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

Stopped early · Phase 2

Conditions studied: Advanced Non Small Cell Lung Cancer (NSCLC)

In brief

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.

Key facts

Study ID

NCT01646125

Run by

Novartis Pharmaceuticals

People needed

59

Starts

2012-11-23

Expected to finish

2015-11-04

Last updated by the study team

2019-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with histologically or cytologically documented, locally advanced (stage IIIB who are not amenable to combined modality treatment) or recurrent or metastatic (Stage IV) non-small cell lung cancer.
• Patients must have EGFR gene mutation in their tumors. This can be source - documented by one of the following:
• Provide a pathology report that indicates the patient's tumor had EGFR activating mutation in the past.
• Or:
• Perform testing (local or central) in an archival tumor or a fresh baseline biopsy tumor tissue to show the presence of EGFR activating mutation.
• Patients must have documented clinical benefit (CR, PR, or patients with SD for 6 months or greater) on prior EGFR TKI (e.g. erlotinib or gefitinib) followed by documented progression according to RECIST.
• Patients must have received prior platinum containing treatment.
• WHO performance status of 0-1

You may not qualify if…

• Patients who have received more than two prior lines of antineoplastic therapy for advanced disease. Chemotherapy administered as neoadjuvant or adjuvant treatment more than six months prior to study enrollment is not considered a prior line of therapy for purposes of this study.
• Evidence of spinal cord compression or current evidence of CNS metastases. Screening CT/MRI of the brain is mandatory. Note: Patients who have been treated for CNS metastases by radiation or gamma knife surgery, who been stable for at least 2 months and have discontinued high dose corticosteroids will be eligible for protocol participation
• Prior treatment with an HSP90 inhibitor

Where it is running

• Cedars Sinai Medical Center Dept.of Cedars-Sinai Med. Ctr. — Los Angeles, California, United States
• Maryland Oncology Hematology, P.A. SC — Rockville, Maryland, United States
• University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 5 — Madison, Wisconsin, United States
• Novartis Investigative Site — Marseille, Bouches Du Rhone, France
• Novartis Investigative Site — Créteil, France
• Novartis Investigative Site — Villejuif, France
• Novartis Investigative Site — Hong Kong, Hong Kong
• Novartis Investigative Site — Monza, MB, Italy
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Parma, PR, Italy
• Novartis Investigative Site — Orbassano, TO, Italy
• Novartis Investigative Site — Koto Ku, Tokyo, Japan
• Novartis Investigative Site — Amsterdam, Netherlands
• Novartis Investigative Site — Groningen, Netherlands
• Novartis Investigative Site — Bergen, Norway
• Novartis Investigative Site — Oslo, Norway
• Novartis Investigative Site — Gdansk, Poland
• Novartis Investigative Site — Seoul, Korea, South Korea
• Novartis Investigative Site — Seoul, Korea, South Korea
• Novartis Investigative Site — Seoul, Seocho Gu, South Korea
• Novartis Investigative Site — Seoul, South Korea
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Kuei-Shan Chiang, Taoyuan/ Taiwan ROC, Taiwan
• Novartis Investigative Site — Taichung, Taiwan

Full record on ClinicalTrials.gov

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