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
Condition: Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Selumetinib; Docetaxel; Placebo; Pegylated G-CSF
Intervention description: Three 25 mg selumetinib capsules (Hyd-Sulfate) be administered orally, twice daily, (total dose 75 mg dose bd) on an uninterrupted schedule.; Docetaxel 75 mg/m2 will be administered intravenously 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.; All patients will receive pegylated Granulocyte Colony Stimulating Factor (G-CSF) at least 24 hours after administration of every docetaxel dose and not within 14 days prior to the next docetaxel administration.
Intervention MeSH terms: Docetaxel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 510.0
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; KRAS mutation

Summary:

      The purpose of this study is to assess the efficacy of selumetinib in combination with
      docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with
      locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also
      assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the
      selumetinib/docetaxel combination, compared to placebo in combination with docetaxel
    

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)

          -  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