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A Phase III Multicenter, Randomized Study of Oral LDK378 Versus Standard Chemotherapy in Previously Untreated Adult Patients With ALK Rearranged (ALK-positive), Stage IIIB or IV, Non-squamous Non-small Cell Lung Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer

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Trial Information

A Phase III Multicenter, Randomized Study of Oral LDK378 Versus Standard Chemotherapy in Previously Untreated Adult Patients With ALK Rearranged (ALK-positive), Stage IIIB or IV, Non-squamous Non-small Cell Lung Cancer


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 or 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. 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 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS)

Outcome Description:

PFS defined as time from date of randomization to date of first documented disease (as assessed by Blinded Independent Review Committee (BIRC) per RECIST 1.1) or date of death due to any cause

Outcome Time Frame:

Month 33

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Austria: Agency for Health and Food Safety

Study ID:

CLDK378A2301

NCT ID:

NCT01828099

Start Date:

June 2013

Completion Date:

January 2018

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non-Small Cell Lung Cancer
  • ALK
  • LDK378
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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