Assess Efficacy and Safety of AZD6244 in Combination With Docetaxel in Patients Receiving Second Line Non Small Cell Lung Cancer Treatment. (SELECT-2)
Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV

About this trial
This is an interventional treatment trial for Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV focused on measuring Mitogen-Activated Protein Kinase Kinase inhibitor, Non Small Cell Lung Cancer, Metastatic, Second line treatment for Non Small Cell Lung Cancer
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.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Selumetinib 75 mg twice daily +Docetaxel 75 mg/m2
Selumetinib 75 mg twice daily + Docetaxel 60 mg/m2
Placebo twice daily + Docetaxel 75 mg/m2
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.
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.
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.