LDK378 versus chemotherapy in ALK rearranged (ALK positive) patients previously treated withchemotherapy (platinum doublet) and crizotinib

Gender:
Female: yes
Male: yes

Inclusion criteria:
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 the Abbott FISH Test.
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

Exclusion criteria:
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