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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03061812




Registration number
NCT03061812
Ethics application status
Date submitted
20/02/2017
Date registered
23/02/2017
Date last updated
19/02/2020

Titles & IDs
Public title
Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE)
Scientific title
A Randomized, Open-label, Multicenter, Phase 3 Study of Rovalpituzumab Tesirine Compared With Topotecan for High DLL3 Expressing Small Cell Lung Cancer (SCLC) Subjects With First Relapse/Recurrence Following Front-Line Platinum-Based Chemotherapy (TAHOE)
Secondary ID [1] 0 0
2016-003726-17
Secondary ID [2] 0 0
M16-289
Universal Trial Number (UTN)
Trial acronym
TAHOE
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 - Rovalpituzumab tesirine
Treatment: Drugs - Topotecan

Experimental: Rovalpituzumab tesirine - Rovalpituzumab tesirine intravenous administration on Day 1 of a 42-Day cycle for 2 cycles.

Active Comparator: Topotecan - Topotecan intravenous on Days 1 through 5 of each 21-Day cycle.


Treatment: Drugs: Rovalpituzumab tesirine
Administered on Day 1 via intravenous infusion in a 42-day cycle for 2 cycles.

Treatment: Drugs: Topotecan
Administered on Day 1-5 via intravenous infusion in a 21-day cycle.

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

Outcomes
Primary outcome [1] 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 [1] 0 0
Approximately 34 months
Secondary outcome [1] 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 [1] 0 0
Approximately 34 months
Secondary outcome [2] 0 0
Change from baseline of the Physical functioning scale score in QLQ-C15-PAL - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative Care (EORTC OLQ-C15-PAL) is a questionnaire developed to assess the quality of life of palliative cancer care. Higher scores reflect greater symptom burden.
Timepoint [2] 0 0
Approximately 34 months
Secondary outcome [3] 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 [3] 0 0
Approximately 34 months
Secondary outcome [4] 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 [4] 0 0
Approximately 34 months
Secondary outcome [5] 0 0
Clinical Benefit Rate (CBR) - CBR is defined as percentage of participants whose best overall response is complete response (CR) + partial response (PR) + stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Timepoint [5] 0 0
Approximately 34 months

Eligibility
Key inclusion criteria
- Participant must have histologically or cytologically confirmed advanced or metastatic
Small Cell Lung Cancer (SCLC) with documented first disease progression during or
following front-line platinum-based systemic regimen

- Tumor must have high Delta-like protein 3 (DLL3) expression defined as having = 75%
tumor cells staining positive according to the VENTANA DLL3 (SP347) IHC Assay.

- Participant must have measurable disease, as defined per Response Evaluation Criteria
in Solid Tumors (RECIST) version 1.1.

- Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status
of 0 or 1.

- Participant must have recovery to Grade 0 or 1 of any clinically significant toxicity
(excluding alopecia) prior to initiation of study drug administration.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participant has a 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 (NYHA) III - IV within 6 months prior
to their first dose of study drug.

- Participant has known leptomeningeal metastases.

- Participant has received more than one prior systemic therapy regimen for SCLC.

- Participant had a serious infection within 2 weeks prior to randomization, including
any Grade 3 or higher viral, bacterial, or fungal infection.

- Participant has a history of active malignancies other than SCLC within the past 2
years prior to study entry, with the exception of in situ cancer which was curatively
treated.

- Participant had prior exposure to topotecan, irinotecan or any other topoisomerase I
inhibitors.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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
Recruitment hospital [1] 0 0
Blacktown Hospital /ID# 158907 - Blacktown
Recruitment hospital [2] 0 0
St George Hospital /ID# 158855 - Kogarah
Recruitment hospital [3] 0 0
Southern Medical Day Care Ctr /ID# 158853 - Wollongong
Recruitment hospital [4] 0 0
The Prince Charles Hospital /ID# 158897 - Chermside
Recruitment hospital [5] 0 0
Ballarat Health Service /ID# 158904 - Ballarat
Recruitment hospital [6] 0 0
Austin Hospital /ID# 158898 - Heidelberg
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment postcode(s) [4] 0 0
4032 - Chermside
Recruitment postcode(s) [5] 0 0
3350 - Ballarat
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment outside Australia
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Preston

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this randomized, open-label, 2-arm, Phase 3 study is to assess the efficacy,
safety and tolerability of rovalpituzumab tesirine versus topotecan in participants with
advanced or metastatic Small Cell Lung Cancer (SCLC) with high levels of delta-like protein 3
(DLL3) and who have first disease progression during or following front-line platinum-based
chemotherapy.
Trial website
https://clinicaltrials.gov/show/NCT03061812
Trial related presentations / publications
Morgensztern D, Besse B, Greillier L, Santana-Davila R, Ready N, Hann CL, Glisson BS, Farago AF, Dowlati A, Rudin CM, Le Moulec S, Lally S, Yalamanchili S, Wolf J, Govindan R, Carbone DP. Efficacy and Safety of Rovalpituzumab Tesirine in Third-Line and Beyond Patients with DLL3-Expressing, Relapsed/Refractory Small-Cell Lung Cancer: Results From the Phase II TRINITY Study. Clin Cancer Res. 2019 Dec 1;25(23):6958-6966. doi: 10.1158/1078-0432.CCR-19-1133. Epub 2019 Sep 10.
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
Other publications