Assess Efficacy and Safety of AZD6244 in Combination With Docetaxel in Patients Receiving Second Line Non Small Cell Lung Cancer Treatment.

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)

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.