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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 : June 18, 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

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 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Rovalpituzumab tesirine/ dexamethasone
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

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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

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United States, Alabama
Clearview Cancer Institute Recruiting
Huntsville, Alabama, United States, 35805
University of South Alabama Recruiting
Mobile, Alabama, United States, 36604-3302
United States, Arkansas
Highlands Oncology Group Recruiting
Fayetteville, Arkansas, United States, 72703-4005
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UCSD Recruiting
La Jolla, California, United States, 92037
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Loma Linda, California, United States, 92354
LA Hem-Oncology Med Group Not yet recruiting
Los Angeles, California, United States, 90017
Palo Alto Veterans Institute for Research Not yet recruiting
Palo Alto, California, United States, 94304-1207
St Jude Hospital dba St Joseph Recruiting
Santa Rosa, California, United States, 95403
ICRI Recruiting
Whittier, California, United States, 90603
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Kaiser Permanente Lone Tree Not yet recruiting
Lone Tree, Colorado, United States, 80124
United States, Delaware
Christiana Care Health Service Recruiting
Newark, Delaware, United States, 19713
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Holy Cross Hospital Recruiting
Fort Lauderdale, Florida, United States, 33308
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Memorial Cancer Institute Not yet recruiting
Hollywood, Florida, United States, 33021-5421
Cancer Specialists Recruiting
Jacksonville, Florida, United States, 32256
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Georgia Cancer Center Not yet recruiting
Atlanta, Georgia, United States, 30060
Southeastern Regional Medical Recruiting
Newnan, Georgia, United States, 30265
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St. Luke's Mountain States Tumor Institute Not yet recruiting
Boise, Idaho, United States, 83712-6267
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Northwestern University Not yet recruiting
Chicago, Illinois, United States, 60611-2927
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Evanston, Illinois, United States, 60201
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Harvey, Illinois, United States, 60426
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Goshen Center for Cancer Care Recruiting
Goshen, Indiana, United States, 46526
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Ashland-Bellefonte Cancer Ctr Not yet recruiting
Ashland, Kentucky, United States, 41101
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Louisville, Kentucky, United States, 40202
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New Orleans, Louisiana, United States, 70121
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Detroit, Michigan, United States, 48202
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Rochester, Minnesota, United States, 55905-0001
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Kansas City, Missouri, United States, 64132
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New York, New York, United States, 10029
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Stony Brook, New York, United States, 11794-8183
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Canton, Ohio, United States, 44718
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Coffs Harbour, New South Wales, Australia, 2450
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Rijeka, Primorsko-goranska Zupanija, Croatia, 51000
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Thomayerova nemocnice Recruiting
Prague, Praha 4, Czechia, 140 59
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Benesov, Czechia, 256 01
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Horovice, Czechia, 268 31
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Ostrava, Czechia, 703 84
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Pribram, Czechia, 262 04
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Copenhagen Ø, Hovedstaden, Denmark, 2100
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Herlev, Hovedstaden, Denmark, 2730
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Aalborg, Nordjylland, Denmark, 9000
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Odense C, Syddanmark, Denmark, 5000
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East Tallinn Central Hospital Recruiting
Tallinn, Estonia, 10138
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Tallinn, Estonia, 13419
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Docrates Cancer Center Not yet recruiting
Helsinki, Finland, 00180
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Marseille, Bouches-du-Rhone, France, 13915
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Pessac CEDEX, Gironde, France, 33604
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Strasbourg, Grand Est, France, 67091
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Lille, Hauts-de-France, France, 59000
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Lyon CEDEX 08, Rhone, France, 69373
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Creteil, France, 94010
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Paris, France, 75970
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Rennes, France, 35033
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Halle (Saale), Sachsen-Anhalt, Germany, 06120
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Berlin, Germany, 10117
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Berlin, Germany, 13125
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Gauting, Germany, 82131
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Heidelberg, Germany, 69126
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Hemer, Germany, 58675
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Kassel, Germany, 34125
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Löwenstein, Germany, 74245
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Wangen, Germany, 88239
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Cholargos, Attiki, Greece, 155 62
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Athens, Greece, 11527
Metropolitan Hospital Recruiting
Athens, Greece, 18547
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Heraklion, Greece, 71110
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
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Kowloon, Hong Kong, 852
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Lai Chi Kok, Hong Kong, 999077
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Tuen Mun, Hong Kong, 999077
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CRU Egeszsegugyi es Szolgaltato Kft. Not yet recruiting
Miskolc, Borsod-Abauj-Zemplen, Hungary, 3529
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Nyiregyhaza, Szabolcs-Szatmar-Bereg, Hungary, 4400
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Budapest, Hungary, 1085
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Budapest, Hungary, 1121
Csongrad Megyei Mellkasi Beteg Not yet recruiting
Deszk, Hungary, 6772
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St. James's Hospital Not yet recruiting
Dublin 8, Dublin, Ireland, D08 E9P6
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Cork, Ireland, T12 E8YV
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Dublin, Ireland, D04 T6F4
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Dublin, Ireland, D09 XR63
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Limerick, Ireland, V94F858
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Waterford, Ireland, X91 ER8E
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Rabin Medical Center Recruiting
Petakh Tikva, Tel-Aviv, Israel, 4941492
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Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
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Be'er Sheva, Israel, 84101
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Be'er Ya'akov, Israel, 70300
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Haifa, Israel, 3109601
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Jerusalem, Israel, 91120
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Kfar Saba, Israel, 44281
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Ramat Gan, Israel, 5262100
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IRST IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Not yet recruiting
Meldola, Emilia-Romagna, Italy, 47014
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Rome, Lazio, Italy, 00128
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Arezzo, Italy, 52100
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Orbassano, Italy, 10043
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Ravenna, Italy, 48121
IFO Istituto Nazionale Tumori Recruiting
Rome, Italy, 00144
Japan
Aichi Cancer Center Hospital Recruiting
Nagoya-shi, Aichi, Japan, 464-8681
National Cancer Ctr Hosp East Recruiting
Kashiwa-shi, Chiba, Japan, 277-8577
Kyushu University Hospital Recruiting
Fukuoka-shi, Fukuoka, Japan, 812-8582
Kurume University Hospital Not yet recruiting
Kurume-shi, Fukuoka, Japan, 830-0011
Kanazawa University Hospital Not yet recruiting
Kanazawa, Ishikawa, Japan, 920-8641
Yokohama City University Hospital Recruiting
Yokohama-shi, Kanagawa, Japan, 2360004
Japanese Red Cross Okayama Hospital Not yet recruiting
岡山市, Okayama, Japan, 〒700-0941
Kansai Medical University Hospital Recruiting
Hirakata-shi, Osaka, Japan, 573-1191
Kindai University Hospital Not yet recruiting
Osakasayama-shi, Osaka, Japan, 589-8511
Shizuoka Cancer Center Not yet recruiting
Sunto-gun, Shizuoka, Japan, 411-8777
Tokushima University Hospital Not yet recruiting
Tokushima-shi, Tokushima, Japan, 770-8503
National Cancer Center Hosp Recruiting
Chuo-ku, Tokyo, Japan, 104-0045
The Cancer Institute Hosp JFCR Not yet recruiting
Koto-ku, Tokyo, Japan, 135-8550
Showa University Hospital Recruiting
Shinagawa-ku, Tokyo, Japan
Hyogo Cancer Center Not yet recruiting
Akashi, Japan, 673-8558
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Himeji, Japan, 670-8520
Matsusaka City Hospital Recruiting
Matsusaka-shi, MIE, Japan, 515-8544
Osaka City General Hospital Recruiting
Osaka, Japan, 534-0021
Hokkaido Cancer Center Recruiting
Sapporo, Japan, 003-0804
Sendai Kousei Hospital Recruiting
Sendai, Japan, 980-0873
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Wakayama, Japan, 641-8510
Kanagawa Cardio Resp Center Not yet recruiting
Yokohama, Japan, 236-0051
Kanagawa Cancer Center Recruiting
Yokohama, Japan, 241-0815
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Dong-A University Hospital Not yet recruiting
Busan, Busan Gwang Yeogsi, Korea, Republic of, 49201
CHA Bundang Medical center, CHA University Recruiting
Seongnam-si, Gyeonggido, Korea, Republic of, 13496
Kyungpook National University Chilgok Hospital Recruiting
Daegu, Seoul Teugbyeolsi, Korea, Republic of, 41404
Asan Medical Center Not yet recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05505
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Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
Korea University Guro Hospital Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 08308
Chungbuk National University Not yet recruiting
Cheongju-si, Korea, Republic of, 28644
Severance Hospital Not yet recruiting
Seoul, Korea, Republic of, 03722
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Pauls Stradins Clinical Recruiting
Riga, Latvia, LV-1002
Riga East Clinical University Recruiting
Riga, Latvia, LV-1079
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Hosp Lithuanian Univ Health Sc Recruiting
Kovno, Kaunas, Lithuania, 50009
Klaipeda University Hospital Recruiting
Klaipeda, Lithuania, LT-92288
National Cancer Institute Recruiting
Vilnius, Lithuania, 08660
Mexico
Instituto Nacional de Cancerol Not yet recruiting
Ciudad de México, Ciudad De Mexico, Mexico, 14080
Centro de Invest Clin Chapulte Not yet recruiting
Morelia, Michoacan, Mexico, 58260
Health Pharma professional Ser Not yet recruiting
Ciudad de México, Mexico, 03810
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 Recruiting
Eindhoven, Netherlands, 5623
Maastricht University Med Ctr Not yet recruiting
Maastricht, Netherlands, 6229 HX
Jeroen Bosch Ziekenhuis Recruiting
S Hertogenbosch, Netherlands, 5223 GZ
Universitair Medisch Centrum U Recruiting
Utrecht, Netherlands, 3584 CX
Norway
Akershus universitetssykehus Not yet recruiting
Nordbyhagen, Akershus, Norway, 1474
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Drammen, Buskerud, Norway, 3004
Haukeland University Hospital Not yet recruiting
Bergen, Hordaland, Norway, 5021
St. Olavs Hospital Recruiting
Trondheim, Sor-Trondelag, Norway, 7006
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Oslo, Norway, 0379
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Stavanger, Norway, 4011
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Wojewodzki Szpital Specjalisty Not yet recruiting
Bytom, Poland, 41- 902
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Gdynia, Poland, 81-519
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Rzeszow, Poland, 35-922
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Centro Hospitalar Lisboa Norte, EPE Not yet recruiting
Lisbon, Lisboa, Portugal, 1769-001
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Lisboa, Portugal, 1099-023
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Lisbon, Portugal, 1500-650
Unidade Local Saude Matosinhos Not yet recruiting
Matosinhos, Portugal, 4464-513
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Porto, Portugal, 4099-003
Hospital CUF Porto Not yet recruiting
Porto, Portugal, 4100-180
IPO Porto FG, EPE Not yet recruiting
Porto, Portugal, 4200-072
Russian Federation
National Medical Research Cntr Recruiting
Moscow, Moskovskaya Oblast, Russian Federation, 115478
Arkhangelsk clinical oncology Recruiting
Arkhangelsk, Russian Federation, 163045
Kaluga Regional Clinical Oncol Not yet recruiting
Kaluga, Russian Federation, 284007
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
LLC Novaya Clinica Not yet recruiting
Pyatigorsk, Russian Federation, 357532
Ogarev Mordovia State Univ Not yet recruiting
Saransk, Russian Federation, 430005
Smolensk Regional Onc Clin Dis Not yet 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, Beograd, Serbia, 11000
Clin Hosp Ctr Bezanijska Kosa Not yet recruiting
Belgrade, Beograd, Serbia, 11080
Clinical Center of Nis Not yet recruiting
NIS, Nisavski Okrug, Serbia, 18000
Institut za onkologiju i radio Recruiting
Belgrade, Serbia, 11000
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 Not yet recruiting
Pretoria, Gauteng, South Africa, 0181
The Oncology Centre Not yet recruiting
Durban, Kwazulu-Natal, South Africa, 4091
Cape Town Oncology Trials Not yet recruiting
Cape Town, Western Cape, South Africa, 7570
Cancercare Outeniqua Oncology Unit Not yet recruiting
George, Western Cape, South Africa, 6530
Spain
Hospital Regional de Malaga Recruiting
Málaga, Malaga, Spain, 29009
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
Hosp Clin Univ Lozano Blesa Recruiting
Zaragoza, Spain, 50009
Sweden
Centralsjukhuset, Karlstad Not yet recruiting
Karlstad, Varmlands Lan, Sweden, 651 85
Sahlgrenska US Gbg Not yet recruiting
Göteborg, Vastra Gotalands Lan, Sweden, 413 46
University Hospital Linkoping Recruiting
Linkoping, Sweden, 58185
Karolinska Univ Sjukhuset Recruiting
Solna, Sweden, 17176
Uppsala University Hospital Not yet recruiting
Uppsala, Sweden, 75185
Switzerland
Hopitaux Universitaires de Geneve Recruiting
Genève, Geneve, Switzerland, 1205
Kantonsspital St. Gallen Recruiting
St. Gallen, Sankt Gallen, Switzerland, 9007
Universitaetsspital Basel Recruiting
Basel, Switzerland, 4056
Luzerner Kantonsspital Recruiting
Luzern, Switzerland, 6000
Kantonsspital Winterthur Recruiting
Winterthur, Switzerland, 8401
Taiwan
China Medical University Hosp Not yet recruiting
Taichung City, Taichung, Taiwan, 40447
National Cheng Kung University Hospital Recruiting
Tainan City, Tainan, Taiwan, 70403
National Taiwan Univ Hosp Recruiting
Taipei City, Taipei, Taiwan, 10002
Tri-Service General Hospital Recruiting
Taipei City, Taipei, Taiwan, 11490
Dalin Tzu Chi General Hospital Not yet recruiting
Dalin Township, Taiwan, 622
Kaohsiung Medical University Recruiting
Kaohsiung, Taiwan, 80708
Taichung Veterans General Hosp Recruiting
Taichung City, Taiwan, 40705
Taipei Veterans General Hosp Not yet recruiting
Taipei City, Taiwan, 11217
Turkey
Hacettepe University Medical Faculty Recruiting
Altindağ, Ankara, Turkey, 06250
Erciyes University Medical Fac Not yet recruiting
Melikgazi, Kayseri, Turkey, 38030
Ataturk Gogus Hastalikl Recruiting
Ankara, Turkey, 06280
Akdeniz Universitesi Tip Fakul Recruiting
Antalya, Turkey, 07059
Bezmi alem Vakif Universitesi Not yet recruiting
Istanbul, Turkey, 34093
Istanbul Medeniyet Universites Not yet recruiting
Istanbul, Turkey, 34722
Ege University Medical Faculty Not yet 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 Recruiting
Chernivtsi, Ukraine, 58013
Municipal institution Multifie Not yet recruiting
Dnipro, Ukraine, 49102
Regional Center of Oncology Recruiting
Kharkiv, Ukraine, 61070
Medical and Diagnostic Center Not yet recruiting
Kropyvnytskyi, Ukraine, 25006
Treatment and prevention Not yet recruiting
Lutsk, Ukraine, 43018
Central Regional Clinical Hos. Recruiting
Uzhgorod, Ukraine
Zaporozhye regional clinical Not yet recruiting
Zaporozhye, Ukraine, 69040
United Kingdom
Cheltenham General Hospital Not yet recruiting
Cheltenham, Gloucestershire, United Kingdom, GL53 7AN
Queen Elizabeth Medical Centre Recruiting
Birmingham, United Kingdom, B15 2TH
The Royal Bournemouth Hospital Recruiting
Bournemouth, United Kingdom, BH7 7DW
Colchester General Hospital Recruiting
Colchester, United Kingdom, CO4 5JL
Hereford County Hospital Recruiting
Hereford, United Kingdom, HR1 2ER
St. George's Healthcare NHS Not yet recruiting
London, United Kingdom, SW17 0QT
Charing Cross Hospital Recruiting
London, United Kingdom, W6 8RF
Maidstone Hospital 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

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: June 18, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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