CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
LDK378drug
Likely dose
LDK378 750mgfrom 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/NCT02450903
NCT02450903Phase 2Completed
CompareCT.gov

A Phase II, Multi-center, Open-label, Single-Arm Study to Evaluate the Efficacy and Safety of Oral LDK378 Treatment for Patients With ALK-Positive Non-Small Cell Lung Cancer Previously Treated With Alectinib

Novartis Pharmaceuticals·interventional·Posted May 21, 2015·Updated Mar 30, 2021

In Brief

A Phase 2 clinical trial evaluating LDK378 for Non-Small-Cell Lung Cancer. Completed, enrolled 20 participants across 9 sites.

Detailed Summary

This was a single-arm, open-label, multicenter, phase II study to evaluate the efficacy and safety of the ALK inhibitor LDK378 when used as single agent in patients with ALK-rearranged stage IIIB or IV NSCLC previously treated with alectinib. Treatment with LDK378 750 mg qd continued until the patient experienced disease progression as determined by the investigator according to RECIST 1.1, unacceptable toxicity that precluded further treatment, pregnancy, start of a new anticancer therapy, discontinued treatment at the discretion of the patient or investigator, lost to follow-up, death, or study was terminated by Sponsor.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small-Cell Lung Cancer
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 21, 2015
Enrollment StartAug 21, 2015
Primary CompletionJul 31, 2017
Study CompletionMay 24, 2018
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 11.1 years ago

Interventions

LDK378drug

Oral LDK378 750mg once daily