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Clinical Trial VICCTHN1379


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)

Principal Investigator(s)

Leora Horn


  • Protocol No. VICCTHN1379
  • Open Date: 02/21/2014
  • Staging: Phase III
  • Age Group: Adults
  • Scope: National
  • Objective: To assess the efficacy in terms of Progression Free Survival (PFS) of selumetinib in combination with docetaxel compared to placebo in combination with docetaxel.
  • Disease Sites: Lung; Non Small Cell
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Docetaxel; Docetaxel (Taxotere); G-CSF; Selumetinib
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01933932
  • Secondary Protocol No: D1532C00079


Patients are being asked to take part in this research study because they have been given a diagnosis of a specific type of lung cancer called -non-small cell lung cancer- (NSCLC). The study is being carried out to see if a new cancer treatment, selumetinib in combination with an established chemotherapy (docetaxel) is more effective than the chemotherapy on its own.


Ages Eligible for Study:18 Years to 130 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No


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