LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer
The primary purpose of the study is to compare the antitumor activity of LDK378 versus reference chemotherapy.
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: 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
Enrollment: 374
Study Start Date: July 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms:
- Experimental: LDK378
- Active Comparator: Reference Chemotherapy
Related journal:
First-line ceritinib versus platinum-based chemotherapy in advanced ALK-rearranged non-small-cell lung cancer (ASCEND-4): a randomised, open-label, phase 3 study.
Category | Value |
---|---|
Date last updated at source | 2016-11-03 |
Study type(s) | Interventional |
Expected enrolment | 374 |
Study start date | 2013-07-01 |
Estimated primary completion date | 2018-06-01 |