A phase III, multicenter, randomized, open-label study of oral LDK378 versus standard chemotherapy in adult patients with ALK-rearranged (ALK-positive) advanced non-small cell lung cancer who have been treated previously with chemotherapy (platinum doublet) and crizotinib

ovartis Pharma Services AG0 个研究点目标入组 236 人开始时间: 2013年5月27日最近更新: 2023年12月4日

适应症

试验速览

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•1. Patient has a histologically or cytologically confirmed diagnosis of non-small cell lung
•cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) positive as assessed by FDA approved Vysis ALK Break Apart FISCH Probe Kit (Abbott Molecular INC) test and scoring algorithm (including positivity criteria). If documentation of ALK rearrangement is not available, the test to confirm ALK rearrangement must be performed according to the above criterion, using a new tumor biopsy obtained prior to the first dose of study treatment (LDK378 or chemotherapy) or archival tumor obtained at or since the time of diagnosis prior to study entry. The test will be performed at a Novartis designated central laboratory.
•2. Patient has stage IIIB or IV diagnosis and must have received previous treatment with crizotinib and one regimen of platinum doublet, cytotoxic chemotherapy for the treatment of locally advanced or metastatic NSCLC.
•3. Patient has at least one measurable lesion as defined by RECIST 1.1. A previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the
•irradiation
•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 126
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 110

•1. Patient with known hypersensitivity to any of the excipients of LDK378 (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate)
•2. Patient with a history of severe hypersensitivity reaction to pemetrexed or docetaxel or any knownexcipients of these drugs.
•3. Patient with symptomatic central nervous system (CNS) metastases who is neurologically unstable or has required increasing doses of steroids within the 2 weeks prior to screening
•to manage CNS symptoms.
•Other protocol-defined exclusion criteria may apply

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