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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01828099
Registration number
NCT01828099
Ethics application status
Date submitted
3/04/2013
Date registered
10/04/2013
Titles & IDs
Public title
LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer
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Scientific title
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
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Secondary ID [1]
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2013-000319-26
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Secondary ID [2]
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CLDK378A2301
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ceritinib
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin
Experimental: Ceritinib - Ceritinib patients were on continuous oral dosing of ceritinib 750 mg once daily in fasted state.
Active comparator: Chemotherapy - Chemotherapy patients (Induction per Investigator's choice) were on four 21-day cycles of Pemetrexed 500mg/m2 iv + Cisplatin 75 mg/m2 or Pemetrexed 500 mg/m2 iv + Carboplatin AUC 5-6 iv followed by Pemetrexed 500 mg/m2 every 21 days followed by Pemetrexed maintenance in non-progressors, etc (other usual rule to stop treatment).
Treatment: Drugs: Ceritinib
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.
Treatment: Drugs: Pemetrexed
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.
Treatment: Drugs: Cisplatin
Cisplatin was administered by IV at a dose of 75 mg/m2 every 21 days for up to 4 cycles.
Treatment: Drugs: Carboplatin
Carboplatin was administered as iv infusion (AUC 5-6) every 21 days up to 4 cycles
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival (PFS) by Blinded Independent Review Committee (BIRC)
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Assessment method [1]
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PFS defined as time from date of randomization to date of first documented disease (as assessed by Blinded Independent Review Committee (BIRC) per RECIST 1.1) or date of death due to any cause
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Timepoint [1]
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from the date of randomization to the date of first radiologically documented disease progression or death due to any cause (assessed every 6 weeks up to approximately 34 months)
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS defined as time from date of randomization to date of death due to any cause
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Timepoint [1]
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From randomization until death (up to approximately 34 months)
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Secondary outcome [2]
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Overall Response Rate (ORR)
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Assessment method [2]
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ORR defined as the proportion of patients with a best overall response defined as Complete Response (CR) or Partial Response (PR) as evaluated by Blinded Independent Review Committee (BIRC) and by investigator assessment per RECIST 1.1
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Timepoint [2]
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From randomization until death (up to approximately 34 months)
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Secondary outcome [3]
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Duration of Response (DOR)
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Assessment method [3]
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DOR defined as the time from date of first documented CR or PR to date of first documented disease progression or death due to any cause
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Timepoint [3]
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From randomization until death (up to approximately 34 months)
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Secondary outcome [4]
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Disease Control Rate (DCR)
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Assessment method [4]
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DCR defined as the proportion of patients with best overall response of CR, PR, or Stable Disease (SD)
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Timepoint [4]
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From randomization until death (up to approximately 34 months)
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Secondary outcome [5]
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Time to Response (TTR)
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Assessment method [5]
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TTR defined as the time from date of randomization to date of first documented response (CR or PR)
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Timepoint [5]
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From randomization until death (up to approximately 34 months)
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Secondary outcome [6]
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Patient Reported Outcomes
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Assessment method [6]
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The time to definitive deterioration from the date of randomization to the date of event for disease related symptoms.
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Timepoint [6]
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Screening, followed by every 6 weeks until Month 33 after Month 33 every 9 weeks.
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Eligibility
Key inclusion criteria
1. Patient has a histologically or cytologically confirmed diagnosis of non-squamous Non-small cell lung cancer (NSCLC) that is Anaplastic lymphoma kinase (ALK) positive as assessed by the Ventana Immunohistochemistry (IHC) test. The test will be performed at Novartis designated central laboratories.
2. Patient has newly diagnosed stage IIIB (who are not a candidate for definitive multimodality therapy) or stage IV NSCLC or relapsed locally advanced or metastatic NSCLC not previously treated with any systemic anti-cancer therapy (e.g. cytotoxic drugs, monoclonal antibody therapy, crizotinib or other ALK inhibitors, or other targeted therapies, either experimental or not), with exception of neo-adjuvant or adjuvant therapy
3. Patient has at least one measurable lesion as defined by RECIST 1.1.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Patient with known hypersensitivity to any of the excipients of LDK378 (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate)
2. Patient with a history of severe hypersensitivity reaction to platinum containing drugs, pemetrexed or any known excipients of these drugs.
3. Patient with symptomatic central nervous system (CNS) metastases who is neurologically unstable or has required increasing doses of steroids within the 2 weeks prior to screening to manage CNS symptoms.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/07/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
7/01/2024
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Sample size
Target
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Accrual to date
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Final
376
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Woolloongabba
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Novartis Investigative Site - Heidelberg
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Novartis Investigative Site - Auckland
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4102 - Woolloongabba
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3084 - Heidelberg
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92024 - Auckland
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Ethics approval
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT01828099
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Trial related presentations / 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. 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.
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Public notes
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01828099