NCT01646125

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to determine if AUY922 had superior efficacy when compared to chemotherapy agents docetaxel or pemetrexed in patients whose tumor had EGFR mutations. The primary purpose of this study was 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 harbored EGFR activating mutations, and had developed resistance to EGFR TKI.

Conditions

• Advanced Non Small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	AUY922	AUY922 was to be given by i.v. once weekly at 70 mg/m2 until disease progression, death or any other reason for discontinuation from study treatment.
DRUG	Docetaxel	Docetaxel was to be given i.v. once every 3 weeks at 75 mg/m2 until progression or unacceptable toxicity
DRUG	Pemetrexed	Pemetrexed was to be given once every 3 weeks at 500 mg/m2 until progression or unacceptable toxicity

Timeline

• Start date: 2012-11-23
• Primary completion: 2015-11-04
• Completion: 2015-11-04
• First posted: 2012-07-20
• Last updated: 2019-07-24
• Results posted: 2017-03-13

Locations

27 sites across 12 countries: United States, France, Hong Kong, Italy, Japan, Netherlands, Norway, Poland, South Korea, Spain, Taiwan, United Kingdom