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)

Study 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 SCLC with high levels of DLL3, who have first disease progression during or following front-line platinum-based chemotherapy.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedRovalpituzumab tesirine and Topotecan

Plus 1 other study approaches.

Who it may be forSmall cell lung cancer (SCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 23, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?195 U.S. locations

Locations may change over time.

Who runs it?AbbVie

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 3
Sponsor: AbbVie
Interventions being studied: Drug: Rovalpituzumab tesirine; Drug: Topotecan; Drug: Dexamethasone

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Small cell lung cancer (SCLC)→

Disease setting

Metastatic or stage IV→

Treatment approach

Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Clearview Cancer Institute /ID# 155873Huntsville, Alabama
Mitchell Cancer Institute /ID# 158151Mobile, Alabama
Carti /Id# 156982Little Rock, Arkansas
Highlands Oncology Group /ID# 155902Springdale, Arkansas
Cedars-Sinai Medical Center /ID# 157102Beverly Hills, California
Moore UC San Diego Cancer Center /ID# 156965La Jolla, California
Los Angeles Hematology Oncolog /ID# 155879Los Angeles, California
University of California, Davis Comprehensive Cancer Center /ID# 157001Sacramento, California
St Jude Hospital dba St Joseph /ID# 155899Santa Rosa, California
Icri /Id# 157090Whittier, California
Christiana Care Health Service /ID# 158171Newark, Delaware
Cancer Specialists of North Florida - Southpoint /ID# 155828Jacksonville, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 23, 2021. Always confirm current availability with the study team.

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