Assess Efficacy and Safety of AZD6244 in Combination with Docetaxel in Patients receiving second line NSCLC treatment

Phase 1

• Conditions: ocally Advanced or Metastatic Non Small Cell Lung Cancer stage IIIb - IV; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-003622-25-BG
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-07
• Last Update Posted: 31 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 225

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 using the COBAS® KRAS Mutation Test (Roche Molecular Systems) 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 68
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 157

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.
Having received an investigational drug within 30 days of first dose of study
treatment or within five half-lives of the compound, or have not recovered from side
effects of an investigational drug.
Receiving or have received systemic anti-cancer therapy within 30 days prior to
starting study treatment.
Other concomitant anti-cancer therapy agents except steroids.
Prior treatment with a MEK 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified