Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC

A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and
Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel, in
Patients receiving second line treatment for KRAS Mutation-Positive Locally Advanced or
Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV) (SELECT-1)

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)

- KRAS mutation positive tumour sample as determined by the designated testing
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.

- Receiving or have received systemic anti-cancer therapy within 30 days prior to
starting study treatment

- Other concomitant anti-cancer therapy agents excepts steroids

- Prior treatment with a Mitogen-Activated protein Kinase (MEK) inhibitor or any
docetaxel-containing regimen (prior treatment with paclitaxel is acceptable).

- Last radiation therapy within 4 weeks prior starting study treatment, or limited field
of radiation for palliation within 7 days of the first dose of study treatment