Actively Recruiting
A Phase 3, Open Label, Randomized Study Comparing First-Line Tarlatamab Combined With Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in Untreated Extensive Stage Small-Cell Lung Cancer
Led by Amgen · Updated on 2026-06-04
330
Participants Needed
157
Research Sites
27 weeks
Total Duration
On this page
Sponsors
A
Amgen
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing the effectiveness of a combination treatment including tarlatamab, durvalumab, carboplatin, and etoposide to a similar combination without tarlatamab in people with untreated extensive stage small-cell lung cancer (ES-SCLC). This Phase 3 study aims to see if adding tarlatamab can improve overall survival and progression-free survival in this patient group. The study is sponsored by Amgen and focuses on first-line treatment options for this aggressive cancer stage. Participants are assigned randomly to one of two groups. One group will receive tarlatamab combined with durvalumab, carboplatin, and etoposide for four cycles, followed by maintenance treatment with tarlatamab and durvalumab. The other group receives durvalumab, carboplatin, and etoposide for four cycles, followed by durvalumab alone. All drugs are given through intravenous infusions. The study is open-label, meaning both participants and researchers know which treatment is being given. During the study, participants will be monitored up to approximately 3.5 years for overall survival and progression-free survival through blinded independent central review. Additional outcomes like objective response, disease control, duration of response, and treatment-related side effects will be tracked for up to four years. Blood samples will be taken to measure tarlatamab levels and to check for antibodies against the drug. Safety and treatment effects are carefully recorded throughout the study period.
CONDITIONS
Brief Title
A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has provided informed consent before starting any study procedures
- Age 18 years or older (or legal adult age in the country if higher)
- Diagnosed with extensive stage small-cell lung cancer (Stage IV or extensive disease with large tumor volume)
- Measurable disease according to RECIST 1.1 criteria
- Suitable to receive carboplatin, etoposide, and durvalumab as first-line treatment
- Minimum life expectancy of at least 12 weeks
You will not qualify if you...
- History of other cancers within the past 2 years
- Presence of symptomatic central nervous system metastases or leptomeningeal disease
- History of severe or life-threatening immune therapy reactions
- Arterial thrombosis (stroke or transient ischemic attack) within 6 months prior to study
- Active autoimmune or inflammatory disorders
- Active HIV or Hepatitis B or C infection
- Evidence of interstitial lung disease or active non-infectious pneumonitis
- History of solid organ transplant
- Myocardial infarction or symptomatic congestive heart failure above NYHA class II within 6 months prior to study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 4 years
Participants receive intravenous drug infusions according to their assigned group: either tarlatamab combined with durvalumab, carboplatin, and etoposide for 4 cycles followed by tarlatamab and durvalumab, or durvalumab, carboplatin, and etoposide for 4 cycles followed by durvalumab alone.
Regular infusions during treatment cycles with follow-up visits
Duration - Up to approximately 3.5 years
Participants are monitored for overall survival, progression-free survival, response to treatment, and adverse events after completing treatment.
Periodic visits for assessments
Trial Site Locations
Total: 157 locations
1
Cancer and Blood Specialists of Arizona
Casa Grande, Arizona, United States, 85222
Actively Recruiting
2
City of Hope Cancer Center Phoenix
Goodyear, Arizona, United States, 85338
Actively Recruiting
3
Saint Bernards Medical Center
Jonesboro, Arkansas, United States, 72401
Actively Recruiting
4
Translational Research in Oncology US Inc, Trio Central Pharmacy
Los Angeles, California, United States, 90095
Actively Recruiting
5
University of California Los Angeles
Santa Monica, California, United States, 90404
Actively Recruiting
6
Presbyterian Intercommunity Hospital Health Whitter Hospital
Whittier, California, United States, 90602
Actively Recruiting
7
Colorado West Healthcare System dba Grand Valley Oncology
Grand Junction, Colorado, United States, 81505
Actively Recruiting
8
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
Actively Recruiting
9
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States, 06360
Actively Recruiting
10
Cancer Specialists of North Florida - Southpoint
Jacksonville, Florida, United States, 32256
Actively Recruiting
11
Orlando Health Cancer Institute
Kissimmee, Florida, United States, 34744
Actively Recruiting
12
City of Hope Atlanta
Newnan, Georgia, United States, 30265
Actively Recruiting
13
University of Illinois Chicago
Chicago, Illinois, United States, 60612
Actively Recruiting
14
Cancer Care Specialists of Illinois
Decatur, Illinois, United States, 62526
Actively Recruiting
15
Midwestern Regional Medical Center dba City of Hope Chicago
Rockford, Illinois, United States, 61108
Actively Recruiting
16
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
17
Hematology Oncology of Indiana
Indianapolis, Indiana, United States, 46260
Actively Recruiting
18
Cancer Center of Kansas, Heritage Plaza Medical Building
Wichita, Kansas, United States, 67214
Actively Recruiting
19
New England Cancer Specialists
Westbrook, Maine, United States, 04092
Actively Recruiting
20
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
21
Minnesota Oncology Hematology PA
Edina, Minnesota, United States, 55435
Actively Recruiting
22
Allina Health System dba Allina Health Cancer Institute
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
23
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
24
Cancer Partners of Nebraska
Lincoln, Nebraska, United States, 68516
Actively Recruiting
25
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
Actively Recruiting
26
New York Oncology Hematology PC
Albany, New York, United States, 12206
Actively Recruiting
27
New York Cancer and Blood Specialists
Shirley, New York, United States, 11967
Actively Recruiting
28
Oncology Hematology Care, Inc
Cincinnati, Ohio, United States, 45242
Actively Recruiting
29
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
30
Willamette Valley Cancer Institute and Research Center - Eugene
Eugene, Oregon, United States, 97401
Actively Recruiting
31
Kaiser Permanente Medical Center
Portland, Oregon, United States, 97227
Actively Recruiting
32
Baptist Cancer Center
Memphis, Tennessee, United States, 38120
Actively Recruiting
33
United States Oncology Regulatory Affairs Corporate Office
Nashville, Tennessee, United States, 37203
Actively Recruiting
34
Texas Oncology - Dallas Fort Worth
Dallas, Texas, United States, 75246
Actively Recruiting
35
Oncology Consultants
Houston, Texas, United States, 77030
Actively Recruiting
36
US Oncology Research Investigational Products Center
Irving, Texas, United States, 75063
Actively Recruiting
37
University of Texas Health Science Center at Tyler
Tyler, Texas, United States, 75701
Actively Recruiting
38
Texas Oncology Northeast Texas
Tyler, Texas, United States, 75702
Actively Recruiting
39
Virginia Cancer Specialists PC
Fairfax, Virginia, United States, 22031
Actively Recruiting
40
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
41
Swedish Cancer Institute Medical Oncology
Seattle, Washington, United States, 98104
Actively Recruiting
42
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States, 98405
Actively Recruiting
43
West Virginia University Health Sciences Center
Morgantown, West Virginia, United States, 26506
Actively Recruiting
44
Cemic
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1431FWO
Actively Recruiting
45
Hospital Universitario Austral
Pilar, Buenos Aires, Argentina, B1629ODT
Actively Recruiting
46
Sanatorio Parque SA
Rosario, Santa Fe Province, Argentina, 2000
Actively Recruiting
47
Chris OBrien Lifehouse
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
48
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Actively Recruiting
49
Medizinische Universitaet Graz
Graz, Austria, 8036
Actively Recruiting
50
Universitaetsklinikum Krems
Krems, Austria, 3500
Actively Recruiting
51
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, Belgium, 3500
Terminated
52
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, Belgium, 3000
Actively Recruiting
53
AZ Delta Campus Rumbeke
Roeselare, Belgium, 8800
Actively Recruiting
54
Centre Hospitalier Universitaire-Universite Catholique de Louvain Namur-Site Godinne
Yvoir, Belgium, 5530
Actively Recruiting
55
Cenantron Centro Avançado de Tratamento Oncologico Ltda
Belo Horizonte, Minas Gerais, Brazil, 30130-090
Actively Recruiting
56
Liga Norte-Riograndense Contra O Cancer
Natal, Rio Grande do Norte, Brazil, 59062-000
Actively Recruiting
57
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
Actively Recruiting
58
Fund Faculdade Regional Med Sao Jose Rio Preto
São José do Rio Preto, São Paulo, Brazil, 15090-000
Actively Recruiting
59
Centro de Pesquisa do Hospital Albert Einstein
São Paulo, São Paulo, Brazil, 05652-900
Actively Recruiting
60
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100080
Actively Recruiting
61
The Second Attached Hospital Of Fujian Medical University
Quanzhou, Fujian, China, 362002
Actively Recruiting
62
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150000
Actively Recruiting
63
Jiamusi Cancer Hospital
Jiamusi, Heilongjiang, China, 154007
Actively Recruiting
64
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
65
Jiangxi Cancer hospital
Nanchang, Jiangxi, China, 330029
Actively Recruiting
66
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330209
Actively Recruiting
67
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Actively Recruiting
68
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
69
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
70
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China, 030009
Actively Recruiting
71
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 611135
Actively Recruiting
72
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
73
Tianjin Peoples Hospital
Tianjin, Tianjin Municipality, China, 300121
Terminated
74
The First Affiliated Hospital Of Ningbo University
Ningbo, Zhejiang, China, 315010
Actively Recruiting
75
Beijing Cancer Hospital
Beijing, China, 100142
Actively Recruiting
76
Fujian Cancer Hospital
Fuzhou, China, 350011
Actively Recruiting
77
Rigshospitalet
Copenhagen, Denmark, 2100
Completed
78
Regionshospitalet Godstrup
Herning, Denmark, 7400
Completed
79
Centre Hospitalier Intercommunal de Creteil
Créteil, France, 94010
Actively Recruiting
80
Centre Leon Berard
Lyon, France, 69008
Actively Recruiting
81
Centre Hospitalier Universitaire Nord
Marseille, France, 13915
Actively Recruiting
82
Institut Curie
Paris, France, 75005
Actively Recruiting
83
Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec
Saint-Herblain, France, 44800
Actively Recruiting
84
Hopital d instruction des armees sainte anne
Toulon, France, 83800
Actively Recruiting
85
Centre Hospitalier Universitaire de Toulouse - Hopital Larrey
Toulouse, France, 31059
Actively Recruiting
86
Klinikum Chemnitz GmbH
Chemnitz, Germany, 09113
Actively Recruiting
87
Krankenhaus Koeln-Merheim - Kliniken der Stadt Koeln gGmbH
Cologne, Germany, 51109
Actively Recruiting
88
Universitaetsklinikum Dresden
Dresden, Germany, 01307
Actively Recruiting
89
Universitaetsklinikum Essen
Essen, Germany, 45147
Actively Recruiting
90
Krankenhaus Nordwest
Frankfurt am Main, Germany, 60488
Actively Recruiting
91
Asklepios Fachkliniken Muenchen Gauting
Gauting, Germany, 82130
Actively Recruiting
92
LungenClinic Grosshansdorf GmbH
Großhansdorf, Germany, 22927
Actively Recruiting
93
Universitaetsklinikum Schleswig-Holstein - Kiel
Kiel, Germany, 24105
Actively Recruiting
94
Universitaetsklinikum Schleswig-Holstein - Luebeck
Lübeck, Germany, 23538
Actively Recruiting
95
Universitaetsklinikum Wuerzburg
Würzburg, Germany, 97078
Actively Recruiting
96
Henry Dunant Hospital Center
Athens, Greece, 11526
Actively Recruiting
97
Alexandra Hospital
Athens, Greece, 11528
Actively Recruiting
98
European Interbalkan Medical Center
Thessaloniki, Greece, 57001
Actively Recruiting
99
Iatriko Diavalkaniko Thessalonikis
Thessaloniki, Greece, 57001
Actively Recruiting
100
Queen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong
Actively Recruiting
101
Prince of Wales Hospital, Chinese University of Hong Kong
Shatin, New Territories, Hong Kong
Actively Recruiting
102
Matrai Gyogyintezet
Gyöngyös, Hungary, 3200
Actively Recruiting
103
Reformatus Pulmonologiai Centrum
Törökbálint, Hungary, 2045
Actively Recruiting
104
Meir Medical Center
Kfar Saba, Israel, 4428164
Actively Recruiting
105
Rabin Medical Center
Petah Tikva, Israel, 4941492
Actively Recruiting
106
IRCCS Istituto Tumori Giovanni Paolo II
Bari, Italy, 70124
Actively Recruiting
107
Humanitas Gavazzeni
Bergamo, Italy, 24125
Completed
108
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
Meldola (FC), Italy, 47014
Terminated
109
IRCCS Istituto Oncologico Europeo
Milan, Italy, 20141
Actively Recruiting
110
Azienda Ospedaliera San Giovanni Addolorata
Roma, Italy, 00184
Actively Recruiting
111
Centro Ricerche Cliniche Di Verona Societa responsabilita limitata
Verona, Italy, 37126
Actively Recruiting
112
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan, 791-0280
Actively Recruiting
113
Kyushu University Hospital
Fukuoka, Fukuoka, Japan, 812-8582
Actively Recruiting
114
Kurume University Hospital
Kurume-shi, Fukuoka, Japan, 830-0011
Actively Recruiting
115
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan, 003-0804
Actively Recruiting
116
Hyogo Cancer Center
Akashi-shi, Hyōgo, Japan, 673-8558
Actively Recruiting
117
Niigata Cancer Center Hospital
Niigata, Niigata, Japan, 951-8566
Actively Recruiting
118
Okayama University Hospital
Okayama, Okayama-ken, Japan, 700-8558
Actively Recruiting
119
Kansai Medical University Hospital
Hirakata-shi, Osaka, Japan, 573-1191
Actively Recruiting
120
Osaka International Cancer Institute
Osaka, Osaka, Japan, 541-8567
Actively Recruiting
121
Kindai University Hospital
Sakai-shi, Osaka, Japan, 590-0197
Actively Recruiting
122
Saitama Medical University International Medical Center
Hidaka-shi, Saitama, Japan, 350-1298
Actively Recruiting
123
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan, 411-8777
Actively Recruiting
124
Wakayama Medical University Hospital
Wakayama, Wakayama, Japan, 641-8510
Actively Recruiting
125
Health Pharma Professional Research SA de CV
Mexico City, Mexico City, Mexico, 03100
Actively Recruiting
126
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9713 GZ
Actively Recruiting
127
Maastricht Universitair Medisch Centrum
Maastricht, Netherlands, 6229 HX
Actively Recruiting
128
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3015 GD
Actively Recruiting
129
Centrum Pulmonologii i Torakochirurgii w Bystrej
Bystra, Poland, 43-360
Actively Recruiting
130
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-214
Actively Recruiting
131
Instytut Gruzlicy i Chorob Pluc
Warsaw, Poland, 01-138
Actively Recruiting
132
Hospital Cuf Tejo
Lisbon, Portugal, 1350-352
Actively Recruiting
133
Hospital da Luz, SA
Lisbon, Portugal, 1500-650
Actively Recruiting
134
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
Matosinhos Municipality, Portugal, 4464-513
Actively Recruiting
135
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
Cluj-Napoca, Romania, 400015
Actively Recruiting
136
Chungbuk National University Hospital
Cheongju Chungbuk, South Korea, 28644
Actively Recruiting
137
National Cancer Center
Goyang-si Gyeonggi-do, South Korea, 10408
Actively Recruiting
138
Severance Hospital Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
139
Hospital Regional Universitario de Malaga
Málaga, Andalusia, Spain, 29010
Actively Recruiting
140
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain, 08035
Actively Recruiting
141
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, Spain, 08036
Actively Recruiting
142
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain, 08041
Actively Recruiting
143
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain, 28222
Actively Recruiting
144
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, Spain, 46026
Actively Recruiting
145
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Actively Recruiting
146
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
147
Universitaetsspital Basel
Basel, Switzerland, 4052
Actively Recruiting
148
Kantonsspital Graubuenden
Chur, Switzerland, 7000
Actively Recruiting
149
Hopitaux universitaires de Geneve
Geneva, Switzerland, 1211
Actively Recruiting
150
National Cheng Kung University Hospital
Tainan, Taiwan, 70403
Actively Recruiting
151
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
152
Memorial Ankara Hastanesi
Ankara, Turkey (Türkiye), 06520
Actively Recruiting
153
Ankara Bilkent Sehir Hastanesi
Ankara, Turkey (Türkiye), 06800
Actively Recruiting
154
Bagcilar Medipol Mega Universite Hastanesi
Istanbul, Turkey (Türkiye), 34214
Actively Recruiting
155
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
Istanbul, Turkey (Türkiye), 34722
Actively Recruiting
156
Ege Universitesi Tip Fakultesi Hastanesi
Izmir, Turkey (Türkiye), 35100
Actively Recruiting
157
Sakarya Egitim ve Arastirma Hastanesi
Sakarya, Turkey (Türkiye), 54290
Actively Recruiting
Research Team
A
Amgen Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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