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

Small Cell Lung Cancer Clinical Trial

— MERU  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03033511
• Other study ID #: M16-298
• Secondary ID: 2016-003503-64
• Status: Terminated
• Phase: Phase 3
• Start date: February 7, 2017
• Est. completion date: November 20, 2019

Study information

• Verified date: July 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 748
• Est. completion date: November 20, 2019
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

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 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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• Placebo for dexamethasone
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 tesirine
Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
• Rovalpituzumab tesirine
Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
• 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.

Locations

Country	Name	City	State
Australia	Calvary North Adelaide Hospita /ID# 161701	Adelaide	South Australia
Australia	Coffs Harbour Hospital /ID# 158880	Coffs Harbour	New South Wales
Australia	Gosford Hospital /ID# 158884	Gosford	New South Wales
Australia	Newcastle Private Hospital /ID# 203506	Lambton Heights	New South Wales
Australia	Affinity Clinical Research Ser /ID# 158887	Nedlands
Australia	Royal North Shore Hospital /ID# 158881	Saint Leonards	New South Wales
Australia	Sunshine Hospital /ID# 161700	St Albans	Victoria
Austria	LKH-Univ. Klinikum Graz /ID# 159563	Graz
Austria	Ordensklinikum Linz GmbH, Elisabethinen /ID# 159564	Linz
Austria	Salzburger Landeskliniken (SALK) /ID# 201779	Salzburg
Austria	Krankenhaus Nord - Klinik Floridsdorf /ID# 201768	Vienna	Wien
Austria	SMZ Baumgartner Höhe, Otto-Wagner-Spital und Pflegezentrum /ID# 201776	Vienna	Wien
Belarus	Bobruysk Interdistrict Onco. /ID# 169393	Bobruisk
Belarus	State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 159383	Lesnoy
Belarus	Mogilev Reg Clin Oncology Dis /ID# 159384	Mogilev
Belgium	ZNA Middelheim /ID# 159007	Antwerp
Belgium	CHU Saint-Pierre /ID# 159009	Bruxelles	Bruxelles-Capitale
Belgium	Grand Hôpital de Charleroi /ID# 159006	Charleroi	Hainaut
Belgium	Hopital de Jolimont /ID# 159005	Haine Saint Paul
Belgium	CHU Charleroi (Vesale) /ID# 159008	Montigny-le-tilleul
Brazil	Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 159012	Barretos	Sao Paulo
Brazil	Hospital Evangelico de Cachoei /ID# 159657	Cachoeiro de Itapemirim	Espirito Santo
Brazil	Associação Hospital de Caridade Ijuí - Centro de Tratamento de Cancer - CACON /ID# 159013	Ijuí	Rio Grande Do Sul
Brazil	Liga Norte Rio Grandense Cont. /ID# 159011	Natal	Rio Grande Do Norte
Brazil	Associação Hospital Beneficente São Vicente de Paulo - Hospital São Vicente de P /ID# 159661	Passo Fundo	Rio Grande Do Sul
Brazil	Hospital Sao Lucas da PUCRS /ID# 159662	Porto Alegre	Rio Grande Do Sul
Brazil	Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 159658	Rio de Janeiro
Brazil	Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 159659	Sao Jose Do Rio Preto	Sao Paulo
Bulgaria	UMHAT Sv. Ivan Rilski /ID# 159639	Sofia
Bulgaria	UMHAT Tsaritsa Joanna - ISUL /ID# 159638	Sofia
Canada	Brampton Civic Hospital /ID# 204425	Brampton	Ontario
Canada	R.S. McLaughlin Durham Regional /ID# 170870	Oshawa	Ontario
Canada	Iucpq-Ul /Id# 159530	Québec	Quebec
Canada	British Columbia Cancer Agency /ID# 163721	Surrey	British Columbia
Canada	Princess Margaret /ID# 170868	Toronto	Ontario
Canada	Windsor Regional Cancer Centre /ID# 170869	Windsor	Ontario
China	Jilin Cancer Hosptial /ID# 204060	Changchun	Jilin
China	Fujian Provincial Cancer Hospital /ID# 204864	Fuzhou	Fujian
China	Zhejiang Cancer hospital /ID# 204640	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital /Id# 203638	Harbin	Heilongjiang
China	Sir Run Run Shaw Hospital /ID# 206802	Jianggan Hangzhou	Zhejiang
China	Yunnan Cancer Hospital /ID# 204911	Kunming	Yunnan
China	Jiangsu Province Hospital /ID# 205183	Nanjing
China	The Affiliated Cancer Hospital of Xinjiang Medical university /ID# 203641	Urumqi	Xinjiang
China	Hubei Cancer Hospital /ID# 202886	Wuhan	Hubei
China	4th Military Medical Universit /ID# 203986	Xi'an
China	First Affiliated Hospital of Xi'an Jiaotong University /ID# 203733	Xi'an
China	Henan Cancer Hospital /ID# 203983	Zhengzhou Henan
China	Henan Cancer Hospital /ID# 204636	Zhengzhou Henan
Croatia	Klinicki bolnicki centar Rijeka /ID# 159504	Rijeka	Primorsko-goranska Zupanija
Croatia	Klinicki bolnicki centar Sestre milosrdnice /ID# 159090	Zagreb	Grad Zagreb
Croatia	Klinika za plucne bolesti Jordanovac /ID# 159505	Zagreb	Grad Zagreb
Czechia	Nemocnice Rudolfa a Stefanie /ID# 159655	Benesov
Czechia	Nemocnice Horovice a.s. /ID# 161186	Horovice
Czechia	Vitkovicka nemocnice a. s. /ID# 161187	Ostrava
Czechia	FN Plzen /ID# 204097	Plzen
Czechia	Thomayerova nemocnice /ID# 159062	Prague	Praha 4
Czechia	Oblastni Nemocnice Pribram /ID# 159654	Pribram
Denmark	Aalborg University Hospital /ID# 203737	Aalborg	Nordjylland
Denmark	Rigshospitalet /ID# 158055	Copenhagen Ø	Hovedstaden
Denmark	Herlev Hospital /ID# 158053	Herlev	Hovedstaden
Denmark	Odense Universitets Hospital /ID# 158054	Odense C	Syddanmark
Estonia	East Tallinn Central Hospital /ID# 160019	Tallinn
Estonia	North Estonian Medical Centre /ID# 159779	Tallinn
Finland	Docrates Cancer Center /ID# 159591	Helsinki
France	Centre Hosp Intercommunal de Creteil /ID# 162686	Creteil	Val-de-Marne
France	CHU Calmette /ID# 202706	Lille	Hauts-de-France
France	Centre Leon Berard /ID# 160550	Lyon CEDEX 08	Rhone
France	CHU Hopital Nord /ID# 160543	Marseille	Bouches-du-Rhone
France	Hopital Tenon /ID# 160541	Paris
France	Institut Curie /ID# 207514	Paris CEDEX 05	Ile-de-France
France	Hopital Haut-Lévêque /ID# 160547	Pessac CEDEX	Gironde
France	Hospital Pontchaillou /ID# 160544	Rennes
France	Nouvel Hopital Civil (NHC) /ID# 204427	Strasbourg
France	Hopital Larrey /ID# 204290	Toulouse
Germany	Charite Universitatsmedizin Berlin Campus Virchow Klinikum /ID# 158783	Berlin
Germany	Evangelische Lungenklinik Berl /ID# 158935	Berlin
Germany	Asklepios Fachkliniken M. Gaut /ID# 158789	Gauting
Germany	KH Martha-Maria Halle Dolau /ID# 158794	Halle (Saale)	Sachsen-Anhalt
Germany	Thoraxklinik Heidelberg gGmbH /ID# 158871	Heidelberg
Germany	Lungenklinik Hemer /ID# 158790	Hemer
Germany	Klinikum Kassel /ID# 158786	Kassel
Germany	Klinik Loewenstein GmbH /ID# 158870	Löwenstein
Germany	Fachkliniken Wangen /ID# 160779	Wangen
Greece	General Hospital of Chest Diseases of Athens SOTIRIA /ID# 159160	Athens
Greece	Metropolitan Hospital /ID# 159157	Athens
Greece	Metropolitan General Hospital /ID# 202422	Cholargos	Attiki
Greece	University General Hospital of Heraklion PA.G.N.I /ID# 202409	Heraklion
Greece	University Hospital of Ioannin /ID# 159158	Ioannina
Greece	General Oncological Hospital /ID# 159159	Nea Kifisia
Greece	Euromedica General Clinic /ID# 159156	Thessaloniki
Hong Kong	Queen Elizabeth Hospital /ID# 159565	Kowloon
Hong Kong	Princess Margaret Hospital /ID# 162810	Lai Chi Kok
Hong Kong	Tuen Mun Hospital /ID# 162435	Tuen Mun
Hungary	Semmelweis Egyetem /ID# 158955	Budapest
Hungary	Orszagos Koranyi Pulmonologiai Intezet /ID# 158953	Budapest XII	Budapest
Hungary	Csongrad Megyei Mellkasi Beteg /ID# 158952	Deszk
Hungary	CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 158962	Miskolc	Borsod-Abauj-Zemplen
Hungary	Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz - Pulmonologia /ID# 202466	Nyiregyhaza	Szabolcs-Szatmar-Bereg
Ireland	Cork University Hospital /ID# 159715	Cork
Ireland	Beaumont Hospital /ID# 159711	Dublin
Ireland	St Vincent's University Hosp /ID# 161678	Dublin
Ireland	St. James's Hospital /ID# 159712	Dublin 8	Dublin
Ireland	University Hospital Limerick /ID# 159714	Limerick
Ireland	University Hospital Waterford /ID# 159713	Waterford
Israel	Soroka University Medical Center /ID# 159762	Be'er Sheva
Israel	Assaf Harofeh Medical Center /ID# 201883	Be'er Ya'akov
Israel	Rambam Health Care Campus /ID# 202336	Haifa
Israel	Hadassah /ID# 159763	Jerusalem
Israel	Meir Medical Center /ID# 159761	Kfar Saba
Israel	Rabin Medical Center /ID# 159764	Petakh Tikva	Tel-Aviv
Israel	Sheba Medical Center /ID# 159760	Ramat Gan
Israel	Tel Aviv Sourasky Medical Center /ID# 161467	Tel Aviv-Yafo	Tel-Aviv
Italy	AUSL 8 Arezzo Ospedale San Don /ID# 160897	Arezzo
Italy	IRST IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori /ID# 160898	Meldola	Emilia-Romagna
Italy	A.O.U. San Luigi Gonzaga /ID# 158916	Orbassano
Italy	Ospedale Santa Maria delle Cro /ID# 158911	Ravenna
Italy	IFO Istituto Nazionale Tumori /ID# 158912	Rome
Italy	Policlinico Universitario Campus Bio-Medico /ID# 160874	Rome	Lazio
Japan	Hyogo Cancer Center /ID# 165138	Akashi
Japan	National Cancer Center Hospital /ID# 166547	Chuo-ku	Tokyo
Japan	Kyushu University Hospital /ID# 165722	Fukuoka-shi	Fukuoka
Japan	National Hospital Organization Himeji Medical Center /ID# 165899	Himeji
Japan	Kansai Medical University Hospital /ID# 165054	Hirakata-shi	Osaka
Japan	Kanazawa University Hospital /ID# 165127	Kanazawa	Ishikawa
Japan	National Cancer Center Hospital East /ID# 165721	Kashiwa-shi	Chiba
Japan	Kurume University Hospital /ID# 164595	Kurume-shi	Fukuoka
Japan	Matsusaka City Hospital /ID# 166156	Matsusaka-shi MIE
Japan	Aichi Cancer Center Hospital /ID# 164976	Nagoya-shi	Aichi
Japan	Japanese Red Cross Okayama Hospital /ID# 165157	Okayama-shi	Okayama
Japan	Osaka City General Hospital /ID# 165714	Osaka
Japan	Kindai University Hospital /ID# 166395	Osaka-sayama-shi	Osaka
Japan	Hokkaido Cancer Center /ID# 165236	Sapporo
Japan	Sendai Kousei Hospital /ID# 166491	Sendai
Japan	Showa University Hospital /ID# 165575	Shinagawa-ku	Tokyo
Japan	Shizuoka Cancer Center /ID# 166272	Sunto-gun	Shizuoka
Japan	Tokushima University Hospital /ID# 166105	Tokushima-shi	Tokushima
Japan	Wakayama Medical University /ID# 165946	Wakayama-shi	Wakayama
Japan	Kanagawa Cancer Center /ID# 165814	Yokohama
Japan	Kanagawa Cardiovascular and Respiratory Center /ID# 165015	Yokohama-shi	Kanagawa
Japan	Yokohama City University Hospital /ID# 165746	Yokohama-shi	Kanagawa
Korea, Republic of	Dong-A University Hospital /ID# 159305	Busan	Busan Gwang Yeogsi
Korea, Republic of	Chungbuk National University /ID# 159300	Cheongju-si
Korea, Republic of	Kyungpook National University Chilgok Hospital /ID# 159301	Daegu	Seoul Teugbyeolsi
Korea, Republic of	CHA Bundang Medical center CHA University /ID# 161281	Seongnam si	Gyeonggido
Korea, Republic of	Asan Medical Center /ID# 159299	Seoul
Korea, Republic of	Korea University Guro Hospital /ID# 159302	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Samsung Medical Center /ID# 159304	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Severance Hospital /ID# 159297	Seoul
Latvia	Pauls Stradins Clinical /ID# 158715	Riga
Latvia	Riga East Clinical University /ID# 158716	Riga
Lithuania	Klaipeda University Hospital /ID# 160018	Klaipeda
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 160016	Kovno	Kaunas
Lithuania	National Cancer Institute /ID# 160017	Vilnius
Mexico	Health Pharma professional Ser /ID# 160734	Ciudad de México
Mexico	Centro de Investigación Clinica Chapultepec /ID# 160965	Morelia	Michoacan
Netherlands	Meander Medisch Centrum /ID# 159064	Amersfoort
Netherlands	Rijnstate /ID# 159063	Arnhem
Netherlands	Amphia Ziekenhuis /ID# 159065	Breda
Netherlands	Catharina Ziekenhuis /ID# 158082	Eindhoven
Netherlands	Maastricht Universitair Medisch Centrum /ID# 161669	Maastricht
Netherlands	Jeroen Bosch Ziekenhuis /ID# 158081	S Hertogenbosch
Netherlands	Universitair Medisch Centrum Utrecht /ID# 158083	Utrecht
Norway	Haukeland University Hospital /ID# 159573	Bergen	Hordaland
Norway	Drammen Sykehus /ID# 159572	Drammen	Buskerud
Norway	Akershus universitetssykehus /ID# 201682	Nordbyhagen	Akershus
Norway	Radiumhospitalet, OUS /ID# 159574	Oslo
Norway	Stavanger Universitetssykehus /ID# 159575	Stavanger
Norway	St. Olavs Hospital HF /ID# 163110	Trondheim	Sor-Trondelag
Poland	Wojewodzki Szpital Specjalisty /ID# 159603	Bytom
Poland	Szpitale Pomorskie Sp. z o.o /ID# 159605	Gdynia
Poland	Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 159604	Rzeszów	Podkarpackie
Portugal	IPO Lisboa FG, EPE /ID# 159949	Lisboa
Portugal	Centro Hospitalar Lisboa Norte, EPE /ID# 159957	Lisbon	Lisboa
Portugal	Hospital da Luz, SA /ID# 159954	Lisbon
Portugal	Unidade Local Saude Matosinhos /ID# 159950	Matosinhos
Portugal	Centro Hospitalar do Porto EPE /ID# 203582	Porto
Portugal	Hospital CUF Porto /ID# 159955	Porto
Portugal	IPO Porto FG, EPE /ID# 159956	Porto
Russian Federation	Arkhangelsk clinical oncology /ID# 159367	Arkhangelsk
Russian Federation	Kaluga Regional Clinical Oncol /ID# 160180	Kaluga
Russian Federation	National Medical Research Cntr /ID# 169885	Moscow	Moskovskaya Oblast
Russian Federation	Clinical Onco Dispensary /ID# 159365	Omsk
Russian Federation	PMI Euromedservice /ID# 159369	Pushkin
Russian Federation	LLC Novaya Clinica /ID# 205523	Pyatigorsk
Russian Federation	OOO Centre of Palliative Medicine De Vita /ID# 206855	Saint Petersburg
Russian Federation	Ogarev Mordovia State Univ /ID# 205742	Saransk
Russian Federation	Smolensk Regional Onc Clin Dis /ID# 159372	Smolensk
Russian Federation	LLC BioEq Ltd. /ID# 159368	St. Petersburg
Russian Federation	N.N. Petrov Research Inst Onc /ID# 159370	St. Petersburg
Serbia	Clin Hosp Ctr Bezanijska Kosa /ID# 160903	Belgrade	Beograd
Serbia	Clinical Center Serbia /ID# 160902	Belgrade	Beograd
Serbia	Institut za onkologiju i radio /ID# 160904	Belgrade
Serbia	Clinical Center of Nis /ID# 160905	NIS	Nisavski Okrug
Serbia	Institute For Pulmonary Diseas /ID# 164250	Sremska Kamenica
South Africa	Cape Town Oncology Trials /ID# 201311	Cape Town	Western Cape
South Africa	The Oncology Centre /ID# 158872	Durban	Kwazulu-Natal
South Africa	Cancercare Outeniqua Oncology Unit /ID# 200689	George	Western Cape
South Africa	Cancercare Langenhoven Drive Oncology Centre /ID# 159126	Port Elizabeth	Eastern Cape
South Africa	Dr Albert, Bouwer and Jordaan Incorporated /ID# 158873	Pretoria	Gauteng
South Africa	Mary Potter Oncology Centre /ID# 158877	Pretoria	Gauteng
Spain	Hospital Teresa Herrera - CHUAC /ID# 164368	A Coruña	A Coruna
Spain	Hospital Parc de Salut del Mar /ID# 159690	Barcelona
Spain	Hospital Universitario Vall d'Hebron /ID# 159708	Barcelona
Spain	Hospital Clinico Universitario San Carlos /ID# 159706	Madrid
Spain	Hospital Universitario Fundacion Jimenez Diaz /ID# 159693	Madrid
Spain	Hospital Universitario La Paz /ID# 159692	Madrid
Spain	Hospital Regional de Malaga /ID# 164371	Málaga	Malaga
Spain	Hospital Clinico Universitario Lozano Blesa /ID# 159709	Zaragoza
Sweden	Sahlgrenska US Gbg /ID# 159524	Göteborg	Vastra Gotalands Lan
Sweden	Centralsjukhuset, Karlstad /ID# 163451	Karlstad	Varmlands Lan
Sweden	University Hospital Linkoping /ID# 159046	Linkoping
Sweden	Karolinska Univ Sjukhuset /ID# 159649	Solna
Sweden	Uppsala University Hospital /ID# 159052	Uppsala
Switzerland	Universitaetsspital Basel /ID# 160605	Basel
Switzerland	Hopitaux Universitaires de Geneve /ID# 160603	Genève	Geneve
Switzerland	Luzerner Kantonsspital /ID# 160607	Luzern
Switzerland	Kantonsspital St. Gallen /ID# 160604	St. Gallen	Sankt Gallen
Switzerland	Kantonsspital Winterthur /ID# 161379	Winterthur
Taiwan	Dalin Tzu Chi General Hospital /ID# 158983	Dalin Township
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 158798	Kaohsiung
Taiwan	China Medical University Hosp /ID# 158981	Taichung City	Taichung
Taiwan	Taichung Veterans General Hosp /ID# 159047	Taichung City
Taiwan	National Cheng Kung University Hospital /ID# 158799	Tainan City	Tainan
Taiwan	National Taiwan Univ Hosp /ID# 159049	Taipei City	Taipei
Taiwan	Taipei Veterans General Hosp /ID# 203699	Taipei City
Taiwan	Tri-Service General Hospital /ID# 158980	Taipei City	Taipei
Turkey	Hacettepe University Medical Faculty /ID# 159242	Altindag	Ankara
Turkey	Ataturk Gogus Hastalikl /ID# 159556	Ankara
Turkey	Akdeniz Universitesi Tip Fakul /ID# 160791	Antalya
Turkey	Bezmi alem Vakif Universitesi /ID# 202267	Istanbul
Turkey	Istanbul Medeniyet Universites /ID# 200126	Istanbul
Turkey	Dr. Suat Seren Gogus Has /ID# 159244	Izmir
Turkey	Ege University Medical Faculty /ID# 159243	Izmir
Turkey	Inonu University /ID# 159245	Malatya
Turkey	Erciyes University Medical Fac /ID# 202269	Melikgazi	Kayseri
Ukraine	Regional Municipal Non-Profit Enterprise Bukovynian Clinical Oncology Center /ID# 159864	Chernivtsi
Ukraine	Municipal institution Multifie /ID# 159130	Dnipro
Ukraine	Regional Center of Oncology /ID# 159132	Kharkiv
Ukraine	PE PMC Acinus, Medical and Diagnostic Center /ID# 165543	Kropyvnytskyi
Ukraine	Volyn Regional Medical Oncology Centre /ID# 159133	Lutsk
Ukraine	Communal Nonprofit Enterprise "Central City Clinical Hospital" of Uzhhorod City /ID# 159865	Uzhhorod
Ukraine	CI Zaporizhzhia Regional Clinical Oncological Dispensary /ID# 159131	Zaporizhzhia	Zaporizka Oblast
United Kingdom	Queen Elizabeth Medical Centre /ID# 162899	Birmingham
United Kingdom	The Royal Bournemouth Hospital /ID# 159039	Bournemouth
United Kingdom	Cheltenham General Hospital /ID# 169096	Cheltenham	Gloucestershire
United Kingdom	Colchester General Hospital /ID# 159042	Colchester
United Kingdom	Hereford County Hospital /ID# 159038	Hereford
United Kingdom	Charing Cross Hospital /ID# 161399	London
United Kingdom	St. George's Healthcare NHS /ID# 202416	London
United Kingdom	Maidstone Hospital /ID# 159043	Maidstone
United Kingdom	Christie NHS Foundation Trust /ID# 159037	Manchester
United Kingdom	The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 159044	Newcastle Upon Tyne
United Kingdom	Torbay Hospital - So Devon HC /ID# 159041	Torquay
United States	Ashland-Bellefonte Cancer Ctr /ID# 202901	Ashland	Kentucky
United States	Georgia Cancer Center /ID# 201894	Atlanta	Georgia
United States	Univ Medical Ctr Brackenridge /ID# 155798	Austin	Texas
United States	Ochsner Clinic Foundation /ID# 159136	Baton Rouge	Louisiana
United States	Billings Clinic /ID# 201788	Billings	Montana
United States	St. Luke's Mountain States Tumor Institute - Boise /ID# 156691	Boise	Idaho
United States	Montefiore Medical Center /ID# 201845	Bronx	New York
United States	MD Anderson Cancer Center at Cooper - Camden /ID# 156681	Camden	New Jersey
United States	Gabrail Cancer Center Research /ID# 156667	Canton	Ohio
United States	Sarah Cannon Research Institute-Chattanooga /ID# 202933	Chattanooga	Tennessee
United States	Parkland Health and Hosp Syste /ID# 170933	Dallas	Texas
United States	UT Southwestern Medical Center /ID# 157848	Dallas	Texas
United States	Henry Ford Health System /ID# 156712	Detroit	Michigan
United States	Duke University Medical Center /ID# 156706	Durham	North Carolina
United States	NorthShore University HealthSystem - Evanston Hospital /ID# 156664	Evanston	Illinois
United States	Highlands Oncology Group /ID# 156722	Fayetteville	Arkansas
United States	Holy Cross Hospital /ID# 156716	Fort Lauderdale	Florida
United States	University of Florida - Archer /ID# 155799	Gainesville	Florida
United States	Goshen Center for Cancer Care /ID# 156682	Goshen	Indiana
United States	Marin Cancer Care /ID# 159207	Greenbrae	California
United States	Cone Health /ID# 156689	Greensboro	North Carolina
United States	Cone Health /ID# 163612	Greensboro	North Carolina
United States	Eastern Carolina University /ID# 159264	Greenville	North Carolina
United States	Ingalls Memorial Hosp /ID# 156685	Harvey	Illinois
United States	Memorial Cancer Institute /ID# 156673	Hollywood	Florida
United States	Memorial Cancer Institute /ID# 164052	Hollywood	Florida
United States	Houston Methodist Hospital - Scurlock Tower /ID# 202323	Houston	Texas
United States	Clearview Cancer Institute /ID# 156699	Huntsville	Alabama
United States	Cancer Specialists of North Florida - Southpoint /ID# 156595	Jacksonville	Florida
United States	MidAmerica Division, Inc. /ID# 163530	Kansas City	Missouri
United States	Thompson Cancer Survival Ctr /ID# 202460	Knoxville	Tennessee
United States	Ucsd /Id# 157764	La Jolla	California
United States	Northwell Health - Monter Cancer Center /ID# 159252	Lake Success	New York
United States	Sparrow Regional Cancer Center, Sparrow Health System /ID# 156590	Lansing	Michigan
United States	Nebraska Hematology Oncology /ID# 156534	Lincoln	Nebraska
United States	Kaiser Permanente Lone Tree /ID# 159331	Lone Tree	Colorado
United States	LA Hem-Oncology Med Group /ID# 156717	Los Angeles	California
United States	University of Louisville /ID# 156683	Louisville	Kentucky
United States	University of South Alabama /ID# 160975	Mobile	Alabama
United States	West Virginia Univ School Med /ID# 156687	Morgantown	West Virginia
United States	Tennessee Oncology-Nashville Centennial /ID# 161168	Nashville	Tennessee
United States	Icahn School of Med Mt. Sinai /ID# 159210	New York	New York
United States	Christiana Care Health Service /ID# 159212	Newark	Delaware
United States	Southeastern Regional Medical /ID# 163064	Newnan	Georgia
United States	Palo Alto Veterans Institute for Research /ID# 203695	Palo Alto	California
United States	Thomas Jefferson University /ID# 156719	Philadelphia	Pennsylvania
United States	VA Pittsburgh HealthcareSystem /ID# 159284	Pittsburgh	Pennsylvania
United States	Kaiser Permanente, NW /ID# 201793	Portland	Oregon
United States	Rhode Island Hospital /ID# 160834	Providence	Rhode Island
United States	Mayo Clinic - Rochester /ID# 160181	Rochester	Minnesota
United States	St Jude Hospital dba St Joseph /ID# 156526	Santa Rosa	California
United States	Medical Oncology Associates /ID# 156715	Spokane	Washington
United States	Stony Brook University Hospital /ID# 159272	Stony Brook	New York
United States	Icri /Id# 157765	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belarus,  Belgium,  Brazil,  Bulgaria,  Canada,  China,  Croatia,  Czechia,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Mexico,  Netherlands,  Norway,  Poland,  Portugal,  Russian Federation,  Serbia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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.	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.
Secondary	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.	Baseline, Weeks 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, Final Visit (up to Week 78)