AzTrials
AzTrials

Small Cell Lung CancerPhase 3MERUNCT03033511

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

A Phase 3 study testing Rovalpituzumab tesirine and Dexamethasone in people with Small Cell Lung Cancer, run by AbbVie at 308 sites in 41 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
Rovalpituzumab tesirine and Dexamethasone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
748 participants
Where
308 sitesin 41 countries
Study dates
7 Feb 2017to 20 Nov 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed extensive-stage disease small cell lung cancer (ED SCLC) at initial diagnosis with ongoing clinical benefit (stable disease [SD], partial response [PR], or complete response [CR]) following completion of 4 cycles of first-line platinum-based therapy
  • Participant is eligible to be randomized at least 3 but no more than 9 weeks from Day 1 of the fourth cycle of first-line platinum-based chemotherapy.
  • Participants with a history of central nervous system (CNS) metastases prior to the initiation of first-line platinum-based chemotherapy must have received definitive local treatment and have documentation of stable or improved CNS disease status
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
  • Participants must have adequate bone marrow, renal and hepatic function
  • Availability of archived or representative tumor material for assessment of DLL3 expression

Who cannot join

  • Any prior systemic chemotherapy, small molecule inhibitors, immune checkpoint inhibitors, other monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, T-cell or other cell-based or biologic therapies, or any other anti-cancer therapy than that described in inclusion criteria for SCLC.
  • Any disease-directed radiotherapy (except prophylactic cranial irradiation, palliative radiotherapy to a radiographically documented non-progressing lesion for symptom control, or pre-planned radiotherapy for CNS metastases present prior to start of first-line therapy and non-progressing) after last dose of first-line chemotherapy.
  • Prior exposure to a pyrrolobenzodiazepine (PBD-based) or indolinobenzodiazepine-based drug, prior participation in a rovalpituzumab tesirine clinical trial, or known hypersensitivity or other contraindications to rovalpituzumab tesirine or excipient contained in the drug formulation.

Trial locations and contacts

308 sites in 41 countries.

308 sites in 41 countries

United States54 sites

  • Ashland-Bellefonte Cancer Ctr /ID# 202901

    Ashland, Kentucky, 41101

  • Georgia Cancer Center /ID# 201894

    Atlanta, Georgia, 30342

  • Univ Medical Ctr Brackenridge /ID# 155798

    Austin, Texas, 78701

  • Ochsner Clinic Foundation /ID# 159136

    Baton Rouge, Louisiana, 70836-6455

  • Billings Clinic /ID# 201788

    Billings, Montana, 59101-0733

  • St. Luke's Mountain States Tumor Institute - Boise /ID# 156691

    Boise, Idaho, 83712

  • MD Anderson Cancer Center at Cooper - Camden /ID# 156681

    Camden, New Jersey, 08103

  • Gabrail Cancer Center Research /ID# 156667

    Canton, Ohio, 44718

  • Sarah Cannon Research Institute-Chattanooga /ID# 202933

    Chattanooga, Tennessee, 37404-1108

  • Parkland Health and Hosp Syste /ID# 170933

    Dallas, Texas, 75235

  • UT Southwestern Medical Center /ID# 157848

    Dallas, Texas, 75390-7208

  • Henry Ford Health System /ID# 156712

    Detroit, Michigan, 48202

  • Duke University Medical Center /ID# 156706

    Durham, North Carolina, 27710-3000

  • NorthShore University HealthSystem - Evanston Hospital /ID# 156664

    Evanston, Illinois, 60201

  • Highlands Oncology Group /ID# 156722

    Fayetteville, Arkansas, 72703-4005

  • Holy Cross Hospital /ID# 156716

    Fort Lauderdale, Florida, 33308

  • University of Florida - Archer /ID# 155799

    Gainesville, Florida, 32610

  • Goshen Center for Cancer Care /ID# 156682

    Goshen, Indiana, 46526

  • Marin Cancer Care /ID# 159207

    Greenbrae, California, 94904

  • Cone Health /ID# 156689

    Greensboro, North Carolina, 27403

  • Cone Health /ID# 163612

    Greensboro, North Carolina, 27403

  • Eastern Carolina University /ID# 159264

    Greenville, North Carolina, 27834

  • Ingalls Memorial Hosp /ID# 156685

    Harvey, Illinois, 60426

  • Memorial Cancer Institute /ID# 156673

    Hollywood, Florida, 33021-5421

  • Memorial Cancer Institute /ID# 164052

    Hollywood, Florida, 33021-5421

  • Houston Methodist Hospital - Scurlock Tower /ID# 202323

    Houston, Texas, 77030

  • Clearview Cancer Institute /ID# 156699

    Huntsville, Alabama, 35805

  • Cancer Specialists of North Florida - Southpoint /ID# 156595

    Jacksonville, Florida, 32256

  • MidAmerica Division, Inc. /ID# 163530

    Kansas City, Missouri, 64132

  • Thompson Cancer Survival Ctr /ID# 202460

    Knoxville, Tennessee, 37916

  • Ucsd /Id# 157764

    La Jolla, California, 92093

  • Northwell Health - Monter Cancer Center /ID# 159252

    Lake Success, New York, 11042

  • Sparrow Regional Cancer Center, Sparrow Health System /ID# 156590

    Lansing, Michigan, 48912

  • Nebraska Hematology Oncology /ID# 156534

    Lincoln, Nebraska, 68506

  • Kaiser Permanente Lone Tree /ID# 159331

    Lone Tree, Colorado, 80124

  • LA Hem-Oncology Med Group /ID# 156717

    Los Angeles, California, 90017

  • University of Louisville /ID# 156683

    Louisville, Kentucky, 40202

  • University of South Alabama /ID# 160975

    Mobile, Alabama, 36604-3302

  • West Virginia Univ School Med /ID# 156687

    Morgantown, West Virginia, 26506

  • Tennessee Oncology-Nashville Centennial /ID# 161168

    Nashville, Tennessee, 37203-1632

  • Icahn School of Med Mt. Sinai /ID# 159210

    New York, New York, 10029

  • Christiana Care Health Service /ID# 159212

    Newark, Delaware, 19713

  • Southeastern Regional Medical /ID# 163064

    Newnan, Georgia, 30265

  • Palo Alto Veterans Institute for Research /ID# 203695

    Palo Alto, California, 94304-1207

  • Thomas Jefferson University /ID# 156719

    Philadelphia, Pennsylvania, 19107-4414

  • VA Pittsburgh HealthcareSystem /ID# 159284

    Pittsburgh, Pennsylvania, 15240

  • Kaiser Permanente, NW /ID# 201793

    Portland, Oregon, 97227

  • Rhode Island Hospital /ID# 160834

    Providence, Rhode Island, 02903

  • Mayo Clinic - Rochester /ID# 160181

    Rochester, Minnesota, 55905-0001

  • St Jude Hospital dba St Joseph /ID# 156526

    Santa Rosa, California, 95403

  • Medical Oncology Associates /ID# 156715

    Spokane, Washington, 99208

  • Stony Brook University Hospital /ID# 159272

    Stony Brook, New York, 11794-8183

  • Montefiore Medical Center /ID# 201845

    The Bronx, New York, 10461

  • Icri /Id# 157765

    Whittier, California, 90603

Other trials in United States

Japan22 sites

  • Hyogo Cancer Center /ID# 165138

    Akashi, 673-8558

  • National Cancer Center Hospital /ID# 166547

    Chuo-ku, Tokyo, 104-0045

  • Kyushu University Hospital /ID# 165722

    Fukuoka, Fukuoka, 812-8582

  • National Hospital Organization Himeji Medical Center /ID# 165899

    Himeji, 670-8520

  • Kansai Medical University Hospital /ID# 165054

    Hirakata-shi, Osaka, 573-1191

  • Kanazawa University Hospital /ID# 165127

    Kanazawa, Ishikawa-ken, 920-8641

  • National Cancer Center Hospital East /ID# 165721

    Kashiwa-shi, Chiba, 277-8577

  • Kurume University Hospital /ID# 164595

    Kurume-shi, Fukuoka, 830-0011

  • Matsusaka City Hospital /ID# 166156

    Matsusaka-shi MIE, 515-8544

  • Aichi Cancer Center Hospital /ID# 164976

    Nagoya, Aichi-ken, 464-8681

  • Japanese Red Cross Okayama Hospital /ID# 165157

    Okayama, Okayama-ken, 7008607

  • Osaka City General Hospital /ID# 165714

    Osaka, 534-0021

  • Kindai University Hospital /ID# 166395

    Osaka-sayama-shi, Osaka, 589-8511

  • Hokkaido Cancer Center /ID# 165236

    Sapporo, 003-0804

  • Sendai Kousei Hospital /ID# 166491

    Sendai, 980-0873

  • Showa University Hospital /ID# 165575

    Shinagawa-ku, Tokyo

  • Shizuoka Cancer Center /ID# 166272

    Sunto-gun, Shizuoka, 411-8777

  • Tokushima University Hospital /ID# 166105

    Tokushima, Tokushima, 770-8503

  • Wakayama Medical University /ID# 165946

    Wakayama, Wakayama, 641-8510

  • Kanagawa Cardiovascular and Respiratory Center /ID# 165015

    Yokohama, Kanagawa, 236-0051

  • Yokohama City University Hospital /ID# 165746

    Yokohama, Kanagawa, 2360004

  • Kanagawa Cancer Center /ID# 165814

    Yokohama, 241-0815

Other trials in Japan

China13 sites

  • Jilin Cancer Hosptial /ID# 204060

    Changchun, Jilin, 130000

  • Fujian Provincial Cancer Hospital /ID# 204864

    Fuzhou, Fujian, 350014

  • Zhejiang Cancer hospital /ID# 204640

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital /Id# 203638

    Harbin, Heilongjiang, 150081

  • Sir Run Run Shaw Hospital /ID# 206802

    Jianggan Hangzhou, Zhejiang, 310018

  • Yunnan Cancer Hospital /ID# 204911

    Kunming, Yunnan, 650118

  • Jiangsu Province Hospital /ID# 205183

    Nanjing, 210029

  • The Affiliated Cancer Hospital of Xinjiang Medical university /ID# 203641

    Ürümqi, Xinjiang, 830000

  • Hubei Cancer Hospital /ID# 202886

    Wuhan, Hubei, 430079

  • 4th Military Medical Universit /ID# 203986

    Xi'an, 710038

  • First Affiliated Hospital of Xi'an Jiaotong University /ID# 203733

    Xi'an, 710061

  • Henan Cancer Hospital /ID# 203983

    Zhengzhou Henan, 450008

  • Henan Cancer Hospital /ID# 204636

    Zhengzhou Henan, 450008

Other trials in China

Russia11 sites

  • Arkhangelsk clinical oncology /ID# 159367

    Arkhangelsk, 163045

  • Kaluga Regional Clinical Oncol /ID# 160180

    Kaluga, 284007

  • National Medical Research Cntr /ID# 169885

    Moscow, Moscow Oblast, 115478

  • Clinical Onco Dispensary /ID# 159365

    Omsk, 644013

  • PMI Euromedservice /ID# 159369

    Pushkin, 196603

  • LLC Novaya Clinica /ID# 205523

    Pyatigorsk, 357532

  • LLC BioEq Ltd. /ID# 159368

    Saint Petersburg, 197342

  • OOO Centre of Palliative Medicine De Vita /ID# 206855

    Saint Petersburg, 197343

  • N.N. Petrov Research Inst Onc /ID# 159370

    Saint Petersburg, 197758

  • Ogarev Mordovia State Univ /ID# 205742

    Saransk, 430005

  • Smolensk Regional Onc Clin Dis /ID# 159372

    Smolensk, 214009

Other trials in Russia

United Kingdom11 sites

  • Queen Elizabeth Medical Centre /ID# 162899

    Birmingham, B15 2TH

  • The Royal Bournemouth Hospital /ID# 159039

    Bournemouth, BH7 7DW

  • Cheltenham General Hospital /ID# 169096

    Cheltenham, Gloucestershire, GL53 7AN

  • Colchester General Hospital /ID# 159042

    Colchester, CO4 5JL

  • Hereford County Hospital /ID# 159038

    Hereford, HR1 2ER

  • St. George's Healthcare NHS /ID# 202416

    London, SW17 0QT

  • Charing Cross Hospital /ID# 161399

    London, W6 8RF

  • Maidstone Hospital /ID# 159043

    Maidstone, ME16 9QQ

  • Christie NHS Foundation Trust /ID# 159037

    Manchester, M20 4BX

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 159044

    Newcastle upon Tyne, NE7 7DN

  • Torbay Hospital - So Devon HC /ID# 159041

    Torquay, TQ2 7AA

Other trials in United Kingdom

France10 sites

  • Centre Hosp Intercommunal de Creteil /ID# 162686

    Créteil, Val-de-Marne, 94000

  • CHU Calmette /ID# 202706

    Lille, Hauts-de-France, 59000

  • Centre Leon Berard /ID# 160550

    Lyon, Rhone, 69373

  • CHU Hopital Nord /ID# 160543

    Marseille, Bouches-du-Rhone, 13915

  • Hopital Tenon /ID# 160541

    Paris, 75970

  • Institut Curie /ID# 207514

    Paris, Île-de-France Region, 75248

  • Hopital Haut-Lévêque /ID# 160547

    Pessac, Gironde, 33604

  • Hospital Pontchaillou /ID# 160544

    Rennes, 35033

  • Nouvel Hopital Civil (NHC) /ID# 204427

    Strasbourg, 67091

  • Hopital Larrey /ID# 204290

    Toulouse, 31059

Other trials in France

Germany9 sites

  • Charite Universitatsmedizin Berlin Campus Virchow Klinikum /ID# 158783

    Berlin, 10117

  • Evangelische Lungenklinik Berl /ID# 158935

    Berlin, 13125

  • Asklepios Fachkliniken M. Gaut /ID# 158789

    Gauting, 82131

  • KH Martha-Maria Halle Dolau /ID# 158794

    Halle, Saxony-Anhalt, 06120

  • Thoraxklinik Heidelberg gGmbH /ID# 158871

    Heidelberg, 69126

  • Lungenklinik Hemer /ID# 158790

    Hemer, 58675

  • Klinikum Kassel /ID# 158786

    Kassel, 34125

  • Klinik Loewenstein GmbH /ID# 158870

    Löwenstein, 74245

  • Fachkliniken Wangen /ID# 160779

    Wangen, 88239

Other trials in Germany

Turkey (Türkiye)9 sites

  • Hacettepe University Medical Faculty /ID# 159242

    Altindağ, Ankara, 06250

  • Ataturk Gogus Hastalikl /ID# 159556

    Ankara, 06280

  • Akdeniz Universitesi Tip Fakul /ID# 160791

    Antalya, 07059

  • Bezmi alem Vakif Universitesi /ID# 202267

    Istanbul, 34093

  • Istanbul Medeniyet Universites /ID# 200126

    Istanbul, 34722

  • Ege University Medical Faculty /ID# 159243

    Izmir, 35040

  • Dr. Suat Seren Gogus Has /ID# 159244

    Izmir, 35110

  • Inonu University /ID# 159245

    Malatya, 44280

  • Erciyes University Medical Fac /ID# 202269

    Melikgazi, Kayseri, 38030

Other trials in Turkey (Türkiye)

Brazil8 sites

  • Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 159012

    Barretos, São Paulo, 14784-400

  • Hospital Evangelico de Cachoei /ID# 159657

    Cachoeiro de Itapemirim, Espírito Santo, 29308-020

  • Associação Hospital de Caridade Ijuí - Centro de Tratamento de Cancer - CACON /ID# 159013

    Ijuí, Rio Grande do Sul, 98700-000

  • Liga Norte Rio Grandense Cont. /ID# 159011

    Natal, Rio Grande do Norte, 59075-740

  • Associação Hospital Beneficente São Vicente de Paulo - Hospital São Vicente de P /ID# 159661

    Passo Fundo, Rio Grande do Sul, 99010-080

  • Hospital Sao Lucas da PUCRS /ID# 159662

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 159658

    Rio de Janeiro, 20231-050

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 159659

    São José do Rio Preto, São Paulo, 15090-000

Other trials in Brazil

Israel8 sites

  • Assaf Harofeh Medical Center /ID# 201883

    Be’er Ya‘aqov, 70300

  • Soroka University Medical Center /ID# 159762

    Beersheba, 84101

  • Rambam Health Care Campus /ID# 202336

    Haifa, 3109601

  • Hadassah /ID# 159763

    Jerusalem, 91120

  • Meir Medical Center /ID# 159761

    Kfar Saba, 4428164

  • Rabin Medical Center /ID# 159764

    Petakh Tikva, Tel Aviv, 4941492

  • Sheba Medical Center /ID# 159760

    Ramat Gan, 5239424

  • Tel Aviv Sourasky Medical Center /ID# 161467

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

South Korea8 sites

  • Dong-A University Hospital /ID# 159305

    Busan, Busan Gwang Yeogsi, 49201

  • Chungbuk National University /ID# 159300

    Cheongju-si, 28644

  • Kyungpook National University Chilgok Hospital /ID# 159301

    Daegu, Seoul Teugbyeolsi, 41404

  • CHA Bundang Medical center CHA University /ID# 161281

    Seongnam-si, Gyeonggido, 13496

  • Samsung Medical Center /ID# 159304

    Seoul, Seoul Teugbyeolsi, 06351

  • Korea University Guro Hospital /ID# 159302

    Seoul, Seoul Teugbyeolsi, 08308

  • Severance Hospital /ID# 159297

    Seoul, 03722

  • Asan Medical Center /ID# 159299

    Seoul, 05505

Other trials in South Korea

Spain8 sites

  • Hospital Teresa Herrera - CHUAC /ID# 164368

    A Coruña, A Coruna, 15006

  • Hospital Parc de Salut del Mar /ID# 159690

    Barcelona, 08003

  • Hospital Universitario Vall d'Hebron /ID# 159708

    Barcelona, 08035

  • Hospital Clinico Universitario San Carlos /ID# 159706

    Madrid, 28040

  • Hospital Universitario Fundacion Jimenez Diaz /ID# 159693

    Madrid, 28040

  • Hospital Universitario La Paz /ID# 159692

    Madrid, 28046

  • Hospital Regional de Malaga /ID# 164371

    Málaga, Malaga, 29010

  • Hospital Clinico Universitario Lozano Blesa /ID# 159709

    Zaragoza, 50009

Other trials in Spain

Taiwan8 sites

  • Dalin Tzu Chi General Hospital /ID# 158983

    Dalin Township, 622

  • Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 158798

    Kaohsiung City, 80708

  • China Medical University Hosp /ID# 158981

    Taichung, Taichung, 40447

  • Taichung Veterans General Hosp /ID# 159047

    Taichung, 40705

  • National Cheng Kung University Hospital /ID# 158799

    Tainan, Tainan, 70403

  • Taipei Veterans General Hosp /ID# 203699

    Taipei, 11217

  • National Taiwan Univ Hosp /ID# 159049

    Taipei City, Taipei, 10002

  • Tri-Service General Hospital /ID# 158980

    Taipei City, Taipei, 11490

Other trials in Taiwan

Australia7 sites

  • Calvary North Adelaide Hospita /ID# 161701

    Adelaide, South Australia, 5006

  • Coffs Harbour Hospital /ID# 158880

    Coffs Harbour, New South Wales, 2450

  • Gosford Hospital /ID# 158884

    Gosford, New South Wales, 2250

  • Newcastle Private Hospital /ID# 203506

    Lambton Heights, New South Wales, 2305

  • Affinity Clinical Research Ser /ID# 158887

    Nedlands, 6009

  • Royal North Shore Hospital /ID# 158881

    Saint Leonards, New South Wales, 2065

  • Sunshine Hospital /ID# 161700

    St Albans, Victoria, 3021

Other trials in Australia

Greece7 sites

  • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 159160

    Athens, 11527

  • Metropolitan Hospital /ID# 159157

    Athens, 18547

  • Metropolitan General Hospital /ID# 202422

    Cholargós, Attica, 15562

  • University General Hospital of Heraklion PA.G.N.I /ID# 202409

    Heraklion, 71110

  • University Hospital of Ioannin /ID# 159158

    Ioannina, 45500

  • General Oncological Hospital /ID# 159159

    Nea Kifissia, 14564

  • Euromedica General Clinic /ID# 159156

    Thessaloniki, 54645

Other trials in Greece

Netherlands7 sites

  • Jeroen Bosch Ziekenhuis /ID# 158081

    's-Hertogenbosch, 5223 GZ

  • Meander Medisch Centrum /ID# 159064

    Amersfoort, 3813 TZ

  • Rijnstate /ID# 159063

    Arnhem, 6815 AD

  • Amphia Ziekenhuis /ID# 159065

    Breda, 4818 CK

  • Catharina Ziekenhuis /ID# 158082

    Eindhoven, 5623 EJ

  • Maastricht Universitair Medisch Centrum /ID# 161669

    Maastricht, 6229 HX

  • Universitair Medisch Centrum Utrecht /ID# 158083

    Utrecht, 3584 CX

Other trials in Netherlands

Portugal7 sites

  • Centro Hospitalar Lisboa Norte, EPE /ID# 159957

    Lisbon, Lisbon District, 1769-001

  • IPO Lisboa FG, EPE /ID# 159949

    Lisbon, 1099-023

  • Hospital da Luz, SA /ID# 159954

    Lisbon, 1500-650

  • Unidade Local Saude Matosinhos /ID# 159950

    Matosinhos Municipality, 4464-513

  • Centro Hospitalar do Porto EPE /ID# 203582

    Porto, 4099-001

  • Hospital CUF Porto /ID# 159955

    Porto, 4100-180

  • IPO Porto FG, EPE /ID# 159956

    Porto, 4200-072

Other trials in Portugal

Ukraine7 sites

  • Regional Municipal Non-Profit Enterprise Bukovynian Clinical Oncology Center /ID# 159864

    Chernivtsi, 58013

  • Municipal institution Multifie /ID# 159130

    Dnipro, 49102

  • Regional Center of Oncology /ID# 159132

    Kharkiv, 61070

  • PE PMC Acinus, Medical and Diagnostic Center /ID# 165543

    Kropyvnytskyi, 25006

  • Volyn Regional Medical Oncology Centre /ID# 159133

    Lutsk, 43018

  • Communal Nonprofit Enterprise "Central City Clinical Hospital" of Uzhhorod City /ID# 159865

    Uzhhorod, 88000

  • CI Zaporizhzhia Regional Clinical Oncological Dispensary /ID# 159131

    Zaporizhzhya, Zaporizhzhia Oblast, 69040

Other trials in Ukraine

Canada6 sites

  • Brampton Civic Hospital /ID# 204425

    Brampton, Ontario, L6R 3J7

  • R.S. McLaughlin Durham Regional /ID# 170870

    Oshawa, Ontario, L1G 2B9

  • Iucpq-Ul /Id# 159530

    Québec, Quebec, G1V 4G5

  • British Columbia Cancer Agency /ID# 163721

    Surrey, British Columbia, V3V 1Z2

  • Princess Margaret /ID# 170868

    Toronto, Ontario, M5G 2M9

  • Windsor Regional Cancer Centre /ID# 170869

    Windsor, Ontario, N8W 2X3

Other trials in Canada

Czechia6 sites

  • Nemocnice Rudolfa a Stefanie /ID# 159655

    Benešov, 256 01

  • Nemocnice Horovice a.s. /ID# 161186

    Hořovice, 268 31

  • Vitkovicka nemocnice a. s. /ID# 161187

    Ostrava, 703 84

  • FN Plzen /ID# 204097

    Pilsen, 323 00

  • Thomayerova nemocnice /ID# 159062

    Prague, Praha 4, 140 59

  • Oblastni Nemocnice Pribram /ID# 159654

    Příbram, 262 04

Other trials in Czechia

Ireland6 sites

  • Cork University Hospital /ID# 159715

    Cork, T12 E8YV

  • St. James's Hospital /ID# 159712

    Dublin, Dublin, D08 E9P6

  • St Vincent's University Hosp /ID# 161678

    Dublin, D04 T6F4

  • Beaumont Hospital /ID# 159711

    Dublin, D09 XR63

  • University Hospital Limerick /ID# 159714

    Limerick, V94F858

  • University Hospital Waterford /ID# 159713

    Waterford, X91 ER8E

Other trials in Ireland

Italy6 sites

  • AUSL 8 Arezzo Ospedale San Don /ID# 160897

    Arezzo, 52100

  • IRST IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori /ID# 160898

    Meldola, Emilia-Romagna, 47014

  • A.O.U. San Luigi Gonzaga /ID# 158916

    Orbassano, 10043

  • Ospedale Santa Maria delle Cro /ID# 158911

    Ravenna, 48121

  • Policlinico Universitario Campus Bio-Medico /ID# 160874

    Rome, Lazio, 00128

  • IFO Istituto Nazionale Tumori /ID# 158912

    Rome, 00144

Other trials in Italy

Norway6 sites

  • Haukeland University Hospital /ID# 159573

    Bergen, Hordaland, 5021

  • Drammen Sykehus /ID# 159572

    Drammen, Buskerud, 3004

  • Akershus universitetssykehus /ID# 201682

    Nordbyhagen, Akershus, 1474

  • Radiumhospitalet, OUS /ID# 159574

    Oslo, 0379

  • Stavanger Universitetssykehus /ID# 159575

    Stavanger, 4011

  • St. Olavs Hospital HF /ID# 163110

    Trondheim, Sor-Trondelag, 7006

Other trials in Norway

South Africa6 sites

  • Cape Town Oncology Trials /ID# 201311

    Cape Town, Western Cape, 7570

  • The Oncology Centre /ID# 158872

    Durban, KwaZulu-Natal, 4091

  • Cancercare Outeniqua Oncology Unit /ID# 200689

    George, Western Cape, 6530

  • Cancercare Langenhoven Drive Oncology Centre /ID# 159126

    Port Elizabeth, Eastern Cape, 6045

  • Dr Albert, Bouwer and Jordaan Incorporated /ID# 158873

    Pretoria, Gauteng, 0044

  • Mary Potter Oncology Centre /ID# 158877

    Pretoria, Gauteng, 0181

Other trials in South Africa

Austria5 sites

  • LKH-Univ. Klinikum Graz /ID# 159563

    Graz, 8036

  • Ordensklinikum Linz GmbH, Elisabethinen /ID# 159564

    Linz, 4020

  • Salzburger Landeskliniken (SALK) /ID# 201779

    Salzburg, 5020

  • SMZ Baumgartner Höhe, Otto-Wagner-Spital und Pflegezentrum /ID# 201776

    Vienna, State of Vienna, 1140

  • Krankenhaus Nord - Klinik Floridsdorf /ID# 201768

    Vienna, State of Vienna, 1210

Other trials in Austria

Belgium5 sites

  • ZNA Middelheim /ID# 159007

    Antwerp, 2020

  • CHU Saint-Pierre /ID# 159009

    Brussels, Brussels Capital, 1000

  • Grand Hôpital de Charleroi /ID# 159006

    Charleroi, Hainaut, 6000

  • Hopital de Jolimont /ID# 159005

    Haine-Saint-Paul, 7100

  • CHU Charleroi (Vesale) /ID# 159008

    Montigny-le-Tilleul, 6110

Other trials in Belgium

Hungary5 sites

  • Semmelweis Egyetem /ID# 158955

    Budapest, 1085

  • Orszagos Koranyi Pulmonologiai Intezet /ID# 158953

    Budapest XII, Budapest, 1122

  • Csongrad Megyei Mellkasi Beteg /ID# 158952

    Deszk, 6772

  • CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 158962

    Miskolc, Borsod-Abauj Zemplen county, 3529

  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz - Pulmonologia /ID# 202466

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

Other trials in Hungary

Serbia5 sites

  • Clinical Center Serbia /ID# 160902

    Belgrade, Beograd, 11000

  • Clin Hosp Ctr Bezanijska Kosa /ID# 160903

    Belgrade, Beograd, 11080

  • Institut za onkologiju i radio /ID# 160904

    Belgrade, 11000

  • Institute For Pulmonary Diseas /ID# 164250

    Kamenitz, 21204

  • Clinical Center of Nis /ID# 160905

    Niš, Nisavski Okrug, 18000

Other trials in Serbia

Sweden5 sites

  • Sahlgrenska US Gbg /ID# 159524

    Gothenburg, Västra Götaland County, 413 46

  • Centralsjukhuset, Karlstad /ID# 163451

    Karlstad, Värmland County, 651 85

  • University Hospital Linkoping /ID# 159046

    Linköping, 581 85

  • Karolinska Univ Sjukhuset /ID# 159649

    Solna, 17176

  • Uppsala University Hospital /ID# 159052

    Uppsala, 75185

Other trials in Sweden

Switzerland5 sites

  • Universitaetsspital Basel /ID# 160605

    Basel, 4031

  • Hopitaux Universitaires de Geneve /ID# 160603

    Geneva, Canton of Geneva, 1205

  • Luzerner Kantonsspital /ID# 160607

    Lucerne, 6000

  • Kantonsspital St. Gallen /ID# 160604

    Sankt Gallen, Canton of St. Gallen, 9007

  • Kantonsspital Winterthur /ID# 161379

    Winterthur, 8401

Other trials in Switzerland

Denmark4 sites

  • Aalborg University Hospital /ID# 203737

    Aalborg, North Denmark, 9000

  • Rigshospitalet /ID# 158055

    Copenhagen Ø, Capital Region, 2100

  • Herlev Hospital /ID# 158053

    Herlev, Capital Region, 2730

  • Odense Universitets Hospital /ID# 158054

    Odense C, Region Syddanmark, 5000

Other trials in Denmark

Belarus3 sites

  • Bobruysk Interdistrict Onco. /ID# 169393

    Babruysk, 213825

  • State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 159383

    Lesnoy, 223040

  • Mogilev Reg Clin Oncology Dis /ID# 159384

    Mogilev, 212018

Other trials in Belarus

Croatia3 sites

  • Klinicki bolnicki centar Rijeka /ID# 159504

    Rijeka, Primorje-Gorski Kotar County, 51000

  • Klinicki bolnicki centar Sestre milosrdnice /ID# 159090

    Zagreb, City of Zagreb, 10000

  • Klinika za plucne bolesti Jordanovac /ID# 159505

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Hong Kong3 sites

  • Queen Elizabeth Hospital /ID# 159565

    Kowloon, 852

  • Princess Margaret Hospital /ID# 162810

    Lai Chi Kok, 999077

  • Tuen Mun Hospital /ID# 162435

    Tuenmen, 999077

Other trials in Hong Kong

Lithuania3 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 160016

    Kaunas, Kaunas County, 50009

  • Klaipeda University Hospital /ID# 160018

    Klaipėda, LT-92288

  • National Cancer Institute /ID# 160017

    Vilnius, 08660

Other trials in Lithuania

Poland3 sites

  • Wojewodzki Szpital Specjalisty /ID# 159603

    Bytom, 41-902

  • Szpitale Pomorskie Sp. z o.o /ID# 159605

    Gdynia, 81-519

  • Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 159604

    Rzeszów, Podkarpackie Voivodeship, 35-021

Other trials in Poland

Bulgaria2 sites

  • UMHAT Tsaritsa Joanna - ISUL /ID# 159638

    Sofia, 1527

  • UMHAT Sv. Ivan Rilski /ID# 159639

    Sofia, 1612

Other trials in Bulgaria

Estonia2 sites

  • East Tallinn Central Hospital /ID# 160019

    Tallinn, 10138

  • North Estonian Medical Centre /ID# 159779

    Tallinn, 13419

Other trials in Estonia

Latvia2 sites

  • Pauls Stradins Clinical /ID# 158715

    Riga, LV-1002

  • Riga East Clinical University /ID# 158716

    Riga, LV-1079

Other trials in Latvia

Mexico2 sites

  • Health Pharma professional Ser /ID# 160734

    Mexico City, 03810

  • Centro de Investigación Clinica Chapultepec /ID# 160965

    Morelia, Michoacán, 58260

Other trials in Mexico

Finland1 site

  • Docrates Cancer Center /ID# 159591

    Helsinki, 00180

Other trials in Finland

About this study

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)

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.

Being tested
Placebo for dexamethasone, Placebo for rovalpituzumab tesirine, Rovalpituzumab tesirine, Dexamethasone
Keywords
Extensive-Stage Small Cell Lung Cancer (ED SCLC), Cancer, Platinum-Based Chemotherapy, Rovalpituzumab tesirine, first-line chemotherapy, Small Cell Lung Cancer (SCLC), Delta-like protein 3 (DLL3)
Medical subject headings
Small Cell Lung Carcinoma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo for dexamethasoneDrug

    Placebo for dexamethasone PO twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle.

  • Placebo for rovalpituzumab tesirineDrug

    Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle

  • Rovalpituzumab tesirineDrug

    Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle

  • DexamethasoneDrug

    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.

Study groups in NCT03033511
Study groupRoleWhat they receive
Rovalpituzumab tesirine/dexamethasoneExperimentalRovalpituzumab tesirine/dexamethasone every 6 weeks (q6 wk); omitting every third cycle
Receives: Drug: Rovalpituzumab tesirine; Drug: Dexamethasone
PlaceboExperimentalPlacebo q6 wk; omitting every third cycle
Receives: Drug: Placebo for dexamethasone; Drug: Placebo for rovalpituzumab tesirine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS) in Participants With Extensive-Stage Small Cell Lung Cancer With Delta-Like Protein 3 High Expression in Tumor (DLL3high)

    OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology.

    Measured: Survival follow-up continued until the endpoint of death, participant was lost to follow-up or withdrew consent, or termination of the study by AbbVie, whichever occurred first. Median time on study overall was 11.9 months.

Secondary outcomes (2)

  1. OS in All Randomized Participants

    OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology.

    Measured: Survival follow-up continued until the endpoint of death, the subject was lost to follow-up or withdrew consent, or termination of the study by AbbVie, whichever occurred first. Median time on study overall was 11.9 months.

  2. Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Physical Functioning Domain Over Time

    The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).

    The Physical Functioning domain includes 5 questions in which participants were asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 7 (excellent). The 5 scores were averaged and transformed to a scale from 0 to 100, where a high score represents a high QoL. A positive change from baseline indicates better quality of life.

    Measured: Baseline, Weeks 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, Final Visit (up to Week 78)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2017 (estimated)
  2. Study start7 Feb 2017
  3. Primary completion20 Nov 2019
  4. Study completion20 Nov 2019

Why it stopped: Independent Data Monitoring Committee recommendation

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
748 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03033511
Sponsor's protocol ID
M16-298
Other IDs
2016-003503-64, 2016
Acronym
MERU
Status last verified
Jul 2021
First submitted
25 Jan 2017
Last updated
29 Jul 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.
Expanded access
Available

Publications

  • Tanaka K, Isse K, Fujihira T, Takenoyama M, Saunders L, Bheddah S, Nakanishi Y, Okamoto I. Prevalence of Delta-like protein 3 expression in patients with small cell lung cancer. Lung Cancer. 2018 Jan;115:116-120. doi: 10.1016/j.lungcan.2017.11.018. Epub 2017 Nov 22.

    PubMed 29290251

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rovalpituzumab tesirine and Dexamethasone in people with Small Cell Lung Cancer, run by AbbVie at 308 sites in 41 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 308 sites in United States, Japan, China, Russia, United Kingdom and 36 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) in Participants With Extensive-Stage Small Cell Lung Cancer With Delta-Like Protein 3 High Expression in Tumor (DLL3high) (time frame: Survival follow-up continued until the endpoint of death, participant was lost to follow-up or withdrew consent, or termination of the study by AbbVie, whichever occurred first. Median time on study overall was 11.9 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03033511, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.

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