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
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3200 Northline Avenue
Greensboro, North Carolina 27403
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Atlanta, Georgia 30060
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601 East 15th Street
Austin, Texas 78701
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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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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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