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