Study of Ganetespib (STA-9090) + Docetaxel in Advanced Non Small Cell Lung Cancer

A Randomized, Phase IIB/III Study of Ganetespib (STA-9090) in Combination With Docetaxel Versus Docetaxel Alone in Subjects With Stage IIIb or IV Non-Small-Cell Lung Cancer

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 subjects with advanced non-small cell lung cancer.

Preliminary signals of clinical activity of ganetespib as a single agent have been observed in NSCLC. A novel approach to treatment of NSCLC is the combination of Hsp90 inhibitors, such as ganetespib, and taxanes. Such combinations have shown potential for synergy in preclinical and clinical evaluations with other Hsp90 inhibitors. Preclinical studies with ganetespib and taxanes have indicated that the combination of these drugs was more effective than either drug alone at inducing cell death, and an ongoing phase 1 study indicates that the combination is well tolerated and warrants systematic evaluation in a larger study.

Inclusion Criteria:

• confirmed diagnosis of NSCLC
• Stage IIIB or IV NSCLC
• ECOG Performance Status 0 or 1
• Prior therapy defined as 1 prior systemic therapy for advanced disease
• measurable disease
• Radiologic evidence of disease progression following most recent prior treatment.
• Adequate hematologic, hepatic, renal function

Exclusion Criteria:

• 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