Phase II study of Osimertinib Treatment on EGFR T790M Cytology Positive NSCLC Patients (DETECTIVE study)
- Conditions
- EGFR mutation-positive non-small cell lung cancer
- Registration Number
- JPRN-UMIN000029763
- Lead Sponsor
- Kobe City Medical Center General Hospital Department of medical oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 6
Not provided
1) Treatment history of osimertinib or other third-generation EGFR tyrosine kinase inhibitors (ex. ASP8273) 2) Patients who received other EGFR-tyrosine kinase inhibitors again after disease progression 3) Treatment history of immune checkpoint inhibitors 4) QTc >470 msec 5) Patients with interstitial pneumonia, pulmonary fibrosis or radiation pneumonitis on chest CT 6) Patients with history of drug-related interstitial lung disease 7) Patients with history of serious drug allergy 8) Patients with serious infection or other serious concomitant disease (ex. gastrointestinal bleeding) 9) Uncontrollable pleural effusion, ascites or pericardial effusion 10) Clinically problematic heart disease 11) Uncontrollable diabetes 12) Central nervous system metastasis with a clinical manifestation 13) Patients with active double cancer 14) Clinically problematic psychiatric disorders 15) Unhealed fracture or heavy wound 16) Pregnant or breast-feeding female patients, female patients who have a possibility of pregnancy and does not intend to use birth control till after 6 weeks after last administration or male patients who does not intend to use birth control till after 4 months after last administration 17) Patients judged to be ineligible for safe implementation of this trial by the investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method