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Clinical trial

LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer

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Last updated:23rd Jan 2024
Status: COMPLETED
Identifier: NCT01828099
LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer


ClinicalTrials.gov ID: NCT01828099
Sponsor: Novartis Pharmaceuticals
Information provided by: Novartis (Novartis Pharmaceuticals) (Responsible Party)
Last Update Posted: 2024-01-24

Brief 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.

Official Title:
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

Intervention / Treatment:
- Drug: Ceritinib
- Drug: Pemetrexed
- Drug: Cisplatin
- Drug: Carboplatin

Category Value
Study Start (Actual) 2013-07-09
Primary Completion (Actual) 2016-06-24
Study Completion (Actual) 2024-01-07
Enrollment (Actual) 376
Study Type Interventional
Phase Phase 3
Other Study ID Numbers
CLDK378A2301

2013-000319-26 (EudraCT Number)


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