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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 - 100.0

Nottingham Leeds Birmingham Manchester London Exeter

Medical Conditions

Non-Small Cell Lung Cancer

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.


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.

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."; "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.

Intervention Arm Group : Ceritinib;

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

Intervention Arm Group : Chemotherapy;

Intervention Type : DRUG
Intervention Description : Cisplatin was administered by iv infusion at a dose of 75 mg/m\^2 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
    Nottingham
    NG5 1PB
  • Novartis Investigative Site
    Leeds
    West Yorkshire
    LS9 7TF
  • Novartis Investigative Site
    Birmingham
    B9 5SS
  • Novartis Investigative Site
    Manchester
    M20 2BX
  • Novartis Investigative Site
    London
    NW1 2BU
  • Novartis Investigative Site
    Exeter
    Devon
    EX2 5DW


The study is sponsored by Novartis Pharmaceuticals



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Read full details for Trial ID: NCT01828099
Last updated 20 December 2024

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