A multicenter, single arm phase 2 study to examine efficacy and cerebrospinal fluid transitivity of Osimertinib in leptomeningeal carcinomatosis (LMC) patients with non-small cell lung cancer harboring EGFR mutatio
- Conditions
- leptomeningeal carcinomatosis (LMC) patients with non-small cell lung cancer harboring EGFR mutation
- Registration Number
- JPRN-UMIN000023710
- Lead Sponsor
- HANSHI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 15
Not provided
1.Patients with interstitial pneumonia or lung fibrosis clearly demonstrated by chest CT 2.Patients with a history of serious drug allergy 3.Patients with any serious infectious disease or other serious concurrent medical condition (e.g., gastrointestinal hemorrhage) 4.Patients with high amount of or uncontrollable pleural effusion, ascites or pericardial effusion -If patients treat synechia with anticancer drugs who can participate in the study 5.Patients with any clinically problematic heart disease (e.g., uncontrollable arrhythmia/angina, cardiac failure) 6.Patients with uncontrollable diabetes mellitus concurrently 7.Patients with active double cancer 8.Patients with any clinically problematic psychiatric disorder 9.Patients with untreated fracture (except compression fracture associated with osteoporosis) or severe wound 10.Pregnant, lactating or possibly pregnant female patients, or patients reluctant to take an effective contraceptive measure 11.Patients have immuno-checkpoint inhibitor as previous treatment 12.Other patients who, in the opinion of the investigator, are not eligible for participation in the present study for any reason
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method