Non-Small Cell Lung Cancer
Conditions
Brief summary
In this study, among the patients with non-small cell lung cancer, those with metastasis or recurrence and previous treatment with chemotherapy will receive gefitinib or docetaxel, and we will compare the effectiveness and safety of gefitinib with docetaxel.
Interventions
DRUGGefitinib or Docetaxel
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the overall survival with these treatments as the primary outcome. | — |
Secondary
| Measure | Time frame |
|---|---|
| - 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) | — |
| Determine the followings as the secondary outcome variables: | — |
| - 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. | — |
| - QOL according to FACT-L questionnaire | — |
Countries
Japan
Outcome results
None listed