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-HU
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-02
• Last Update Posted: 2 May 2022

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