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Sponsor: AstraZeneca
Conditions: Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV
Interventions: Selumetinib, Docetaxel, Placebo, Pegylated G-CSF
Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada
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
Sex: ALL
Age: 18 Years to 130 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Aurora, Colorado, United States
- Pembroke Pines, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Metairie, Louisiana, United States
- Boston, Massachusetts, United States
- Boston, Massachusetts, United States
- Danvers, Massachusetts, United States
- New York, New York, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Hershey, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Nashville, Tennessee, United States
- Seattle, Washington, United States
- Morgantown, West Virginia, United States
- Buenos Aires, Argentina
- Ciudad de Buenos Aires, Argentina
- Ciudad de Buenos Aires, Argentina
- Córdoba, Argentina
- Rosario, Argentina
- Camperdown, Australia
- Chermside, Australia
- Darlinghurst, Australia
- Fitzroy, Australia
- Kogarah, Australia
- Kurralta Park, Australia
- Malvern, Australia
- Wendouree, Australia
- + 167 more on CT.gov