A phase III multicenter, randomized study of oral LDK378 versus standard chemotherapy in previously untreated adult patients with ALK rearranged (ALK-positive), stage IIIB or IV, non-squamous non-small cell lung cancer

ovartis Farmacéutica, S.A.0 个研究点目标入组 346 人开始时间: 2013年6月10日最近更新: 2023年10月23日

试验速览

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•1. Patient has a histologically or cytologically confirmed diagnosis of non-squamous NSCLC that is ALK positive as assessed by the Ventana IHC test. The test will be performed at Novartis designated central laboratories.
•2. Patient has newly diagnosed stage IIIB or IV NSCLC or relapsed locally advanced or metastatic NSCLC not previously treated with any systemic anti-cancer therapy (e.g. cytotoxic drugs, monoclonal antibody therapy, crizotinib or other ALK inhibitors, or other targeted therapies, either experimental or not), with exception of neo-adjuvant or adjuvant therapy as depicted in criterion 6. (For AJCC stage groupings and TNM definitions, refer to NCI 2012 guidelines)
•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 208
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 138

•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 platinum containing drugs, pemetrexed or any known excipients of these drugs.
•3. Patient with symptomatic 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

发起方

ovartis Farmacéutica, S.A.