Randomized phase II trial evaluating the efficacy and safety of standard care +/- continuous gefitinib treatment beyond progression in patients with advanced NSCLC after 1st line treatment with gefitinib(TORG1019)
Phase 2
- Conditions
- EGFR positive non-sqamous non-small cell lung cancer
- Registration Number
- JPRN-UMIN000013316
- Lead Sponsor
- Thoracic Oncology Research Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Not provided
Exclusion Criteria
1) Treated by other molecular targeted drug or cytotoxic agent 2) Prior radiation for primary lesions 3) History of steroid therapy for radiation pneumonitis 4) Patients with symptomatic brain metastasis 5) Interstitial pneumonitis or pulmonary fibrosis detectable on CT scan 6) Patient with pleural effusion, pericardial effusion, ascites or superior vena cave 7) With active infection or other serious medical complications 8) Clinically significant allergy 9) With active double cancer 10) Pregnancy or lactating patients 11) Judged to be not suitable by the attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2 years survival rate after randomization
- Secondary Outcome Measures
Name Time Method Frequency of the flare, overall survival, safety, QOL, response rates of 2nd and 3rd line therapies , and progression-free survivals of 2nd and 3rd line therapies