leptomeningeal carcinomatosis (LMC) patients with non-small cell lung cancer harboring EGFR mutation
Conditions
Interventions
Osimertinib 80 mg/day
Sponsors
HANSHIN
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with non-small cell lung cancer diagnosed histologically or cytologically (except SCC) 2.Patients with EGFR gene mutation 3.Patients who shows acquired EGFR-TKI resistance. Patients resistant to a regimen of EGFR-TKI + other drug can also be enrolled 4.Patients with documented EGFR exon 20 T790M mutation in any lesion when EGFR-TKI failure 5.Patients who are detected; -cytologically positive in CSF -EGFR gene mutation positive in CSF If both negative image can be confirmed as LMC with; 1:findings of thickened dura mater 2:image with exudation of contrast medium and attending doctor and clinical study officer as central review are confirmed. 6.For patients who received radiotherapy, time defined below has been passed from the last radiotherapy till their enrollment to the present study [1]Radiotherapy to lung field - over 4 weeks [2]Radiotherapy to whole brain or whole spinal marrow 7.Patients aged 20 years or more at informed consent 8.PS 0 to 2 9.Patients with maintaining sufficient functioning of major organs 10.Three weeks has passed since the last dose of cytotoxic anticancer drug 11.expected survival of not less than 3 months from start of the study treatment 12.Patients who were fully explained about the study and submitted written informed consent before enrollment 13.Desirably, patients have measurable or evaluable lesion according to definition in RECIST (Ver. 1.1), but this criterion is not mandatory.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Progression-free survival 2.Cerebrospinal fluid transitivity of osimertinib | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.ORR, DCR, OS, Safety profile 2.QOL Evaluation (EORTC QLQ-C30) 3.Change of neurological finding (Neurologogical exam) 4.CNS-RR,CNS-DCR,CNS-PFS 5.To explore a resistance factor | — |
Countries
Japan,North America
Contacts
Public ContactShigeki Nanjo, Akito Hata
Institute of Biomedical Research and Innovation Integrated Onclogy
Outcome results
None listed