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Trial record 1 of 1 for:    NCT03033511
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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)

This study is currently recruiting participants.
Verified October 2017 by AbbVie
Sponsor:
ClinicalTrials.gov Identifier:
NCT03033511
First Posted: January 26, 2017
Last Update Posted: November 2, 2017
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.
Information provided by (Responsible Party):
AbbVie
  Purpose
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 Intervention Phase
Small Cell Lung Cancer (SCLC) Drug: Rovalpituzumab tesirine Drug: Dexamethasone Drug: Placebo for rovalpituzumab tesirine Drug: Placebo for dexamethasone Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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.

  • 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:
  • 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.

  • 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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Estimated Enrollment: 740
Actual Study Start Date: February 7, 2017
Estimated Study Completion Date: April 1, 2020
Estimated Primary Completion Date: November 14, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 rovalpituzumab tesirine
Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

  Hide Study Locations
Locations
United States, Alabama
Clearview Cancer Institute /ID# 156699 Recruiting
Huntsville, Alabama, United States, 35805
USA Mitchell Cancer Institute /ID# 160975 Recruiting
Mobile, Alabama, United States, 36604
United States, Arkansas
Highlands Oncology Group /ID# 156722 Recruiting
Fayetteville, Arkansas, United States, 72703
United States, California
Marin Cancer Care /ID# 159207 Recruiting
Greenbrae, California, United States, 94904
UCSD Moores Cancer Center, US /ID# 157764 Not yet recruiting
La Jolla, California, United States, 92093-0698
Los Angeles Hematology Oncology Medical Group /ID# 156717 Recruiting
Los Angeles, California, United States, 90017
St Jude Hospital dba St Joseph Heritage Healthcare /ID# 156526 Recruiting
Santa Rosa, California, United States, 95403
Innovative Clinical Research Institute /ID# 157765 Recruiting
Whittier, California, United States, 90603
United States, Colorado
Kaiser Permanente Lone Tree Medical Office /ID# 159331 Recruiting
Lone Tree, Colorado, United States, 80124
United States, Delaware
Christiana Care Health Services, Inc. /ID# 159212 Recruiting
Newark, Delaware, United States, 19713
United States, Florida
Holy Cross Hospital /ID# 156716 Recruiting
Fort Lauderdale, Florida, United States, 33308
University of Florida /ID# 155799 Not yet recruiting
Gainesville, Florida, United States, 32610
Memorial Cancer Institute /ID# 156673 Recruiting
Hollywood, Florida, United States, 33021
Memorial Cancer Institute at Memorial Hospital West /ID# 164052 Recruiting
Pembroke Pines, Florida, United States, 33028
United States, Georgia
Southeastern Regional Medical Center /ID# 163064 Not yet recruiting
Newnan, Georgia, United States, 30265
United States, Idaho
St. Luke's Mountain States Tumor Institute-Boise /ID# 156691 Recruiting
Meridian, Idaho, United States, 83642
United States, Illinois
NorthShore University HealthSystem /ID# 156664 Recruiting
Evanston, Illinois, United States, 60201
Ingalls Memorial Hospital /ID# 156685 Recruiting
Harvey, Illinois, United States, 60426
United States, Indiana
Goshen Center for Cancer Care /ID# 156682 Recruiting
Goshen, Indiana, United States, 46526
United States, Kentucky
James Graham Brown Cancer Center, Univ Louisville /ID# 156683 Recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Ochsner Clinic Foundation /ID# 159136 Recruiting
New Orleans, Louisiana, United States, 70121
United States, Michigan
Edward W. Sparrow Hospital Association /ID# 156590 Recruiting
Lansing, Michigan, United States, 48912
United States, Missouri
MidAmerica Division, Inc. c/o Research Medical Center /ID# 163530 Recruiting
Kansas City, Missouri, United States, 64132
United States, Nebraska
Nebraska Hematology Oncology, PC /ID# 156534 Recruiting
Lincoln, Nebraska, United States, 68506
United States, New Jersey
MD Anderson Cancer Center at Cooper /ID# 156681 Not yet recruiting
Camden, New Jersey, United States, 08103
United States, New York
Northwell Health, Monter Cancer Center /ID# 159252 Recruiting
Lake Success, New York, United States, 11042
Icahn School of Medicine at Mount Sinai /ID# 159210 Recruiting
New York, New York, United States, 10029
Stony Brook University Hospital /ID# 159272 Recruiting
Stony Brook, New York, United States, 11794
United States, North Carolina
Duke University Medical Center /ID# 156706 Recruiting
Durham, North Carolina, United States, 27710
Cone Health /ID# 156689 Recruiting
Greensboro, North Carolina, United States, 27403
Cone Health /ID# 163612 Recruiting
Greensboro, North Carolina, United States, 27403
Eastern Carolina University /ID# 159264 Not yet recruiting
Greenville, North Carolina, United States, 27834
United States, Ohio
Gabrail Cancer Center Research /ID# 156667 Recruiting
Canton, Ohio, United States, 44718
United States, Pennsylvania
Thomas Jefferson University Hospital /ID# 156719 Recruiting
Philadelphia, Pennsylvania, United States, 19107
VA Pittsburgh Healthcare System /ID# 159284 Recruiting
Pittsburgh, Pennsylvania, United States, 15240
United States, Tennessee
Tennessee Oncology, PLLC /ID# 161168 Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
University Medical Center Brackenridge /ID# 155798 Recruiting
Austin, Texas, United States, 78701
United States, Washington
Medical Oncology Associates, PS (dba Summit Cancer Centers) /ID# 156715 Recruiting
Spokane, Washington, United States, 99208
Australia
Coffs Harbour Hospital /ID# 158880 Not yet recruiting
Coffs Harbour, Australia, 2450
Gosford Hospital /ID# 158884 Not yet recruiting
Gosford, Australia, 2250
Affinity Clinical Research Services /ID# 158887 Not yet recruiting
Nedlands, Australia, 6009
Calvary North Adelaide /ID# 161701 Recruiting
North Adelaide, Australia, 5006
Sunshine Hospital /ID# 161700 Not yet recruiting
St Albans, Australia, 3021
Austria
Landeskrankenhaus Universitaetsklinikum Graz /ID# 159563 Recruiting
Graz, Austria, 8036
Krankenhaus der Elisabethinen Linz GmbH /ID# 159564 Recruiting
Linz, Austria, 4020
Belarus
Republican Research and Practice Centre of Oncology /ID# 159383 Not yet recruiting
Agro-town Lesnoy, Belarus, 223040
Mogilev Regional Clinical Oncology Dispensary /ID# 159384 Recruiting
Mogilev, Belarus, 212018
Belgium
ZNA Middelheim /ID# 159007 Recruiting
Antwerp, Belgium, 2020
Grand Hopital de Charleroi /ID# 159006 Recruiting
Charleroi, Belgium, 6000
Hopital de Jolimont /ID# 159005 Not yet recruiting
La Louviere, Belgium, 7100
Bulgaria
UMHAT Sveti Ivan Rilski EAD /ID# 159639 Not yet recruiting
Sofia, Bulgaria, 1431
UMHAT Tsaritsa Joanna - ISUL /ID# 159638 Not yet recruiting
Sofia, Bulgaria, 1527
Croatia
Klinicki bolnicki Centar Rijeka /ID# 159504 Recruiting
Rijeka, Croatia, 51000
Klinicki Bolnicki Centar Sestre Milosrdnice /ID# 159090 Not yet recruiting
Zagreb, Croatia, 10000
Klinicki bolnicki Centar Zagreb /ID# 159505 Not yet recruiting
Zagreb, Croatia, 10000
Czechia
Vitkovicka nemocnice a. s. /ID# 161187 Recruiting
Ostrava, Czechia, 703 84
Eticka Komise IKEM a Thomayerovy nemocnice /ID# 159062 Recruiting
Prague 4, Czechia, 14059
Oblastni Nemocnice Pribram, a. s. /ID# 159654 Recruiting
Pribham I, Czechia, 26101
Denmark
Rigshospitalet /ID# 158055 Recruiting
Copenhagen, Denmark, DK-2100
Herlev Hospital /ID# 158053 Recruiting
Herlev, Denmark, 2730
Odense University Hospital /ID# 158054 Recruiting
Odense C, Denmark, 5000
Estonia
East Tallinn Central Hospital /ID# 160019 Not yet recruiting
Tallinn, Estonia, 11312
North Estonia Medical Centre Foundation /ID# 159779 Recruiting
Tallinn, Estonia, 13419
Finland
Docrates Cancer Center /ID# 159591 Recruiting
Helsinki, Finland, 00180
France
CHI Creteil-Service de Pneumologie /ID# 162686 Recruiting
Creteil, France, 94000
CHU Hopital Nord /ID# 160543 Recruiting
Marseille, France, 13015
Hopital Tenon /ID# 160541 Recruiting
Paris, France, 75020
Hopital du Haut Leveque /ID# 160547 Recruiting
Pessac, France, 33604
Hospital de Pontchaillou- CHU Rennes /ID# 160544 Recruiting
RENNES Cedex 9, France, 35033
Germany
Zentralklinik Bad Berka GmbH /ID# 158793 Not yet recruiting
Bad Berka, Germany, 99437
Charite Universitatsmedizin Berlin /ID# 158783 Not yet recruiting
Berlin, Germany, 13353
Krankenhaus Martha-Maria Halle Dolau GGMBII /ID# 158794 Recruiting
Halle, Germany, 06120
Thoraxklinik Heidelberg gGmbH /ID# 158871 Not yet recruiting
Heidelberg, Germany, 69126
Lungenklinik Hemer /ID# 158790 Recruiting
Hemer, Germany, 58675
Klinikum Kassel /ID# 158786 Recruiting
Kassel, Germany, 34125
Klinik Loewenstein GmbH /ID# 158870 Not yet recruiting
Lowenstein, Germany, 74245
Fachkliniken Wangen /ID# 160779 Recruiting
Wangen, Germany, 88239
Hong Kong
Queen Elizabeth Hospital /ID# 159565 Not yet recruiting
Kowloon, Hong Kong, 999077
Tuen Mun Hospital /ID# 162435 Not yet recruiting
Tuen Mun, N.T., Hong Kong
Hungary
Csongrad Megyei Mellkasi Betegsegek Szakkorhaza /ID# 158952 Recruiting
Deszk, Hungary, 6772
Ireland
St Vincent's University Hospital /ID# 161678 Recruiting
Dublin, Ireland, DUBLIN 4
St. James Hospital /ID# 159712 Recruiting
Dublin, Ireland, DUBLIN 8
University Hospital Waterford /ID# 159713 Not yet recruiting
Waterford, Ireland, X91 ER8E
Israel
Soroka University Medical Center /ID# 159762 Recruiting
Beer Sheva, Israel, 8410101
Hadassah Medical Center /ID# 159763 Recruiting
Jerusalem, Israel, 91120
Meir Medical Center /ID# 159761 Recruiting
Kfar Saba, Israel, 4428164
Rabin Medical Center /ID# 159764 Recruiting
Petach tikva, Israel, 49100
Sheba Medical Center /ID# 159760 Recruiting
Ramat Gan, Israel, 52621
Tel Aviv Sourasky Medical Center /ID# 161467 Recruiting
Tel Aviv, Israel, 64239
Italy
AUSL 8 Arezzo Ospedale San Donato /ID# 160897 Recruiting
Arezzo, Italy, 52100
IRST Istituto Scientifico Romagnolo per lo studio e la cura /ID# 160898 Recruiting
Meldola (FC), Italy, 40-47014
A.O.U. San Luigi Gonzaga di Orbassano /ID# 158916 Recruiting
Orbassano, Italy, 10043
Ospedale Santa Maria delle Croci /ID# 158911 Recruiting
Ravenna, Italy, 48121
Policlinico Universitario Campus Bio-Medico di Roma /ID# 160874 Recruiting
Roma, Italy, 00128
Istituto Nazionale Tumori Regina Elena /ID# 158912 Recruiting
Rome, Italy, 00144
Japan
National Hospital Organization Hokkaido Cancer Center /ID# 165236 Not yet recruiting
Sapporo-Shi, Japan
Sendai Kousei Hospital /ID# 166491 Not yet recruiting
Sendai-city, Miyagi,, Japan
Latvia
Pauls Stradins Clinical University Hospital, Clinic of Oncol /ID# 158715 Recruiting
Riga, Latvia, LV-1002
Riga East Clinical University Hospital, Oncology Center of /ID# 158716 Recruiting
Riga, Latvia, LV-1079
Lithuania
Hospital of Lithuanian Univ of Health Sciences Kauno kliniko /ID# 160016 Not yet recruiting
Kaunas, Lithuania, 50161
Klaipeda University Hospital /ID# 160018 Recruiting
Klaipeda, Lithuania, LT-92288
National Cancer Institute /ID# 160017 Not yet recruiting
Vilnius, Lithuania, LT-08660
Netherlands
Meander Medisch Centrum /ID# 159064 Recruiting
Amersfoort, Netherlands, 3813 TZ
Meander Medisch Centrum /ID# 164061 Withdrawn
Amersfoort, Netherlands, 3813 TZ
Rijnstate Hospital /ID# 159063 Recruiting
Arnhem, Netherlands, 6815 AD
Amphia Ziekenhuis /ID# 159065 Recruiting
Breda, Netherlands, 4818
Catharina ziekenhuis /ID# 158082 Not yet recruiting
Eindhoven, Netherlands, 5623 EJ
Jeroen Bosch Ziekenhuis /ID# 158081 Not yet recruiting
GZ, 's Hertogenbosch, Netherlands, 5223
Maastricht University Medical Center /ID# 161669 Recruiting
Maastricht, Netherlands, 6229 HX
Universitair Medisch Centrum Utrecht /ID# 158083 Recruiting
Utrecht, Netherlands, 3584 CX
Norway
Drammen Sykehus /ID# 159572 Recruiting
Drammen, Norway, 3004
Sorlandet Sykehus HF /ID# 159577 Not yet recruiting
Kristiansand, Norway, 4615
Radiumhospitalet /ID# 159574 Recruiting
Oslo, Norway, 0310
Stavanger Universitetssykehus /ID# 159575 Not yet recruiting
Stavanger, Norway, 4011
St. Olavs Hospital /ID# 163110 Recruiting
Trondheim, Norway, 7030
Poland
Szpitale Pomorskie Sp. z o.o /ID# 159605 Recruiting
Gdynia, Poland, 81-519
Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 159604 Recruiting
Rzeszow, Poland, 35-021
Portugal
Unidade Local Saude Matosinhos, EPE-Hospital Pedro Hispano /ID# 159950 Recruiting
Matoshinhos, Portugal, 4464-543
Russian Federation
Arkhangelsk clinical oncology /ID# 159367 Not yet recruiting
Arkhangelsk, Russian Federation, 163045
State Healthcare Institution "Regional Clinical Hospital of /ID# 159366 Not yet recruiting
Kaliningrad, Russian Federation, 236016
Kaluga Regional Clinical Oncological Dispensary /ID# 160180 Not yet recruiting
Kaluga, Russian Federation, 284007
PMI Euromedservice /ID# 159369 Not yet recruiting
Saint Petersburg, Russian Federation, 196603
LLC BioEq Ltd. /ID# 159368 Not yet recruiting
Saint-Petersburg, Russian Federation, 197342
Smolensk Regional Oncology Clinical Dispensary /ID# 159372 Not yet recruiting
Smolensk,, Russian Federation, 214000
N.N. Petrov Science-Research Institute of Oncology /ID# 159370 Not yet recruiting
St. Petersburg, Russian Federation, 197758
Serbia
Clinical Center of Serbia /ID# 160902 Not yet recruiting
Belgrade, Serbia, 11000
Institut za onkologiju i radiologiju Srbije /ID# 160904 Not yet recruiting
Belgrade, Serbia, 11000
Klinicko bolnicki centar " Bezanijska Kosa" /ID# 160903 Not yet recruiting
Belgrade, Serbia, 11080
Institute For Pulmonary Diseases of Vojvodina /ID# 164250 Not yet recruiting
Sremska Kamenica, Serbia, 21204
South Africa
The Oncology Centre /ID# 158872 Recruiting
Durban, South Africa, 4001
Langenhoven Drive Oncology Centre /ID# 159126 Recruiting
Port Elizabeth, South Africa, 6045
Mary Potter Oncology Centre /ID# 158877 Recruiting
Pretoria,, South Africa, 0181
Wilgers Oncology Centre /ID# 158873 Recruiting
Pretoria, South Africa, 0081
Spain
Hospital Teresa Herrera /ID# 164368 Recruiting
A Coruna, Spain, 15006
H. Del Mar, Barcelona /ID# 159690 Recruiting
Barcelona, Spain, 08003
Hospital Vall d'Hebron /ID# 159708 Recruiting
Barcelona, Spain, 08035
Fundacion Jimenez Diaz /ID# 159693 Recruiting
Madrid, Spain, 28040
Hospital Universitario Clinico San Carlos /ID# 159706 Recruiting
Madrid, Spain, 28040
Hospital Universitario La Paz /ID# 159692 Recruiting
Madrid, Spain, 28046
Hospital Regional Universitario de Malaga /ID# 164371 Recruiting
Malaga, Spain, 29010
Hospital Clinico Universitario Lozano Blesa /ID# 159709 Recruiting
Zaragoza, Spain, 50009
Sweden
Sahlgrenska Universitetssjukhuset /ID# 159524 Not yet recruiting
Goteborg, Sweden, SE-413 46
Kpe /Id# 163451 Not yet recruiting
Karlstad, Sweden, 651 85
University Hospital Linkoping /ID# 159046 Not yet recruiting
Linkoping, Sweden, 581 85
Karolinska University Hospital /ID# 159649 Not yet recruiting
Stockholm, Sweden, 171 76
Akademiska sjukhuset /ID# 159052 Not yet recruiting
Uppsala, Sweden, 751 85
Switzerland
Universitaetsspital Basel /ID# 160605 Recruiting
Basel, Switzerland, 4031
Hopitaux Universitaires de Geneva /ID# 160603 Recruiting
Geneve 14, Switzerland, 1211
Luzerner Kantonsspital - Luzern /ID# 160607 Recruiting
Luzern, Switzerland, 6000
Kantonsspital St. Gallen /ID# 160604 Recruiting
St. Gallen, Switzerland, 9007
Kantonsspital St. Gallen /ID# 167816 Withdrawn
St. Gallen, Switzerland, 9007
Kantonsspital Winterthur /ID# 161379 Recruiting
Winterthur, Switzerland, 8401
Taiwan
Dalin Tzu Chi General Hospital /ID# 158983 Recruiting
Dalin Township, Taiwan, 622
Taichung Veterans General Hospital /ID# 159047 Recruiting
Taichung, R.O.C, Taiwan, 40705
China Medical University Hospital /ID# 158981 Recruiting
Taichung, Taiwan, 404
National Cheng Kung University Hospital /ID# 158799 Recruiting
Tainan, Taiwan, 704
National Taiwan University Hospital /ID# 159049 Recruiting
Taipei City, Taiwan, 100
Tri-Service General Hospital /ID# 158980 Recruiting
Taipei City, Taiwan, 114
Turkey
Hacettepe Universitesi Tip Fakultesi Sihhiye Yerleskesi /ID# 159242 Recruiting
Altindag/Ankara, Turkey, 06100
Akdeniz Universitesi Tip Fakultesi /ID# 160791 Recruiting
Antalya, Turkey, 07059
Inonu University /ID# 159245 Recruiting
Battalgazi/ Malatya, Turkey, 44280
Ataturk Gogus Hastaliklari ve Gogus Cerrahi Egitim /ID# 159556 Recruiting
Kecioeren, Ankara, Turkey, 06280
Dr. Suat Seren Gogus Hastaliklari /ID# 159244 Recruiting
Yenisehir, Izmir, Turkey, 35110
Ukraine
Municipal institution Multifield City Clinical Hospital /ID# 159130 Recruiting
Dnipro, Ukraine, 49102
Medical and Diagnostic Center PE PMC ''Acinus'' /ID# 165543 Recruiting
Kropyvnytskyi, Ukraine, 25006
Treatment and prevention institution Volyn regional oncology /ID# 159133 Not yet recruiting
Lutsk, Ukraine, 43018
Central Regional Clinical Hospital /ID# 159865 Not yet recruiting
Uzhgorod, Ukraine, 88000
Zaporozhye regional clinical oncology center /ID# 159131 Recruiting
Zaporizhzhia, Ukraine, 69040
United Kingdom
The Royal Bournemouth Hospital /ID# 159039 Recruiting
Bournemouth, United Kingdom, BH7 7DW
Colchester General Hospital /ID# 159042 Recruiting
Colchester, United Kingdom, CO4 5JL
Freeman Hospital /ID# 159044 Recruiting
Newcastle upon Tyne, United Kingdom, NE7 7DN
Torbay Hospital - So Devon Healthcare NHS Foundation Trust /ID# 159041 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 Submitted: January 25, 2017
First Posted: January 26, 2017
Last Update Posted: November 2, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

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