Status:
COMPLETED
LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
Brief Summary
To compare the efficacy and safety of ceritinib with standard first-line chemotherapy (pemetrexed plus cisplatin or carboplatin) in patients with stage IIIB (not candidates for definitive multimodalit...
Detailed Description
This was an open-label, randomized, global, Phase III study that compared the efficacy and safety of ceritinib to standard first-line chemotherapy in patients with advanced (NSCLC) harboring ALK rearr...
Eligibility Criteria
Inclusion
- Key
- The patient had a histologically or cytologically confirmed diagnosis of non-squamous Non-small cell lung cancer (NSCLC) that was Anaplastic lymphoma kinase (ALK) positive as assessed by the Ventana Immunohistochemistry (IHC) test. The test was performed at Novartis designated central laboratories.
- The patient had a newly diagnosed stage IIIB (who was 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 the exception of neo-adjuvant or adjuvant therapy.
- The patient had at least one measurable lesion as defined by RECIST 1.1.
- Key
Exclusion
- The patient had known hypersensitivity to any of the excipients of LDK378 (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide, and magnesium stearate).
- The patient had a history of severe hypersensitivity reaction to platinum-containing drugs, pemetrexed, or any known excipients of these drugs.
- The patient had symptomatic central nervous system (CNS) metastases and was neurologically unstable or had required increasing doses of steroids within the 2 weeks prior to screening to manage CNS symptoms.
Key Trial Info
Start Date :
July 9 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2024
Estimated Enrollment :
376 Patients enrolled
Trial Details
Trial ID
NCT01828099
Start Date
July 9 2013
End Date
January 7 2024
Last Update
January 16 2025
Active Locations (167)
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1
Novartis Investigative Site
CABA, Buenos Aires, Argentina, C1050AAK
2
Novartis Investigative Site
CABA, Buenos Aires, Argentina, C1180AAX
3
Novartis Investigative Site
La Rioja, Argentina, 5300
4
Novartis Investigative Site
Woolloongabba, Queensland, Australia, 4102