['non-small-cell lung cancer']
['ldk378']

        Key Inclusion Criteria:

          -  Histologically or cytologically confirmed diagnosis of Stage IIIb or IV NSCLC that
             carries an ALK rearrangement as determined locally by Vysis ALK Break Apart FISH Probe
             Kit (Abbott Molecular Inc.) test.

          -  Patients must have NSCLC that has progressed at study enrollment.

          -  Patients must have received previous treatment with alectinib for treatment of locally
             advanced or metastatic NSCLC. Prior therapy with crizotinib as ALK inhibitor therapy
             in addition to alectinib is allowed. Alectinib doesn't need to be the last therapy
             prior to study enrollment. No particular sequence of prior alectinib and crizotinib is
             required for enrollment.

          -  Patients must be chemotherapy-naïve or have received only one line of prior cytotoxic
             chemotherapy.

          -  Age 18 years or older at the time of informed consent.

        Key Exclusion Criteria:

          -  Patients with known hypersensitivity to any of the excipients of LDK378.

          -  Prior therapy with other ALK inhibitor investigational agents except crizotinib and
             alectinib.

          -  Prior systemic anti-cancer (including investigational) therapy aside from alectinib,
             crizotinib and one regimen of previous cytotoxic chemotherapy for locally advanced or
             metastatic NSCLC.

          -  Patients with symptomatic central nervous system (CNS) metastases who are
             neurologically unstable or have required increasing doses of steroids within the 2
             weeks prior to study entry to manage CNS symptoms.

          -  Patient with history of interstitial lung disease or interstitial pneumonitis,
             including clinically significant radiation pneumonitis.

          -  Patients with history of carcinomatous meningitis.

          -  Patient with a concurrent malignancy or history of a malignant disease other than
             NSCLC that has been diagnosed and/or required therapy within the past 3 years.

          -  Patient has clinically significant, uncontrolled heart disease and/or recent cardiac
             event (within 6 months)
      