The purpose of the study is to determine if the addition of Iressa to Best Supportive Care treatment will increase the progression free survival of chemo-naïve, poor performance status patients, with stage IIIB or IV NSCLC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
216
To compare Iressa v best supportive care in terms of progression free survival
Time frame: Progression-free survival
To compare Iressa v best supportive care in terms of objective tumour response rate
Time frame: Overall objective tumour response rate (CR and PR) according to the RECIST criteria
To compare Iressa v best supportive care in terms of overall survival
Time frame: Time to death
To compare Iressa v best supportive care in terms of quality of life
Time frame: Improvement in patient-reported functionality as measured by trial outcome index, comprised of the physical and functional well being sections and LCS of FACT-L and quality of life measured by the FACT-L total score
To compare Iressa v best supportive care in terms of tolerability
Time frame: Adverse event profile (type, frequency and severity of adverse events); laboratory parameters and vital signs
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Bedford Park, Australia
Research Site
Chermside, Australia
Research Site
Concord, Australia
Research Site
Melbourne, Australia
Research Site
Newcastle, Australia
Research Site
Prahran, Australia
Research Site
Randwick, Australia
Research Site
Calgary, Alberta, Canada
Research Site
Edmonton, Alberta, Canada
Research Site
Kelowna, British Columbia, Canada
...and 26 more locations