Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC) | NCT06117774 | Trialant

Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC) | NCT06117774 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: 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 RECIST 1.1 (ie, achieved complete response [CR], partial response [PR], or stable disease [SD]).

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 or fatigue.

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) or active 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 60 days after the last dose of study treatment.

Female participants who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of study treatment.

Female participants planning to become pregnant or donate eggs while on study through 60 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 60 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 60 days after the last dose of study treatment.

Male participants unwilling to abstain from donating sperm during treatment and for an additional 60 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 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.

Valkyrie Clinical Trials

Los Angeles, California 90067, United States

University of California Los Angeles

Santa Monica, California 90404, United States

Yale New Haven Hospital

New Haven, Connecticut 06510, United States

Boca Raton Clinical Research Global South Florida

Plantation, Florida 33322, United States

University of Louisville James Graham Brown Cancer Center

Louisville, Kentucky 40202, United States

Our Lady of the Lake Cancer Institute

Baton Rouge, Louisiana 70808, United States

Morristown Medical Center

Morristown, New Jersey 07960, United States

New York University Grossman School of Medicine and New York University Langone Hospitals

New York, New York 10016, United States

Perlmutter Cancer Center at New York University Langone Hospital - Long Island

New York, New York 10016, United States

Montefiore Einstein Center for Cancer Care

The Bronx, New York 10461, United States

FirstHealth Cancer Center

Pinehurst, North Carolina 28374, United States

Lehigh Valley Health Network

Allentown, Pennsylvania 18103, United States

Spokenword Clinical Trials

Easton, Pennsylvania 18045, United States

Renovatio Clinical

The Woodlands, Texas 77380, United States

US Oncology Research Investigational Products Center

The Woodlands, Texas 77380, United States

University of Virginia Health System

Charlottesville, Virginia 22908, United States

Virginia Cancer Specialists, PC

Fairfax, Virginia 22031, United States

West Virginia University Health Sciences Center

Morgantown, West Virginia 26506, United States

Fundacion Respirar

Ciudad Autonoma de Buenos Aires, Buenos Aires C1426ABP, Argentina

Hospital Italiano de La Plata

La Plata, Buenos Aires 1900, Argentina

Hospital Universitario Austral

Pilar, Buenos Aires B1629ODT, Argentina

Instituto Oncologico de Cordoba Ionc Fundacion Richardet Longo

Córdoba, Córdoba Province 5003, Argentina

Hospital Aleman Buenos Aires

CABA, Distrito Federal C1118AAT, Argentina

Clinica Viedma

Viedma, Río Negro Province R8500ACE, Argentina

Sanatorio 9 de Julio Cice 9 de Julio

San Miguel de Tucumán, Tucumán Province 4000, Argentina

Instituto Argentino de Diagnóstico y Tratamiento

Buenos Aires, C1122AAL, Argentina

Port Macquarie Base Hospital

Port Macquarie, New South Wales 2444, Australia

Westmead Hospital

Westmead, New South Wales 2145, Australia

Flinders Medical Centre

Bedford Park, South Australia 5042, Australia

Monash Medical Centre

Clayton, Victoria 3168, Australia

Fiona Stanley Hospital

Murdoch, Western Australia 6150, Australia

Medizinische Universitaet Graz

Graz, 8036, Austria

Universitaetsklinikum Allgemeines Krankenhaus Wien

Vienna, 1090, Austria

Institut Jules Bordet

Brussels, B-1070, Belgium

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Hospital Santa Rita

Vitória, Espírito Santo 29043-260, Brazil

Oncoclinicas Onco Vida Distrito Federal

Brasília, Federal District 70200-730, Brazil

Liga Paranaense do Combate ao Cancer - Hospital Erasto Gaertner

Curitba, Paraná 81520-060, Brazil

Londrina Cancer Hospital

Londrina, Paraná 86015-520, Brazil

Liga Norte-Riograndense Contra O Cancer

Natal, Rio Grande do Norte 59075-740, Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul 90035-003, Brazil

Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul 90610-000, Brazil

Cipo - Centro Integrado de Pesquisa em Oncologia

Porto Alegre, Rio Grande do Sul 91350-200, Brazil

Centro de pesquisa em oncologia Hospital Ana Nery

Santa Cruz do Sul, Rio Grande do Sul 96835-090, Brazil

Centro Catarinense de Pesquisa LTDA

Blumenau, Santa Catarina 89015-200, Brazil

Fundacao pio xII Barretos

Barretos, São Paulo 14784-400, Brazil

Fundacao Amaral Carvalho

Jaú, São Paulo 17210-120, Brazil

Cepho

Santo André, São Paulo 09060-650, Brazil

Instituto Dor de Pesquisa e Ensino

Rio de Janeiro, 22793-080, Brazil

Instituto Cancer Sao Paulo Icesp

São Paulo, 01246-000, Brazil

Multiprofile Hospital for Active Treatment - Uni Hospital OOD

Panagyurishte, 4500, Bulgaria

Complex Oncology Center Plovdiv EOOD

Plovdiv, 4004, Bulgaria

Complex Oncology Center Shumen EOOD

Shumen, 9700, Bulgaria

University Multiprofile Hospital for Active Treatment Sofiamed OOD

Sofia, 1113, Bulgaria

University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

Sofia, 1527, Bulgaria

Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia

Sofia, 1606, Bulgaria

Multiprofile Hospital for Active Treatment Serdikamed EOOD

Sofia, 1632, Bulgaria

Beijing Cancer Hospital

Beijing, Beijing Municipality 100142, China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality 400030, China

Fujian Cancer Hospital

Fuzhou, Fujian 350014, China

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian 350025, China

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong 510060, China

Henan Cancer Hospital

Zhengzhou, Henan 450003, China

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei 430030, China

Renmin Hospital of Wuhan University

Wuhan, Hubei 430060, China

Hubei Cancer Hospital

Wuhan, Hubei 430070, China

Hunan Cancer Hospital

Changsha, Hunan 410013, China

Northern Jiangsu Peoples hospital

Yangzhou, Jiangsu 225009, China

Jiangxi Cancer hospital

Nanchang, Jiangxi 330029, China

The First Bethune Hospital of Jilin University

Changchun, Jilin 130021, China

Cancer Hospital of Shandong First Medical University

Jinan, Shandong 250117, China

Qingdao Municipal Hospital

Qingdao, Shandong 266000, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality 200032, China

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi 030009, China

Shanxi Bethune Hospital

Taiyuan, Shanxi 030032, China

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality 300060, China

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang 830011, China

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang 310003, China

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang 315016, China

Zhejiang Taizhou Hospital

Taizhou, Zhejiang 317099, China

Centro de Tratamiento e Investigación sobre Cancer Luis Carlos Sarmiento Angulo Ctic

Bogota, Cundinamarca 0129, Colombia

Instituto Nacional de Cancerologia

Bogota, Cundinamarca 111711, Colombia

Instituto Medico de Alta Tecnologia sas - Imat sas

Montería, Departamento de Córdoba, Colombia

Oncologos del Occidente SAS

Pereira, Risaralda Department 660001, Colombia

Fundacion cardiovascular de Colombia

Bucaramanga, Santander Department 681017, Colombia

Centre Hospitalier Régional Universitaire de Lille - Institut Coeur Poumon

Lille, 59037, France

Centre Hospitalier Universitaire Nord

Marseille, 13915, France

Centre Hospitalier Universitaire de Nice - Hopital Pasteur

Nice, 06002, France

Hopital Bichat Claude Bernard

Paris, 75018, France

Hopital Nord Ouest Villefranche sur Saone

Villefranche-sur-Saône, 69400, France

Universitaetsklinikum Essen

Essen, 45147, Germany

Universitaetsmedizin Goettingen

Göttingen, 37075, Germany

Universitaetsklinikum Wuerzburg

Würzburg, 97078, Germany

Agios Savvas Anticancer Hospital

Athens, 11522, Greece

Henry Dunant Hospital Center

Athens, 11526, Greece

Sotiria General Hospital

Athens, 11527, Greece

University General Hospital Attikon General Hospital Of West Attica H Agia Varvara

Athens, 12462, Greece

Metropolitan General

Athens, 15562, Greece

Metropolitan Hospital

Athens, 18547, Greece

Saint Luke Hospital

Thessaloniki, 55236, Greece

European Interbalkan Medical Center

Thessaloniki, 57001, Greece

Queen Mary Hospital, The University of Hong Kong

Hong Kong, Hong Kong

Prince of Wales Hospital, Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

Centro di Riferimento Oncologico di Aviano

Aviano PN, 33081, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

IRCCS Istituto Oncologico Europeo

Milan, 20141, Italy

Azienda Ospedaliera Universitaria San Luigi Gonzaga

Orbassano, 10043, Italy

Istituto Oncologico Veneto IRCCS

Padova, 35128, Italy

Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia

Perugia, 06156, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, 56124, Italy

Azienda Unita Sanitaria Locale di Reggio Emilia Arcispedale Santa Maria Nuova

Reggio Emilia, 42123, Italy

IRCCS Istituto Clinico Humanitas

Rozzano MI, 20089, Italy

Ospedale San Giuseppe Moscati

Statte, 74010, Italy

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken 460-0001, Japan

National Cancer Center Hospital East

Kashiwa-shi, Chiba 277-8577, Japan

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime 791-0280, Japan

Kurume University Hospital

Kurume-shi, Fukuoka 830-0011, Japan

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido 003-0804, Japan

Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

Yokohama, Kanagawa 241-8515, Japan

Sendai Kousei Hospital

Sendai, Miyagi 981-0914, Japan

Niigata Cancer Center Hospital

Niigata, Niigata 951-8566, Japan

Okayama University Hospital

Okayama, Okayama-ken 700-8558, Japan

Kansai Medical University Hospital

Hirakata-shi, Osaka 573-1191, Japan

Osaka International Cancer Institute

Osaka, Osaka 541-8567, Japan

Kindai University Hospital

Osakasayama-shi, Osaka 589-8511, Japan

Saitama Medical University International Medical Center

Hidaka-Shi, Saitama 350-1298, Japan

Saitama Cancer Center

Kitaadachi-gun, Saitama 362-0806, Japan

Shizuoka Cancer Center

Sunto-gun, Shizuoka 411-8777, Japan

Dokkyo Medical University Hospital

Shimotsuga-gun, Tochigi 321-0293, Japan

Juntendo University Hospital

Bunkyo-ku, Tokyo 113-8431, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo 104-0045, Japan

The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Koto-ku, Tokyo 135-8550, Japan

Wakayama Medical University Hospital

Wakayama, 641-8509, Japan

Centro Oncologico Personalizado

Cuauhtémoc, Mexico City 06760, Mexico

Oncare

Mexico City, Mexico City 03810, Mexico

Oncocenter Clinica Integral Internacional de Oncologia

Puebla City, 72530, Mexico

Phylasis Clinicas Research Toluca

Toluca, 50090, Mexico

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, 15-540, Poland

Centrum Pulmonologii i Torakochirurgii w Bystrej

Bystra, 43-360, Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214, Poland

Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie

Lublin, 20-090, Poland

Wielkopolskie Centrum Pulmonologii i Torakochirurgii imienia Eugenii i Janusza Zeylandow

Poznan, 60-569, Poland

Szpital Specjalistyczny w Prabutach Spolka z Ograniczoną Odpowiedzialnoscia

Prabuty, 82-550, Poland

Wojewodzki Szpital im Sw Ojca Pio w Przemyslu

Przemyśl, 37-700, Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

Warsaw, 02-781, Poland

Unidade Local de Saude de Braga, EPE

Braga, 4710-243, Portugal

Hospital da Luz, SA

Lisbon, 1500-650, Portugal

Hospital Cuf porto

Porto, 4100-180, Portugal

Spitalul Clinic de Urgenta Prof Dr Agrippa Ionescu

Balotesti, Ilfov, 077015, Romania

Institutul Oncologic, Prof Dr Alexandru Trestioreanu

Bucharest, 022328, Romania

Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

Cluj-Napoca, 400015, Romania

Centrul de Oncologie Sf Nectarie SRL

Craiova, 200542, Romania

Institutul Regional de Oncologie Iasi

Iași, 700483, Romania

Spitalul Municipal Ploiesti

Ploieşti, 100337, Romania

SC Oncomed SRL

Timișoara, 300239, Romania

National Cancer Centre Singapore

Singapore, 168583, Singapore

Icon - Mount Alvernia

Singapore, 217562, Singapore

Chungbuk National University Hospital

Cheongju Chungbuk, 28644, South Korea

National Cancer Center

Goyang-si Gyeonggi-do, 10408, South Korea

Gachon University Gil Medical Center

Incheon, 405-760, South Korea

Gyeongsang National University Hospital

Jinju, 52727, South Korea

Cha Bundang Medical Center, Cha University

Seongnam-si, Gyeonggi-do, 13496, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

Asan Medical Center

Seoul, 05505, South Korea

Samsung Medical Center

Seoul, 06351, South Korea

Seoul National University Hospital

Seoul, 110-744, South Korea

Hospital Regional Universitario de Malaga

Málaga, Andalusia 29011, Spain

Hospital Universitario Virgen del Rocio

Seville, Andalusia 41013, Spain

Hospital Clinico Universitario Lozano Blesa

Zaragoza, Aragon 50009, Spain

Hospital Universitario Insular de Gran Canaria

Las Palmas de Gran Canaria, Canary Islands 35016, Spain

Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol

Badalona, Catalonia 08916, Spain

Hospital del Mar

Barcelona, Catalonia 08003, Spain

Hospital Universitari Vall d Hebron

Barcelona, Catalonia 08035, Spain

Hospital Clinic i Provincial de Barcelona

Barcelona, Catalonia 08036, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia 08041, Spain

Hospital Clinico Universitario de Santiago

Santiago de Compostela, Galicia 15706, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid 28222, Spain

Clinica Universidad de Navarra

Pamplona, Navarre 31008, Spain

Instituto Valenciano de Oncologia

Valencia, Valencia 46009, Spain

Hospital General Universitario Gregorio Maranon

Madrid, 28009, Spain

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Sahlgrenska Universitetssjukhuset

Gothenburg, 413 45, Sweden

Norrlands Universitetssjukhus

Umeå, 901 85, Sweden

Kantonsspital Baden

Baden, 5404, Switzerland

Universitaetsspital Basel

Basel, 4052, Switzerland

Ospedale Regionale di Bellinzona e Vali

Mendrisio, 6850, Switzerland

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

National Taiwan University Hospital

Taipei, 10002, Taiwan

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Ankara Etlik Sehir Hastanesi

Ankara, 06200, Turkey (Türkiye)

Memorial Ankara Hastanesi

Ankara, 06520, Turkey (Türkiye)

Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

Ankara, 06560, Turkey (Türkiye)

Ankara Bilkent Sehir Hastanesi

Ankara, 06800, Turkey (Türkiye)

Bagcilar Medipol Mega Universite Hastanesi

Istanbul, 34214, Turkey (Türkiye)

Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

Istanbul, 34722, Turkey (Türkiye)

Marmara Universitesi Tip Fakultesi Hastanesi

Istanbul, 34890, Turkey (Türkiye)

Dr Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi

Izmir, 35110, Turkey (Türkiye)

Izmir Ekonomi Universitesi Medical Point Hastanesi

Izmir, 35575, Turkey (Türkiye)

Kocaeli Universitesi Tip Fakultesi Hastanesi

Kocaeli, 41380, Turkey (Türkiye)

Medical Park Seyhan Hastanesi

Mersin, 33200, Turkey (Türkiye)

Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

Samsun, 55200, Turkey (Türkiye)

Guys Hospital

London, SE1 9RT, United Kingdom

Christie Hospital

Manchester, M20 4BX, United Kingdom