None listed
Conditions
Interventions
Drug : Patients will be treated 160 mg/day of AZD9291 orally (1 cycle for 28 days). Subjects (with the exception of subjects with insulin dependent diabetes) must fast for = 1 hours prior to taking a
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? EGFR activating mutant NSCLC patients who failed EGFR TKIs (gefitinib, erlotinib, or afatinib) and develop CNS disease (BM and/or LM) with T790M mutation either tissue or plasma. For patients with intracranial progression, prior radiation therapy is not mandatory. Extracranial progression is allowed. ? Patients who failed to 3rd generation EGFR TKIs (AZD9291 (80mg), Rociletinib, HM61713, or others) and develop CNS progression but stable extracranial disease ? Age =18 years ? ECOG performance status of 0 to 2 ? For BM, at least one measurable intracranial lesion as = 10mm in the longest diameter by magnetic resonance imaging (MRI) ? For LM, at least one site of CNS leptomeningeal disease that can be assessed by MRI ? Adequate organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; total bilirubin =1.5 UNL; AST and/or ALT < 5 UNL, CCr = 50mL/min ? Female subjects must either be of non-reproductive potential ? Subject is willing and able to comply with the protocol ? Signed written informed consent
Exclusion criteria
Exclusion criteria: ? Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 1 week ? Any unresolved toxicities from prior therapy, greater than CTCAE grade 1 ? Mean QT interval corrected for heart rate (QTc) = 470 ms ? Uncontrolled systemic illness including uncontrolled hypertension, active bleeding, or active infection. ? Past medical history of interstitial lung disease, drug induced interstitial lung disease, radiation pneumonitis which required steroid treatment ? History of hypersensitivity to AZD9291 ? Known intracranial haemorrahge which is unrelated to tumor ? Refractory nausea and vomiting
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) in CNS –brain metastasis cohort, - Overall survival – Leptomeningeal with or without brain metastasis cohort | — |
Secondary
| Measure | Time frame |
|---|---|
| Whole body disease control rate (DCR), Time to brain progression, Progression free survival (PFS) in BM cohort, Overall survival (OS), Adverse events (AEs), Exploratory analysis of EGFR mutation/T790M in tissue, plasma or cerebrospinal fluid (CSF) | — |
Countries
Korea, Republic of
Contacts
Public ContactMyungJu An
Samsung Medical Center
Outcome results
None listed