Status:
COMPLETED
LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
Brief 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 ch...
Detailed Description
A total of 231 patients were randomized to one of the two treatment arms in a 1:1 ratio. Randomization was stratified by World Health Organization (WHO) performance status (0 versus 1-2) and whether t...
Eligibility Criteria
Inclusion
- 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.
- 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.
- 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
- Patients must have received previous treatment with crizotinib for the treatment of locally advanced or metastatic NSCLC.
Exclusion
- Patient with known hypersensitivity to any of the excipients of LDK378 (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate)
- Patient with a history of severe hypersensitivity reaction to pemetrexed or docetaxel or any known excipients of these drugs.
- 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.
Key Trial Info
Start Date :
June 28 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2023
Estimated Enrollment :
231 Patients enrolled
Trial Details
Trial ID
NCT01828112
Start Date
June 28 2013
End Date
November 10 2023
Last Update
February 7 2025
Active Locations (97)
Enter a location and click search to find clinical trials sorted by distance.
1
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
2
Memorial Cancer Institute
Hollywood, Florida, United States, 33021
3
Cancer Specialists of North Florida
Jacksonville, Florida, United States, 32256
4
University Of Miami
Miami, Florida, United States, 33136