Assess Efficacy and Safety of AZD6244 in Combination With Docetaxel in Patients Receiving Second Line Non Small Cell Lung Cancer Treatment.
Condition: Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Selumetinib 75 mg; Docetaxel 75 mg/m2; Docetaxel 60 mg/m2; Placebo
Intervention description: 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.; Three placebo capsules will be administered orally uninterrupted twice daily.
Intervention MeSH terms: Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 212.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Mitogen-Activated Protein Kinase Kinase inhibitor; Non Small Cell Lung Cancer; Metastatic; Second line treatment for Non Small Cell Lung Cancer

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
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed, written and dated informed consent prior to any study specific
             procedures

          -  Male or female, aged 18 years or older

          -  Histological or cytological confirmation of locally advanced or metastatic NSCLC
             (IIIB-IV)

          -  Prospective confirmation of KRAS mutation negative status as determined via an AZ
             approved laboratory

          -  Failure of 1st line anti-cancer therapy due to radiological documentation of disease
             progression in advanced disease or subsequent relapse of disease following 1st line
             therapy

        Exclusion Criteria:

          -  Mixed small cell and non-small cell lung cancer histology

          -  Received >1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients
             who develop disease progression while on switch maintenance therapy (maintenance using
             an agent not in the first-line regimen) will not be eligible.

          -  Other concomitant anti-cancer therapy agents except steroids

          -  Prior treatment with a MEK (Mitogen-Activated Protein Kinase) inhibitor or any
             docetaxel-containing regimen (prior treatment with paclitaxel is acceptable)

          -  The last radiation therapy within 4 weeks prior to starting study treatment, or
             limited field of radiation for palliation within 7 days of the first dose of study
             treatment.