be commercially available anywhere in the world. This is a clinical research study sponsored by the pharmaceutical company named Novartis.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  12/EM/0349

• Date of REC Opinion

  27 Dec 2012

• REC opinion

  Further Information Favourable Opinion