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

Study ID
STU 022013-049

Study Sites

  • Clements University Hospital

Contact
Laurin Priddy
214/648-1688
LAURIN.LOUDAT@UTSouthwestern.edu

Principal Investigator
Joan Schiller

Official Title

A Randomized, Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced Non-Small-Cell Lung Adenocarcinoma

Brief Overview

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.

Description

Preliminary signals of clinical activity of ganetespib as a single agent have been observed in patients with advanced NSCLC. A Phase 2b/3 Study (9090-08) was initiated to evaluate the safety and activity of ganetespib in combination with docetaxel vs. docetaxel alone in NSCLC. Study 9090-08 is ongoing. Results from an interim analysis show that the combination has been well tolerated and an encouraging improvement in efficacy, including overall survival(OS) has been observed.

Eligibility

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:
- EGFR mutations
- ALK translocations
- 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