Assess Efficacy and Safety of AZD6244 in Combination With Docetaxel in Patients Receiving Second Line Non Small Cell Lung Cancer Treatment.

Launched by ASTRAZENECA · Dec 13, 2012

Keywords

ClinConnect Summary

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

Gender

ALL

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.