LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Ceritinib; pemetrexed; docetaxel
Intervention description: Ceritinib is the investigational treatment and is referred to as the investigational study drug and was provided as 150 mg hard gelatin capsules for oral use. The dose was 750 mg once daily.; Pemetrexed was one of the chemotherapy treatments. Pemetrexed, a reconstituted solution, was intravenously administered over 10 minutes at 500 mg/m2 every 21 days.; Docetaxel was one of the chemotherapy treatments. Docetaxel, a reconstituted solution, was intravenously administered over 1 hour, at 75 mg/m2 every 21 days.
Intervention MeSH terms: Docetaxel; Pemetrexed; Ceritinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 231.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-Small Cell Lung Cancer; ALK; LDK378; Non-small cell lung carcinoma (NSCLC); treatment of lung cancer after first metastasis; lung cancer; lung adenocarcinoma; Non small cell lung carcinoma; Non small cell lung cancer; NSCLC; chemotherapy; ALK-positive; ALK-rearranged advanced non-small cell lung cancer; crizotinib

Summary:

      The primary purpose of the study was to compare the antitumor activity of LDK378 vs.
      chemotherapy in patients previously treated with chemotherapy (platinum doublet) and
      crizotinib. Patients in the chemotherapy arm were given the option to switch to LDK378 after
      confirmed progressive disease (PD), while also had the choice to continue with pemetrexed
      treatment.
    

Eligibility criteria:

        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 FDA approved Abbott FISH Test.

          2. Patient has stage IIIB or IV diagnosis and must have received one or two prior
             regimens (including platinum- doublet) of 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

          4. Patients must have received previous treatment with crizotinib for the treatment of
             locally advanced or metastatic NSCLC.

        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 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.