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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02393625




Registration number
NCT02393625
Ethics application status
Date submitted
23/02/2015
Date registered
19/03/2015
Date last updated
6/01/2020

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
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)
Secondary ID [1] 0 0
CLDK378A2120C
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ALK-positive NSCLC 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
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


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion
Timepoint [1] 0 0
Study Day 42 (6 weeks)
Primary outcome [2] 0 0
Overall response rate (ORR) - ORR (complete response (CR)+ partial response (PR)) per RECIST 1.1 as assessed by investigator
Timepoint [2] 0 0
24 Weeks
Secondary outcome [1] 0 0
Duration of Response (DOR)
Timepoint [1] 0 0
24 weeks
Secondary outcome [2] 0 0
Disease Control Rate (DCR)
Timepoint [2] 0 0
24 weeks
Secondary outcome [3] 0 0
Time to Response (TTR)
Timepoint [3] 0 0
24 weeks
Secondary outcome [4] 0 0
Progression Free Survival (PFS)
Timepoint [4] 0 0
24 weeks
Secondary outcome [5] 0 0
Overall survival (OS)
Timepoint [5] 0 0
24 weeks

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Heidelberg
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania
Country [4] 0 0
Belgium
State/province [4] 0 0
Leuven
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Hong Kong
State/province [6] 0 0
Hong Kong
Country [7] 0 0
Italy
State/province [7] 0 0
MI
Country [8] 0 0
Italy
State/province [8] 0 0
MO
Country [9] 0 0
Netherlands
State/province [9] 0 0
Rotterdam
Country [10] 0 0
Singapore
State/province [10] 0 0
Singapore
Country [11] 0 0
Spain
State/province [11] 0 0
Catalunya

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/show/NCT02393625
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications