A phase II, multicenter, single-arm study of oral LDK378 in adult patients with ALK-activated non-small cell lung cancer previously treated with chemotherapy and crizotinib

ovartis Pharma Services AG0 个研究点目标入组 137 人开始时间: 2013年1月10日最近更新: 2016年9月19日

适应症

试验速览

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•1. Histologically or cytologically confirmed diagnosis of stage IIIb or IV NSCLC that carries an ALK rearrangement as per the FDA-approved Vysis-ALK break-apart FISH test (Abbott Molecular Inc)
•2. Age 18 years or older at the time of informed consent.
•3. Patients must have NSCLC that has progressed during therapy with crizotinib or within 30 days of the last dose
•4. Patients must have received 1-3 lines of cytotoxic chemotherapy (of which 1 must have been a platinum doublet) to treat their locally advanced or metastatic NSCLC
•5. Patients must have archival tissue sample available, collected either at the time of diagnosis of NSCLC or any time since.
•6. Patients must have recovered from all toxicities related to prior anticancer therapies to grade = 2, except for patients with grade 2 nausea/vomiting and/or grade 2 diarrhea despite optimal supportive therapy who will not be allowed to participate in the study
•Other protocol defined inclusion criteria may apply
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 112
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 25

•1. Patients with known hypersensitivity to any of the excipients of LDK378
•2. Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
•3. History of carcinomatous meningitis.
•4. Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years.
•5. Clinically significant, uncontrolled heart disease
•6. Systemic anti-cancer therapy given after the last dose of crizotinib and prior to starting study drug.
•Other protocol defined exclusion criteria may apply

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