CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 376 enrolled
Drug / intervention
Ceritinib +3 moredrug
Likely dose
Ceritinib 750 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01828099
NCT01828099Phase 3Completed
CompareCT.gov

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

Novartis Pharmaceuticals·interventional·Posted Apr 10, 2013·Updated Jan 16, 2025

In Brief

A Phase 3 clinical trial evaluating Ceritinib, Pemetrexed, and 2 other interventions for Non-Small Cell Lung Cancer. Completed, enrolled 376 participants across 167 sites in 29 countries.

Detailed 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 multimodality therapy) or stage IV, non-squamous non-small cell lung cancer (NSCLC) harboring a confirmed anaplastic lymphoma kinase (ALK) rearrangement, using the Ventana immunohistochemistry (IHC) test.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer
CountriesArgentina, Australia, Austria, Brazil, China, Colombia, Denmark, France, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Lebanon, Mexico, Netherlands, Norway, Poland, Russia, Singapore, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 10, 2013
Enrollment StartJul 9, 2013
Primary CompletionJun 24, 2016
Study CompletionJan 7, 2024
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 13.2 years ago

Interventions

Ceritinibdrug

Ceritinib was administered orally once-daily fasted at a dose of 750 mg capsules on a continuous dosing schedule.

Pemetrexeddrug

Pemetrexed was administered at a dose of 500 mg/m\^2 as an intravenous (iv) infusion on Day 1 of each 21-day cycle

Cisplatindrug

Cisplatin was administered by iv infusion at a dose of 75 mg/m\^2 every 21 days for up to 4 cycles.

Carboplatindrug

Carboplatin was administered as iv infusion (AUC 5-6) every 21 days up to 4 cycles