LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Ceritinib; Pemetrexed; Cisplatin; Carboplatin
Intervention description: Ceritinib was administered orally once-daily fasted at a dose of 750 mg capsules on a continuous dosing schedule. Ceritinib (LDK378) was the investigational treatment and is referred to as the investigational study treatment/drug.; Pemetrexed was administered at a dose of 500 mg/m2 as an iv infusion on Day 1 of each 21-day cycle to patients randomized to the chemotherapy arm.; Cisplatin was administered by IV at a dose of 75 mg/m2 every 21 days for up to 4 cycles.; Carboplatin was administered as iv infusion (AUC 5-6) every 21 days up to 4 cycles
Intervention MeSH terms: Carboplatin; Pemetrexed; Ceritinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 376.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-Small Cell Lung Cancer; NSCLC; 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; non-squamous non-small cell lung cancer

Summary:

      The primary purpose of the study was to compare the antitumor activity of LDK378 versus
      reference chemotherapy. 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-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 therapy

          3. Patient has at least one measurable lesion as defined by RECIST 1.1.

        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 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.