Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer
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)
2 other identifiers
interventional
57
8 countries
12
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2015
Longer than P75 for phase_1
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2015
CompletedFirst Posted
Study publicly available on registry
March 19, 2015
CompletedStudy Start
First participant enrolled
May 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 9, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 9, 2027
April 2, 2026
March 1, 2026
11.9 years
February 23, 2015
April 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion
Study Day 42 (6 weeks)
Overall response rate (ORR)
ORR (complete response (CR)+ partial response (PR)) per RECIST 1.1 as assessed by investigator
24 Weeks
Secondary Outcomes (5)
Duration of Response (DOR)
24 weeks
Disease Control Rate (DCR)
24 weeks
Time to Response (TTR)
24 weeks
Progression Free Survival (PFS)
24 weeks
Overall survival (OS)
24 weeks
Study Arms (2)
Dose Escalation
EXPERIMENTALDose Expansion
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Mayo Clinic - Arizona
Scottsdale, Arizona, 85259, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Massachusetts General Hospital Thoracic Oncolgoy
Boston, Massachusetts, 02115, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Novartis Investigative Site
Heidelberg, Victoria, 3084, Australia
Novartis Investigative Site
Leuven, Vlaams Brabant, 3000, Belgium
Novartis Investigative Site
Toronto, Ontario, M5G 2M9, Canada
Novartis Investigative Site
Hong Kong, 999077, Hong Kong
Novartis Investigative Site
Milan, MI, 20133, Italy
Novartis Investigative Site
Modena, MO, 41124, Italy
Novartis Investigative Site
Singapore, 168583, Singapore
Novartis Investigative Site
Barcelona, 08035, Spain
Related Publications (1)
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.
PMID: 29518553DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2015
First Posted
March 19, 2015
Study Start
May 27, 2015
Primary Completion (Estimated)
April 9, 2027
Study Completion (Estimated)
April 9, 2027
Last Updated
April 2, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share