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Be Part of Research - Trial Details - LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer
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LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer

Completed

Open to: ALL

Age: 18.0 - N/A

Leeds London Birmingham Manchester

Medical Conditions

Lung Neoplasms
Carcinoma, Non-Small-Cell Lung

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jul 2013 Jun 2016

Publications

"Soria JC, Tan DSW, Chiari R, Wu YL, Paz-Ares L, Wolf J, Geater SL, Orlov S, Cortinovis D, Yu CJ, Hochmair M, Cortot AB, Tsai CM, Moro-Sibilot D, Campelo RG, McCulloch T, Sen P, Dugan M, Pantano S, Branle F, Massacesi C, de Castro G Jr. 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. Lancet. 2017 Mar 4;389(10072):917-929. doi: 10.1016/S0140-6736(17)30123-X. Epub 2017 Jan 24. Erratum In: Lancet. 2017 Mar 4;389(10072):908. doi: 10.1016/S0140-6736(17)30603-7."; "28126333"; "Lin YT, Yu CJ, Yang JC, Shih JY. Anaplastic Lymphoma Kinase (ALK) Kinase Domain Mutation Following ALK Inhibitor(s) Failure in Advanced ALK Positive Non-Small-Cell Lung Cancer: Analysis and Literature Review. Clin Lung Cancer. 2016 Sep;17(5):e77-e94. doi: 10.1016/j.cllc.2016.03.005. Epub 2016 Mar 30."; "27130468"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Ceritinib was administered orally once-daily fasted at a dose of 750 mg capsules on a continuous dosing schedule. Ceritinib (LDK378) was the investigational treatment and is referred to as the investigational study treatment/drug.

Intervention Arm Group : Ceritinib;

Intervention Type : DRUG
Intervention Description : Pemetrexed was administered at a dose of 500 mg/m2 as an iv infusion on Day 1 of each 21-day cycle to patients randomized to the chemotherapy arm.

Intervention Arm Group : Chemotherapy;

Intervention Type : DRUG
Intervention Description : Cisplatin was administered by IV at a dose of 75 mg/m2 every 21 days for up to 4 cycles.

Intervention Arm Group : Chemotherapy;

Intervention Type : DRUG
Intervention Description : Carboplatin was administered as iv infusion (AUC 5-6) every 21 days up to 4 cycles

Intervention Arm Group : Chemotherapy;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Novartis Investigative Site
    Leeds
    West Yorkshire
    LS9 7TF
  • Novartis Investigative Site
    London
    NW1 2PJ
  • Novartis Investigative Site
    Birmingham
    B9 5SS
  • Novartis Investigative Site
    Manchester
    M20 2BX


The study is sponsored by Novartis Pharmaceuticals



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Read full details for Trial ID: NCT01828099
Last updated 22 January 2024

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