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 Pharma Services AG0 个研究点目标入组 346 人开始时间: 2013年5月17日最近更新: 2024年3月18日

适应症

试验速览

暂无简介。

•1. Patient has a histologically or cytologically confirmed diagnosis of
•non-squamous Non-small cell lung cancer (NSCLC) that is Anaplastic lymphoma kinase (ALK) positive as assessed by the Ventana
•Immunohistochemistry (IHC) test. The test will be performed at Novartis
•designated central laboratories.
•2. Patient has newly diagnosed stage IIIB (who are not a candidate for
•definitive multimodality therapy) or stage 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
•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 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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