Conditions: Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV
Keywords: Mitogen-Activated Protein Kinase Kinase inhibitor Non Small Cell Lung Cancer Metastatic Second line treatment for Non Small Cell Lung Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 212
Healthy volunteers: no

Brief summary:
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

Detailed description:
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)

Arms:
arm 1: Selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle. arm 2: Selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 60 mg/m2 intravenously administered on day 1 of each 21 day cycle. arm 3: Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.

Interventions: intervention 1: Selumetinib 75 mg intervention 2: Docetaxel 75 mg/m2 intervention 3: Docetaxel 60 mg/m2 intervention 4: Placebo
Intervention descriptions: intervention 1: Three selumetinib capsules (Hyd-Sulfate) 25 mg will be administered orally, twice daily, (75 mg dose bd) on an uninterrupted schedule. intervention 2: Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle. intervention 3: Docetaxel 60 mg/m2 will be administered intravenously on day 1 of each 21 day cycle. intervention 4: Three placebo capsules will be administered orally uninterrupted twice daily.

Protocol document: