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
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 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
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
1. Patient with known hypersensitivity to any of the excipients of LDK378
(microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and
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.