CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 231 enrolled
Drug / intervention
Ceritinib +2 moredrug
Likely dose
Ceritinib 150 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/NCT01828112
NCT01828112Phase 3Completed
CompareCT.gov

A Phase III, Multicenter, Randomized, Open-label Study of Oral LDK378 Versus Standard Chemotherapy in Adult Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer Who Have Been Treated Previously With Chemotherapy (Platinum Doublet) and Crizotinib

Novartis Pharmaceuticals·interventional·Posted Apr 10, 2013·Updated Feb 7, 2025

In Brief

A Phase 3 clinical trial evaluating Ceritinib, Pemetrexed, and 1 other intervention for Non-Small Cell Lung Cancer. Completed, enrolled 231 participants across 97 sites in 20 countries.

Detailed Summary

The primary purpose of the study was to compare the antitumor activity of LDK378 vs. chemotherapy in patients previously treated with chemotherapy (platinum doublet) and crizotinib. 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer
CountriesBelgium, Canada, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Lebanon, Netherlands, Portugal, Russia, Singapore, South Korea, Spain, Switzerland, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 10, 2013
Enrollment StartJun 28, 2013
Primary CompletionJan 26, 2016
Study CompletionNov 10, 2023
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 13.2 years ago

Interventions

Ceritinibdrug

Ceritinib was the investigational treatment and was provided as 150 mg hard gelatin capsules for oral use. The dose was 750 mg once daily.

Pemetrexeddrug

Pemetrexed was one of the chemotherapy treatments. Pemetrexed, a reconstituted solution, was intravenously administered over 10 minutes at 500 mg/m\^2 every 21 days.

Docetaxeldrug

Docetaxel was one of the chemotherapy treatments. Docetaxel, a reconstituted solution, was intravenously administered over 1 hour, at 75 mg/m\^2 every 21 days.