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)

Completed · Phase 3

Conditions studied: Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT03061812

Run by

AbbVie

People needed

444

Starts

2017-04-11

Expected to finish

2020-02-12

Last updated by the study team

2021-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Mitchell Cancer Institute /ID# 158151 — Mobile, Alabama, United States
• Carti /Id# 156982 — Little Rock, Arkansas, United States
• Highlands Oncology Group /ID# 155902 — Springdale, Arkansas, United States
• Cedars-Sinai Medical Center /ID# 157102 — Beverly Hills, California, United States
• Moore UC San Diego Cancer Center /ID# 156965 — La Jolla, California, United States
• Los Angeles Hematology Oncolog /ID# 155879 — Los Angeles, California, United States
• University of California, Davis Comprehensive Cancer Center /ID# 157001 — Sacramento, California, United States
• St Jude Hospital dba St Joseph /ID# 155899 — Santa Rosa, California, United States
• Icri /Id# 157090 — Whittier, California, United States
• Christiana Care Health Service /ID# 158171 — Newark, Delaware, United States
• Cancer Specialists of North Florida - Southpoint /ID# 155828 — Jacksonville, Florida, United States
• Georgia Cancer Center /ID# 160206 — Atlanta, Georgia, United States
• St. Luke's Mountain States Tumor Institute - Meridian /ID# 164550 — Meridian, Idaho, United States
• NorthShore University HealthSystem - Evanston Hospital /ID# 157054 — Evanston, Illinois, United States
• Ingalls Memorial Hosp /ID# 155871 — Harvey, Illinois, United States
• Goshen Center for Cancer Care /ID# 155946 — Goshen, Indiana, United States
• University of Louisville /ID# 155947 — Louisville, Kentucky, United States
• Ochsner Clinic Foundation /ID# 160807 — Baton Rouge, Louisiana, United States
• Dana-Farber Cancer Institute /ID# 160210 — Boston, Massachusetts, United States
• Sparrow Regional Cancer Center, Sparrow Health System /ID# 157021 — Lansing, Michigan, United States
• Nebraska Hematology Oncology /ID# 155900 — Lincoln, Nebraska, United States
• Gabrail Cancer Center Research /ID# 155920 — Canton, Ohio, United States
• Oregon Health and Science University /ID# 157055 — Portland, Oregon, United States
• UPMC Hillman Cancer Ctr /ID# 164403 — Pittsburgh, Pennsylvania, United States
• Clearview Cancer Institute /ID# 155873 — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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