A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First- Line Platinum-Based Chemotherapy in Participants With Extensive Stage Small Cell Lung Cancer (MERU)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Small Cell Lung Cancer

In brief

This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, and multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy following first-line platinum-based chemotherapy.

Key facts

Study ID

NCT03033511

Run by

AbbVie

People needed

748

Starts

2017-02-07

Expected to finish

2019-11-20

Last updated by the study team

2021-07-29

Who can join

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

You may qualify if…

• Histologically or cytologically confirmed extensive-stage disease small cell lung cancer (ED SCLC) at initial diagnosis with ongoing clinical benefit (stable disease [SD], partial response [PR], or complete response [CR]) following completion of 4 cycles of first-line platinum-based therapy
• Participant is eligible to be randomized at least 3 but no more than 9 weeks from Day 1 of the fourth cycle of first-line platinum-based chemotherapy.
• Participants with a history of central nervous system (CNS) metastases prior to the initiation of first-line platinum-based chemotherapy must have received definitive local treatment and have documentation of stable or improved CNS disease status
• Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
• Participants must have adequate bone marrow, renal and hepatic function
• Availability of archived or representative tumor material for assessment of DLL3 expression

You may not qualify if…

• Any prior systemic chemotherapy, small molecule inhibitors, immune checkpoint inhibitors, other monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, T-cell or other cell-based or biologic therapies, or any other anti-cancer therapy than that described in inclusion criteria for SCLC.
• Any disease-directed radiotherapy (except prophylactic cranial irradiation, palliative radiotherapy to a radiographically documented non-progressing lesion for symptom control, or pre-planned radiotherapy for CNS metastases present prior to start of first-line therapy and non-progressing) after last dose of first-line chemotherapy.
• Prior exposure to a pyrrolobenzodiazepine (PBD-based) or indolinobenzodiazepine-based drug, prior participation in a rovalpituzumab tesirine clinical trial, or known hypersensitivity or other contraindications to rovalpituzumab tesirine or excipient contained in the drug formulation.

Where it is running

• University of South Alabama /ID# 160975 — Mobile, Alabama, United States
• Highlands Oncology Group /ID# 156722 — Fayetteville, Arkansas, United States
• Marin Cancer Care /ID# 159207 — Greenbrae, California, United States
• Ucsd /Id# 157764 — La Jolla, California, United States
• LA Hem-Oncology Med Group /ID# 156717 — Los Angeles, California, United States
• Palo Alto Veterans Institute for Research /ID# 203695 — Palo Alto, California, United States
• St Jude Hospital dba St Joseph /ID# 156526 — Santa Rosa, California, United States
• Icri /Id# 157765 — Whittier, California, United States
• Kaiser Permanente Lone Tree /ID# 159331 — Lone Tree, Colorado, United States
• Christiana Care Health Service /ID# 159212 — Newark, Delaware, United States
• Holy Cross Hospital /ID# 156716 — Fort Lauderdale, Florida, United States
• University of Florida - Archer /ID# 155799 — Gainesville, Florida, United States
• Memorial Cancer Institute /ID# 156673 — Hollywood, Florida, United States
• Memorial Cancer Institute /ID# 164052 — Hollywood, Florida, United States
• Cancer Specialists of North Florida - Southpoint /ID# 156595 — Jacksonville, Florida, United States
• Georgia Cancer Center /ID# 201894 — Atlanta, Georgia, United States
• Southeastern Regional Medical /ID# 163064 — Newnan, Georgia, United States
• St. Luke's Mountain States Tumor Institute - Boise /ID# 156691 — Boise, Idaho, United States
• NorthShore University HealthSystem - Evanston Hospital /ID# 156664 — Evanston, Illinois, United States
• Ingalls Memorial Hosp /ID# 156685 — Harvey, Illinois, United States
• Goshen Center for Cancer Care /ID# 156682 — Goshen, Indiana, United States
• Ashland-Bellefonte Cancer Ctr /ID# 202901 — Ashland, Kentucky, United States
• University of Louisville /ID# 156683 — Louisville, Kentucky, United States
• Ochsner Clinic Foundation /ID# 159136 — Baton Rouge, Louisiana, United States
• Clearview Cancer Institute /ID# 156699 — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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