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

Use our guide to learn which trials are right for you!

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
1600 Southwest Archer Road
Gainesville, Florida 32610
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
?
mi
from
Ashland, KY
Click here to add this to my saved trials
Atlanta, Georgia 30060
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
601 East 15th Street
Austin, Texas 78701
?
mi
from
Austin, TX
Click here to add this to my saved trials
Billings, Montana 59101
?
mi
from
Billings, MT
Click here to add this to my saved trials
?
mi
from
Boise, ID
Click here to add this to my saved trials
?
mi
from
Bronx, NY
Click here to add this to my saved trials
400 Haddon Avenue
Camden, New Jersey 08103
?
mi
from
Camden, NJ
Click here to add this to my saved trials
4875 Higbee Avenue Northwest
Canton, Ohio 44718
?
mi
from
Canton, OH
Click here to add this to my saved trials
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Coffs Harbour, New South Wales
?
mi
from
Coffs Harbour,
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
2301 Erwin Road
Durham, North Carolina 27710
?
mi
from
Durham, NC
Click here to add this to my saved trials
?
mi
from
Evanston, IL
Click here to add this to my saved trials
3232 North Northhills Boulevard
Fayetteville, Arkansas 72703
?
mi
from
Fayetteville, AR
Click here to add this to my saved trials
4725 North Federal Highway
Fort Lauderdale, Florida 33308
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
200 High Park Avenue
Goshen, Indiana 46526
?
mi
from
Goshen, IN
Click here to add this to my saved trials
1350 South Eliseo Drive
Greenbrae, California 94904
?
mi
from
Greenbrae, CA
Click here to add this to my saved trials
3200 Northline Avenue
Greensboro, North Carolina 27403
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
3200 Northline Avenue
Greensboro, North Carolina 27403
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
Greenville, North Carolina 27834
?
mi
from
Greenville, NC
Click here to add this to my saved trials
1 Ingalls Drive
Harvey, Illinois 60246
?
mi
from
Harvey, IL
Click here to add this to my saved trials
1150 North 35th Avenue
Hollywood, Florida 33021
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
1150 North 35th Avenue
Hollywood, Florida 33021
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
3601 Cci Drive Northwest
Huntsville, Alabama 35805
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
7015 A C Skinner Parkway
Jacksonville, Florida 32256
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Kansas City, Missouri 64132
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Knoxville, Tennessee 37916
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
La Jolla, California 92037
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Lake Success, New York 11042
?
mi
from
Lake Success, NY
Click here to add this to my saved trials
Lansing, Michigan 48912
?
mi
from
Lansing, MI
Click here to add this to my saved trials
4004 Pioneer Woods Drive
Lincoln, Nebraska 68506
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
Lone Tree, Colorado 80124
?
mi
from
Lone Tree, CO
Click here to add this to my saved trials
Los Angeles, California 90017
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Louisville, Kentucky 40202
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Mobile, AL
Click here to add this to my saved trials
Morgantown, West Virginia 26506
?
mi
from
Morgantown, WV
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New Orleans, Louisiana 70121
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Newark, DE
Click here to add this to my saved trials
?
mi
from
Newnan, GA
Click here to add this to my saved trials
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19107
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15240
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Portland, Oregon 97227
?
mi
from
Portland, OR
Click here to add this to my saved trials
593 Eddy Street
Providence, Rhode Island 02903
?
mi
from
Providence, RI
Click here to add this to my saved trials
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
Click here to add this to my saved trials
Santa Rosa, California 95403
?
mi
from
Santa Rosa, CA
Click here to add this to my saved trials
Spokane, Washington 99208
?
mi
from
Spokane, WA
Click here to add this to my saved trials
100 Nicolls Road
Stony Brook, New York 11794
?
mi
from
Stony Brook, NY
Click here to add this to my saved trials
Whittier, California 90603
?
mi
from
Whittier, CA
Click here to add this to my saved trials