non-small cell lung cancer
Conditions
Interventions
Osimertinib
Sponsors
The Japan-Multinational Trial Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Diagnosis of Stage4 NSCLC with malignant pleural effusion 2)Pleural effusion requiring at least manual drainage treatment 3)Cytology in pleural effusion is positive 4)Cases with at least one measurable lesion that can be evaluated with RECIST ver.1.1 5) EGFR-TKI susceptibility gene at diagnosis Positive mutation EGFR gene mutation positive Example: with exon 19 deletion or L858R Exclude double mutation cases with EGFR minor mutation 6) Cases with treatment with at least one or more first generation or second generation EGFR-TKI Enable past history of cytokide anti-cancer drug 7) When progression of a pathological condition is imagewise observed from pretreatment 8)A case in which a case of T790M gene mutation positive was confirmed by an approved diagnostic method 9)When the registration age is over 20 years old 10)When the performance status (WHO Scale)is 0-2 11)When the following major organ abilities are held at the examination price within 7 days before registration Number of neutrophils:1,500/mm3 or more Platelet count:100,000/mm3 or more Hemoglobin:9.0g/dl or more AST(GOT), ALT(GPT):100IU/L or less Total bilirubin:1.5mg/dL or less Serum creatinine value:1.5mg/dl or less 12)Cases satisfying SpO2 more than 90% before pleural drainage 13)Cases in which survival can be expected for 12 weeks or more from the administration start date 14)In the case of men, for example, when using a contraceptive method using condoms 15)In case of a fertile woman, if appropriate contraceptive measures are taken 16)When consent is obtained from the patient himself for participation of this research
Exclusion criteria
Exclusion criteria: 1) Patients with a history of severe allergy or hypersensitivity to the ingredients of the drugs used 2) Cases with pleurodesis 3) Case of treatment history of Osimeltinib and other third generation EGFR-TKI 4) Patients treated with immune checkpoint inhibitors 5) Cases with major surgery within 4 weeks 6) Patients who are concomitantly taking drugs with strong inducing action on cytochrome P450 (CYP) 3A4 or supplements of Chinese traditional herbs (or patients who can not be discontinued at least 1 week before the first dose) 7) Cases with complications of malignancy and / or other active malignant tumors requiring treatment within one year prior to the first dose 8) Cases with serious complications 9) Examples of symptomatic brain metastasis and spinal cord pressure exclusion (cases that can be controlled by treatment can be registered) 10) Cases with obvious interstitial pneumonia or pulmonary fibrosis in chest CT or cases with a history of interstitial pneumonia 11) Patients with a history of gastrointestinal resection such as refractory nausea and vomiting, chronic gastrointestinal disorder, inability to swallow or absorption possibly significantly affecting absorption of osimertinib 12) Case in which QTc value is 470 msec or more in electrocardiogram examination at screening 13) Case with corneal ulcer 14) Cases with difficult ingestion 15) Pregnant women or lactating women 16) Other cases, cases in which doctor in charge judged inappropriate as the subject of this study (examples where dementia patients or psychiatric patients are difficult to perform the test)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate, Overall Survival, Pleural effusion Progression Free Survival, QOL(EORTC-QLQ-LC13), Safety, Biomarkers of blood and pleural effusion(VEGF, FGF2, CXCL12, HGF) | — |
Countries
Japan
Contacts
Public ContactShoko Sonobe
National hospital organization Kinki-chuo Chest Medical Center internal medecine
Outcome results
None listed