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

Study ID
9090-14

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Clements University Hospital
  • UT Southwestern Ambulatory Services
  • Zale Lipshy University Hospital
  • Parkland Health & Hospital System

Contact


Principal Investigator

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.

Summary


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.

Participant 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