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



Status:Recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/24/2019
Start Date:February 7, 2017
End Date:September 22, 2022
Contact:ABBVIE CALL CENTER
Email:abbvieclinicaltrials@abbvie.com
Phone:847.283.8955

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A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects With Extensive Stage Small Cell Lung Cancer (MERU)

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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.
We found this trial at
55
sites
601 East 15th Street
Austin, Texas 78701
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Atlanta, Georgia 30060
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Billings, Montana 59101
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Boise, ID
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400 Haddon Avenue
Camden, New Jersey 08103
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4875 Higbee Avenue Northwest
Canton, Ohio 44718
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Chattanooga, TN
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Coffs Harbour, New South Wales
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Detroit, Michigan 48202
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2301 Erwin Road
Durham, North Carolina 27710
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Evanston, IL
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3232 North Northhills Boulevard
Fayetteville, Arkansas 72703
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
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1600 Southwest Archer Road
Gainesville, Florida 32610
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200 High Park Avenue
Goshen, Indiana 46526
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1350 South Eliseo Drive
Greenbrae, California 94904
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3200 Northline Avenue
Greensboro, North Carolina 27403
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3200 Northline Avenue
Greensboro, North Carolina 27403
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Greenville, North Carolina 27834
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1 Ingalls Drive
Harvey, Illinois 60246
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1150 North 35th Avenue
Hollywood, Florida 33021
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1150 North 35th Avenue
Hollywood, Florida 33021
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Houston, Texas 77030
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3601 Cci Drive Northwest
Huntsville, Alabama 35805
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7015 A C Skinner Parkway
Jacksonville, Florida 32256
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Kansas City, Missouri 64132
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Knoxville, Tennessee 37916
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La Jolla, California 92037
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Lake Success, New York 11042
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Lansing, Michigan 48912
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4004 Pioneer Woods Drive
Lincoln, Nebraska 68506
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Lone Tree, Colorado 80124
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Los Angeles, California 90017
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Louisville, Kentucky 40202
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Morgantown, West Virginia 26506
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New Orleans, Louisiana 70121
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Philadelphia, Pennsylvania 19107
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Pittsburgh, Pennsylvania 15240
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Portland, Oregon 97227
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593 Eddy Street
Providence, Rhode Island 02903
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Rochester, Minnesota 55905
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Santa Rosa, California 95403
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Spokane, Washington 99208
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100 Nicolls Road
Stony Brook, New York 11794
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Whittier, California 90603
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