Non-Small Cell Lung Cancer
Conditions
Interventions
investigational material(s)
Generic name etc : Gefitinib or Docetaxel
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigat
Sponsors
AstraZeneca
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Ages Eligible for Study: 20 Years and above, Genders Eligible for Study: Both Criteria Inclusion Criteria: - You are "histologically" or "cytologically" confirmed to have recurrent or metastatic NSCLC - You have been treated with chemotherapy including platinums for NSCLC. Exclusion Criteria: - You have received treatment for non-small lung cancer within 4 weeks before your participation in this study (except for specific therapies) - You have or had any disease of acute lung injury, idiopathic pulmonary fibrosis, pulmonary pneumonia, or pneumoconiosis evident on the X-ray - You have or had any disease of radiation pneumonia or drug-induced pneumonia, which requires treatment with corticosteroids
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Primary Outcomes: Determine the overall survival with these treatments as the primary outcome. Secondary Outcomes: Determine the followings as the secondary outcome variables:; - Progression-free survival (PFS); - Time to treatment failure (TTF); - Objective tumour response (CR, PR) and the disease control rate (CR, PR, SD [>=12 weeks]) based on the RECIST guidelines; - Lung cancer subscale (LCS); - QOL according to FACT-L questionnaire; - Frequency and severity of adverse events.; Determine the followings as the exploratory outcome variables:; - Biomarkers related to expression, activation and dimerisation of EGFR and other ErbB family receptors and associated pathways including downstream signalling pathways; - Biomarkers related to somatic (non-inheritable) mutation analyses of genes of the ErbB family, their signalling pathways and associated pathways which are thought to be influenced by gefitinib in tumour cells. | — |
Outcome results
None listed