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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02393625
Registration number
NCT02393625
Ethics application status
Date submitted
23/02/2015
Date registered
19/03/2015
Date last updated
24/05/2024
Titles & IDs
Public title
Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer
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Scientific title
A Multi-center, Open-label Study to Assess the Safety and Efficacy of Combination Ceritinib (LDK378) and Nivolumab in Adult Patients With Anaplastic Lymphoma Kinase (ALK)-Positive Non-small Cell Lung Cancer (NSCLC)
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Secondary ID [1]
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2014-005054-19
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Secondary ID [2]
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CLDK378A2120C
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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:
ALK-positive NSCLC
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Condition category
Condition code
Cancer
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Lung - Non small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ceritinib (LDK378)
Treatment: Drugs - Nivolumab
Experimental: Dose Escalation -
Experimental: Dose Expansion -
Treatment: Drugs: Ceritinib (LDK378)
Treatment: Drugs: Nivolumab
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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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Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion
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Assessment method [1]
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Timepoint [1]
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Study Day 42 (6 weeks)
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Primary outcome [2]
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Overall response rate (ORR)
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Assessment method [2]
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ORR (complete response (CR)+ partial response (PR)) per RECIST 1.1 as assessed by investigator
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Timepoint [2]
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24 Weeks
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Secondary outcome [1]
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Duration of Response (DOR)
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Assessment method [1]
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Timepoint [1]
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24 weeks
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Secondary outcome [2]
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Disease Control Rate (DCR)
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Assessment method [2]
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Timepoint [2]
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24 weeks
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Secondary outcome [3]
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Time to Response (TTR)
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Assessment method [3]
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0
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Timepoint [3]
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24 weeks
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Secondary outcome [4]
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Progression Free Survival (PFS)
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Assessment method [4]
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0
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Timepoint [4]
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24 weeks
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Secondary outcome [5]
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Overall survival (OS)
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Assessment method [5]
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Timepoint [5]
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24 weeks
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Eligibility
Key inclusion criteria
- Histologically or cytologically confirmed diagnosis of NSCLC that carries an ALK
rearrangement
- Stage IIIB or IV NSCLC or relapsed locally advanced or metastatic NSCLC
- Presence of at least one measurable lesion as defined by RECIST 1.1
- Patients who have received prior chemotherapy, other ALK inhibitors, biologic therapy,
or other investigational agents, must have recovered from all toxicities related to
prior anticancer therapies to grade =1 (CTCAE v 4.03). Patients with grade = 2
peripheral neuropathy or any grade of alopecia, fatigue, nail changes or skin changes
are allowed to enter the study
- Patient has a WHO performance status 0-1
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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
- Presence or history of a malignant disease other than NSCLC that has been diagnosed
and/or required therapy within the past 3 years
- Patients with an active, known or suspected autoimmune disease
- Unable or unwilling to swallow tablets or capsules
- Patient has other severe, acute, or chronic medical conditions including uncontrolled
diabetes mellitus or psychiatric conditions or laboratory abnormalities that in the
opinion of the Investigator may increase the risk associated with study participation,
or that may interfere with the interpretation of study results
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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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
27/05/2015
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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
10/09/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
57
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Heidelberg
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Recruitment postcode(s) [1]
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3084 - Heidelberg
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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United States of America
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State/province [2]
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Massachusetts
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United States of America
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Pennsylvania
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Belgium
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Leuven
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Country [5]
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Canada
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State/province [5]
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Ontario
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Country [6]
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Hong Kong
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State/province [6]
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Hong Kong
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Italy
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MI
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Country [8]
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Italy
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MO
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Singapore
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State/province [9]
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Singapore
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Country [10]
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Spain
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State/province [10]
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Catalunya
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is an open label multi center trial to determine the safety and efficacy of ceritinib in
combination with nivolumab in ALK-positive NSCLC patients
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02393625
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02393625
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