The purpose of this study is to treat patients with locally advanced or metastatic NSCLC with a combination therapy of selumetinib and two different doses of docetaxel 75mg/m2 or 60 mg/m2 vs placebo and compare how well each dose affects how their cancer responds. It will also help us to understand the tolerability profile of the different dosing regimens in these patients
A Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel, Compared with Placebo in Combination with Docetaxel, in Patients receiving second line treatment for Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
212
Three selumetinib capsules (Hyd-Sulfate) 25 mg will be administered orally, twice daily, (75 mg dose bd) on an uninterrupted schedule.
Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.
Docetaxel 60 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.
Progression Free Survival (PFS)
Median time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression). Progression is defined using Response Evaluation Criteria in Solid Tumours (RECIST v1.1): \>= 20% increase in the sum of diameters of Target Lesions (TL) and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of Non TLs or a new lesion.
Time frame: Baseline and then every 6 weeks after randomization until objective disease progression, up to 29 months (at the time of the analysis)
Overall Survival (OS)
The time from randomisation until death due to any cause. Any subject not known to have died at the time of analysis will be censored based on the last recorded date on which the subject was known to be alive
Time frame: Following progression, survival status was collected every 8 weeks until death, withdrawal of consent, or end of study, whichever occurred first, up to 29 months (at the time of the analysis)
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Three placebo capsules will be administered orally uninterrupted twice daily.
Research Site
Santa Monica, California, United States
Research Site
Aurora, Colorado, United States
Research Site
Hollywood, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Marrero, Louisiana, United States
Research Site
Boston, Massachusetts, United States
Research Site
Mineola, New York, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
...and 58 more locations