A Randomized, Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced Non-Small-Cell Lung Adenocarcinoma
A Randomized, Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced Non-Small-Cell Lung Adenocarcinoma
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.
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.
Inclusion Criteria:
Exclusion Criteria:
Orange, California 92868, United States
Santa Barbara, California 93105-4230, United States
Deerfield Beach, Florida 33442-7753, United States
Hackensack, New Jersey 07601, United States
Wilmington, North Carolina 28401, United States
Roeselaere, West-Vlaanderen 8800, Belgium
Ostrava - Poruba, 708 52, Czechia
Großhansdorf, Schleswig-Holstein 22927, Germany
Budapest, Pest County 1145, Hungary
Poznan, Greater Poland Voivodeship 60569, Poland
Warsaw, Masovian Voivodeship 02-781, Poland