DeLLphi-306: Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)

Sponsor

Amgen (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06117774

Collaborator

(none)

400

Enrollment

125

Locations

Arms

68.6

Anticipated Duration (Months)

3.2

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to compare the efficacy of tarlatamab with placebo as assessed by progression free survival (PFS).

Condition or Disease	Intervention/Treatment	Phase
Limited Stage Small Cell Lung Cancer Small Cell Lung Cancer	Drug: Tarlatamab Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Tarlatamab Therapy in Subjects With Limited-Stage Small-Cell Lung Cancer (LS-SCLC) Who Have Not Progressed Following Concurrent Chemoradiation Therapy

Anticipated Study Start Date :

Jan 27, 2024

Anticipated Primary Completion Date :

Oct 16, 2026

Anticipated Study Completion Date :

Oct 15, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tarlatamab Participants will receive tarlatamab on Cycle 1 Day 1, 8 and 15, and once every 2 weeks (Q2W) thereafter (cycle is 28 days).	Drug: Tarlatamab Intravenous (IV) infusion Other Names: AMG 757
Placebo Comparator: Placebo Participants will receive placebo on Cycle 1 Day 1, 8 and 15, and Q2W thereafter (cycle is 28 days).	Drug: Placebo IV infusion

Arm

Intervention/Treatment

Experimental: Tarlatamab

Participants will receive tarlatamab on Cycle 1 Day 1, 8 and 15, and once every 2 weeks (Q2W) thereafter (cycle is 28 days).

Drug: Tarlatamab

Intravenous (IV) infusion

Other Names:

AMG 757

Placebo Comparator: Placebo

Participants will receive placebo on Cycle 1 Day 1, 8 and 15, and Q2W thereafter (cycle is 28 days).

Drug: Placebo

IV infusion

Outcome Measures

Primary Outcome Measures

PFS as Determined by Blinded Independent Central Review (BICR) [Up to approximately 6 years]

Secondary Outcome Measures

Overall Survival (OS) Over the Whole Trial [Up to approximately 6 years]
PFS Determined by Investigator Assessment [Up to approximately 6 years]
Objective Response (OR) Rate [Up to approximately 6 years]
Disease Control (DC) Rate [Up to approximately 6 years]
Duration of Response (DOR) [Up to approximately 6 years]
PFS at 6 months, 1 year, 2 years [6 months, 1 year, 2 years]
OS at 6 months, 1 year, 2 years, 3 years [6 months, 1 year, 2 years, 3 years]
Time to Progression (TTP) [Up to approximately 6 years]
Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Up to approximately 6 years]
Serum Concentration of Tarlatamab [Up to approximately 4 months]
Incidence of Anti-tarlatamab Antibody Formation [Up to approximately 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria: -Participants are eligible to be included in the study only if all of the following criteria apply:

Participant has provided informed consent prior to initiation of any study specific activities/procedures.
Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
Histologically or cytologically confirmed small-cell lung cancer (SCLC).
Diagnosed and treated for LS-SCLC with concurrent chemotherapy and radiotherapy.
Has completed chemoradiotherapy without progression per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1.)
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
Minimum life expectancy of 12 weeks.
Adequate organ function.
Toxicities attributed to concurrent chemoradiotherapy resolved to grade ≤ 1, unless otherwise specified. Excluding alopecia.

Exclusion Criteria: -Participants are excluded from the study if any of the following criteria apply:

Disease Related

Extensive-stage SCLC (ES-SCLC).
Any previous diagnosis of transformed non-small-cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that has transformed to SCLC, or mixed SCLC NSCLC histology.
Evidence of interstitial lung disease or active, non-infectious pneumonitis. Other Medical Conditions
History of other malignancy within the past 2 years, with certain exceptions.
History of solid organ transplantation.
Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 6 months prior to first dose of study treatment.
History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.
Exclusion of human immunodeficiency virus (HIV) and hepatitis infection based on criteria per protocol.
Participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment.

Prior/Concomitant Therapy

Received sequential chemotherapy and thoracic radiotherapy (no overlap of thoracic radiotherapy with chemotherapy) during chemoradiation.
Prior therapy with any selective inhibitor of the delta-like ligand 3 (DLL3) pathway.
Prior history of severe or life-threatening events from any immune-mediated therapy.
Receiving another anti-cancer therapy. Adjuvant hormonal therapy for resected breast cancer is permitted.
Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to enrollment.
Major surgical procedures within 28 days prior to first dose of study treatment.
Treatment with live virus, including live-attenuated vaccination, within 14 days prior to the first dose of study treatment. Inactive vaccines and live viral non-replicating vaccines within 3 days prior to first dose of study treatment.

Prior/Concurrent Clinical Study Experience

• Treatment in an alternative investigational trial within 28 days prior to enrollment.

Other Exclusions

Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 72 days after the last dose of study treatment.
Female participants who are breastfeeding or who plan to breastfeed while on study through 72 days after the last dose of study treatment.
Female participants planning to become pregnant or donate eggs while on study through 72 days after the last dose of study treatment.
Female participants of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive serum pregnancy test.
Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 132 days after the last dose of study treatment.
Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 132 days after the last dose of study treatment.
Male participants unwilling to abstain from donating sperm during treatment and for an additional 132 days after the last dose of study treatment.
Participant has known sensitivity to any of the products or components to be administered during dosing.
Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the participant and investigator's knowledge.
History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Allina Health System dba Virginia Piper Cancer Institute	Minneapolis	Minnesota	United States	55407
2	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
3	Morristown Medical Center	Morristown	New Jersey	United States	07960
4	Montefiore Einstein Center for Cancer Care	Bronx	New York	United States	10461
5	Laura and Isaac Perlmutter Cancer Center at New York University Langone	New York	New York	United States	10016
6	FirstHealth Outpatient Cancer Center	Pinehurst	North Carolina	United States	28374
7	Lehigh Valley Health Network	Allentown	Pennsylvania	United States	18103
8	Hospital Aleman Buenos Aires	Ciudad Autonoma de Buenos Aires	Buenos Aires	Argentina	C1118AAT
9	Hospital Italiano de La Plata	La Plata	Buenos Aires	Argentina	1900
10	Instituto Oncologico de Cordoba Ionc Fundacion Richardet Longo	Cordoba	Córdoba	Argentina	5003
11	Sanatorio 9 de julio - C.I.C.E. 9 de Julio	San Miguel de Tucuman	Tucuman	Argentina	4000
12	Fundacion Respirar	Buenos Aires		Argentina	C1426ABP
13	Chris OBrien Lifehouse	Camperdown	New South Wales	Australia	2050
14	Port Macquarie Base Hospital	Port Macquarie	New South Wales	Australia	2444
15	Westmead Hospital	Westmead	New South Wales	Australia	2145
16	Monash Medical Centre	Clayton	Victoria	Australia	3168
17	Fiona Stanley Hospital	Murdoch	Western Australia	Australia	6150
18	Medizinische Universitaet Graz	Graz		Austria	8036
19	Universitaetsklinikum Allgemeines Krankenhaus Wien	Wein		Austria	1090
20	Institut Jules Bordet	Anderlecht		Belgium	1070
21	Universitair Ziekenhuis Gent	Gent		Belgium	9000
22	Universitair Ziekenhuis Leuven - Campus Gasthuisberg	Leuven		Belgium	3000
23	Hospital Santa Rita	Vitoria	Espírito Santo	Brazil	29043-260
24	Londrina Cancer Hospital	Londrina	Paraná	Brazil	86015-520
25	Cipo Centro Integrado de Pesquisa e Servicos Hospitalares em Oncologia Ltda	Porto Alegre	Rio Grande Do Sul	Brazil	91350-200
26	Centro de pesquisa em oncologia Hospital Ana Nery	Santa Cruz do Sul	Rio Grande Do Sul	Brazil	96835-090
27	Centro Catarinense de Pesquisa LTDA	Blumenau	Santa Catarina	Brazil	89015-200
28	Fundacao Pio 12 Hospital de Amor de Barretos	Barretos	São Paulo	Brazil	14784-400
29	Fundacao Amaral Carvalho	Jau	São Paulo	Brazil	17210-120
30	Cepho	Santo Andre	São Paulo	Brazil	09060-650
31	Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira Icesp	Sao Paulo	São Paulo	Brazil	01308-050
32	Multiprofile Hospital for Active Treatment - Uni Hospital OOD	Panagyurishte		Bulgaria	4500
33	Complex Oncology Center Plovdiv EOOD	Plovdiv		Bulgaria	4004
34	Complex Oncology Center Shumen EOOD	Shumen		Bulgaria	9700
35	University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD	Sofia		Bulgaria	1527
36	Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia	Sofia		Bulgaria	1606
37	Multiprofile Hospital for Active Treatment Serdika EOOD	Sofia		Bulgaria	1632
38	University Multiprofile Hospital for Active Treatment Sofiamed OOD	Sofia		Bulgaria	1797
39	Centre Hospitalier Universitaire de Marseille - Hopital de la Timone	Marseille		France	13005
40	Universitaetsklinikum	Essen		Germany	45147
41	Universitaetsmedizin Goettingen	Göttingen		Germany	37075
42	Universitaetsklinikum Heidelberg	Heidelberg		Germany	69126
43	Universitaetsklinikum Wuerzburg	Wuerzburg		Germany	97080
44	Agios Savvas Anticancer Hospital	Athens		Greece	11522
45	Henry Dunant Hospital Center	Athens		Greece	11526
46	Sotiria General Hospital	Athens		Greece	11527
47	Attikon University Hospital	Athens		Greece	12462
48	Metropolitan Hospital	Athens		Greece	18547
49	Saint Lukes Hospital SA	Thessaloniki		Greece	55236
50	European Interbalkan Medical Center	Thessaloniki		Greece	57001
51	Princess Margaret Hospital	Kowloon		Hong Kong
52	Prince of Wales Hospital	Shatin		Hong Kong
53	Rambam Medical Center	Haifa		Israel	3109601
54	Fondazione IRCCS Istituto Nazionale dei Tumori	Milano		Italy	20133
55	Istituto Oncologico Veneto IRCCS	Padova		Italy	35128
56	Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia	Perugia		Italy	06132
57	Azienda Ospedaliero Universitaria Pisana, Presidio Cisanello	Pisa		Italy	56126
58	Policlinico Universitario Agostino Gemelli	Rome		Italy	00168
59	National Hospital Organization Nagoya Medical Center	Nagoya-shi	Aichi	Japan	460-0001
60	National Cancer Center Hospital East	Kashiwa-shi	Chiba	Japan	277-8577
61	National Hospital Organization Shikoku Cancer Center	Matsuyama-shi	Ehime	Japan	791-0280
62	Kurume University Hospital	Kurume-shi	Fukuoka	Japan	830-0011
63	National Hospital Organization Hokkaido Cancer Center	Sapporo-shi	Hokkaido	Japan	003-0804
64	Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center	Yokohama-shi	Kanagawa	Japan	241-8515
65	Sendai Kousei Hospital	Sendai-shi	Miyagi	Japan	980-0873
66	Niigata Cancer Center Hospital	Niigata-shi	Niigata	Japan	951-8566
67	Okayama University Hospital	Okayama-shi	Okayama	Japan	700-8558
68	Kansai Medical University Hospital	Hirakata-shi	Osaka	Japan	573-1191
69	Osaka International Cancer Institute	Osaka-shi	Osaka	Japan	541-8567
70	Kindai University Hospital	Osakasayama-shi	Osaka	Japan	589-8511
71	Saitama Medical University International Medical Center	Hidaka-Shi	Saitama	Japan	350-1298
72	Shizuoka Cancer Center	Nagaizumi	Shizuoka	Japan	411-8777
73	Dokkyo Medical University Hospital	Mibu	Tochigi	Japan	321-0293
74	Juntendo University Hospital	Bunkyo-ku	Tokyo	Japan	113-8431
75	National Cancer Center Hospital	Chuo-ku	Tokyo	Japan	104-0045
76	The Cancer Institute Hospital of Japanese Foundation for Cancer Research	Koto-ku	Tokyo	Japan	135-8550
77	Wakayama Medical University Hospital	Wakayama-shi	Wakayama	Japan	641-8510
78	Oncare	México City	Distrito Federal	Mexico	03810
79	Phylasis Clínicas Research (Toluca)	Toluca		Mexico	50090
80	Uniwersytecki Szpital Kliniczny w Bialymstoku	Bialystok		Poland	15-540
81	Centrum Pulmunologii i Torakochirurgii w Bystrej	Bystra		Poland	43-360
82	Uniwersyteckie Centrum Kliniczne	Gdańsk		Poland	80-214
83	Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie	Lublin		Poland	20-954
84	Wielkopolskie Centrum Pulmonologii i Torakochirurgii imienia Eugenii i Janusza Zeylandow	Poznań		Poland	60-569
85	Wojewodzki Szpital im Sw Ojca Pio w Przemyslu	Przemysl		Poland	37-700
86	Specjalistyczny Szpital Onkologiczny NU-MED Sp z o o	Tomaszow Mazowiecki		Poland	97-200
87	Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy	Warsaw		Poland	02-781
88	Hospital de Braga, EPE	Braga		Portugal	4710-243
89	Hospital da Luz, SA	Lisbon		Portugal	1500-650
90	Hospital Cuf porto	Porto		Portugal	4100-180
91	Centro Hospitalar de Setubal EPE Hospital de Sao Bernardo	Setubal		Portugal	2910-446
92	Spitalul Universitar de Urgenta Elias	Bucharest		Romania	011461
93	Institutul Oncologic, Prof Dr Alexandru Trestioreanu	Bucuresti		Romania	022328
94	Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca	Cluj Napoca		Romania	400015
95	Centrul de Oncologie Sf Nectarie SRL	Craiova		Romania	200542
96	Institutul Regional de Oncologie Iasi	Iasi		Romania	700483
97	Spitalul Municipal Ploiesti	Ploiesti		Romania	100337
98	SC Oncomed SRL	Timisoara		Romania	300239
99	National Cancer Centre Singapore	Singapore		Singapore	168583
100	Icon Cancer Centre Singapore - Farrer Park	Singapore		Singapore	217562
101	Hospital Universitario Insular de Gran Canaria	Las Palmas de Gran Canaria	Canarias	Spain	35016
102	Hospital Universitari Germans Trias i Pujol	Badalona	Cataluña	Spain	08916
103	Hospital del Mar	Barcelona	Cataluña	Spain	08003
104	Instituto Valenciano de Oncologia	Valencia	Comunidad Valenciana	Spain	46009
105	Hospital Clinico Universitario de Santiago	Santiago de Compostela	Galicia	Spain	15706
106	Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda	Madrid	Spain	28222
107	Hospital General Universitario Gregorio Marañon	Madrid		Spain	28007
108	Hospital Universitario 12 de Octubre	Madrid		Spain	28041
109	Hospital Regional Universitario de Malaga	Malaga		Spain	29010
110	Hospital Universitario Virgen del Rocio	Sevilla		Spain	41013
111	Sahlgrenska Universitetssjukhuset	Göteborg		Sweden	41346
112	Kantonsspital Baden	Baden		Switzerland	5404
113	Universitaetsspital Basel	Basel		Switzerland	4052
114	Ospedale Regionale di Bellinzona e Vali	Bellinzona		Switzerland	6500
115	Inselspital Bern	Bern		Switzerland	3010
116	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung		Taiwan	80756
117	National Taiwan University Hospital	Taipei		Taiwan	10048
118	Taipei Veterans General Hospital	Taipei		Taiwan	11217
119	Ankara Bilkent Sehir Hastanesi	Istanbul		Turkey	34485
120	Izmir Medical Point Hastanesi	Istanbul		Turkey	34485
121	Kocaeli Universitesi Arastirma ve Uygulama Hastanesi	Istanbul		Turkey	34485
122	Marmara Universitesi Pendik Egitim Arastirma Hastanesi	Istanbul		Turkey	34485
123	Medical Park Adana Hastanesi	Istanbul		Turkey	34485
124	Medipol Mega Universite Hastanesi	Istanbul		Turkey	34485
125	Christie Hospital	Manchester		United Kingdom	M20 4BX