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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03033511




Registration number
NCT03033511
Ethics application status
Date submitted
25/01/2017
Date registered
26/01/2017

Titles & IDs
Public title
A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)
Scientific title
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects With Extensive Stage Small Cell Lung Cancer (MERU)
Secondary ID [1] 0 0
2016-003503-64
Secondary ID [2] 0 0
M16-298
Universal Trial Number (UTN)
Trial acronym
MERU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Placebo for dexamethasone
Treatment: Drugs - Placebo for rovalpituzumab tesirine
Treatment: Drugs - Rovalpituzumab tesirine
Treatment: Drugs - Dexamethasone

Experimental: Rovalpituzumab tesirine/dexamethasone - Rovalpituzumab tesirine/dexamethasone every 6 weeks (q6 wk); omitting every third cycle

Experimental: Placebo - Placebo q6 wk; omitting every third cycle


Treatment: Drugs: Placebo for dexamethasone
Placebo for dexamethasone PO twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle.

Treatment: Drugs: Placebo for rovalpituzumab tesirine
Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle

Treatment: Drugs: Rovalpituzumab tesirine
Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle

Treatment: Drugs: Dexamethasone
Dexamethasone 8 mg administered orally (PO) twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) in Participants With Extensive-Stage Small Cell Lung Cancer With Delta-Like Protein 3 High Expression in Tumor (DLL3high)
Timepoint [1] 0 0
Survival follow-up continued until the endpoint of death, participant was lost to follow-up or withdrew consent, or termination of the study by AbbVie, whichever occurred first. Median time on study overall was 11.9 months.
Secondary outcome [1] 0 0
OS in All Randomized Participants
Timepoint [1] 0 0
Survival follow-up continued until the endpoint of death, the subject was lost to follow-up or withdrew consent, or termination of the study by AbbVie, whichever occurred first. Median time on study overall was 11.9 months.
Secondary outcome [2] 0 0
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Physical Functioning Domain Over Time
Timepoint [2] 0 0
Baseline, Weeks 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, Final Visit (up to Week 78)

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed extensive-stage disease small cell lung cancer (ED SCLC) at initial diagnosis with ongoing clinical benefit (stable disease [SD], partial response [PR], or complete response [CR]) following completion of 4 cycles of first-line platinum-based therapy
* Participant is eligible to be randomized at least 3 but no more than 9 weeks from Day 1 of the fourth cycle of first-line platinum-based chemotherapy.
* Participants with a history of central nervous system (CNS) metastases prior to the initiation of first-line platinum-based chemotherapy must have received definitive local treatment and have documentation of stable or improved CNS disease status
* Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
* Participants must have adequate bone marrow, renal and hepatic function
* Availability of archived or representative tumor material for assessment of DLL3 expression
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any prior systemic chemotherapy, small molecule inhibitors, immune checkpoint inhibitors, other monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, T-cell or other cell-based or biologic therapies, or any other anti-cancer therapy than that described in inclusion criteria for SCLC.
* Any disease-directed radiotherapy (except prophylactic cranial irradiation, palliative radiotherapy to a radiographically documented non-progressing lesion for symptom control, or pre-planned radiotherapy for CNS metastases present prior to start of first-line therapy and non-progressing) after last dose of first-line chemotherapy.
* Prior exposure to a pyrrolobenzodiazepine (PBD-based) or indolinobenzodiazepine-based drug, prior participation in a rovalpituzumab tesirine clinical trial, or known hypersensitivity or other contraindications to rovalpituzumab tesirine or excipient contained in the drug formulation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/02/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/11/2019
Sample size
Target
Accrual to date
Final
748
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Coffs Harbour Hospital /ID# 158880 - Coffs Harbour
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Gosford Hospital /ID# 158884 - Gosford
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Newcastle Private Hospital /ID# 203506 - Lambton Heights
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Royal North Shore Hospital /ID# 158881 - Saint Leonards
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Calvary North Adelaide Hospita /ID# 161701 - Adelaide
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Sunshine Hospital /ID# 161700 - St Albans
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Affinity Clinical Research Ser /ID# 158887 - Nedlands
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2450 - Coffs Harbour
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2250 - Gosford
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2305 - Lambton Heights
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2065 - Saint Leonards
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5006 - Adelaide
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3021 - St Albans
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6009 - Nedlands
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State/province [212] 0 0
Istanbul
Country [213] 0 0
Turkey
State/province [213] 0 0
Izmir
Country [214] 0 0
Turkey
State/province [214] 0 0
Malatya
Country [215] 0 0
Ukraine
State/province [215] 0 0
Zaporizka Oblast
Country [216] 0 0
Ukraine
State/province [216] 0 0
Chernivtsi
Country [217] 0 0
Ukraine
State/province [217] 0 0
Dnipro
Country [218] 0 0
Ukraine
State/province [218] 0 0
Kharkiv
Country [219] 0 0
Ukraine
State/province [219] 0 0
Kropyvnytskyi
Country [220] 0 0
Ukraine
State/province [220] 0 0
Lutsk
Country [221] 0 0
Ukraine
State/province [221] 0 0
Uzhhorod
Country [222] 0 0
United Kingdom
State/province [222] 0 0
Gloucestershire
Country [223] 0 0
United Kingdom
State/province [223] 0 0
Birmingham
Country [224] 0 0
United Kingdom
State/province [224] 0 0
Bournemouth
Country [225] 0 0
United Kingdom
State/province [225] 0 0
Colchester
Country [226] 0 0
United Kingdom
State/province [226] 0 0
Hereford
Country [227] 0 0
United Kingdom
State/province [227] 0 0
London
Country [228] 0 0
United Kingdom
State/province [228] 0 0
Maidstone
Country [229] 0 0
United Kingdom
State/province [229] 0 0
Manchester
Country [230] 0 0
United Kingdom
State/province [230] 0 0
Newcastle Upon Tyne
Country [231] 0 0
United Kingdom
State/province [231] 0 0
Torquay

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AbbVie Inc.
Address 0 0
AbbVie
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03033511