Conditions: Non-Small-Cell Lung Adenocarcinoma Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer Metastatic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 696
Healthy volunteers: no

Brief summary:
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.

Detailed 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.

Update: An independent data monitoring committee (DMC) was established to review accumulating unblinded safety data, and efficacy data at two specified Interim Analyses. The DMC monitored the conduct of the trial (including the accrual/retention of patients) and reviewed the risks and benefits. The study was stopped after the first Interim Analysis due to futility.

The efficacy portion of this report is based on a 05 October 2015 data cut after the number of protocol-defined death events (336) for the first interim analysis had been achieved. The safety portion is based on the final database locked on 23 December 2015.

Arms:
arm 1: Ganetespib (150 mg/m\^2) and docetaxel (75 mg/m\^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle. arm 2: Docetaxel (75 mg/m\^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.

Interventions: intervention 1: Docetaxel intervention 2: Ganetespib
Intervention descriptions: intervention 1: Docetaxel, 75 mg/m\^2, was administered according to prevailing practice and Investigator decision, generally until disease progression, intolerability, or patient's withdrawal of consent. intervention 2: Ganetespib, 150 mg/m\^2, was administered with docetaxel. After docetaxel treatment ceased, participants whose disease has not progressed continued to receive ganetespib alone until disease progression, unacceptable toxicity, or patient's withdrawal of consent.

Protocol document: