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Clinical Trial VICCTHN1332

Title

A Phase III, Multicenter, Randomized, Open-Label Study of Oral LDK378 Versus Standard Chemotherapy in Adult Patients with ALK-Rearranged (ALK-Positive) Advanced Non-Small Cell Lung Cancer Who Have Been Treated Previously with Chemotherapy (Platinum Doublet) and Crizotinib

Principal Investigator(s)

Leora Horn

Details

  • Protocol No. VICCTHN1332
  • Open Date: 07/18/2014
  • Staging: Phase III
  • Age Group: Adults
  • Scope: National
  • Objective: To compare the antitumor activity of LDK378 versus reference chemotherapy, as measured by PFS determined by a BIRC.
  • Disease Sites: Lung; Non Small Cell
  • Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Alimta; Docetaxel; Docetaxel (Taxotere); LDK378; Pemetrexed
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01828112
  • Secondary Protocol No: CLDK378A2303

Description

Patients are being asked to take part in this research study because they have non-small cell lung cancer (NSCLC). The purpose of this clinical research study is to compare the benefit and safety profile of LDK378 against a standard chemotherapy medicine (docetaxel or pemetrexed). The reason for this study is to find out which of these two medicines gives better relief of disease recurrence, disease symptoms, quality of life and safety of -anaplastic lymphoma kinase (ALK) positive- non-small cell lung cancer (NSCLC). Because we do not know which medicine is best, we need to make comparisons.. If patients agree to join in this study, they may get either LDK378, which is taken as 5 capsules one time a day, or one of two standard chemotherapy medicines based on your Study Doctors choice. This standard chemotherapy medicine may either be pemetrexed or docetaxel. Pemetrexed or docetaxel will be given by infusion every 3 weeks according to your locally approved country label.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

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
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.