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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03033511
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer (SCLC) Drug: Placebo for dexamethasone Drug: Placebo for rovalpituzumab tesirine Drug: Rovalpituzumab tesirine Drug: Dexamethasone Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 740 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : February 7, 2017
Estimated Primary Completion Date : November 14, 2019
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Rovalpituzumab tesirine/dexamthasone
Rovalpituzumab tesirine/dexamethasone every 6 weeks (q6 wk); omitting every third cycle
Drug: Rovalpituzumab tesirine
Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
Drug: Dexamethasone
Dexamethasone 8 mg administered orally (PO) twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle.
Experimental: Placebo
Placebo q6 wk; omitting every third cycle
Drug: Placebo for dexamethasone
Placebo for administered orally (PO) twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle.
Drug: Placebo for rovalpituzumab tesirine
Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle


Outcome Measures

Primary Outcome Measures :
  1. Progression-free survival (PFS) determined by a Central Radiographic Assessment Committee (CRAC) [ Time Frame: Approximately 24 months since the first subject enrolled ]
    PFS is defined as the number of months from randomization to disease progression, as assessed by the CRAC per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death of any cause, whichever occurs first.

  2. Overall survival (OS) [ Time Frame: Approximately 31 months since first subject enrolled ]
    OS is defined as the number of months from randomization to death of any cause.


Secondary Outcome Measures :
  1. Objective response rate (ORR) per the CRAC based on RECIST v1.1 [ Time Frame: Approximately 31 months since first subject enrolled ]
    ORR the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) per CRAC according to RECIST version 1.1 from the date of randomization until disease progression or death, whichever occurs first.

  2. DOR per the investigator assessment [ Time Frame: Approximately 31 months since first subject enrolled ]
    DOR is the time from the initial objective response (CR/PR) by investigator to disease progression by investigator or death, whichever occurs first.

  3. ORR per investigator assessment based on RECIST v1.1 [ Time Frame: Approximately 31 months since first subject enrolled ]
    ORR is the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) per investigator assessment according to RECIST version 1.1 from the date of randomization until disease progression or death, whichever occurs first.

  4. Change in patient reported outcomes (PROs)--physical functioning domain [ Time Frame: Approximately 31 months since first subject enrolled ]
    EORTC QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Lung Cancer Module (QLQ-LC13) is a supplementary lung cancer-specific questionnaire to be used in conjunction with the EORTC QLQ-C30

  5. Clinical benefit rate (CBR) per the CRAC assessment based on RECIST v1.1 [ Time Frame: Approximately 31 months since first subject enrolled ]
    CBR is the percentage of participants whose best overall response is either CR, PR, or stable disease (SD) per CRAC according to RECIST version 1.1 from the date of randomization until disease progression or death, whichever occurs first.

  6. CBR per the investigator assessment based on RECIST v1.1 [ Time Frame: Approximately 31 months since first subject enrolled ]
    CBR is the percentage of participants whose best overall response is either CR, PR, or stable disease (SD) per investigator from the date of randomization until disease progression or death, whichever occurs first.

  7. Duration of response (DOR) per the CRAC assessment [ Time Frame: Approximately 31 months since first subject enrolled ]
    DOR is the time from the initial objective response (CR/PR) by CRAC to disease progression or death, whichever occurs first.

  8. Progression-free survival (PFS) per investigator assessment based on RECIST v1.1 [ Time Frame: Approximately 24 months since the first subject enrolled ]
    PFS is defined as the number of months from randomization to disease progression, as assessed by the investigator per RECIST version 1.1, or death of any cause, whichever occurs first.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed extensive-stage disease small cell lung cancer (ED SCLC) 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
  • At least 3 but no more than 9 weeks between the administration of the last cycle of platinum-based chemotherapy and randomization.
  • 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
  • Any disease-directed radiotherapy (except prophylactic cranial irradiation 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)- 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033511


Contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

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Locations
United States, Alabama
Clearview Cancer Institute Recruiting
Huntsville, Alabama, United States, 35805
University of South Alabama Recruiting
Mobile, Alabama, United States, 36604
United States, Arkansas
Highlands Oncology Group Recruiting
Fayetteville, Arkansas, United States, 72703
United States, California
Marin Cancer Care Recruiting
Greenbrae, California, United States, 94904
LA Hem-Oncology Med Group Recruiting
Los Angeles, California, United States, 90017
UCSD Not yet recruiting
San Diego, California, United States, 92122
St Jude Hospital dba St Joseph Recruiting
Santa Rosa, California, United States, 95403
ICRI Recruiting
Whittier, California, United States, 90603
United States, Colorado
Kaiser Permanente Lone Tree Recruiting
Lone Tree, Colorado, United States, 80124
United States, Delaware
Christiana Care Health Service Recruiting
Newark, Delaware, United States, 19713
United States, Florida
Holy Cross Hospital Recruiting
Fort Lauderdale, Florida, United States, 33308
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Cancer Specialists Recruiting
Jacksonville, Florida, United States, 32256
Memorial Cancer Institute West Recruiting
Pembroke Pines, Florida, United States, 33028
United States, Georgia
Southeastern Regional Medical Recruiting
Newnan, Georgia, United States, 30265
United States, Idaho
St. Luke's Mountain States Recruiting
Boise, Idaho, United States, 83712
United States, Illinois
University of Chicago Not yet recruiting
Chicago, Illinois, United States, 60637
NorthShore Univ HealthSystem Recruiting
Evanston, Illinois, United States, 60201
Ingalls Memorial Hosp Recruiting
Harvey, Illinois, United States, 60426
United States, Indiana
St. Vincent Anderson Regional Not yet recruiting
Anderson, Indiana, United States, 46016
Goshen Center for Cancer Care Recruiting
Goshen, Indiana, United States, 46526
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Ochsner Clinic Foundation Recruiting
Baton Rouge, Louisiana, United States, 70809
United States, Michigan
Edward W. Sparrow Hosp Assn Recruiting
Lansing, Michigan, United States, 48912
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
MidAmerica Division, Inc. Recruiting
Kansas City, Missouri, United States, 64132
Washington Univ School Med Not yet recruiting
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Nebraska Hematology Oncology Recruiting
Lincoln, Nebraska, United States, 68506
United States, New Jersey
Cooper Health System Not yet recruiting
Voorhees, New Jersey, United States, 08043
United States, New York
Northwell Health, Monter Cance Recruiting
Lake Success, New York, United States, 11042
Icahn School of Med Mt. Sinai Recruiting
New York, New York, United States, 10128
Stony Brook University Hospita Recruiting
Stony Brook, New York, United States, 11794-8183
United States, North Carolina
Duke Univ Med Ctr Recruiting
Durham, North Carolina, United States, 27710
Cone Health Recruiting
Greensboro, North Carolina, United States, 27403
Eastern Carolina University Recruiting
Greenville, North Carolina, United States, 27834
United States, Ohio
Gabrail Cancer Center Research Recruiting
Canton, Ohio, United States, 44718
United States, Pennsylvania
Penn State, Milton Hershey Med Not yet recruiting
Hershey, Pennsylvania, United States, 17033
Thomas Jefferson Univ Hosp Recruiting
Philadelphia, Pennsylvania, United States, 19107
VA Pittsburgh HealthcareSystem Recruiting
Pittsburgh, Pennsylvania, United States, 15240
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02905
United States, Tennessee
Sarah Cannon Research Institut Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Univ Medical Ctr Brackenridge Recruiting
Austin, Texas, United States, 78701
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75235
United States, Vermont
Fletcher Allen Health Care, In Not yet recruiting
Burlington, Vermont, United States, 05401
United States, Washington
Medical Oncology Associates Recruiting
Spokane, Washington, United States, 99208
Australia, New South Wales
Coffs Harbour Hospital Not yet recruiting
Coffs Harbour, New South Wales, Australia, 2450
Gosford Hospital Not yet recruiting
Gosford, New South Wales, Australia, 2250
Royal North Shore Hospital Not yet recruiting
Saint Leonards, New South Wales, Australia, 2065
Australia, South Australia
Calvary North Adelaide Hospita Recruiting
Adelaide, South Australia, Australia, 5006
Australia, Victoria
Sunshine Hospital Not yet recruiting
St Albans, Victoria, Australia, 3021
Australia
Affinity Clinical Research Ser Recruiting
Nedlands, Australia, 6009
Austria
LKH-Univ. Klinikum Graz Recruiting
Graz, Austria, 8036
KH der Elisabethinen Linz GmbH Recruiting
Linz, Austria, 4020
Belarus
Bobruysk Interdistrict Onco. Not yet recruiting
Bobruisk, Belarus, 213825
Rep Res and Practice Ctr Onc Recruiting
Lesnoy, Belarus, 223040
Mogilev Reg Clin Oncology Dis Recruiting
Mogilev, Belarus, 212018
Belgium
CHU Saint-Pierre Not yet recruiting
Bruxelles, Bruxelles-Capitale, Belgium, 1000
ZNA Middelheim Recruiting
Antwerp, Belgium, 2020
Grand Hopital de Charleroi Recruiting
Charleroi, Belgium, 6000
Hopital de Jolimont Recruiting
Haine Saint Paul, Belgium, 7100
CHU Charleroi (Vesale) Not yet recruiting
Montigny-le-tilleul, Belgium, 6110
Brazil
Hospital Evangelico de Cachoei Not yet recruiting
Cachoeiro DO Itapemirim, Espirito Santo, Brazil, 29308-014
Liga Norte Rio Grandense Cont. Not yet recruiting
Natal, Rio Grande Do Norte, Brazil, 59075-740
Associacao Hospital Beneficent Not yet recruiting
Passo Fundo, Rio Grande Do Norte, Brazil, 99010
Assoc Hosp de Caridade de Ijui Not yet recruiting
Ijui, Rio Grande Do Sul, Brazil, 98700-000
Hospital Sao Lucas da PUCRS Not yet recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
Fundacao Faculdade Regional de Not yet recruiting
Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15090-000
INCA Not yet recruiting
Rio de Janeiro, Brazil, 20231-050
Hospital de Cancer de Barretos Not yet recruiting
Sao Paulo, Brazil, 14784-400
Bulgaria
UMHAT St. Ivan Rilski Recruiting
Sofia, Bulgaria, 1431
UMHAT Tsaritsa Joanna - ISUL Recruiting
Sofia, Bulgaria, 1527
SHAT Hematologic Diseases Not yet recruiting
Sofia, Bulgaria, 1756
Canada, Ontario
Princess Margaret Not yet recruiting
Toronto, Ontario, Canada, M5G 2M9
Windsor Regional Cancer Centre Not yet recruiting
Windsor, Ontario, Canada, N8W 2X3
Canada, Quebec
IUCPQ Not yet recruiting
Sainte-foy, Quebec, Canada, G1V 4G5
Croatia
Klinicki bolnicki centar Zagreb Not yet recruiting
Zagreb, Grad Zagreb, Croatia, 10000
Klinicki bolnicki Centar Rijek Recruiting
Rijeka, Croatia, 51000
Klinicki Bolnicki Centar Sestr Not yet recruiting
Zagreb, Croatia, 10000
Czechia
Nemocnice Rudolfa a Stefanie Not yet recruiting
Benesov, Czechia, 256 01
Nemocnice Horovice a.s. Recruiting
Horovice, Czechia, 268 31
Vitkovicka nemocnice a. s. Recruiting
Ostrava, Czechia, 703 84
Eticka Komise IKEM a Thomayero Recruiting
Prague, Czechia, 140 59
Oblastni Nemocnice Pribram Not yet recruiting
Pribram, Czechia, 262 04
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Herlev Hospital Recruiting
Herlev, Denmark, 2730
Odense Universitets Hospital Recruiting
Odense, Denmark, 5000
Estonia
East Tallinn Central Hospital Recruiting
Tallinn, Estonia, 10138
North Estonian Medical Centre Recruiting
Tallinn, Estonia, 13419
Finland
Docrates Cancer Center Recruiting
Helsinki, Finland, 00180
France
Centre Hosp Intercommunal Recruiting
Creteil, France, 94010
Centre Leon Berard Not yet recruiting
Lyon, France, 69373
CHU Hopital Nord Recruiting
Marseille, France, 13915
Hopital Tenon Recruiting
Paris, France, 75970
Hopital du Haut Leveque Recruiting
Pessac, France, 33604
Hospital Pontchaillou Recruiting
Rennes, France, 35033
Germany
Zentralklinik Bad Berka GmbH Not yet recruiting
Bad Berka, Germany, 99437
Charite Universitaetsmedizin Not yet recruiting
Berlin, Germany, 13125
Asklepios Fachkliniken M. Gaut Recruiting
Gauting, Germany, 82131
KH Martha-Maria Halle Dolau Recruiting
Halle, Germany, 06120
Thoraxklinik Heidelberg gGmbH Recruiting
Heidelberg, Germany, 69126
Lungenklinik Hemer Recruiting
Hemer, Germany, 58675
Klinikum Kassel Recruiting
Kassel, Germany, 34125
Klinik Loewenstein GmbH Recruiting
Löwenstein, Germany, 74245
Fachkliniken Wangen Not yet recruiting
Wangen, Germany, 88239
Greece
Gen Hosp Chest Athens Sotiria Not yet recruiting
Athens, Greece, 11527
Metropolitan Hospital Not yet recruiting
Athens, Greece, 18547
University Hospital of Ioannin Not yet recruiting
Ioannina, Greece, 45500
General Oncological Hospital Not yet recruiting
Nea Kifisia, Greece, 14564
Euromedica General Clinic Not yet recruiting
Thessaloniki, Greece, 54645
Hong Kong
Queen Elizabeth Hospital Not yet recruiting
Kowloon, Hong Kong, 852
Princess Margaret Hospital Not yet recruiting
Lai Chi Kok, Hong Kong, 999077
Tuen Mun Hospital Not yet recruiting
Tuen Mun, Hong Kong, 999077
Hungary
Semmelweis Egyetem Recruiting
Budapest, Hungary, 1085
Orszagos Koranyi TBC/Pulmon Recruiting
Budapest, Hungary, 1121
Csongrad Megyei Mellkasi Beteg Recruiting
Deszk, Hungary, 6772
Ireland
St Vincent's University Hosp Recruiting
Dublin, Ireland, D04 T6F4
St. James Hospital Recruiting
Dublin, Ireland, D08 E9P6
University Hospital Limerick Not yet recruiting
Limerick, Ireland, V94 F858
University Hospital Waterford Recruiting
Waterford, Ireland, X91 ER8E
Israel
Soroka Medical Ctr Recruiting
Be'er Sheva, Israel, 84101
Hadassah Recruiting
Jerusalem, Israel, 91120
Meir Medical Center Recruiting
Kfar Saba, Israel, 44281
Rabin Medical Center Recruiting
Petah Tikva, Israel, 49100
Sheba Medical Center Recruiting
Ramat Gan, Israel, 5262100
Tel Aviv Sourasky Medical Ctr Recruiting
Tel Aviv, Israel, 64239
Italy
AUSL 8 Arezzo Ospedale San Don Recruiting
Arezzo, Italy, 52100
IRST Istituto Scientifico Roma Recruiting
Meldola, Italy, 47014
A.O.U. San Luigi Gonzaga Recruiting
Orbassano, Italy, 10043
Ospedale Santa Maria delle Cro Recruiting
Ravenna, Italy, 48121
Policlinico Universitario Camp Recruiting
Rome, Italy, 00128
IFO Istituto Nazionale Tumori Recruiting
Rome, Italy, 00144
Japan
Kurume University Hospital Not yet recruiting
久留米市, Fukuoka, Japan, 〒830-0011
National Cancer Center Hosp Not yet recruiting
中央区, Tokyo, Japan, 〒104-0045
The Cancer Institute Hosp JFCR Not yet recruiting
江東区, Tokyo, Japan, 〒135-8550
Hyogo Cancer Center Not yet recruiting
Akashi, Japan, 673-8558
Kyushu University Hospital Not yet recruiting
Fukuoka, Japan, 812-8582
NHO Himeji Medical Center Not yet recruiting
Himeji, Japan, 670-8520
Kanazawa University Hospital Not yet recruiting
Kanazawa, Japan, 920-0934
National Cancer Ctr Hosp East Not yet recruiting
Kashiwa, Japan, 277-8577
Matsusaka City Hospital Recruiting
Matsusaka-shi, MIE, Japan, 515-8544
Shizuoka Cancer Center Not yet recruiting
Nagaizumi, Japan, 411-8777
Aichi Cancer Center Hospital Not yet recruiting
Nagoya, Japan, 464-8681
Japanese Red Cross Okayama Hos Not yet recruiting
Okayama, Japan, 700-0941
Osaka City General Hospital Not yet recruiting
Osaka, Japan, 534-0021
Kansai Med University Hospital Not yet recruiting
Osaka, Japan, 573-1191
Kindai University Hospital Not yet recruiting
Osaka, Japan, 589-8511
Hokkaido Cancer Center Not yet recruiting
Sapporo, Japan, 003-0804
Sendai Kousei Hospital Recruiting
Sendai, Japan, 980-0873
Tokushima University Hospital Not yet recruiting
Tokushima, Japan, 770-8503
Showa University Hospital Not yet recruiting
Tokyo, Japan
Wakayama Medical University Not yet recruiting
Wakayama, Japan, 641-0012
Yokohama City University Hosp Not yet recruiting
Yokohama, Japan, 236-0004
Kanagawa Cardio Resp Center Not yet recruiting
Yokohama, Japan, 236-0051
Kanagawa Cancer Center Not yet recruiting
Yokohama, Japan, 241-0815
Korea, Republic of
Kyungpook National University Not yet recruiting
Daegu, Korea, Republic of, 41404
CHA Bundang Not yet recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of
Severance Hospital Not yet recruiting
Seoul, Korea, Republic of, 03722
Korea University Guro Not yet recruiting
Seoul, Korea, Republic of, 08308
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Latvia
Pauls Stradins Clinical Recruiting
Riga, Latvia, LV-1002
Riga East Clinical University Recruiting
Riga, Latvia, LV-1079
Lithuania
Hosp Lithuanian Univ Health Sc Not yet recruiting
Kaunas, Lithuania, 50009
Klaipeda University Hospital Not yet recruiting
Klaipeda, Lithuania, LT-92288
Mexico
Health Pharma professional Ser Not yet recruiting
Mexico, Mexico, 03810
Instituto Nacional de Cancerol Not yet recruiting
Mexico, Mexico, 14000
Centro de Invest Clin Chapulte Not yet recruiting
Morelia, Mexico, 58260
Netherlands
Meander Medisch Centrum Recruiting
Amersfoort, Netherlands, 3813 TZ
Rijnstate Hospital Recruiting
Arnhem, Netherlands, 6815 AD
Amphia Ziekenhuis Recruiting
Breda, Netherlands, 4818 CK
Catharina ziekenhuis Not yet recruiting
Eindhoven, Netherlands, 5623
Maastricht University Med Ctr Recruiting
Maastricht, Netherlands, 6229 HX
Jeroen Bosch Ziekenhuis Recruiting
S Hertogenbosch, Netherlands, 5223 GZ
Universitair Medisch Centrum U Recruiting
Utrecht, Netherlands, 3584 CX
Norway
Haukeland University Hospital Not yet recruiting
Bergen, Norway, 5021
Drammen Sykehus Recruiting
Drammen, Norway, N-3004
Radiumhospitalet Recruiting
Oslo, Norway, 0310
Stavanger Universitetssykehus Recruiting
Stavanger, Norway, 4011
St. Olavs Hospital Recruiting
Trondheim, Norway, 7052
Poland
Wojewodzki Szpital Specjalisty Not yet recruiting
Bytom, Poland, 41- 902
Szpitale Pomorskie Sp. z o.o Recruiting
Gdynia, Poland, 81-519
Mrukmed. Lekarz Beata Madej Recruiting
Rzeszow, Poland, 35-922
Portugal
Instituto Portugues de Oncolog Not yet recruiting
Lisbon, Portugal, 1099-023
Hospital da Luz, SA Not yet recruiting
Lisbon, Portugal, 1500-650
Centro Hospitalar Lisboa Norte Not yet recruiting
Lisbon, Portugal, 17690-01
Unidade Local Saude Matosinhos Recruiting
Matosinhos, Portugal, 4464-513
Hospital CUF Porto Not yet recruiting
Porto, Portugal, 4100-180
Instituto Portugues Oncologia Not yet recruiting
Porto, Portugal, 4200-072
Russian Federation
Arkhangelsk clinical oncology Recruiting
Arkhangelsk, Russian Federation, 163045
State budgetary health care in Not yet recruiting
Kaliningrad, Russian Federation, 236016
Kaluga Regional Clinical Oncol Recruiting
Kaluga, Russian Federation, 284007
National Medical Research Cntr Not yet recruiting
Moscow, Russian Federation, 115478
Moscow Res Onc Inst Hertsen Not yet recruiting
Moscow, Russian Federation, 125284
Clinical Onco Dispensary Recruiting
Omsk, Russian Federation, 644013
PMI Euromedservice Recruiting
Pushkin, Russian Federation, 196603
Smolensk Regional Onc Clin Dis Recruiting
Smolensk, Russian Federation, 214009
LLC BioEq Ltd. Recruiting
St. Petersburg, Russian Federation, 197342
N.N. Petrov Research Inst Onc Not yet recruiting
St. Petersburg, Russian Federation, 197758
Republican Clin Onc Dispensary Not yet recruiting
UFA, Russian Federation, 450054
Serbia
Clinical Center Serbia Not yet recruiting
Belgrade, Serbia, 11000
Institut za onkologiju i radio Not yet recruiting
Belgrade, Serbia, 11000
Klinicko bolnicki centar Not yet recruiting
Belgrade, Serbia, 11080
Clinical Center of Nis Recruiting
NIS, Serbia, 18000
Institute For Pulmonary Diseas Recruiting
Sremska Kamenica, Serbia, 21204
South Africa
Langenhoven Drive Onco Cent Recruiting
Port Elizabeth, Eastern Cape, South Africa, 6045
Life Wilgers Hospital Recruiting
Pretoria, Gauteng, South Africa, 0040
Mary Potter Oncology Centre Recruiting
Pretoria, Gauteng, South Africa, 0181
The Oncology Centre Recruiting
Durban, Kwazulu-Natal, South Africa, 4091
Spain
Hospital Teresa Herrera Recruiting
A Coruna, Spain, 15006
H. Del Mar, Barcelona Recruiting
Barcelona, Spain, 08003
Hospital Univ Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Fundacion Jimenez Diaz Recruiting
Madrid, Spain, 28040
Hospital Clin Univ San Carlos Recruiting
Madrid, Spain, 28040
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Hospital Reg Uni de Malaga Not yet recruiting
Malaga, Spain, 29009
Hosp Clin Univ Lozano Blesa Recruiting
Zaragoza, Spain, 50009
Sweden
Sahlgrenska Universitetssjukhuset Not yet recruiting
Mölndal, Vastra Gotalands Lan, Sweden, 431 30
KPE Not yet recruiting
Karlstad, Sweden, 651 85
University Hospital Linkoping Not yet recruiting
Linkoping, Sweden, 58185
Karolinska Univ Sjukhuset Recruiting
Solna, Sweden, 17176
Uppsala University Hospital Not yet recruiting
Uppsala, Sweden, 75185
Switzerland
Universitaetsspital Basel Recruiting
Basel, Switzerland, 4056
Hopitaux Universitaires de Gen Recruiting
Geneva, Switzerland, 1205
Luzerner Kantonsspital Recruiting
Luzern, Switzerland, 6000
Kantonsspital St. Gallen Recruiting
Saint Gallen, Switzerland, 9007
Kantonsspital Winterthur Recruiting
Winterthur, Switzerland, 8401
Taiwan
Dalin Tzu Chi General Hospital Recruiting
Dalin Township, Taiwan, 622
Kaohsiung Medical University Recruiting
Kaohsiung, Taiwan, 80708
China Medical University Hosp Recruiting
Taichung City, Taiwan, 40402
Taichung Veterans General Hosp Recruiting
Taichung City, Taiwan, 40705
National Cheng Kung Univ Hosp Recruiting
Tainan City, Taiwan, 70101
National Taiwan Univ Hosp Recruiting
Taipei City, Taiwan, 10002
Tri-Service General Hospital Recruiting
Taipei City, Taiwan, 11490
Turkey
Hacettepe Universitesi Tip Fak Recruiting
Altindag/ankara, Turkey, 06100
Ataturk Gogus Hastalikl Recruiting
Ankara, Turkey, 06280
Akdeniz Universitesi Tip Fakul Recruiting
Antalya, Turkey, 07059
Ege University Medical Faculty Recruiting
Izmir, Turkey, 35040
Dr. Suat Seren Gogus Has Recruiting
Izmir, Turkey, 35110
Inonu University Recruiting
Malatya, Turkey, 44280
Ukraine
Chernivetskyi Reg Clin Onc Hos Not yet recruiting
Chernivtsi, Ukraine, 58013
Municipal institution Multifie Recruiting
Dnipro, Ukraine, 49102
Regional Center of Oncology Not yet recruiting
Kharkiv, Ukraine, 61070
Medical and Diagnostic Center Recruiting
Kropyvnytskyi, Ukraine, 25006
Treatment and prevention Not yet recruiting
Lutsk, Ukraine, 43018
Central Regional Clinical Hos. Not yet recruiting
Uzhgorod, Ukraine
Zaporozhye regional clinical Recruiting
Zaporozhye, Ukraine, 69040
United Kingdom
Queen Elizabeth Medical Centre Not yet recruiting
Birmingham, United Kingdom, B15 2TH
The Royal Bournemouth Hospital Recruiting
Bournemouth, United Kingdom, BH7 7DW
Colchester General Hospital Not yet recruiting
Colchester, United Kingdom, CO4 5JL
Hereford County Hospital Not yet recruiting
Hereford, United Kingdom, HR1 2ER
Charing Cross Hospital Recruiting
London, United Kingdom, W6 8RF
Maidstone Hospital Not yet recruiting
Maidstone, United Kingdom, ME16 9QQ
Christie NHS Foundation Trust Recruiting
Manchester, United Kingdom, M20 4BX
Freeman Hospital Recruiting
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Torbay Hospital - So Devon HC Recruiting
Torquay, United Kingdom, TQ2 7AA
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie
More Information

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03033511     History of Changes
Other Study ID Numbers: M16-298
2016-003503-64 ( EudraCT Number )
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
Extensive-Stage Small Cell Lung Cancer (ED SCLC)
Cancer
Platinum-Based Chemotherapy
Rovalpituzumab tesirine
first-line chemotherapy

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action