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

Sponsor

AbbVie (Industry)

Overall Status

Terminated

CT.gov ID

NCT03033511

Collaborator

(none)

748

Enrollment

308

Locations

Arms

33.4

Actual Duration (Months)

2.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Actual Enrollment :

748 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 :

Feb 7, 2017

Actual Primary Completion Date :

Nov 20, 2019

Actual Study Completion Date :

Nov 20, 2019

Arms and Interventions

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

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 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.

Drug: Placebo for rovalpituzumab tesirine

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

Outcome Measures

Primary Outcome Measures

Overall Survival (OS) in Participants With Extensive-Stage Small Cell Lung Cancer With Delta-Like Protein 3 High Expression in Tumor (DLL3high) [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.]
OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology.

Secondary Outcome Measures

OS in All Randomized Participants [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.]
OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology.
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 [Baseline, Weeks 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, Final Visit (up to Week 78)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clearview Cancer Institute /ID# 156699	Huntsville	Alabama	United States	35805
2	University of South Alabama /ID# 160975	Mobile	Alabama	United States	36604-3302
3	Highlands Oncology Group /ID# 156722	Fayetteville	Arkansas	United States	72703-4005
4	Marin Cancer Care /ID# 159207	Greenbrae	California	United States	94904
5	Ucsd /Id# 157764	La Jolla	California	United States	92093
6	LA Hem-Oncology Med Group /ID# 156717	Los Angeles	California	United States	90017
7	Palo Alto Veterans Institute for Research /ID# 203695	Palo Alto	California	United States	94304-1207
8	St Jude Hospital dba St Joseph /ID# 156526	Santa Rosa	California	United States	95403
9	Icri /Id# 157765	Whittier	California	United States	90603
10	Kaiser Permanente Lone Tree /ID# 159331	Lone Tree	Colorado	United States	80124
11	Christiana Care Health Service /ID# 159212	Newark	Delaware	United States	19713
12	Holy Cross Hospital /ID# 156716	Fort Lauderdale	Florida	United States	33308
13	University of Florida - Archer /ID# 155799	Gainesville	Florida	United States	32610
14	Memorial Cancer Institute /ID# 156673	Hollywood	Florida	United States	33021-5421
15	Memorial Cancer Institute /ID# 164052	Hollywood	Florida	United States	33021-5421
16	Cancer Specialists of North Florida - Southpoint /ID# 156595	Jacksonville	Florida	United States	32256
17	Georgia Cancer Center /ID# 201894	Atlanta	Georgia	United States	30342
18	Southeastern Regional Medical /ID# 163064	Newnan	Georgia	United States	30265
19	St. Luke's Mountain States Tumor Institute - Boise /ID# 156691	Boise	Idaho	United States	83712
20	NorthShore University HealthSystem - Evanston Hospital /ID# 156664	Evanston	Illinois	United States	60201
21	Ingalls Memorial Hosp /ID# 156685	Harvey	Illinois	United States	60426
22	Goshen Center for Cancer Care /ID# 156682	Goshen	Indiana	United States	46526
23	Ashland-Bellefonte Cancer Ctr /ID# 202901	Ashland	Kentucky	United States	41101
24	University of Louisville /ID# 156683	Louisville	Kentucky	United States	40202
25	Ochsner Clinic Foundation /ID# 159136	Baton Rouge	Louisiana	United States	70836-6455
26	Henry Ford Health System /ID# 156712	Detroit	Michigan	United States	48202
27	Sparrow Regional Cancer Center, Sparrow Health System /ID# 156590	Lansing	Michigan	United States	48912
28	Mayo Clinic - Rochester /ID# 160181	Rochester	Minnesota	United States	55905-0001
29	MidAmerica Division, Inc. /ID# 163530	Kansas City	Missouri	United States	64132
30	Billings Clinic /ID# 201788	Billings	Montana	United States	59101-0733
31	Nebraska Hematology Oncology /ID# 156534	Lincoln	Nebraska	United States	68506
32	MD Anderson Cancer Center at Cooper - Camden /ID# 156681	Camden	New Jersey	United States	08103
33	Montefiore Medical Center /ID# 201845	Bronx	New York	United States	10461
34	Northwell Health - Monter Cancer Center /ID# 159252	Lake Success	New York	United States	11042
35	Icahn School of Med Mt. Sinai /ID# 159210	New York	New York	United States	10029
36	Stony Brook University Hospital /ID# 159272	Stony Brook	New York	United States	11794-8183
37	Duke University Medical Center /ID# 156706	Durham	North Carolina	United States	27710-3000
38	Cone Health /ID# 156689	Greensboro	North Carolina	United States	27403
39	Cone Health /ID# 163612	Greensboro	North Carolina	United States	27403
40	Eastern Carolina University /ID# 159264	Greenville	North Carolina	United States	27834
41	Gabrail Cancer Center Research /ID# 156667	Canton	Ohio	United States	44718
42	Kaiser Permanente, NW /ID# 201793	Portland	Oregon	United States	97227
43	Thomas Jefferson University /ID# 156719	Philadelphia	Pennsylvania	United States	19107-4414
44	VA Pittsburgh HealthcareSystem /ID# 159284	Pittsburgh	Pennsylvania	United States	15240
45	Rhode Island Hospital /ID# 160834	Providence	Rhode Island	United States	02903
46	Sarah Cannon Research Institute-Chattanooga /ID# 202933	Chattanooga	Tennessee	United States	37404-1108
47	Thompson Cancer Survival Ctr /ID# 202460	Knoxville	Tennessee	United States	37916
48	Tennessee Oncology-Nashville Centennial /ID# 161168	Nashville	Tennessee	United States	37203-1632
49	Univ Medical Ctr Brackenridge /ID# 155798	Austin	Texas	United States	78701
50	Parkland Health and Hosp Syste /ID# 170933	Dallas	Texas	United States	75235
51	UT Southwestern Medical Center /ID# 157848	Dallas	Texas	United States	75390-7208
52	Houston Methodist Hospital - Scurlock Tower /ID# 202323	Houston	Texas	United States	77030
53	Medical Oncology Associates /ID# 156715	Spokane	Washington	United States	99208
54	West Virginia Univ School Med /ID# 156687	Morgantown	West Virginia	United States	26506
55	Coffs Harbour Hospital /ID# 158880	Coffs Harbour	New South Wales	Australia	2450
56	Gosford Hospital /ID# 158884	Gosford	New South Wales	Australia	2250
57	Newcastle Private Hospital /ID# 203506	Lambton Heights	New South Wales	Australia	2305
58	Royal North Shore Hospital /ID# 158881	Saint Leonards	New South Wales	Australia	2065
59	Calvary North Adelaide Hospita /ID# 161701	Adelaide	South Australia	Australia	5006
60	Sunshine Hospital /ID# 161700	St Albans	Victoria	Australia	3021
61	Affinity Clinical Research Ser /ID# 158887	Nedlands		Australia	6009
62	SMZ Baumgartner Höhe, Otto-Wagner-Spital und Pflegezentrum /ID# 201776	Vienna	Wien	Austria	1140
63	Krankenhaus Nord - Klinik Floridsdorf /ID# 201768	Vienna	Wien	Austria	1210
64	LKH-Univ. Klinikum Graz /ID# 159563	Graz		Austria	8036
65	Ordensklinikum Linz GmbH, Elisabethinen /ID# 159564	Linz		Austria	4020
66	Salzburger Landeskliniken (SALK) /ID# 201779	Salzburg		Austria	5020
67	Bobruysk Interdistrict Onco. /ID# 169393	Bobruisk		Belarus	213825
68	State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 159383	Lesnoy		Belarus	223040
69	Mogilev Reg Clin Oncology Dis /ID# 159384	Mogilev		Belarus	212018
70	CHU Saint-Pierre /ID# 159009	Bruxelles	Bruxelles-Capitale	Belgium	1000
71	Grand Hôpital de Charleroi /ID# 159006	Charleroi	Hainaut	Belgium	6000
72	ZNA Middelheim /ID# 159007	Antwerp		Belgium	2020
73	Hopital de Jolimont /ID# 159005	Haine Saint Paul		Belgium	7100
74	CHU Charleroi (Vesale) /ID# 159008	Montigny-le-tilleul		Belgium	6110
75	Hospital Evangelico de Cachoei /ID# 159657	Cachoeiro de Itapemirim	Espirito Santo	Brazil	29308-020
76	Liga Norte Rio Grandense Cont. /ID# 159011	Natal	Rio Grande Do Norte	Brazil	59075-740
77	Associação Hospital de Caridade Ijuí - Centro de Tratamento de Cancer - CACON /ID# 159013	Ijuí	Rio Grande Do Sul	Brazil	98700-000
78	Associação Hospital Beneficente São Vicente de Paulo - Hospital São Vicente de P /ID# 159661	Passo Fundo	Rio Grande Do Sul	Brazil	99010-080
79	Hospital Sao Lucas da PUCRS /ID# 159662	Porto Alegre	Rio Grande Do Sul	Brazil	90610-000
80	Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 159012	Barretos	Sao Paulo	Brazil	14784-400
81	Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 159659	Sao Jose Do Rio Preto	Sao Paulo	Brazil	15090-000
82	Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 159658	Rio de Janeiro		Brazil	20231-050
83	UMHAT Tsaritsa Joanna - ISUL /ID# 159638	Sofia		Bulgaria	1527
84	UMHAT Sv. Ivan Rilski /ID# 159639	Sofia		Bulgaria	1612
85	British Columbia Cancer Agency /ID# 163721	Surrey	British Columbia	Canada	V3V 1Z2
86	Brampton Civic Hospital /ID# 204425	Brampton	Ontario	Canada	L6R 3J7
87	R.S. McLaughlin Durham Regional /ID# 170870	Oshawa	Ontario	Canada	L1G 2B9
88	Princess Margaret /ID# 170868	Toronto	Ontario	Canada	M5G 2M9
89	Windsor Regional Cancer Centre /ID# 170869	Windsor	Ontario	Canada	N8W 2X3
90	Iucpq-Ul /Id# 159530	Québec	Quebec	Canada	G1V 4G5
91	Fujian Provincial Cancer Hospital /ID# 204864	Fuzhou	Fujian	China	350014
92	Harbin Medical University Cancer Hospital /Id# 203638	Harbin	Heilongjiang	China	150081
93	Hubei Cancer Hospital /ID# 202886	Wuhan	Hubei	China	430079
94	Jilin Cancer Hosptial /ID# 204060	Changchun	Jilin	China	130000
95	The Affiliated Cancer Hospital of Xinjiang Medical university /ID# 203641	Urumqi	Xinjiang	China	830000
96	Yunnan Cancer Hospital /ID# 204911	Kunming	Yunnan	China	650118
97	Zhejiang Cancer hospital /ID# 204640	Hangzhou	Zhejiang	China	310022
98	Sir Run Run Shaw Hospital /ID# 206802	Jianggan Hangzhou	Zhejiang	China	310018
99	Jiangsu Province Hospital /ID# 205183	Nanjing		China	210029
100	4th Military Medical Universit /ID# 203986	Xi'an		China	710038
101	First Affiliated Hospital of Xi'an Jiaotong University /ID# 203733	Xi'an		China	710061
102	Henan Cancer Hospital /ID# 203983	Zhengzhou Henan		China	450008
103	Henan Cancer Hospital /ID# 204636	Zhengzhou Henan		China	450008
104	Klinicki bolnicki centar Sestre milosrdnice /ID# 159090	Zagreb	Grad Zagreb	Croatia	10000
105	Klinika za plucne bolesti Jordanovac /ID# 159505	Zagreb	Grad Zagreb	Croatia	10000
106	Klinicki bolnicki centar Rijeka /ID# 159504	Rijeka	Primorsko-goranska Zupanija	Croatia	51000
107	Thomayerova nemocnice /ID# 159062	Prague	Praha 4	Czechia	140 59
108	Nemocnice Rudolfa a Stefanie /ID# 159655	Benesov		Czechia	256 01
109	Nemocnice Horovice a.s. /ID# 161186	Horovice		Czechia	268 31
110	Vitkovicka nemocnice a. s. /ID# 161187	Ostrava		Czechia	703 84
111	FN Plzen /ID# 204097	Plzen		Czechia	323 00
112	Oblastni Nemocnice Pribram /ID# 159654	Pribram		Czechia	262 04
113	Rigshospitalet /ID# 158055	Copenhagen Ø	Hovedstaden	Denmark	2100
114	Herlev Hospital /ID# 158053	Herlev	Hovedstaden	Denmark	2730
115	Aalborg University Hospital /ID# 203737	Aalborg	Nordjylland	Denmark	9000
116	Odense Universitets Hospital /ID# 158054	Odense C	Syddanmark	Denmark	5000
117	East Tallinn Central Hospital /ID# 160019	Tallinn		Estonia	10138
118	North Estonian Medical Centre /ID# 159779	Tallinn		Estonia	13419
119	Docrates Cancer Center /ID# 159591	Helsinki		Finland	00180
120	CHU Hopital Nord /ID# 160543	Marseille	Bouches-du-Rhone	France	13915
121	Hopital Haut-Lévêque /ID# 160547	Pessac CEDEX	Gironde	France	33604
122	CHU Calmette /ID# 202706	Lille	Hauts-de-France	France	59000
123	Institut Curie /ID# 207514	Paris CEDEX 05	Ile-de-France	France	75248
124	Centre Leon Berard /ID# 160550	Lyon CEDEX 08	Rhone	France	69373
125	Centre Hosp Intercommunal de Creteil /ID# 162686	Creteil	Val-de-Marne	France	94000
126	Hopital Tenon /ID# 160541	Paris		France	75970
127	Hospital Pontchaillou /ID# 160544	Rennes		France	35033
128	Nouvel Hopital Civil (NHC) /ID# 204427	Strasbourg		France	67091
129	Hopital Larrey /ID# 204290	Toulouse		France	31059
130	KH Martha-Maria Halle Dolau /ID# 158794	Halle (Saale)	Sachsen-Anhalt	Germany	06120
131	Charite Universitatsmedizin Berlin Campus Virchow Klinikum /ID# 158783	Berlin		Germany	10117
132	Evangelische Lungenklinik Berl /ID# 158935	Berlin		Germany	13125
133	Asklepios Fachkliniken M. Gaut /ID# 158789	Gauting		Germany	82131
134	Thoraxklinik Heidelberg gGmbH /ID# 158871	Heidelberg		Germany	69126
135	Lungenklinik Hemer /ID# 158790	Hemer		Germany	58675
136	Klinikum Kassel /ID# 158786	Kassel		Germany	34125
137	Klinik Loewenstein GmbH /ID# 158870	Löwenstein		Germany	74245
138	Fachkliniken Wangen /ID# 160779	Wangen		Germany	88239
139	Metropolitan General Hospital /ID# 202422	Cholargos	Attiki	Greece	15562
140	General Hospital of Chest Diseases of Athens SOTIRIA /ID# 159160	Athens		Greece	11527
141	Metropolitan Hospital /ID# 159157	Athens		Greece	18547
142	University General Hospital of Heraklion PA.G.N.I /ID# 202409	Heraklion		Greece	71110
143	University Hospital of Ioannin /ID# 159158	Ioannina		Greece	45500
144	General Oncological Hospital /ID# 159159	Nea Kifisia		Greece	14564
145	Euromedica General Clinic /ID# 159156	Thessaloniki		Greece	54645
146	Queen Elizabeth Hospital /ID# 159565	Kowloon		Hong Kong	852
147	Princess Margaret Hospital /ID# 162810	Lai Chi Kok		Hong Kong	999077
148	Tuen Mun Hospital /ID# 162435	Tuen Mun		Hong Kong	999077
149	CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 158962	Miskolc	Borsod-Abauj-Zemplen	Hungary	3529
150	Orszagos Koranyi Pulmonologiai Intezet /ID# 158953	Budapest XII	Budapest	Hungary	1122
151	Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz - Pulmonologia /ID# 202466	Nyiregyhaza	Szabolcs-Szatmar-Bereg	Hungary	4400
152	Semmelweis Egyetem /ID# 158955	Budapest		Hungary	1085
153	Csongrad Megyei Mellkasi Beteg /ID# 158952	Deszk		Hungary	6772
154	St. James's Hospital /ID# 159712	Dublin 8	Dublin	Ireland	D08 E9P6
155	Cork University Hospital /ID# 159715	Cork		Ireland	T12 E8YV
156	St Vincent's University Hosp /ID# 161678	Dublin		Ireland	D04 T6F4
157	Beaumont Hospital /ID# 159711	Dublin		Ireland	D09 XR63
158	University Hospital Limerick /ID# 159714	Limerick		Ireland	V94F858
159	University Hospital Waterford /ID# 159713	Waterford		Ireland	X91 ER8E
160	Rabin Medical Center /ID# 159764	Petakh Tikva	Tel-Aviv	Israel	4941492
161	Tel Aviv Sourasky Medical Center /ID# 161467	Tel Aviv-Yafo	Tel-Aviv	Israel	6423906
162	Soroka University Medical Center /ID# 159762	Be'er Sheva		Israel	84101
163	Assaf Harofeh Medical Center /ID# 201883	Be'er Ya'akov		Israel	70300
164	Rambam Health Care Campus /ID# 202336	Haifa		Israel	3109601
165	Hadassah /ID# 159763	Jerusalem		Israel	91120
166	Meir Medical Center /ID# 159761	Kfar Saba		Israel	4428164
167	Sheba Medical Center /ID# 159760	Ramat Gan		Israel	5239424
168	IRST IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori /ID# 160898	Meldola	Emilia-Romagna	Italy	47014
169	Policlinico Universitario Campus Bio-Medico /ID# 160874	Rome	Lazio	Italy	00128
170	AUSL 8 Arezzo Ospedale San Don /ID# 160897	Arezzo		Italy	52100
171	A.O.U. San Luigi Gonzaga /ID# 158916	Orbassano		Italy	10043
172	Ospedale Santa Maria delle Cro /ID# 158911	Ravenna		Italy	48121
173	IFO Istituto Nazionale Tumori /ID# 158912	Rome		Italy	00144
174	Aichi Cancer Center Hospital /ID# 164976	Nagoya-shi	Aichi	Japan	464-8681
175	National Cancer Center Hospital East /ID# 165721	Kashiwa-shi	Chiba	Japan	277-8577
176	Kyushu University Hospital /ID# 165722	Fukuoka-shi	Fukuoka	Japan	812-8582
177	Kurume University Hospital /ID# 164595	Kurume-shi	Fukuoka	Japan	830-0011
178	Kanazawa University Hospital /ID# 165127	Kanazawa	Ishikawa	Japan	920-8641
179	Kanagawa Cardiovascular and Respiratory Center /ID# 165015	Yokohama-shi	Kanagawa	Japan	236-0051
180	Yokohama City University Hospital /ID# 165746	Yokohama-shi	Kanagawa	Japan	2360004
181	Japanese Red Cross Okayama Hospital /ID# 165157	Okayama-shi	Okayama	Japan	7008607
182	Kansai Medical University Hospital /ID# 165054	Hirakata-shi	Osaka	Japan	573-1191
183	Kindai University Hospital /ID# 166395	Osaka-sayama-shi	Osaka	Japan	589-8511
184	Shizuoka Cancer Center /ID# 166272	Sunto-gun	Shizuoka	Japan	411-8777
185	Tokushima University Hospital /ID# 166105	Tokushima-shi	Tokushima	Japan	770-8503
186	National Cancer Center Hospital /ID# 166547	Chuo-ku	Tokyo	Japan	104-0045
187	Showa University Hospital /ID# 165575	Shinagawa-ku	Tokyo	Japan
188	Wakayama Medical University /ID# 165946	Wakayama-shi	Wakayama	Japan	641-8510
189	Hyogo Cancer Center /ID# 165138	Akashi		Japan	673-8558
190	National Hospital Organization Himeji Medical Center /ID# 165899	Himeji		Japan	670-8520
191	Matsusaka City Hospital /ID# 166156	Matsusaka-shi MIE		Japan	515-8544
192	Osaka City General Hospital /ID# 165714	Osaka		Japan	534-0021
193	Hokkaido Cancer Center /ID# 165236	Sapporo		Japan	003-0804
194	Sendai Kousei Hospital /ID# 166491	Sendai		Japan	980-0873
195	Kanagawa Cancer Center /ID# 165814	Yokohama		Japan	241-0815
196	Dong-A University Hospital /ID# 159305	Busan	Busan Gwang Yeogsi	Korea, Republic of	49201
197	CHA Bundang Medical center CHA University /ID# 161281	Seongnam si	Gyeonggido	Korea, Republic of	13496
198	Kyungpook National University Chilgok Hospital /ID# 159301	Daegu	Seoul Teugbyeolsi	Korea, Republic of	41404
199	Samsung Medical Center /ID# 159304	Seoul	Seoul Teugbyeolsi	Korea, Republic of	06351
200	Korea University Guro Hospital /ID# 159302	Seoul	Seoul Teugbyeolsi	Korea, Republic of	08308
201	Chungbuk National University /ID# 159300	Cheongju-si		Korea, Republic of	28644
202	Severance Hospital /ID# 159297	Seoul		Korea, Republic of	03722
203	Asan Medical Center /ID# 159299	Seoul		Korea, Republic of	05505
204	Pauls Stradins Clinical /ID# 158715	Riga		Latvia	LV-1002
205	Riga East Clinical University /ID# 158716	Riga		Latvia	LV-1079
206	Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 160016	Kovno	Kaunas	Lithuania	50009
207	Klaipeda University Hospital /ID# 160018	Klaipeda		Lithuania	LT-92288
208	National Cancer Institute /ID# 160017	Vilnius		Lithuania	08660
209	Centro de Investigación Clinica Chapultepec /ID# 160965	Morelia	Michoacan	Mexico	58260
210	Health Pharma professional Ser /ID# 160734	Ciudad de México		Mexico	03810
211	Meander Medisch Centrum /ID# 159064	Amersfoort		Netherlands	3813 TZ
212	Rijnstate /ID# 159063	Arnhem		Netherlands	6815 AD
213	Amphia Ziekenhuis /ID# 159065	Breda		Netherlands	4818 CK
214	Catharina Ziekenhuis /ID# 158082	Eindhoven		Netherlands	5623 EJ
215	Maastricht Universitair Medisch Centrum /ID# 161669	Maastricht		Netherlands	6229 HX
216	Jeroen Bosch Ziekenhuis /ID# 158081	S Hertogenbosch		Netherlands	5223 GZ
217	Universitair Medisch Centrum Utrecht /ID# 158083	Utrecht		Netherlands	3584 CX
218	Akershus universitetssykehus /ID# 201682	Nordbyhagen	Akershus	Norway	1474
219	Drammen Sykehus /ID# 159572	Drammen	Buskerud	Norway	3004
220	Haukeland University Hospital /ID# 159573	Bergen	Hordaland	Norway	5021
221	St. Olavs Hospital HF /ID# 163110	Trondheim	Sor-Trondelag	Norway	7006
222	Radiumhospitalet, OUS /ID# 159574	Oslo		Norway	0379
223	Stavanger Universitetssykehus /ID# 159575	Stavanger		Norway	4011
224	Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 159604	Rzeszów	Podkarpackie	Poland	35-021
225	Wojewodzki Szpital Specjalisty /ID# 159603	Bytom		Poland	41-902
226	Szpitale Pomorskie Sp. z o.o /ID# 159605	Gdynia		Poland	81-519
227	Centro Hospitalar Lisboa Norte, EPE /ID# 159957	Lisbon	Lisboa	Portugal	1769-001
228	IPO Lisboa FG, EPE /ID# 159949	Lisboa		Portugal	1099-023
229	Hospital da Luz, SA /ID# 159954	Lisbon		Portugal	1500-650
230	Unidade Local Saude Matosinhos /ID# 159950	Matosinhos		Portugal	4464-513
231	Centro Hospitalar do Porto EPE /ID# 203582	Porto		Portugal	4099-001
232	Hospital CUF Porto /ID# 159955	Porto		Portugal	4100-180
233	IPO Porto FG, EPE /ID# 159956	Porto		Portugal	4200-072
234	National Medical Research Cntr /ID# 169885	Moscow	Moskovskaya Oblast	Russian Federation	115478
235	Arkhangelsk clinical oncology /ID# 159367	Arkhangelsk		Russian Federation	163045
236	Kaluga Regional Clinical Oncol /ID# 160180	Kaluga		Russian Federation	284007
237	Clinical Onco Dispensary /ID# 159365	Omsk		Russian Federation	644013
238	PMI Euromedservice /ID# 159369	Pushkin		Russian Federation	196603
239	LLC Novaya Clinica /ID# 205523	Pyatigorsk		Russian Federation	357532
240	OOO Centre of Palliative Medicine De Vita /ID# 206855	Saint Petersburg		Russian Federation	197343
241	Ogarev Mordovia State Univ /ID# 205742	Saransk		Russian Federation	430005
242	Smolensk Regional Onc Clin Dis /ID# 159372	Smolensk		Russian Federation	214009
243	LLC BioEq Ltd. /ID# 159368	St. Petersburg		Russian Federation	197342
244	N.N. Petrov Research Inst Onc /ID# 159370	St. Petersburg		Russian Federation	197758
245	Clinical Center Serbia /ID# 160902	Belgrade	Beograd	Serbia	11000
246	Clin Hosp Ctr Bezanijska Kosa /ID# 160903	Belgrade	Beograd	Serbia	11080
247	Clinical Center of Nis /ID# 160905	NIS	Nisavski Okrug	Serbia	18000
248	Institut za onkologiju i radio /ID# 160904	Belgrade		Serbia	11000
249	Institute For Pulmonary Diseas /ID# 164250	Sremska Kamenica		Serbia	21204
250	Cancercare Langenhoven Drive Oncology Centre /ID# 159126	Port Elizabeth	Eastern Cape	South Africa	6045
251	Dr Albert, Bouwer and Jordaan Incorporated /ID# 158873	Pretoria	Gauteng	South Africa	0044
252	Mary Potter Oncology Centre /ID# 158877	Pretoria	Gauteng	South Africa	0181
253	The Oncology Centre /ID# 158872	Durban	Kwazulu-Natal	South Africa	4091
254	Cape Town Oncology Trials /ID# 201311	Cape Town	Western Cape	South Africa	7570
255	Cancercare Outeniqua Oncology Unit /ID# 200689	George	Western Cape	South Africa	6530
256	Hospital Teresa Herrera - CHUAC /ID# 164368	A Coruña	A Coruna	Spain	15006
257	Hospital Regional de Malaga /ID# 164371	Málaga	Malaga	Spain	29010
258	Hospital Parc de Salut del Mar /ID# 159690	Barcelona		Spain	08003
259	Hospital Universitario Vall d'Hebron /ID# 159708	Barcelona		Spain	08035
260	Hospital Clinico Universitario San Carlos /ID# 159706	Madrid		Spain	28040
261	Hospital Universitario Fundacion Jimenez Diaz /ID# 159693	Madrid		Spain	28040
262	Hospital Universitario La Paz /ID# 159692	Madrid		Spain	28046
263	Hospital Clinico Universitario Lozano Blesa /ID# 159709	Zaragoza		Spain	50009
264	Centralsjukhuset, Karlstad /ID# 163451	Karlstad	Varmlands Lan	Sweden	651 85
265	Sahlgrenska US Gbg /ID# 159524	Göteborg	Vastra Gotalands Lan	Sweden	413 46
266	University Hospital Linkoping /ID# 159046	Linkoping		Sweden	581 85
267	Karolinska Univ Sjukhuset /ID# 159649	Solna		Sweden	17176
268	Uppsala University Hospital /ID# 159052	Uppsala		Sweden	75185
269	Hopitaux Universitaires de Geneve /ID# 160603	Genève	Geneve	Switzerland	1205
270	Kantonsspital St. Gallen /ID# 160604	St. Gallen	Sankt Gallen	Switzerland	9007
271	Universitaetsspital Basel /ID# 160605	Basel		Switzerland	4031
272	Luzerner Kantonsspital /ID# 160607	Luzern		Switzerland	6000
273	Kantonsspital Winterthur /ID# 161379	Winterthur		Switzerland	8401
274	China Medical University Hosp /ID# 158981	Taichung City	Taichung	Taiwan	40447
275	National Cheng Kung University Hospital /ID# 158799	Tainan City	Tainan	Taiwan	70403
276	National Taiwan Univ Hosp /ID# 159049	Taipei City	Taipei	Taiwan	10002
277	Tri-Service General Hospital /ID# 158980	Taipei City	Taipei	Taiwan	11490
278	Dalin Tzu Chi General Hospital /ID# 158983	Dalin Township		Taiwan	622
279	Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 158798	Kaohsiung		Taiwan	80708
280	Taichung Veterans General Hosp /ID# 159047	Taichung City		Taiwan	40705
281	Taipei Veterans General Hosp /ID# 203699	Taipei City		Taiwan	11217
282	Hacettepe University Medical Faculty /ID# 159242	Altindağ	Ankara	Turkey	06250
283	Erciyes University Medical Fac /ID# 202269	Melikgazi	Kayseri	Turkey	38030
284	Ataturk Gogus Hastalikl /ID# 159556	Ankara		Turkey	06280
285	Akdeniz Universitesi Tip Fakul /ID# 160791	Antalya		Turkey	07059
286	Bezmi alem Vakif Universitesi /ID# 202267	Istanbul		Turkey	34093
287	Istanbul Medeniyet Universites /ID# 200126	Istanbul		Turkey	34722
288	Ege University Medical Faculty /ID# 159243	Izmir		Turkey	35040
289	Dr. Suat Seren Gogus Has /ID# 159244	Izmir		Turkey	35110
290	Inonu University /ID# 159245	Malatya		Turkey	44280
291	CI Zaporizhzhia Regional Clinical Oncological Dispensary /ID# 159131	Zaporizhzhia	Zaporizka Oblast	Ukraine	69040
292	Regional Municipal Non-Profit Enterprise Bukovynian Clinical Oncology Center /ID# 159864	Chernivtsi		Ukraine	58013
293	Municipal institution Multifie /ID# 159130	Dnipro		Ukraine	49102
294	Regional Center of Oncology /ID# 159132	Kharkiv		Ukraine	61070
295	PE PMC Acinus, Medical and Diagnostic Center /ID# 165543	Kropyvnytskyi		Ukraine	25006
296	Volyn Regional Medical Oncology Centre /ID# 159133	Lutsk		Ukraine	43018
297	Communal Nonprofit Enterprise "Central City Clinical Hospital" of Uzhhorod City /ID# 159865	Uzhhorod		Ukraine	88000
298	Cheltenham General Hospital /ID# 169096	Cheltenham	Gloucestershire	United Kingdom	GL53 7AN
299	Queen Elizabeth Medical Centre /ID# 162899	Birmingham		United Kingdom	B15 2TH
300	The Royal Bournemouth Hospital /ID# 159039	Bournemouth		United Kingdom	BH7 7DW
301	Colchester General Hospital /ID# 159042	Colchester		United Kingdom	CO4 5JL
302	Hereford County Hospital /ID# 159038	Hereford		United Kingdom	HR1 2ER
303	St. George's Healthcare NHS /ID# 202416	London		United Kingdom	SW17 0QT
304	Charing Cross Hospital /ID# 161399	London		United Kingdom	W6 8RF
305	Maidstone Hospital /ID# 159043	Maidstone		United Kingdom	ME16 9QQ
306	Christie NHS Foundation Trust /ID# 159037	Manchester		United Kingdom	M20 4BX
307	The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 159044	Newcastle Upon Tyne		United Kingdom	NE7 7DN
308	Torbay Hospital - So Devon HC /ID# 159041	Torquay		United Kingdom	TQ2 7AA

Sponsors and Collaborators

AbbVie

Investigators

Study Director: AbbVie Inc., AbbVie

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

AbbVie

ClinicalTrials.gov Identifier:

NCT03033511

Other Study ID Numbers:

M16-298
2016-003503-64

First Posted:

Jan 26, 2017

Last Update Posted:

Jul 29, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by AbbVie

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)

Additional relevant MeSH terms:

Lung Neoplasms

Small Cell Lung Carcinoma

Dexamethasone

Dexamethasone acetate

BB 1101

Immunoconjugates

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail

Arm/Group Title	Placebo	Rovalpituzumab Tesirine/Dexamethasone
Arm/Group Description	Placebo every 6 weeks (q6 wk); 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 Placebo for dexamethasone: Placebo for dexamethasone administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle	Rovalpituzumab tesirine/dexamethasone q6 wk; 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 twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle
Period Title: Overall Study
STARTED	376	372
COMPLETED	376	372
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Placebo	Rovalpituzumab Tesirine/Dexamethasone	Total
Arm/Group Description	Placebo every 6 weeks (q6 wk); 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 Placebo for dexamethasone: Placebo for dexamethasone administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle	Rovalpituzumab tesirine/dexamethasone q6 wk; 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 twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle	Total of all reporting groups
Overall Participants	376	372	748
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.8 (8.20)	64.1 (8.40)	63.9 (8.29)
Sex: Female, Male (Count of Participants)
Female	137 36.4%	114 30.6%	251 33.6%
Male	239 63.6%	258 69.4%	497 66.4%
Race/Ethnicity, Customized (Count of Participants)
Hispanic or Latino	18 4.8%	15 4%	33 4.4%
Not Hispanic or Latino	356 94.7%	355 95.4%	711 95.1%
Missing	2 0.5%	2 0.5%	4 0.5%
Race/Ethnicity, Customized (Count of Participants)
White	301 80.1%	314 84.4%	615 82.2%
Black or African American	7 1.9%	2 0.5%	9 1.2%
Asian	66 17.6%	55 14.8%	121 16.2%
American Indian or Alaska Native	2 0.5%	0 0%	2 0.3%
Multiple Races	0 0%	1 0.3%	1 0.1%

Outcome Measures

1. Primary Outcome

Title	Overall Survival (OS) in Participants With Extensive-Stage Small Cell Lung Cancer With Delta-Like Protein 3 High Expression in Tumor (DLL3high)
Description	OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology.
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.

Outcome Measure Data

Analysis Population Description
DLL3 High Set: all randomized participants with extensive-stage small cell lung cancer with delta-like protein 3 high expression in tumor (DLL3high), defined as ≥ 75% tumor cells staining positive according to the VENTANA DLL3 [SP347] immunohistochemistry [IHC] assay.

Arm/Group Title	Placebo	Rovalpituzumab Tesirine/Dexamethasone
Arm/Group Description	Placebo every 6 weeks (q6 wk); 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 Placebo for dexamethasone: Placebo for dexamethasone administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle	Rovalpituzumab tesirine/dexamethasone q6 wk; 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 twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle
Measure Participants	240	217
Median (95% Confidence Interval) [months]	9.79	8.48

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rovalpituzumab Tesirine/Dexamethasone
	Comments
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.537
	Comments	stratified log-rank test
	Method	Log Rank
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 95% 0.84 to 1.36
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	OS in All Randomized Participants
Description	OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology.
Time Frame	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.

Outcome Measure Data

Analysis Population Description
Randomized Set: all randomized participants, grouped according to the treatment arm to which they were randomized regardless the actual treatment received.

Arm/Group Title	Placebo	Rovalpituzumab Tesirine/Dexamethasone
Arm/Group Description	Placebo every 6 weeks (q6 wk); 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 Placebo for dexamethasone: Placebo for dexamethasone administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle	Rovalpituzumab tesirine/dexamethasone q6 wk; 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 twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle
Measure Participants	376	372
Median (95% Confidence Interval) [months]	9.89	8.80

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rovalpituzumab Tesirine/Dexamethasone
	Comments
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	0.237
	Comments	stratified log-rank test
	Method	Log Rank
	Comments

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.12
	Confidence Interval	(2-Sided) 95% 0.92 to 1.36
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	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
Description	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.
Time Frame	Baseline, Weeks 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, Final Visit (up to Week 78)

Outcome Measure Data

Analysis Population Description
Randomized Set: all randomized participants, grouped according to the treatment arm to which they were randomized regardless the actual treatment received. Participants with an assessment at given time point.

Arm/Group Title	Placebo	Rovalpituzumab Tesirine/Dexamethasone
Arm/Group Description	Placebo every 6 weeks (q6 wk); 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 Placebo for dexamethasone: Placebo for dexamethasone administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle	Rovalpituzumab tesirine/dexamethasone q6 wk; 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 twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle
Measure Participants	376	372
Change at Week 6	-3.97 (1.00)	-4.34 (0.95)
Change at Week 12	-1.70 (1.67)	-12.13 (1.27)
Change at Week 18	8.15 (4.02)	-19.52 (4.92)
Change at Week 24	-0.95 (7.32)	-19.39 (6.61)
Change at Week 30	5.33 (4.22)	-16.67 (6.78)
Change at Week 36	-13.33 (NA)	-13.33 (NA)
Change at Week 42	-6.67 (NA)	-3.33 (NA)
Change at Week 48	-6.67 (NA)	-63.33 (NA)
Change at Week 54	-6.67 (NA)
Change at Week 60	0.00 (NA)	0.00 (NA)
Change at Week 66	0.00 (NA)	0.00 (NA)
Change at Week 72	0.00 (NA)
Change at Week 78	0.00 (NA)	0.00 (NA)
Change at Week Final Visit	-4.14 (1.02)	-13.31 (1.12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rovalpituzumab Tesirine/Dexamethasone
	Comments	Change at Week 6
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Least Squares (LS) Mean of Difference
	Estimated Value	-0.36
	Confidence Interval	(2-Sided) 95% -3.08 to 2.35
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.39
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rovalpituzumab Tesirine/Dexamethasone
	Comments	Change at Week 12
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	LS Mean of Difference
	Estimated Value	-10.43
	Confidence Interval	(2-Sided) 95% -14.58 to -6.29
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.12
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rovalpituzumab Tesirine/Dexamethasone
	Comments	Change at Week 18
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	LS Mean of Difference
	Estimated Value	-27.67
	Confidence Interval	(2-Sided) 95% -46.19 to -9.16
	Parameter Dispersion	Type: Standard Error of the Mean Value: 10.57
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rovalpituzumab Tesirine/Dexamethasone
	Comments	Change at Week 24
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	LS Mean of Difference
	Estimated Value	-18.44
	Confidence Interval	(2-Sided) 95% -38.28 to 1.39
	Parameter Dispersion	Type: Standard Error of the Mean Value: 9.99
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rovalpituzumab Tesirine/Dexamethasone
	Comments	Change at Week 30
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	LS Mean of Difference
	Estimated Value	-22.00
	Confidence Interval	(2-Sided) 95% -42.63 to -1.37
	Parameter Dispersion	Type: Standard Error of the Mean Value: 11.27
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rovalpituzumab Tesirine/Dexamethasone
	Comments	Change at Week 36
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	LS Mean of Difference
	Estimated Value	0.00
	Confidence Interval	(2-Sided) % to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rovalpituzumab Tesirine/Dexamethasone
	Comments	Change at Week 42
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	LS Mean of Difference
	Estimated Value	3.33
	Confidence Interval	(2-Sided) % to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rovalpituzumab Tesirine/Dexamethasone
	Comments	Change at Week 48
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	LS Mean of Difference
	Estimated Value	-56.67
	Confidence Interval	(2-Sided) % to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rovalpituzumab Tesirine/Dexamethasone
	Comments	Change at Week 60
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	LS Mean of Difference
	Estimated Value	0.00
	Confidence Interval	(2-Sided) % to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rovalpituzumab Tesirine/Dexamethasone
	Comments	Change at Week 66
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	LS Mean of Difference
	Estimated Value	-0.00
	Confidence Interval	(2-Sided) % to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rovalpituzumab Tesirine/Dexamethasone
	Comments	Change at Week 78
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	LS Mean of Difference
	Estimated Value	0.00
	Confidence Interval	(2-Sided) % to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, Rovalpituzumab Tesirine/Dexamethasone
	Comments	Change at Final Visit
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	LS Mean of Difference
	Estimated Value	-9.17
	Confidence Interval	(2-Sided) 95% -12.16 to -6.19
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.52
	Estimation Comments

Adverse Events

	Placebo		Rovalpituzumab Tesirine/Dexamethasone
Time Frame	All-Cause Mortality: participants were followed for survival for a mean of 7.86 months in the Placebo arm and 8.08 months in the Rovalpituzumab Tesirine Plus Dexamethasone arm. Serious and Other Adverse Events: Day 1 of study treatment through 70 days after last treatment. Mean number of weeks on study treatment was 12.8 in the Placebo arm and 17.5 weeks in the Rovalpituzumab Tesirine Plus Dexamethasone arm.
Adverse Event Reporting Description	All-Cause Mortality is presented for all participants who were enrolled and randomized. Serious and Other Adverse Events are presented for all participants who were enrolled, randomized, and received at least 1 dose of study medication.

Arm/Group Title	Placebo		Rovalpituzumab Tesirine/Dexamethasone
Arm/Group Description	Placebo q6 wk; 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 Placebo for dexamethasone: Placebo for dexamethasone administered orally twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle		Rovalpituzumab tesirine/dexamethasone q6 wk; 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 twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	201/376 (53.5%)		226/372 (60.8%)
Serious Adverse Events
	Placebo		Rovalpituzumab Tesirine/Dexamethasone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	87/373 (23.3%)		157/368 (42.7%)
Blood and lymphatic system disorders
ANAEMIA	1/373 (0.3%)	1	0/368 (0%)	0
FEBRILE NEUTROPENIA	3/373 (0.8%)	3	2/368 (0.5%)	2
LEUKOPENIA	1/373 (0.3%)	1	0/368 (0%)	0
NEUTROPENIA	0/373 (0%)	0	2/368 (0.5%)	2
PANCYTOPENIA	0/373 (0%)	0	2/368 (0.5%)	2
THROMBOCYTOPENIA	0/373 (0%)	0	8/368 (2.2%)	9
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION	1/373 (0.3%)	1	0/368 (0%)	0
ATRIAL FIBRILLATION	1/373 (0.3%)	1	1/368 (0.3%)	2
MYOCARDIAL INFARCTION	1/373 (0.3%)	1	0/368 (0%)	0
PERICARDIAL EFFUSION	2/373 (0.5%)	2	4/368 (1.1%)	4
RIGHT VENTRICULAR FAILURE	0/373 (0%)	0	1/368 (0.3%)	1
SUPRAVENTRICULAR TACHYCARDIA	1/373 (0.3%)	1	1/368 (0.3%)	1
Ear and labyrinth disorders
VERTIGO	1/373 (0.3%)	1	0/368 (0%)	0
Endocrine disorders
HYPERTHYROIDISM	0/373 (0%)	0	1/368 (0.3%)	1
INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION	1/373 (0.3%)	1	0/368 (0%)	0
Eye disorders
ANGLE CLOSURE GLAUCOMA	0/373 (0%)	0	1/368 (0.3%)	1
EYELID OEDEMA	0/373 (0%)	0	1/368 (0.3%)	1
PERIORBITAL SWELLING	0/373 (0%)	0	2/368 (0.5%)	2
VISUAL IMPAIRMENT	1/373 (0.3%)	1	0/368 (0%)	0
Gastrointestinal disorders
ABDOMINAL ADHESIONS	0/373 (0%)	0	1/368 (0.3%)	1
ABDOMINAL PAIN	2/373 (0.5%)	2	6/368 (1.6%)	6
ABDOMINAL PAIN UPPER	0/373 (0%)	0	1/368 (0.3%)	1
ASCITES	0/373 (0%)	0	2/368 (0.5%)	2
COLITIS	0/373 (0%)	0	1/368 (0.3%)	1
CONSTIPATION	1/373 (0.3%)	1	1/368 (0.3%)	1
DIARRHOEA	1/373 (0.3%)	1	0/368 (0%)	0
DUODENAL OBSTRUCTION	0/373 (0%)	0	1/368 (0.3%)	1
DUODENAL ULCER	0/373 (0%)	0	1/368 (0.3%)	1
GASTRIC PERFORATION	0/373 (0%)	0	1/368 (0.3%)	1
GASTRITIS	0/373 (0%)	0	1/368 (0.3%)	1
GASTROINTESTINAL HAEMORRHAGE	1/373 (0.3%)	1	0/368 (0%)	0
INTESTINAL OBSTRUCTION	0/373 (0%)	0	2/368 (0.5%)	2
NAUSEA	0/373 (0%)	0	3/368 (0.8%)	4
PANCREATITIS	0/373 (0%)	0	1/368 (0.3%)	1
STOMATITIS	2/373 (0.5%)	2	1/368 (0.3%)	1
UPPER GASTROINTESTINAL HAEMORRHAGE	0/373 (0%)	0	2/368 (0.5%)	2
VOMITING	2/373 (0.5%)	2	1/368 (0.3%)	1
General disorders
ASTHENIA	1/373 (0.3%)	1	3/368 (0.8%)	3
CHILLS	0/373 (0%)	0	1/368 (0.3%)	1
DEATH	1/373 (0.3%)	1	0/368 (0%)	0
DISEASE PROGRESSION	1/373 (0.3%)	1	0/368 (0%)	0
EUTHANASIA	1/373 (0.3%)	1	0/368 (0%)	0
FACE OEDEMA	0/373 (0%)	0	1/368 (0.3%)	1
FATIGUE	0/373 (0%)	0	2/368 (0.5%)	3
GENERAL PHYSICAL HEALTH DETERIORATION	8/373 (2.1%)	10	9/368 (2.4%)	11
GENERALISED OEDEMA	0/373 (0%)	0	2/368 (0.5%)	2
HYPOTHERMIA	1/373 (0.3%)	1	0/368 (0%)	0
MALAISE	2/373 (0.5%)	2	1/368 (0.3%)	1
MULTIPLE ORGAN DYSFUNCTION SYNDROME	1/373 (0.3%)	1	0/368 (0%)	0
NON-CARDIAC CHEST PAIN	1/373 (0.3%)	1	0/368 (0%)	0
OEDEMA PERIPHERAL	0/373 (0%)	0	2/368 (0.5%)	2
PYREXIA	2/373 (0.5%)	2	2/368 (0.5%)	2
SEROSITIS	0/373 (0%)	0	1/368 (0.3%)	1
SUDDEN DEATH	0/373 (0%)	0	1/368 (0.3%)	1
SWELLING FACE	0/373 (0%)	0	1/368 (0.3%)	1
Hepatobiliary disorders
CHOLECYSTITIS ACUTE	0/373 (0%)	0	1/368 (0.3%)	1
DRUG-INDUCED LIVER INJURY	0/373 (0%)	0	2/368 (0.5%)	2
HEPATIC FAILURE	1/373 (0.3%)	1	0/368 (0%)	0
HEPATIC FUNCTION ABNORMAL	1/373 (0.3%)	1	2/368 (0.5%)	2
HEPATITIS	0/373 (0%)	0	1/368 (0.3%)	1
HEPATOTOXICITY	0/373 (0%)	0	1/368 (0.3%)	1
HYPERBILIRUBINAEMIA	1/373 (0.3%)	1	0/368 (0%)	0
JAUNDICE CHOLESTATIC	0/373 (0%)	0	1/368 (0.3%)	1
LIVER DISORDER	0/373 (0%)	0	1/368 (0.3%)	1
Infections and infestations
BILIARY TRACT INFECTION	1/373 (0.3%)	1	0/368 (0%)	0
BRONCHITIS	0/373 (0%)	0	1/368 (0.3%)	1
CAMPYLOBACTER GASTROENTERITIS	0/373 (0%)	0	1/368 (0.3%)	1
CELLULITIS	0/373 (0%)	0	1/368 (0.3%)	1
CORONA VIRUS INFECTION	0/373 (0%)	0	1/368 (0.3%)	1
CYTOMEGALOVIRUS CHORIORETINITIS	0/373 (0%)	0	1/368 (0.3%)	1
DIVERTICULITIS	0/373 (0%)	0	2/368 (0.5%)	2
ERYSIPELAS	0/373 (0%)	0	1/368 (0.3%)	1
ESCHERICHIA URINARY TRACT INFECTION	0/373 (0%)	0	1/368 (0.3%)	1
GANGRENE	0/373 (0%)	0	1/368 (0.3%)	1
HAEMOPHILUS INFECTION	0/373 (0%)	0	1/368 (0.3%)	1
INFLUENZA	0/373 (0%)	0	1/368 (0.3%)	1
KLEBSIELLA INFECTION	0/373 (0%)	0	1/368 (0.3%)	1
LOWER RESPIRATORY TRACT INFECTION	0/373 (0%)	0	3/368 (0.8%)	3
LUNG ABSCESS	0/373 (0%)	0	1/368 (0.3%)	1
METAPNEUMOVIRUS INFECTION	0/373 (0%)	0	1/368 (0.3%)	1
PNEUMOCYSTIS JIROVECII PNEUMONIA	0/373 (0%)	0	1/368 (0.3%)	1
PNEUMONIA	8/373 (2.1%)	8	14/368 (3.8%)	16
PNEUMONIA BACTERIAL	1/373 (0.3%)	1	0/368 (0%)	0
PNEUMONIA PSEUDOMONAL	1/373 (0.3%)	1	0/368 (0%)	0
PSEUDOMONAS INFECTION	0/373 (0%)	0	1/368 (0.3%)	1
RESPIRATORY TRACT INFECTION	2/373 (0.5%)	2	2/368 (0.5%)	2
RHINITIS	0/373 (0%)	0	1/368 (0.3%)	1
SEPSIS	2/373 (0.5%)	2	6/368 (1.6%)	8
SEPTIC SHOCK	0/373 (0%)	0	1/368 (0.3%)	1
SUBCUTANEOUS ABSCESS	1/373 (0.3%)	1	0/368 (0%)	0
URINARY TRACT INFECTION	1/373 (0.3%)	1	3/368 (0.8%)	3
Injury, poisoning and procedural complications
ANKLE FRACTURE	0/373 (0%)	0	1/368 (0.3%)	1
FALL	1/373 (0.3%)	1	1/368 (0.3%)	1
HIP FRACTURE	1/373 (0.3%)	1	0/368 (0%)	0
HUMERUS FRACTURE	0/373 (0%)	0	1/368 (0.3%)	1
PELVIC FRACTURE	0/373 (0%)	0	1/368 (0.3%)	1
RADIATION PNEUMONITIS	0/373 (0%)	0	1/368 (0.3%)	1
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED	1/373 (0.3%)	1	0/368 (0%)	0
BLOOD CREATININE INCREASED	0/373 (0%)	0	1/368 (0.3%)	1
BLOOD URIC ACID INCREASED	0/373 (0%)	0	1/368 (0.3%)	1
C-REACTIVE PROTEIN INCREASED	0/373 (0%)	0	1/368 (0.3%)	1
HEPATIC ENZYME INCREASED	0/373 (0%)	0	3/368 (0.8%)	4
OXYGEN SATURATION DECREASED	1/373 (0.3%)	1	0/368 (0%)	0
PANCREATIC ENZYMES INCREASED	1/373 (0.3%)	1	0/368 (0%)	0
PLATELET COUNT DECREASED	1/373 (0.3%)	2	2/368 (0.5%)	2
Metabolism and nutrition disorders
CACHEXIA	1/373 (0.3%)	2	0/368 (0%)	0
DECREASED APPETITE	1/373 (0.3%)	2	3/368 (0.8%)	3
DEHYDRATION	0/373 (0%)	0	4/368 (1.1%)	4
DIABETES MELLITUS	1/373 (0.3%)	1	0/368 (0%)	0
DIABETES MELLITUS INADEQUATE CONTROL	0/373 (0%)	0	1/368 (0.3%)	1
FAILURE TO THRIVE	1/373 (0.3%)	1	0/368 (0%)	0
HYPERCALCAEMIA	1/373 (0.3%)	1	0/368 (0%)	0
HYPERGLYCAEMIA	0/373 (0%)	0	1/368 (0.3%)	1
HYPOALBUMINAEMIA	0/373 (0%)	0	3/368 (0.8%)	3
HYPOKALAEMIA	0/373 (0%)	0	1/368 (0.3%)	1
HYPONATRAEMIA	5/373 (1.3%)	6	6/368 (1.6%)	7
HYPOPROTEINAEMIA	0/373 (0%)	0	1/368 (0.3%)	1
Musculoskeletal and connective tissue disorders
ARTHRALGIA	0/373 (0%)	0	2/368 (0.5%)	2
BONE PAIN	1/373 (0.3%)	1	0/368 (0%)	0
FIBROMYALGIA	0/373 (0%)	0	1/368 (0.3%)	1
MUSCULAR WEAKNESS	0/373 (0%)	0	2/368 (0.5%)	2
MUSCULOSKELETAL PAIN	0/373 (0%)	0	1/368 (0.3%)	1
MYALGIA	0/373 (0%)	0	1/368 (0.3%)	1
OSTEOLYSIS	1/373 (0.3%)	1	0/368 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA GASTRIC	0/373 (0%)	0	1/368 (0.3%)	1
INFECTED NEOPLASM	0/373 (0%)	0	1/368 (0.3%)	1
LUNG NEOPLASM	1/373 (0.3%)	1	1/368 (0.3%)	1
MALIGNANT NEOPLASM PROGRESSION	21/373 (5.6%)	25	16/368 (4.3%)	17
METASTASES TO CENTRAL NERVOUS SYSTEM	7/373 (1.9%)	10	7/368 (1.9%)	8
METASTASES TO LIVER	1/373 (0.3%)	1	0/368 (0%)	0
METASTASES TO MENINGES	1/373 (0.3%)	2	2/368 (0.5%)	2
METASTATIC NEOPLASM	1/373 (0.3%)	1	0/368 (0%)	0
NEOPLASM PROGRESSION	1/373 (0.3%)	1	1/368 (0.3%)	1
NEUROENDOCRINE CARCINOMA	1/373 (0.3%)	1	0/368 (0%)	0
SINONASAL PAPILLOMA	0/373 (0%)	0	1/368 (0.3%)	1
SMALL CELL CARCINOMA	1/373 (0.3%)	1	0/368 (0%)	0
SMALL CELL LUNG CANCER METASTATIC	1/373 (0.3%)	1	0/368 (0%)	0
TUMOUR PAIN	0/373 (0%)	0	1/368 (0.3%)	1
Nervous system disorders
BRAIN OEDEMA	0/373 (0%)	0	1/368 (0.3%)	1
COGNITIVE DISORDER	1/373 (0.3%)	1	0/368 (0%)	0
DIZZINESS	0/373 (0%)	0	2/368 (0.5%)	2
DYSMETRIA	1/373 (0.3%)	1	0/368 (0%)	0
EPILEPSY	1/373 (0.3%)	1	2/368 (0.5%)	2
FACIAL PARESIS	1/373 (0.3%)	1	0/368 (0%)	0
HAEMORRHAGE INTRACRANIAL	1/373 (0.3%)	1	0/368 (0%)	0
HYPERAESTHESIA	0/373 (0%)	0	1/368 (0.3%)	1
HYPOAESTHESIA	1/373 (0.3%)	1	0/368 (0%)	0
METABOLIC ENCEPHALOPATHY	0/373 (0%)	0	1/368 (0.3%)	1
NERVOUS SYSTEM DISORDER	0/373 (0%)	0	1/368 (0.3%)	1
PARAPLEGIA	0/373 (0%)	0	1/368 (0.3%)	1
SEIZURE	1/373 (0.3%)	1	1/368 (0.3%)	1
SPINAL CORD COMPRESSION	1/373 (0.3%)	1	0/368 (0%)	0
SYNCOPE	1/373 (0.3%)	1	0/368 (0%)	0
TRANSIENT ISCHAEMIC ATTACK	0/373 (0%)	0	1/368 (0.3%)	1
VOCAL CORD PARALYSIS	0/373 (0%)	0	1/368 (0.3%)	1
Psychiatric disorders
CONFUSIONAL STATE	1/373 (0.3%)	1	1/368 (0.3%)	1
DELIRIUM	0/373 (0%)	0	1/368 (0.3%)	1
MENTAL STATUS CHANGES	1/373 (0.3%)	1	1/368 (0.3%)	1
Renal and urinary disorders
ACUTE KIDNEY INJURY	2/373 (0.5%)	2	1/368 (0.3%)	1
DYSURIA	1/373 (0.3%)	1	0/368 (0%)	0
RENAL FAILURE	0/373 (0%)	0	1/368 (0.3%)	1
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME	0/373 (0%)	0	3/368 (0.8%)	4
ACUTE RESPIRATORY FAILURE	2/373 (0.5%)	3	0/368 (0%)	0
BRONCHIAL OBSTRUCTION	1/373 (0.3%)	1	0/368 (0%)	0
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	2/373 (0.5%)	2	1/368 (0.3%)	1
COUGH	1/373 (0.3%)	1	0/368 (0%)	0
DYSPNOEA	4/373 (1.1%)	5	12/368 (3.3%)	14
DYSPNOEA EXERTIONAL	0/373 (0%)	0	1/368 (0.3%)	1
EPISTAXIS	0/373 (0%)	0	1/368 (0.3%)	1
HYPOXIA	1/373 (0.3%)	1	0/368 (0%)	0
LUNG DISORDER	0/373 (0%)	0	1/368 (0.3%)	1
PLEURAL EFFUSION	2/373 (0.5%)	2	22/368 (6%)	23
PNEUMONITIS	0/373 (0%)	0	7/368 (1.9%)	11
PULMONARY ARTERY THROMBOSIS	1/373 (0.3%)	1	0/368 (0%)	0
PULMONARY EMBOLISM	1/373 (0.3%)	1	1/368 (0.3%)	1
RESPIRATORY DISORDER	0/373 (0%)	0	1/368 (0.3%)	1
RESPIRATORY DISTRESS	0/373 (0%)	0	2/368 (0.5%)	3
RESPIRATORY FAILURE	1/373 (0.3%)	1	5/368 (1.4%)	7
Skin and subcutaneous tissue disorders
DERMATITIS BULLOUS	0/373 (0%)	0	1/368 (0.3%)	1
PHOTOSENSITIVITY REACTION	0/373 (0%)	0	3/368 (0.8%)	3
RASH ERYTHEMATOUS	0/373 (0%)	0	1/368 (0.3%)	1
SKIN EXFOLIATION	0/373 (0%)	0	1/368 (0.3%)	1
Vascular disorders
HYPOTENSION	0/373 (0%)	0	1/368 (0.3%)	1
JUGULAR VEIN THROMBOSIS	0/373 (0%)	0	1/368 (0.3%)	1
SHOCK	0/373 (0%)	0	1/368 (0.3%)	1
SUPERIOR VENA CAVA SYNDROME	3/373 (0.8%)	3	2/368 (0.5%)	2
VASCULAR COMPRESSION	1/373 (0.3%)	1	0/368 (0%)	0
VENA CAVA THROMBOSIS	0/373 (0%)	0	1/368 (0.3%)	1
Other (Not Including Serious) Adverse Events
	Placebo		Rovalpituzumab Tesirine/Dexamethasone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	248/373 (66.5%)		315/368 (85.6%)
Blood and lymphatic system disorders
ANAEMIA	11/373 (2.9%)	18	45/368 (12.2%)	51
NEUTROPENIA	10/373 (2.7%)	11	31/368 (8.4%)	37
THROMBOCYTOPENIA	14/373 (3.8%)	19	61/368 (16.6%)	79
Cardiac disorders
PERICARDIAL EFFUSION	6/373 (1.6%)	7	58/368 (15.8%)	63
Gastrointestinal disorders
ABDOMINAL PAIN	14/373 (3.8%)	14	21/368 (5.7%)	24
CONSTIPATION	35/373 (9.4%)	37	48/368 (13%)	57
DIARRHOEA	35/373 (9.4%)	39	30/368 (8.2%)	35
DYSPEPSIA	4/373 (1.1%)	4	20/368 (5.4%)	23
NAUSEA	51/373 (13.7%)	56	77/368 (20.9%)	86
VOMITING	35/373 (9.4%)	40	35/368 (9.5%)	41
General disorders
ASTHENIA	25/373 (6.7%)	27	34/368 (9.2%)	48
FACE OEDEMA	5/373 (1.3%)	5	41/368 (11.1%)	48
FATIGUE	60/373 (16.1%)	66	91/368 (24.7%)	112
OEDEMA PERIPHERAL	28/373 (7.5%)	32	93/368 (25.3%)	134
PYREXIA	12/373 (3.2%)	13	20/368 (5.4%)	24
Investigations
ALANINE AMINOTRANSFERASE INCREASED	8/373 (2.1%)	8	39/368 (10.6%)	45
ASPARTATE AMINOTRANSFERASE INCREASED	12/373 (3.2%)	13	48/368 (13%)	59
BLOOD ALKALINE PHOSPHATASE INCREASED	6/373 (1.6%)	7	29/368 (7.9%)	44
GAMMA-GLUTAMYLTRANSFERASE INCREASED	3/373 (0.8%)	3	19/368 (5.2%)	21
WEIGHT DECREASED	16/373 (4.3%)	17	19/368 (5.2%)	22
Metabolism and nutrition disorders
DECREASED APPETITE	49/373 (13.1%)	55	95/368 (25.8%)	115
HYPERGLYCAEMIA	3/373 (0.8%)	4	29/368 (7.9%)	32
HYPOALBUMINAEMIA	3/373 (0.8%)	4	32/368 (8.7%)	41
HYPOKALAEMIA	9/373 (2.4%)	10	27/368 (7.3%)	34
Musculoskeletal and connective tissue disorders
ARTHRALGIA	19/373 (5.1%)	20	30/368 (8.2%)	33
BACK PAIN	29/373 (7.8%)	29	22/368 (6%)	23
Nervous system disorders
DIZZINESS	18/373 (4.8%)	18	30/368 (8.2%)	34
HEADACHE	19/373 (5.1%)	19	31/368 (8.4%)	39
Psychiatric disorders
INSOMNIA	13/373 (3.5%)	13	33/368 (9%)	33
Respiratory, thoracic and mediastinal disorders
COUGH	43/373 (11.5%)	47	56/368 (15.2%)	69
DYSPNOEA	39/373 (10.5%)	41	67/368 (18.2%)	83
PLEURAL EFFUSION	11/373 (2.9%)	12	76/368 (20.7%)	98
PRODUCTIVE COUGH	11/373 (2.9%)	12	23/368 (6.3%)	27
Skin and subcutaneous tissue disorders
DRY SKIN	9/373 (2.4%)	9	21/368 (5.7%)	21
ERYTHEMA	5/373 (1.3%)	6	22/368 (6%)	38
PHOTOSENSITIVITY REACTION	5/373 (1.3%)	5	88/368 (23.9%)	128
PRURITUS	17/373 (4.6%)	18	21/368 (5.7%)	25
RASH	8/373 (2.1%)	9	24/368 (6.5%)	30
SKIN TOXICITY	6/373 (1.6%)	6	22/368 (6%)	24

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.

Results Point of Contact

Name/Title	Global Medical Services
Organization	AbbVie
Phone	800-633-9110
Email	abbvieclinicaltrials@abbvie.com

Responsible Party:

AbbVie

ClinicalTrials.gov Identifier:

NCT03033511

Other Study ID Numbers:

M16-298
2016-003503-64

First Posted:

Jan 26, 2017

Last Update Posted:

Jul 29, 2021

Last Verified:

Jul 1, 2021

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

Study Details

Study Description

Brief Summary

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

More Information

Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Statistical Analysis 3

Statistical Analysis 4

Statistical Analysis 5

Statistical Analysis 6

Statistical Analysis 7

Statistical Analysis 8

Statistical Analysis 9

Statistical Analysis 10

Statistical Analysis 11

Statistical Analysis 12

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

More Information

Certain Agreements

Results Point of Contact