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Trial details
ASCEND 4:LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib
Current status:
Approved
|
Date registered:
18/06/2021
Trial version(s)
History: 27/12/2019
History: 27/12/2019
History: 27/12/2019
History: 27/12/2019
History: 27/12/2019
History: 27/12/2019
History: 27/12/2019
History: 27/12/2019
History: 27/12/2019
History: 27/12/2019
History: 27/12/2019
History: 27/12/2019
History: 27/12/2019
Current: 27/12/2019
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Main Information
Primary registry identifying number
LBCTR2019121370
Protocol number
CLDK378A2301
MOH registration number
10117/ص
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Retrospective
Type of registration: Justify
This study was already submitted prior to LBCTR initiation. This study is still ongoing.
Date of registration in national regulatory agency
17/11/2014
Primary sponsor
Novartis Pharma Services Inc
Primary sponsor: Country of origin
Novartis Pharma Services Inc
Public title
ASCEND 4:LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib
Acronym
Scientific title
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
Acronym
Brief summary of the study: English
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.
Brief summary of the study: Arabic
دراسة مرحلة ثالثة متعددة المراكز وعشوائيّة التوزيع لدواء LDK378 عن طريق الفم مقابل المعالجة الكيميائيّة العاديّة لدى مرضى بالغين غير معالجين سابقًا ومصابين بسرطان الرئة غير الحرشفي غير ذي الخلايا الصغيرة، كيناز الورم اللمفي الكشمي المعاد ترتيبه (كيناز الورم اللمفي الكشمي الإيجابي)، المرحلة IIIB أو IV
Health conditions/problem studied: Specify
stage IIIB (not candidates for definitive multimodality therapy) or stage IV non-squamous NSCLC
Interventions: Specify
•Drug: Ceritinib Ceritinib is the investigational treatment and is referred to as the investigational study drug and was provided as 150 mg hard gelatin capsules for oral use. The dose was 750 mg once daily. •Drug: pemetrexed Pemetrexed was one of the chemotherapy treatments. Pemetrexed, a reconstituted solution, was intravenously administered over 10 minutes at 500 mg/m2 every 21 days. •Drug: docetaxel Docetaxel was one of the chemotherapy treatments. Docetaxel, a reconstituted solution, was intravenously administered over 1 hour, at 75 mg/m2 every 21 days. •Experimental: Ceritinib Patients in this arm received 750 mg of ceritinib. Intervention: Drug: Ceritinib •Active Comparator: Chemotherapy Patients in this arm received chemotherapy of either pemetrexed or docetaxel as determined by BIRC. Interventions:◦Drug: pemetrexed ◦Drug: docetaxel
Key inclusion and exclusion criteria: Inclusion criteria
Inclusion Criteria: 1.Patient has a histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) positive as assessed by the FDA approved Abbott FISH Test. 2.Patient has stage IIIB or IV diagnosis and must have received one or two prior regimens (including platinum- doublet) of cytotoxic chemotherapy for the treatment of locally advanced or metastatic NSCLC. 3.Patient has at least one measurable lesion as defined by RECIST 1.1. A previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the irradiation 4.Patients must have received previous treatment with crizotinib for the treatment of locally advanced or metastatic NSCLC.
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
99
Key inclusion and exclusion criteria: Exclusion criteria
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 pemetrexed or docetaxel 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.
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Safety
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Open (masking not used)
Study design: Control
Active
Study phase
3
Study design: Purpose
Treatment
Study design: Assignment
Parallel
IMP has market authorization
Yes, Worldwide
IMP has market authorization: Specify the countries
Argentina, Aruba, Australia, Austria, Belgium, Brunei, Canada, Chile, China, Costa Rica, Croatia, Curacao, Czech Republic, Denmark, Dominican Republic, El Salvador, Finland, France, Germany...
Name of IMP
LDK378 (ceritinib)
Type of IMP
Cell therapy
Pharmaceutical class
5-Chloro-2-N-{5-methyl-4-(piperidin-4-yl)-2-[(propan-2-yl)oxy]phenyl}-4-N-[2-(propane-2-sulfonyl)phenyl]pyrimidine-2,4-diamine
Therapeutic indication
This study will be conducted in previously untreated adult patients, with ALK-rearranged (ALK-positive; as determined by the Ventana IHC-based diagnostic test) stage IIIB (not candidates for definitive multimodality therapy) or stage IV non-squamous NSCLC.
Therapeutic benefit
Progression Free Survival (PFS) and Overall Survival (OS)
Biospecimen retention
None retained
Biospecimen description
NA
Target sample size
3
Actual enrollment target size
3
Date of first enrollment: Type
Actual
Date of first enrollment: Date
11/07/2014
Date of study closure: Type
Actual
Date of study closure: Date
31/12/2020
Recruitment status
Complete
Date of completion
30/06/2015
IPD sharing statement plan
No
IPD sharing statement description
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
Additional data URL
https://clinicaltrials.gov/ct2/show/record/NCT01828112?term=ldk378&cond=Lung+Cancer&cntry=LB&draw=1&rank=2
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
clinicaltrials.gov
NCT01828099
Sources of Monetary or Material Support
Name
Novartis Pharma services inc
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Marwan
Ghosn
Beirut
Lebanon
03-226842
marwanghosnmd@yahoo.com
Hotel Dieu De France
Scientific
Hind
Khairallah
Sin elfil
Lebanon
+961 1512002512002
Hind.Khairallah@fattal.com.lb
Khalil Fattal et Fils s.a.l.
Public
Fadi
Farhat
Saida
Lebanon
03-753155
drfadi.trials@gmail.com
Hammoud Hospital
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Hotel Dieu De France
Marwan Ghosn
Hematology oncology
Approved
Hammoud Hospital
Fadi Farhat
Hematology Oncology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hotel Dieu de France
01/07/2013
Sami Richa
cue@usj.edu.lb
961421229
Hammoud Hospital University Medical Center
11/06/2013
Ahmad Zaatari
zaatari@hammoudhospital.com
961 (0) 7 723111 ext 1160
Countries of Recruitment
Name
Lebanon
Belgium
Canada
France
Germany
Ireland
Japan
Netherlands
Portugal
Spain
Switzerland
Turkey
United Kingdom
United States of America
Health Conditions or Problems Studied
Condition
Code
Keyword
Lung Cancer
Bronchus or lung, unspecified (C34.9)
NSCLC
Interventions
Intervention
Description
Keyword
Lab tests , ICF, ECOG, Vital signs, CT scan, Bone scan
Lab tests , ICF, ECOG, Vital signs, CT scan, Bone scan
Lab tests , ICF, ECOG, Vital signs, CT scan, Bone scan
Primary Outcomes
Name
Time points
Measure
Progression Free Survival (PFS)
24 months
24 months
Key Secondary Outcomes
Name
Time points
Measure
Overall Survival (OS)
18 months
18 months
Overall Response Rate (ORR)
18 months
18 months
Patient Reported Outcomes (PRO)
every 6 weeks
every 6 weeks
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
SUSAR(s) 01OCT2020 31MAR2021
15/06/2021
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