An Open label, Multicenter, Phase II study of AZD9291 in non-small cell lung cancer (NSCLC) patients harboring T790M mutation who failed EGFR TKIs and with brain and/or leptomeningeal metastasis

Samsung Medical Center0 个研究点目标入组 80 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

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•?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

•?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

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