Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer
NCT ID: NCT02393625
Last Updated: 2025-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
57 participants
INTERVENTIONAL
2015-05-27
2026-04-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dose Escalation
Ceritinib (LDK378)
Nivolumab
Dose Expansion
Ceritinib (LDK378)
Nivolumab
Interventions
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Ceritinib (LDK378)
Nivolumab
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Mayo Clinic - Arizona
Scottsdale, Arizona, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Massachusetts General Hospital Thoracic Oncolgoy
Boston, Massachusetts, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Novartis Investigative Site
Heidelberg, Victoria, Australia
Novartis Investigative Site
Leuven, , Belgium
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Hong Kong, , Hong Kong
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Modena, MO, Italy
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Barcelona, Catalonia, Spain
Countries
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References
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Spigel DR, Reynolds C, Waterhouse D, Garon EB, Chandler J, Babu S, Thurmes P, Spira A, Jotte R, Zhu J, Lin WH, Blumenschein G Jr. Phase 1/2 Study of the Safety and Tolerability of Nivolumab Plus Crizotinib for the First-Line Treatment of Anaplastic Lymphoma Kinase Translocation - Positive Advanced Non-Small Cell Lung Cancer (CheckMate 370). J Thorac Oncol. 2018 May;13(5):682-688. doi: 10.1016/j.jtho.2018.02.022. Epub 2018 Mar 6.
Other Identifiers
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2014-005054-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLDK378A2120C
Identifier Type: -
Identifier Source: org_study_id
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