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
18 Years
N/A
Both
Advanced Non Small Cell Lung Cancer (NSCLC)
Trial Information
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
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.
Inclusion Criteria:
1. 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.
2. Patients must have EGFR gene mutation in their tumors
3. 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.
4. Patients must have received prior platinum containing treatment.
5. Patients must be suitable and willing to undergo mandatory baseline biopsy according
to treating institution's own guidelines and requirements for such procedure.
Exclusion Criteria:
1. Patients who have received more than two prior lines of antineoplastic therapy for
advanced disease.
2. 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
3. Prior treatment with an HSP90 inhibitor
Other protocol-defined inclusion/exclusion criteria may apply
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival (PFS)
Outcome Description:
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
Outcome Time Frame:
up to 12 months
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CAUY922A2207
NCT ID:
NCT01646125
Start Date:
November 2012
Completion Date:
February 2015
Related Keywords:
- Advanced Non Small Cell Lung Cancer (NSCLC)
- HSP90, AUY922, Pemetrexed, Docetaxel, EGFR TKI, EGFR mutations, NSCLC, non small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Cedars Sinai Medical Center Dept.of Cedars-Sinai Med. Ctr. | Los Angeles, California 90048 |
| Associates in Oncology/Hematology, P.C. SC | Rockville, Maryland 20850 |
| University of California at Los Angeles David Geffen School - UCLA | Los Angeles, California 90095 |
| Norton Cancer Institute Clinical Research Program | Louisville, Kentucky 40202 |
| Dana Farber Cancer Institute DFCI AUY | Boston, Massachusetts 02115 |
| Arena Oncology Associates, PC SC Location | Lake Success, New York 11042 |
| University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 5 | Madison, Wisconsin 53792-6164 |
