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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03334487




Registration number
NCT03334487
Ethics application status
Date submitted
3/11/2017
Date registered
7/11/2017
Date last updated
26/12/2018

Titles & IDs
Public title
Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer
Scientific title
Open-Label, Single Arm, Phase 3b Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects With Relapsed or Refractory DLL3 Expressing Small Cell Lung Cancer
Secondary ID [1] 0 0
2017-003173-33
Secondary ID [2] 0 0
M16-292
Universal Trial Number (UTN)
Trial acronym
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 - Dexamethasone
Treatment: Drugs - Rovalpituzumab tesirine

Experimental: Rovalpituzumab tesirine + dexamethasone - Rovalpituzumab tesirine 0.3 mg/kg administered intravenously on Day 1 of each 6-week cycle plus oral dexamethasone 8 mg twice daily on Day -1, Day 1, and Day 2 of 6-week each cycle.


Treatment: Drugs: Dexamethasone
Oral

Treatment: Drugs: Rovalpituzumab tesirine
Intravenous

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

Outcomes
Primary outcome [1] 0 0
Number of Participants with a High Grade (>= Grade 3) Protocol Specified TEAE - Number of participants with a high grade (= Grade 3) protocol specified Treatment-Emergent Adverse Events (TEAEs) during and after treatment with rovalpituzumab tesirine. Severity of TEAEs will be graded at each study visit according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03.
Timepoint [1] 0 0
Approximately 32 months
Secondary outcome [1] 0 0
Change in Participant Reported Outcome EORTC QLQC15-PAL - The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Palliative Cancer (EORTC QLQ-C15-PAL) is a 15-item self-report questionnaire composed of 4 multi-item scales (physical & emotional functioning, fatigue and pain) along with 6 individual items (nausea & vomiting, dyspnea, insomnia, appetite loss, constipation, and global quality of life).
Timepoint [1] 0 0
Approximately 32 months
Secondary outcome [2] 0 0
Progression Free Survival (PFS) - PFS is based on independent review of radiographic assessment, defined as the time from randomization to documented disease progression or death from any cause, whichever occurs earlier.
Timepoint [2] 0 0
Approximately 32 months
Secondary outcome [3] 0 0
Overall Survival (OS) - Overall Survival (OS) is defined as the time from the date of randomization to the date of death from any cause.
Timepoint [3] 0 0
Approximately 32 months
Secondary outcome [4] 0 0
Objective response rate (ORR) - ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Timepoint [4] 0 0
Approximately 32 months
Secondary outcome [5] 0 0
Change in EORTC QLQ-LC-13 - The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer (EORTC QLQ-LC 13) is a lung cancer specific module developed to assess lung cancer-associated symptoms and treatment-related side effects among lung cancer patients.
Timepoint [5] 0 0
Approximately 32 months
Secondary outcome [6] 0 0
Duration of Objective Response (DOR) - DOR is defined as the time between the date of first response (CR or PR, whichever is recorded first) to the date of the first documented tumor progression (per RECIST version 1.1) or death due to any cause, whichever comes first.
Timepoint [6] 0 0
Approximately 32 months
Secondary outcome [7] 0 0
Clinical Benefit Rate (CBR) - CBR is defined as the proportion of participants with an objective response or stable disease (CR+PR+SD) according to RECIST version 1.1.
Timepoint [7] 0 0
Approximately 32 months

Eligibility
Key inclusion criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Minimum life expectancy of at least 12 weeks.

- Laboratory values meeting the criteria specified in the protocol.

- Histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) with
documented disease progression after at least 2 prior systemic regimens, including at
least one platinum-based regimen.

- Delta-Like Protein 3 (DLL3)-expressing SCLC based on central immunohistochemistry
(IHC) assessment of banked or otherwise representative tumor tissue.

- Measurable disease as described per protocol.

- In participants with a history of central nervous system (CNS) metastases,
documentation of stable or improved status based on brain imaging for at least 2 weeks
after completion of definitive treatment and within 2 weeks prior to first dose of
study drug, off or on a stable dose of corticosteroids.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Documented history of a cerebral vascular event (stroke or transient ischemic attack),
unstable angina, myocardial infarction, or cardiac symptoms consistent with New York
Heart Association Class III - IV within 6 months prior to first dose of study drug.

- Recent or on-going serious infection.

- History of other invasive malignancy that has not been in remission for at least 3
years.

- History of exposure to a pyrrolobenzodiazepine (PBD)-based drug or known
hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug
formulation.

- Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells.

- Documented history of capillary leak syndrome.

- Grade 2 or higher pleural or pericardial effusion within 4 weeks of investigational
drug start, or earlier history of recurrent Grade 2 or higher effusions with ongoing
requirements for pericardiocentesis or thoracentesis.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
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)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Coffs Harbour Health Campus /ID# 200642 - Coffs Harbour
Recruitment hospital [2] 0 0
The Tweed Hospital /ID# 200646 - Tweed Heads
Recruitment hospital [3] 0 0
The Townsville Hospital /ID# 200640 - Douglas
Recruitment hospital [4] 0 0
Austin Hospital /ID# 200639 - Heidelberg
Recruitment hospital [5] 0 0
Border Medical /ID# 200645 - Wodonga
Recruitment hospital [6] 0 0
Perron Institute for Neurological and Translational Science /ID# 200644 - Nedlands
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [3] 0 0
4814 - Douglas
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3690 - Wodonga
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
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
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
Brazil
State/province [17] 0 0
Bahia
Country [18] 0 0
Brazil
State/province [18] 0 0
Rio Grande Do Sul
Country [19] 0 0
Brazil
State/province [19] 0 0
Sao Paulo
Country [20] 0 0
Brazil
State/province [20] 0 0
Rio de Janeiro
Country [21] 0 0
Canada
State/province [21] 0 0
Alberta
Country [22] 0 0
Canada
State/province [22] 0 0
Nova Scotia
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
Germany
State/province [24] 0 0
Niedersachsen
Country [25] 0 0
Germany
State/province [25] 0 0
Berlin
Country [26] 0 0
Germany
State/province [26] 0 0
Gauting
Country [27] 0 0
Germany
State/province [27] 0 0
Heidelberg
Country [28] 0 0
Germany
State/province [28] 0 0
Kassel
Country [29] 0 0
Germany
State/province [29] 0 0
Muenster
Country [30] 0 0
Germany
State/province [30] 0 0
Oldenburg
Country [31] 0 0
Sweden
State/province [31] 0 0
Uppsala Lan
Country [32] 0 0
Sweden
State/province [32] 0 0
Gavle
Country [33] 0 0
Sweden
State/province [33] 0 0
Linkoping
Country [34] 0 0
Sweden
State/province [34] 0 0
Stockholm
Country [35] 0 0
Sweden
State/province [35] 0 0
Umeå
Country [36] 0 0
United Kingdom
State/province [36] 0 0
England
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Manchester
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Preston

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

Ethics approval
Ethics application status

Summary
Brief summary
A single-arm, open-label study to assess the overall safety of rovalpituzumab tesirine in
participants with relapsed or refractory delta-like protein 3 (DLL3) expressing small cell
lung cancer by evaluating the frequency of high grade (>= Grade 3) select treatment-emergent
adverse events (TEAEs).
Trial website
https://clinicaltrials.gov/show/NCT03334487
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03334487