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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)

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ClinicalTrials.gov Identifier: NCT03033511
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

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 Drug: Placebo for dexamethasone Drug: Placebo for rovalpituzumab tesirine Drug: Rovalpituzumab tesirine Drug: Dexamethasone Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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 : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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




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.



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 and older   (Adult, Older Adult)
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.

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
University of South Alabama /ID# 160975 Recruiting
Mobile, Alabama, United States, 36604-3302
United States, Arkansas
Highlands Oncology Group /ID# 156722 Recruiting
Fayetteville, Arkansas, United States, 72703-4005
United States, California
Ucsd /Id# 157764 Recruiting
La Jolla, California, United States, 92037
Loma Linda University Medical /ID# 201835 Not yet recruiting
Loma Linda, California, United States, 92354
LA Hem-Oncology Med Group /ID# 156717 Not yet recruiting
Los Angeles, California, United States, 90017
Palo Alto Veterans Institute for Research /ID# 203695 Not yet recruiting
Palo Alto, California, United States, 94304-1207
St Jude Hospital dba St Joseph /ID# 156526 Recruiting
Santa Rosa, California, United States, 95403
Icri /Id# 157765 Recruiting
Whittier, California, United States, 90603
United States, Colorado
Kaiser Permanente Lone Tree /ID# 159331 Recruiting
Lone Tree, Colorado, United States, 80124
United States, Delaware
Christiana Care Health Service /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 Recruiting
Gainesville, Florida, United States, 32610
Memorial Cancer Institute /ID# 156673 Not yet recruiting
Hollywood, Florida, United States, 33021-5421
Memorial Cancer Institute /ID# 164052 Not yet recruiting
Hollywood, Florida, United States, 33021-5421
Cancer Specialists /ID# 156595 Recruiting
Jacksonville, Florida, United States, 32256
United States, Georgia
Georgia Cancer Center /ID# 201894 Not yet recruiting
Atlanta, Georgia, United States, 30060
Southeastern Regional Medical /ID# 163064 Recruiting
Newnan, Georgia, United States, 30265
United States, Idaho
St. Luke's Mountain States Tumor Institute /ID# 156691 Not yet recruiting
Boise, Idaho, United States, 83712-6267
United States, Illinois
Northwestern University /ID# 156690 Not yet recruiting
Chicago, Illinois, United States, 60611-2927
NorthShore Univ HealthSystem /ID# 156664 Recruiting
Evanston, Illinois, United States, 60201
Ingalls Memorial Hosp /ID# 156685 Not yet 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
Ashland-Bellefonte Cancer Ctr /ID# 202901 Not yet recruiting
Ashland, Kentucky, United States, 41101
University of 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
Henry Ford Health System /ID# 156712 Not yet recruiting
Detroit, Michigan, United States, 48202
Edward W. Sparrow Hosp Assn /ID# 156590 Recruiting
Lansing, Michigan, United States, 48912
United States, Minnesota
Mayo Clinic - Rochester /ID# 160181 Recruiting
Rochester, Minnesota, United States, 55905-0001
United States, Missouri
MidAmerica Division, Inc. /ID# 163530 Recruiting
Kansas City, Missouri, United States, 64132
United States, Montana
Billings Clinic /ID# 201788 Not yet recruiting
Billings, Montana, United States, 59101-0733
United States, Nebraska
Nebraska Hematology Oncology /ID# 156534 Recruiting
Lincoln, Nebraska, United States, 68506
United States, New Jersey
MD Anderson Cancer Center at Cooper /ID# 156681 Recruiting
Camden, New Jersey, United States, 08103
United States, New York
Montefiore Medical Center /ID# 201845 Not yet recruiting
Bronx, New York, United States, 10461
Northwell Health, Monter Cance /ID# 159252 Recruiting
Lake Success, New York, United States, 11042
Icahn School of Med Mt. Sinai /ID# 159210 Recruiting
New York, New York, United States, 10029
Stony Brook University Hospita /ID# 159272 Recruiting
Stony Brook, New York, United States, 11794-8183
United States, North Carolina
Duke Univ Med Ctr /ID# 156706 Not yet recruiting
Durham, North Carolina, United States, 27710
Cone Health /ID# 156689 Recruiting
Greensboro, North Carolina, United States, 27403
Cone Health /ID# 163612 Not yet recruiting
Greensboro, North Carolina, United States, 27403
Eastern Carolina University /ID# 159264 Recruiting
Greenville, North Carolina, United States, 27834
United States, Ohio
Gabrail Cancer Center Research /ID# 156667 Recruiting
Canton, Ohio, United States, 44718
The Ohio State University /ID# 203348 Not yet recruiting
Columbus, Ohio, United States, 43210-1257
United States, Oregon
Kaiser Permanente, NW /ID# 201793 Not yet recruiting
Portland, Oregon, United States, 97227
United States, Pennsylvania
Thomas Jefferson University /ID# 156719 Recruiting
Philadelphia, Pennsylvania, United States, 19107-4414
VA Pittsburgh HealthcareSystem /ID# 159284 Recruiting
Pittsburgh, Pennsylvania, United States, 15240
United States, Rhode Island
Rhode Island Hospital /ID# 160834 Recruiting
Providence, Rhode Island, United States, 02905
United States, Tennessee
Sarah Cannon Research Institute-Chattanooga /ID# 202933 Not yet recruiting
Chattanooga, Tennessee, United States, 37404-1108
Thompson Cancer Survival Ctr /ID# 202460 Not yet recruiting
Knoxville, Tennessee, United States, 37916
Tennessee Oncology-Sarah Cannon Research Institute /ID# 161168 Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Univ Medical Ctr Brackenridge /ID# 155798 Not yet recruiting
Austin, Texas, United States, 78701
Parkland Health and Hosp Syste /ID# 170933 Not yet recruiting
Dallas, Texas, United States, 75235
UT Southwestern Medical Center /ID# 157848 Not yet recruiting
Dallas, Texas, United States, 75390-7208
The Methodist Hospital /ID# 202323 Not yet recruiting
Houston, Texas, United States, 77030
United States, Washington
Medical Oncology Associates /ID# 156715 Recruiting
Spokane, Washington, United States, 99208
United States, West Virginia
West Virginia Univ School Med /ID# 156687 Not yet recruiting
Morgantown, West Virginia, United States, 26506
Australia, New South Wales
Coffs Harbour Hospital /ID# 158880 Recruiting
Coffs Harbour, New South Wales, Australia, 2450
Gosford Hospital /ID# 158884 Recruiting
Gosford, New South Wales, Australia, 2250
Newcastle Private Hospital /ID# 203506 Not yet recruiting
Lambton Heights, New South Wales, Australia, 2305
Royal North Shore Hospital /ID# 158881 Recruiting
Saint Leonards, New South Wales, Australia, 2065
Australia, South Australia
Calvary North Adelaide Hospita /ID# 161701 Not yet recruiting
Adelaide, South Australia, Australia, 5006
Australia, Victoria
Sunshine Hospital /ID# 161700 Recruiting
St Albans, Victoria, Australia, 3021
Australia
Affinity Clinical Research Ser /ID# 158887 Not yet recruiting
Nedlands, Australia, 6009
Austria
SMZ Baumgartner Höhe, Otto-Wagner-Spital und Pflegezentrum /ID# 201768 Not yet recruiting
Vienna, Wien, Austria, 1140
LKH-Univ. Klinikum Graz /ID# 159563 Recruiting
Graz, Austria, 8036
KH der Elisabethinen Linz GmbH /ID# 159564 Recruiting
Linz, Austria, 4020
Salzburger Landeskliniken (SALK) /ID# 201779 Not yet recruiting
Salzburg, Austria, 5020
Belarus
Bobruysk Interdistrict Onco. /ID# 169393 Recruiting
Bobruisk, Belarus, 213825
Belarus Cancer Center N.N. Alexandrov /ID# 159383 Recruiting
Lesnoy, Belarus, 223040
Mogilev Reg Clin Oncology Dis /ID# 159384 Recruiting
Mogilev, Belarus, 212018
Belgium
CHU Saint-Pierre /ID# 159009 Recruiting
Bruxelles, Bruxelles-Capitale, Belgium, 1000
Grand Hôpital de Charleroi /ID# 159006 Recruiting
Charleroi, Hainaut, Belgium, 6000
ZNA Middelheim /ID# 159007 Recruiting
Antwerp, Belgium, 2020
Hopital de Jolimont /ID# 159005 Not yet recruiting
Haine Saint Paul, Belgium, 7100
CHU Charleroi (Vesale) /ID# 159008 Not yet recruiting
Montigny-le-tilleul, Belgium, 6110
Brazil
Hospital Evangelico de Cachoei /ID# 159657 Not yet recruiting
Cachoeiro DO Itapemirim, Espirito Santo, Brazil, 29308-014
Liga Norte Rio Grandense Cont. /ID# 159011 Not yet recruiting
Natal, Rio Grande Do Norte, Brazil, 59075-740
Associacao Hospital Beneficent /ID# 159661 Not yet recruiting
Passo Fundo, Rio Grande Do Norte, Brazil, 99010
Associação Hospital de Caridade Ijuí - Centro de Tratamento de Cancer - CACON /ID# 159013 Not yet recruiting
Ijuí, Rio Grande Do Sul, Brazil, 98700-000
Hospital Sao Lucas da PUCRS /ID# 159662 Not yet recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 159659 Not yet recruiting
Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15090-000
Inca /Id# 159658 Not yet recruiting
Rio de Janeiro, Brazil, 20231-050
Hospital de Cancer de Barretos /ID# 159012 Not yet recruiting
Sao Paulo, Brazil, 14784-400
Bulgaria
UMHAT Tsaritsa Joanna - ISUL /ID# 159638 Not yet recruiting
Sofia, Bulgaria, 1527
UMHAT Sv. Ivan Rilski /ID# 159639 Not yet recruiting
Sofia, Bulgaria, 1612
SHAT Hematologic Diseases /ID# 161924 Not yet recruiting
Sofia, Bulgaria, 1756
Canada, British Columbia
British Columbia Cancer Agency /ID# 163721 Recruiting
Surrey, British Columbia, Canada, V3V 1Z2
Canada, Ontario
Brampton Civic Hospital /ID# 204425 Not yet recruiting
Brampton, Ontario, Canada, L6R 3J7
Brampton Civic Hospital Not yet recruiting
Brampton, Ontario, Canada, L6R 3J7
R.S. McLaughlin Durham Regional /ID# 170870 Not yet recruiting
Oshawa, Ontario, Canada, L1G 2B9
Princess Margaret /ID# 170868 Not yet recruiting
Toronto, Ontario, Canada, M5G 2M9
Windsor Regional Cancer Centre /ID# 170869 Not yet recruiting
Windsor, Ontario, Canada, N8W 2X3
Canada, Quebec
Iucpq /Id# 159530 Not yet recruiting
Sainte-foy, Quebec, Canada, G1V 4G5
China, Beijing
Peking Union Medical College Hospital /ID# 204025 Not yet recruiting
Beijing, Beijing, China, 100032
China, Fujian
Fujian Provincial Cancer Hospital /ID# 204864 Not yet recruiting
Fuzhou, Fujian, China, 350014
China, Hubei
Hubei Cancer Hospital /ID# 202886 Not yet recruiting
Wuhan, Hubei, China, 430079
China, Hunan
Hunan Cancer Hospital /ID# 202797 Not yet recruiting
Changsha, Hunan, China, 410006
China, Xinjiang
Cancer Center of Xinjiang Medical University /ID# 203641 Not yet recruiting
Urumqi, Xinjiang, China, 830000
China, Yunnan
Yunnan Cancer Hospital /ID# 204911 Not yet recruiting
Kunming, Yunnan, China, 650118
China, Zhejiang
Zhejiang Cancer hospital /ID# 204640 Not yet recruiting
Hangzhou, Zhejiang, China, 310022
China
Beijing Cancer Hospital /ID# 202882 Not yet recruiting
Beijing, China, 100142
Fujian Medical Univ Union Hosp /ID# 204862 Not yet recruiting
Fuzhou, China, 350025
Jiangsu Province Hospital /ID# 205183 Not yet recruiting
Nanjing, China, 210029
4th Military Medical Universit /ID# 203986 Not yet recruiting
Xi'an, China, 710038
1st Aff Hos Xi'an Jiaotong Uni /ID# 203733 Not yet recruiting
Xi'an, China, 710061
Henan Cancer Hospital /ID# 203983 Not yet recruiting
Zhengzhou, Henan, China, 450008
Henan Cancer Hospital /ID# 204636 Not yet recruiting
Zhengzhou, Henan, China, 450008
1st Affiliated Hosp of Zhengzh /ID# 203029 Not yet recruiting
Zhengzhou, China, 450052
Croatia
Klinicki bolnicki centar Sestre milosrdnice /ID# 159090 Not yet recruiting
Zagreb, Grad Zagreb, Croatia, 10000
Klinika za plucne bolesti Jordanovac /ID# 159505 Recruiting
Zagreb, Grad Zagreb, Croatia, 10000
Klinicki bolnicki centar Rijeka /ID# 159504 Recruiting
Rijeka, Primorsko-goranska Zupanija, Croatia, 51000
Czechia
Thomayerova nemocnice /ID# 159062 Recruiting
Prague, Praha 4, Czechia, 140 59
Nemocnice Rudolfa a Stefanie /ID# 159655 Not yet recruiting
Benesov, Czechia, 256 01
Nemocnice Horovice a.s. /ID# 161186 Not yet recruiting
Horovice, Czechia, 268 31
Vitkovicka nemocnice a. s. /ID# 161187 Recruiting
Ostrava, Czechia, 703 84
Oblastni Nemocnice Pribram /ID# 159654 Not yet recruiting
Pribram, Czechia, 262 04
Denmark
Rigshospitalet /ID# 158055 Recruiting
Copenhagen Ø, Hovedstaden, Denmark, 2100
Herlev Hospital /ID# 158053 Recruiting
Herlev, Hovedstaden, Denmark, 2730
Aalborg University Hospital /ID# 203737 Not yet recruiting
Aalborg, Nordjylland, Denmark, 9000
Odense Universitets Hospital /ID# 158054 Recruiting
Odense C, Syddanmark, Denmark, 5000
Estonia
East Tallinn Central Hospital /ID# 160019 Recruiting
Tallinn, Estonia, 10138
North Estonian Medical Centre /ID# 159779 Recruiting
Tallinn, Estonia, 13419
Finland
Docrates Cancer Center /ID# 159591 Not yet recruiting
Helsinki, Finland, 00180
France
CHU Hopital Nord /ID# 160543 Recruiting
Marseille, Bouches-du-Rhone, France, 13915
Hopital Haut-Lévêque /ID# 160547 Not yet recruiting
Pessac CEDEX, Gironde, France, 33604
CHU Calmette /ID# 202706 Not yet recruiting
Lille, Hauts-de-France, France, 59000
Centre Leon Berard /ID# 160550 Recruiting
Lyon CEDEX 08, Rhone, France, 69373
Centre Hosp Intercommunal /ID# 162686 Recruiting
Creteil, France, 94010
Hopital Tenon /ID# 160541 Recruiting
Paris, France, 75970
Hospital Pontchaillou /ID# 160544 Recruiting
Rennes, France, 35033
Nouvel Hopital Civil (NHC) /ID# 204427 Not yet recruiting
Strasbourg, France, 67091
Germany
KH Martha-Maria Halle Dolau /ID# 158794 Recruiting
Halle (Saale), Sachsen-Anhalt, Germany, 06120
Charité Universitätsmedizin Campus Mitte /ID# 158783 Recruiting
Berlin, Germany, 10117
Evangelische Lungenklinik Berl /ID# 158935 Not yet recruiting
Berlin, Germany, 13125
Asklepios Fachkliniken M. Gaut /ID# 158789 Recruiting
Gauting, Germany, 82131
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
Löwenstein, Germany, 74245
Universitatsklinikum Munster /ID# 206072 Not yet recruiting
Muenster, Germany, 48149
Fachkliniken Wangen /ID# 160779 Recruiting
Wangen, Germany, 88239
Greece
IASO General Hospital /ID# 202422 Not yet recruiting
Cholargos, Attiki, Greece, 155 62
Gen Hosp Chest Athens Sotiria /ID# 159160 Recruiting
Athens, Greece, 11527
Metropolitan Hospital /ID# 159157 Recruiting
Athens, Greece, 18547
General UH of Heraklion /ID# 202409 Not yet recruiting
Heraklion, Greece, 71110
University Hospital of Ioannin /ID# 159158 Not yet recruiting
Ioannina, Greece, 45500
General Oncological Hospital /ID# 159159 Not yet recruiting
Nea Kifisia, Greece, 14564
Euromedica General Clinic /ID# 159156 Recruiting
Thessaloniki, Greece, 54645
Hong Kong
Queen Elizabeth Hospital /ID# 159565 Not yet recruiting
Kowloon, Hong Kong, 852
Princess Margaret Hospital /ID# 162810 Not yet recruiting
Lai Chi Kok, Hong Kong, 999077
Tuen Mun Hospital /ID# 162435 Not yet recruiting
Tuen Mun, Hong Kong, 999077
Hungary
CRU Egeszsegugyi es Szolgaltato Kft. /ID# 158962 Not yet recruiting
Miskolc, Borsod-Abauj-Zemplen, Hungary, 3529
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz - Pulmonologia /ID# 202466 Not yet recruiting
Nyiregyhaza, Szabolcs-Szatmar-Bereg, Hungary, 4400
Semmelweis Egyetem /ID# 158955 Recruiting
Budapest, Hungary, 1085
Orszagos Koranyi TBC/Pulmon /ID# 158953 Recruiting
Budapest, Hungary, 1121
Csongrad Megyei Mellkasi Beteg /ID# 158952 Not yet recruiting
Deszk, Hungary, 6772
Ireland
St. James's Hospital /ID# 159712 Not yet recruiting
Dublin 8, Dublin, Ireland, D08 E9P6
Cork University Hospital /ID# 159715 Not yet recruiting
Cork, Ireland, T12 E8YV
St Vincent's University Hosp /ID# 161678 Recruiting
Dublin, Ireland, D04 T6F4
Beaumont Hospital /ID# 159711 Not yet recruiting
Dublin, Ireland, D09 XR63
University Hospital Limerick /ID# 159714 Not yet recruiting
Limerick, Ireland, V94F858
University Hospital Waterford /ID# 159713 Recruiting
Waterford, Ireland, X91 ER8E
Israel
Rabin Medical Center /ID# 159764 Recruiting
Petakh Tikva, Tel-Aviv, Israel, 4941492
Tel Aviv Sourasky Medical Ctr /ID# 161467 Not yet recruiting
Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
Soroka Medical Ctr /ID# 159762 Recruiting
Be'er Sheva, Israel, 84101
Assaf Harofeh Medical Center /ID# 201883 Not yet recruiting
Be'er Ya'akov, Israel, 70300
Rambam Health Care Campus /ID# 202336 Not yet recruiting
Haifa, Israel, 3109601
Hadassah /ID# 159763 Recruiting
Jerusalem, Israel, 91120
Meir Medical Center /ID# 159761 Recruiting
Kfar Saba, Israel, 44281
Sheba Medical Center /ID# 159760 Recruiting
Ramat Gan, Israel, 5262100
Italy
IRST IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori /ID# 160898 Not yet recruiting
Meldola, Emilia-Romagna, Italy, 47014
Policlinico Universitario Campus Bio-Medico /ID# 160874 Recruiting
Rome, Lazio, Italy, 00128
AUSL 8 Arezzo Ospedale San Don /ID# 160897 Not yet recruiting
Arezzo, Italy, 52100
A.O.U. San Luigi Gonzaga /ID# 158916 Recruiting
Orbassano, Italy, 10043
Ospedale Santa Maria delle Cro /ID# 158911 Recruiting
Ravenna, Italy, 48121
IFO Istituto Nazionale Tumori /ID# 158912 Recruiting
Rome, Italy, 00144
Japan
Aichi Cancer Center Hospital /ID# 164976 Recruiting
Nagoya-shi, Aichi, Japan, 464-8681
National Cancer Ctr Hosp East /ID# 165721 Recruiting
Kashiwa-shi, Chiba, Japan, 277-8577
Kyushu University Hospital /ID# 165722 Recruiting
Fukuoka-shi, Fukuoka, Japan, 812-8582
Kurume University Hospital /ID# 164595 Not yet recruiting
Kurume-shi, Fukuoka, Japan, 830-0011
Kanazawa University Hospital /ID# 165127 Not yet recruiting
Kanazawa, Ishikawa, Japan, 920-8641
Yokohama City University Hospital /ID# 165746 Recruiting
Yokohama-shi, Kanagawa, Japan, 2360004
Japanese Red Cross Okayama Hospital /ID# 165157 Not yet recruiting
Okayama-shi, Okayama, Japan, 7008607
Kansai Medical University Hospital /ID# 165054 Recruiting
Hirakata-shi, Osaka, Japan, 573-1191
Kinki University -Osakasayama Campus /ID# 166395 Not yet recruiting
Osakasayama-shi, Osaka, Japan, 589-8511
Shizuoka Cancer Center /ID# 166272 Not yet recruiting
Sunto-gun, Shizuoka, Japan, 411-8777
Tokushima University Hospital /ID# 166105 Not yet recruiting
Tokushima-shi, Tokushima, Japan, 770-8503
National Cancer Center Hospital /ID# 166547 Recruiting
Chuo-ku, Tokyo, Japan, 104-0045
Showa University Hospital /ID# 165575 Recruiting
Shinagawa-ku, Tokyo, Japan
Hyogo Cancer Center /ID# 165138 Not yet recruiting
Akashi, Japan, 673-8558
NHO Himeji Medical Center /ID# 165899 Not yet recruiting
Himeji, Japan, 670-8520
Matsusaka City Hospital /ID# 166156 Recruiting
Matsusaka-shi, MIE, Japan, 515-8544
Osaka City General Hospital /ID# 165714 Recruiting
Osaka, Japan, 534-0021
Hokkaido Cancer Center /ID# 165236 Recruiting
Sapporo, Japan, 003-0804
Sendai Kousei Hospital /ID# 166491 Recruiting
Sendai, Japan, 980-0873
Wakayama Medical University /ID# 165946 Not yet recruiting
Wakayama, Japan, 641-8510
Kanagawa Cardio Resp Center /ID# 165015 Not yet recruiting
Yokohama, Japan, 236-0051
Kanagawa Cancer Center /ID# 165814 Recruiting
Yokohama, Japan, 241-0815
Korea, Republic of
Dong-A University Hospital /ID# 159305 Not yet recruiting
Busan, Busan Gwang Yeogsi, Korea, Republic of, 49201
CHA Bundang Medical center, CHA University /ID# 161281 Recruiting
Seongnam-si, Gyeonggido, Korea, Republic of, 13496
Kyungpook National University Chilgok Hospital /ID# 159301 Recruiting
Daegu, Seoul Teugbyeolsi, Korea, Republic of, 41404
Samsung Medical Center /ID# 159304 Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
Korea University Guro Hospital /ID# 159302 Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 08308
Chungbuk National University /ID# 159300 Not yet recruiting
Cheongju-si, Korea, Republic of, 28644
Severance Hospital /ID# 159297 Not yet recruiting
Seoul, Korea, Republic of, 03722
Asan Medical Center /ID# 159299 Not yet recruiting
Seoul, Korea, Republic of, 05505
Latvia
Pauls Stradins Clinical /ID# 158715 Recruiting
Riga, Latvia, LV-1002
Riga East Clinical University /ID# 158716 Recruiting
Riga, Latvia, LV-1079
Lithuania
Hosp Lithuanian Univ Health Sc /ID# 160016 Recruiting
Kovno, Kaunas, Lithuania, 50009
Klaipeda University Hospital /ID# 160018 Recruiting
Klaipeda, Lithuania, LT-92288
National Cancer Institute /ID# 160017 Recruiting
Vilnius, Lithuania, 08660
Mexico
Instituto Nacional de Cancerol /ID# 160735 Not yet recruiting
Ciudad de México, Ciudad De Mexico, Mexico, 14080
Centro de Invest Clin Chapulte /ID# 160965 Not yet recruiting
Morelia, Michoacan, Mexico, 58260
Health Pharma professional Ser /ID# 160734 Recruiting
Ciudad de México, Mexico, 03810
Netherlands
Meander Medisch Centrum /ID# 159064 Recruiting
Amersfoort, Netherlands, 3813 TZ
Rijnstate Hospital /ID# 159063 Recruiting
Arnhem, Netherlands, 6815 AD
Amphia Ziekenhuis /ID# 159065 Recruiting
Breda, Netherlands, 4818 CK
Catharina ziekenhuis /ID# 158082 Recruiting
Eindhoven, Netherlands, 5623
Maastricht University Med Ctr /ID# 161669 Not yet recruiting
Maastricht, Netherlands, 6229 HX
Jeroen Bosch Ziekenhuis /ID# 158081 Recruiting
S Hertogenbosch, Netherlands, 5223 GZ
Universitair Medisch Centrum U /ID# 158083 Recruiting
Utrecht, Netherlands, 3584 CX
Norway
Akershus universitetssykehus /ID# 201682 Not yet recruiting
Nordbyhagen, Akershus, Norway, 1474
Drammen Sykehus /ID# 159572 Recruiting
Drammen, Buskerud, Norway, 3004
Haukeland University Hospital /ID# 159573 Not yet recruiting
Bergen, Hordaland, Norway, 5021
St. Olavs Hospital /ID# 163110 Recruiting
Trondheim, Sor-Trondelag, Norway, 7006
Radiumhospitalet, OUS /ID# 159574 Recruiting
Oslo, Norway, 0379
Stavanger Universitetssykehus /ID# 159575 Recruiting
Stavanger, Norway, 4011
Poland
Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 159604 Not yet recruiting
Rzeszów, Podkarpackie, Poland, 35-021
Wojewodzki Szpital Specjalisty /ID# 159603 Not yet recruiting
Bytom, Poland, 41- 902
Szpitale Pomorskie Sp. z o.o /ID# 159605 Recruiting
Gdynia, Poland, 81-519
Portugal
Centro Hospitalar Lisboa Norte, EPE /ID# 159957 Not yet recruiting
Lisbon, Lisboa, Portugal, 1769-001
IPO Lisboa FG, EPE /ID# 159949 Recruiting
Lisboa, Portugal, 1099-023
Hospital da Luz, SA /ID# 159954 Not yet recruiting
Lisbon, Portugal, 1500-650
Unidade Local Saude Matosinhos /ID# 159950 Not yet recruiting
Matosinhos, Portugal, 4464-513
Centro Hospitalar do Porto EPE /ID# 203582 Not yet recruiting
Porto, Portugal, 4099-001
Hospital CUF Porto /ID# 159955 Not yet recruiting
Porto, Portugal, 4100-180
IPO Porto FG, EPE /ID# 159956 Not yet recruiting
Porto, Portugal, 4200-072
Russian Federation
National Medical Research Cntr /ID# 169885 Recruiting
Moscow, Moskovskaya Oblast, Russian Federation, 115478
Arkhangelsk clinical oncology /ID# 159367 Recruiting
Arkhangelsk, Russian Federation, 163045
Kaluga Regional Clinical Oncol /ID# 160180 Not yet recruiting
Kaluga, Russian Federation, 284007
Clinical Onco Dispensary /ID# 159365 Recruiting
Omsk, Russian Federation, 644013
PMI Euromedservice /ID# 159369 Recruiting
Pushkin, Russian Federation, 196603
LLC Novaya Clinica /ID# 205523 Not yet recruiting
Pyatigorsk, Russian Federation, 357532
Ogarev Mordovia State Univ /ID# 205742 Not yet recruiting
Saransk, Russian Federation, 430005
Smolensk Regional Onc Clin Dis /ID# 159372 Not yet recruiting
Smolensk, Russian Federation, 214009
LLC BioEq Ltd. /ID# 159368 Recruiting
St. Petersburg, Russian Federation, 197342
N.N. Petrov Research Inst Onc /ID# 159370 Recruiting
St. Petersburg, Russian Federation, 197758
Republican Clin Onc Dispensary /ID# 159371 Not yet recruiting
UFA, Russian Federation, 450054
Serbia
Clinical Center Serbia /ID# 160902 Not yet recruiting
Belgrade, Beograd, Serbia, 11000
Clin Hosp Ctr Bezanijska Kosa /ID# 160903 Not yet recruiting
Belgrade, Beograd, Serbia, 11080
Clinical Center of Nis /ID# 160905 Not yet recruiting
NIS, Nisavski Okrug, Serbia, 18000
Institut za onkologiju i radio /ID# 160904 Recruiting
Belgrade, Serbia, 11000
Institute For Pulmonary Diseas /ID# 164250 Recruiting
Sremska Kamenica, Serbia, 21204
South Africa
Langenhoven Drive Onco Cent /ID# 159126 Recruiting
Port Elizabeth, Eastern Cape, South Africa, 6045
Life Wilgers Hospital /ID# 158873 Recruiting
Pretoria, Gauteng, South Africa, 0040
Mary Potter Oncology Centre /ID# 158877 Not yet recruiting
Pretoria, Gauteng, South Africa, 0181
The Oncology Centre /ID# 158872 Recruiting
Durban, Kwazulu-Natal, South Africa, 4091
Cape Town Oncology Trials /ID# 201311 Not yet recruiting
Cape Town, Western Cape, South Africa, 7570
Cancercare Outeniqua Oncology Unit /ID# 200689 Not yet recruiting
George, Western Cape, South Africa, 6530
Spain
Hospital Regional de Malaga /ID# 164371 Recruiting
Málaga, Malaga, Spain, 29009
Hospital Teresa Herrera /ID# 164368 Recruiting
A Coruna, Spain, 15006
H. Del Mar, Barcelona /ID# 159690 Recruiting
Barcelona, Spain, 08003
Hospital Univ Vall d'Hebron /ID# 159708 Recruiting
Barcelona, Spain, 08035
Fundacion Jimenez Diaz /ID# 159693 Recruiting
Madrid, Spain, 28040
Hospital Clin Univ San Carlos /ID# 159706 Recruiting
Madrid, Spain, 28040
Hospital Universitario La Paz /ID# 159692 Recruiting
Madrid, Spain, 28046
Hosp Clin Univ Lozano Blesa /ID# 159709 Recruiting
Zaragoza, Spain, 50009
Sweden
Centralsjukhuset, Karlstad /ID# 163451 Not yet recruiting
Karlstad, Varmlands Lan, Sweden, 651 85
Sahlgrenska US Gbg /ID# 159524 Not yet recruiting
Göteborg, Vastra Gotalands Lan, Sweden, 413 46
University Hospital Linkoping /ID# 159046 Recruiting
Linkoping, Sweden, 58185
Karolinska Univ Sjukhuset /ID# 159649 Recruiting
Solna, Sweden, 17176
Uppsala University Hospital /ID# 159052 Not yet recruiting
Uppsala, Sweden, 75185
Switzerland
Hopitaux Universitaires de Geneve /ID# 160603 Recruiting
Genève, Geneve, Switzerland, 1205
Kantonsspital St. Gallen /ID# 160604 Recruiting
St. Gallen, Sankt Gallen, Switzerland, 9007
Universitaetsspital Basel /ID# 160605 Recruiting
Basel, Switzerland, 4056
Luzerner Kantonsspital /ID# 160607 Recruiting
Luzern, Switzerland, 6000
Kantonsspital Winterthur /ID# 161379 Recruiting
Winterthur, Switzerland, 8401
Taiwan
China Medical University Hosp /ID# 158981 Not yet recruiting
Taichung City, Taichung, Taiwan, 40447
National Cheng Kung University Hospital /ID# 158799 Recruiting
Tainan City, Tainan, Taiwan, 70403
National Taiwan Univ Hosp /ID# 159049 Recruiting
Taipei City, Taipei, Taiwan, 10002
Tri-Service General Hospital /ID# 158980 Recruiting
Taipei City, Taipei, Taiwan, 11490
Dalin Tzu Chi General Hospital /ID# 158983 Not yet recruiting
Dalin Township, Taiwan, 622
Kaohsiung Medical University /ID# 158798 Recruiting
Kaohsiung, Taiwan, 80708
Taichung Veterans General Hosp /ID# 159047 Recruiting
Taichung City, Taiwan, 40705
Taipei Veterans General Hosp /ID# 203699 Not yet recruiting
Taipei City, Taiwan, 11217
Turkey
Hacettepe University Medical Faculty /ID# 159242 Recruiting
Altindağ, Ankara, Turkey, 06250
Erciyes University Medical Fac /ID# 202269 Not yet recruiting
Melikgazi, Kayseri, Turkey, 38030
Ataturk Gogus Hastalikl /ID# 159556 Recruiting
Ankara, Turkey, 06280
Akdeniz Universitesi Tip Fakul /ID# 160791 Recruiting
Antalya, Turkey, 07059
Bezmi alem Vakif Universitesi /ID# 202267 Not yet recruiting
Istanbul, Turkey, 34093
Istanbul Medeniyet Universites /ID# 200126 Not yet recruiting
Istanbul, Turkey, 34722
Ege University Medical Faculty /ID# 159243 Not yet recruiting
Izmir, Turkey, 35040
Dr. Suat Seren Gogus Has /ID# 159244 Recruiting
Izmir, Turkey, 35110
Inonu University /ID# 159245 Recruiting
Malatya, Turkey, 44280
Ukraine
Chernivetskyi Reg Clin Onc Hos /ID# 159864 Recruiting
Chernivtsi, Ukraine, 58013
Municipal institution Multifie /ID# 159130 Not yet recruiting
Dnipro, Ukraine, 49102
Regional Center of Oncology /ID# 159132 Recruiting
Kharkiv, Ukraine, 61070
Medical and Diagnostic Center /ID# 165543 Not yet recruiting
Kropyvnytskyi, Ukraine, 25006
Treatment and prevention /ID# 159133 Not yet recruiting
Lutsk, Ukraine, 43018
Central Regional Clinical Hos. /ID# 159865 Recruiting
Uzhgorod, Ukraine
Zaporozhye regional clinical /ID# 159131 Not yet recruiting
Zaporozhye, Ukraine, 69040
United Kingdom
Cheltenham General Hospital /ID# 169096 Not yet recruiting
Cheltenham, Gloucestershire, United Kingdom, GL53 7AN
Queen Elizabeth Medical Centre /ID# 162899 Recruiting
Birmingham, United Kingdom, B15 2TH
The Royal Bournemouth Hospital /ID# 159039 Recruiting
Bournemouth, United Kingdom, BH7 7DW
Colchester General Hospital /ID# 159042 Recruiting
Colchester, United Kingdom, CO4 5JL
Hereford County Hospital /ID# 159038 Recruiting
Hereford, United Kingdom, HR1 2ER
St. George's Healthcare NHS /ID# 202416 Not yet recruiting
London, United Kingdom, SW17 0QT
Charing Cross Hospital /ID# 161399 Recruiting
London, United Kingdom, W6 8RF
Maidstone Hospital /ID# 159043 Recruiting
Maidstone, United Kingdom, ME16 9QQ
Christie NHS Foundation Trust /ID# 159037 Recruiting
Manchester, United Kingdom, M20 4BX
Freeman Hospital /ID# 159044 Recruiting
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Torbay Hospital - So Devon HC /ID# 159041 Recruiting
Torquay, United Kingdom, TQ2 7AA
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

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: August 1, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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
(SCLC)

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