Non-small cell lung cancer
Conditions
Interventions
Erlotinib plus Docetaxel
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Phase1 1)Histologically or cytologically Non-small cell lung cancer 2)EGFR wild type of Exon 19 and 21 3)Unsuitable for surgery nor radiation therapy 4)Stage IIIB, or IV 5)Previously treated with one chemotherapy or chemoradiotherapy regimen 6)Aged 20 years and older 7)ECOG performance status 0-1 8)Adequate organ functions 9)Life expectancy of at least 3 months 10)At least 4weeks after the ad ministration of the previous chemotherapy and/or chest RT and surgery,2weeks after RT for ex-thoracic lesion 11)Written informed consent Phase2 1)Histologically or cytologically Non-small cell lung cancer 2)EGFR wild type of Exon 18, 19 and 21 3)Unsuitable for surgery nor radiation therapy 4)Stage IIIB, or IV 5)Previously treated with one chemotherapy or chemoradiotherapy regimen 6)Measurable lesion defined by RECIST ver1.1 7)Aged 20 years and older 8)ECOG performance status 0-1 9)Adequate organ functions 10)Life expectancy of at least 3 months 11)At least 4weeks after the ad ministration of the previous chemotherapy and/or chest RT and surgery,2weeks after RT for ex-thoracic lesion 12)Written informed consent
Exclusion criteria
Exclusion criteria: Phase1 1)Previous treatment with an agent of which the main mechanism of action is inhibition of EGFR families or its associated tyrosine kinase 2)Previously received docetaxel 3)Obvious pulmonary interstitial abnormality on chest CT 4)Uncontrolled infections or uncontrolled serious systematic disease 5)symptomatic brain metastasis 6)Other co-existing malignancies or malignancies diagnosed within the last 5 years 7)significant pleural effusion, pericardial effusions or ascites, 8)patient who cannot eat enough 9)severe drug allergies 10)Hypersensitive to polysorbate80 11)Pregnant or breast feeding 12)HBs-Ag positive or HCV-Ab positive 13)Patient for whom this clinical trial is judged to be inappropriate by physicians Phase2 1)Previous treatment with an agent of which the main mechanism of action is inhibition of EGFR families or its associated tyrosine kinase 2)Previously received docetaxel 3)Obvious pulmonary interstitial abnormality on chest CT 4)Uncontrolled significant active infections or uncontrolled systematic disease 5)symptomatic brain metastasis 6)Other co-existing malignancies or malignancies diagnosed within the last 5 years 7)significant pleural effusion, pericardial effusions or ascites, 8)patient who cannot eat enough 9)severe drug allergies 10)Hypersensitive to polysorbate80 11)Pregnant or breast feeding 12)HBs-Ag positive or HCV-Ab positive 13)Patient for whom this clinical trial is judged to be inappropriate by physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I study:Safety Determine recommended dose Phase II study: Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Disease control rate Progression free survival Overall survival 1 year survival rate | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed