A Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC

Status: Recruiting
Diagnosis: Lung Cancer
NCT ID: NCT01798485 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-324


The purpose of this study is to determine whether combining ganetespib (STA-9090) with docetaxel is more effective than docetaxel alone in the treatment of patients with advanced non-small cell lung cancer.


Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute

Overall PI:
Stephanie Cardarella, MD, Dana Farber Cancer Institute

Site-responsible Investigators:

Dana-Farber Cancer Institute: Kelly Masone, 617-632-3383, kmasone@partners.org

Eligibility Criteria

Inclusion Criteria: - Advanced Stage IIIB or IV NSCLC - Eastern Oncology Cooperative Group (ECOG) Performance Status 0 or 1 - Prior therapy defined as 1 prior systemic therapy for advanced disease - Documented disease progression during or following most first line therapy for advanced disease - Adequate hematologic, hepatic, renal function Exclusion Criteria: - Predominantly squamous, adenosquamous or unclear histologic type - Active or untreated CNS metastases - Active malignancies other than NSCLC within the last 5 years with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin - Serious cardiac illness or medical conditions - Pregnant or lactating women - Uncontrolled intercurrent illness
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