CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 444 enrolled
Drug / intervention
Rovalpituzumab tesirine +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03061812
NCT03061812Phase 3Completed
CompareCT.gov

A Randomized, Open-Label, Multicenter, Phase 3 Study of Rovalpituzumab Tesirine Compared With Topotecan for Subjects With Advanced or Metastatic DLL3high Small Cell Lung Cancer (SCLC) Who Have First Disease Progression During or Following Front-Line Platinum-Based Chemotherapy (TAHOE)

AbbVie·interventional·Posted Feb 23, 2017·Updated Feb 23, 2021

In Brief

A Phase 3 clinical trial evaluating Rovalpituzumab tesirine, Topotecan, and 1 other intervention for Small Cell Lung Cancer. Completed, enrolled 444 participants across 195 sites in 33 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmall Cell Lung Cancer
CountriesAustralia, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Japan, Latvia, Mexico, Netherlands, Poland, Portugal, Romania, Russia, Serbia, Singapore, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 23, 2017
Enrollment StartApr 11, 2017
Primary CompletionFeb 12, 2020
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 9.4 years ago

Interventions

Rovalpituzumab tesirinedrug

Powder for solution for infusion in vials.

Topotecandrug

Powder or solution for infusion in vials. Topotecan is commercially available as both a powder and solution for infusion. Availability will vary by region.

Dexamethasonedrug

Oral tablet.