A phase III study comparing gefitinib and inserted cisplatin and pemetrexed with gefitinib as a first-line treatment for patients with advanced non-squamous non-small-cell lung cancer harboring EGFR activating mutation (JCOG1404/WJOG8214L, AGAIN study)
- Conditions
- advanced non-squamous non-small cell lung cancer harboring EGFR mutaiton
- Registration Number
- JPRN-UMIN000020242
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 500
Not provided
1) Synchronous double or multiple cancer or metachronous double or multiple cancer with progression free period less than 5 years. 2) Infectious disease requiring systemic treatment. 3) Pyrexia of 38 degrees centigrade or higher. 4) During pregnancy, within 28 days of postparturition, or during lactation. 5) Psychological disorder difficult to participate in this clinical study. 6) Receiving continuous systemic corticosteroid or immunosuppressant treatment. 7) Diabetes mellitus uncontrollable with the appropriate treatment. 8) Uncontrollable hypertension. 9) History of unstable angina pectoris or myocardial infarction within 6 months before registration. 10) Positive for serum hepatitis B surface antigen.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method Progression free survival, response rate, adverse events, severe adverse events, proportion of EGFR T790M mutation positive in biopsy tisuues at disease progression