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)



Status:Active, not recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/10/2019
Start Date:April 10, 2017
End Date:February 12, 2020

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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)

The purpose of this randomized, open-label, 2-arm, Phase 3 study is to assess the 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.


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.

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.
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Atlanta, Georgia 30060
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601 East 15th Street
Austin, Texas 78701
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Beverly Hills, California 90211
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Blacktown, New South Wales
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Boston, Massachusetts 02215
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Boston, Massachusetts 02215
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Burlington, VT
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4875 Higbee Avenue Northwest
Canton, Ohio 44718
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3232 North Northhills Boulevard
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200 High Park Avenue
Goshen, Indiana 46526
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1 Ingalls Drive
Harvey, Illinois 60426
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3601 Cci Drive Northwest
Huntsville, Alabama 35805
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Jacksonville, Florida 32256
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La Jolla, California 92037
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Lansing, Michigan 48912
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