Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer | NCT05740566 | Trialant

Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer | NCT05740566 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Participant has provided informed consent prior to initiation of any study specific activities/procedures.

Age ≥ 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent.

Histologically or cytologically confirmed SCLC with demonstrated progression or relapse.

Participants who progressed or recurred following 1 platinum-based regimen.

Measurable disease as defined per RECIST 1.1 within the 21-day screening period.

Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.

Minimum life expectancy of 12 weeks.

Adequate organ function.

Exclusion Criteria:

Disease Related

Symptomatic central nervous system (CNS) metastases with exceptions defined in the protocol.

Diagnosis or evidence of leptomeningeal disease.

Prior history of immune checkpoint inhibitors resulting in events defined in the protocol.

Other Medical Conditions

Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy.

History of solid organ transplantation.

History of other malignancy within the past 2 years, with exceptions defined in the protocol.

Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months prior to first dose of study treatment.

History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months prior to first dose of study treatment.

Presence or history of viral infection based on criteria per protocol.

Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to first dose of study treatment.

Symptoms and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection requiring antibiotics within 7 days prior to the first dose study treatment.

Evidence of interstitial lung disease or active, non-infectious pneumonitis.

Prior/Concomitant Therapy

Prior therapy with tarlatamab or any of the standard of care chemotherapy included as part of this trial or participation in any tarlatamab or any other DLL3 targeted agent clinical trial.

Prior therapy with any selective inhibitor of the DLL3 pathway.

Participant received more than one prior systemic therapy regimen for SCLC.

Prior anti-cancer therapy within 21 days prior to first dose of study treatment with exceptions defined in protocol.

Current anti-cancer therapy such as chemotherapy, immunotherapy, or targeted therapy with exceptions.

Use of herbal or prescription/non-prescription medications known to inhibit membrane transporters P-glycoprotein (P-gp) and/or breast cancer resistance protein (BCRP) within 7 days prior to the first dose of study treatment.

Use of herbal or prescription/non-prescription medications known to be moderate or strong inhibitors of cytochrome P450 3A (CYP3A) enzymes within 7 days prior to the first dose of study treatment.

Use of herbal or prescription/non-prescription medications known to be moderate or strong inducers of CYP3A enzymes within 28 days prior to first dose of study treatment.

Participants who have reached the limit dose of prior treatment with cardiotoxic drugs.

Major surgical procedures within 28 days prior to first dose of study treatment.

Live and live-attenuated vaccines within 14 days prior to the start of study treatment.

Inactive vaccines and live viral non-replicating vaccines within 3 days prior to the first dose of study treatment.

Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.

Diagnostic Assessments

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, with exceptions defined in the protocol.

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 tarlatamab.

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

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

Female participants of childbearing potential with a positive pregnancy test assessed at screening by a 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 tarlatamab.

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 tarlatamab.

Male participants unwilling to abstain from donating sperm during treatment and for an additional 60 days after the last dose of tarlatamab.

Contraception requirements for male and female participants receiving SOC therapies are based on regional prescribing information.

Breastfeeding restrictions for female participants receiving SOC therapies are based on regional prescribing information.

Participant has known sensitivity or is contraindicated 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.

History or evidence of any other clinically significant disorder, condition or disease determined by the investigator or Amgen physician that would pose a risk to the subject safety or interfere with the study evaluation..

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama 36604, United States

Alaska Oncology and Hematology

Anchorage, Alaska 99508, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas 72205, United States

University of California Los Angeles

Santa Monica, California 90404, United States

Northwestern University

Chicago, Illinois 60611, United States

University of Illinois Chicago

Chicago, Illinois 60612, United States

Indiana University

Indianapolis, Indiana 46202, United States

University of Iowa

Iowa City, Iowa 52242, United States

Pikeville Medical Center

Pikeville, Kentucky 41501, United States

Our Lady of the Lake Cancer Institute

Baton Rouge, Louisiana 70808, United States

Trinity Health Saint Joseph Mercy Ann Arbor

Ann Arbor, Michigan 48106, United States

University of Minnesota Cancer Center

Minneapolis, Minnesota 55455, United States

University of Missouri Health Care

Columbia, Missouri 65212, United States

Summit Medical Group, Overlook Oncology Center

Summit, New Jersey 91010, 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

Memorial Sloan Kettering Cancer Center

New York, New York 10021, United States

Northport Veterans Affairs Medical Center

Northport, New York 11768, United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota 58102, United States

Sanford Oncology Clinic and Pharmacy

Sioux Falls, South Dakota 57104, United States

University of Tennessee Medical Center Knoxville

Knoxville, Tennessee 37920, United States

Baptist Cancer Center

Memphis, Tennessee 38120, United States

Virginia Commonwealth University

Richmond, Virginia 23298, United States

Swedish Cancer Institute Medical Oncology

Edmonds, Washington 98026, United States

The Medical College of Wisconsin

Milwaukee, Wisconsin 53226, United States

Cemic

Ciudad Autonoma de Buenos Aires, Buenos Aires C1431FWO, Argentina

Hospital Universitario Austral

Pilar, Buenos Aires B1629ODT, Argentina

Sociedad de Beneficencia Hospital Italiano

Córdoba, Córdoba Province X5004BAL, Argentina

Clinica Viedma

Viedma, Río Negro Province R8500ACE, Argentina

Sanatorio Parque SA

Rosario, Santa Fe Province 2000, Argentina

Instituto Argentino de Diagnostico y Tratamiento IADT

Buenos Aires, C1122AAL, Argentina

Sanatorio Allende

Córdoba, X5000JHQ, Argentina

Liverpool Hospital

Liverpool, New South Wales 2170, Australia

Calvary Mater Newcastle Hospital

Waratah, New South Wales 2298, Australia

Monash Medical Centre

Clayton, Victoria 3168, Australia

The Alfred Hospital

Melbourne, Victoria 3004, Australia

Medizinische Universitaet Graz

Graz, 8036, Austria

Universitaetsklinikum Krems

Krems, 3500, Austria

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Jessa Ziekenhuis - Campus Virga Jesse

Hasselt, 3500, Belgium

AZ Delta Campus Rumbeke

Roeselare, 8800, Belgium

Vitaz campus Sint-Niklaas Moerland

Sint-Niklaas, 9100, Belgium

Hospital Santa Izabel

Salvador, Estado de Bahia 40050-410, Brazil

Instituto de Ensino e Pesquisa do Hospital da Bahia

Salvador, Estado de Bahia, Brazil

Liga Norte-Riograndense Contra O Cancer

Natal, Rio Grande do Norte 59075-740, Brazil

Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda

Ijuí, Rio Grande do Sul 98700-000, Brazil

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

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

Hospital de Amor da Amazonia

Porto Velho, Rondônia 76834-899, Brazil

Hospital de Base de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo 15090-000, Brazil

Beneficencia Portuguesa de Sao Paulo - Bp

São Paulo, São Paulo 01323-900, Brazil

Oncologia Rede D Or

São Paulo, São Paulo 04502-001, Brazil

Instituto Coi

Rio de Janeiro, 22793-080, Brazil

Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira Icesp

São Paulo, 01246-000, Brazil

London Health Sciences Centre

London, Ontario N6A 5W9, Canada

Princess Margaret Cancer Centre

Toronto, Ontario M5G 2M9, Canada

Anhui Chest Hospital

Hefei, Anhui 230022, China

Beijing Tongren Hospital affiliated to Capital Medical University

Beijing, Beijing Municipality 100010, China

Beijing Cancer Hospital

Beijing, Beijing Municipality 100142, China

The Second Affiliated Hospital of Army Medical University, PLA

Chongqing, Chongqing Municipality 400037, China

Army Special Medical Center of Peoples Liberation Army

Chongqing, Chongqing Municipality 400042, China

Fujian Medical University Union Hospital

Fuzhou, Fujian 350001, China

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian 350025, China

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong 510060, China

Jiangmen Central Hospital

Jiangmen, Guangdong 529030, China

The 4th Hospital of Hebei Medical University

Shijiazhuang, Hebei 050000, China

Affiliated Cancer Hospital of Harbin Medical University

Harbin, Heilongjiang 150000, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei 430022, China

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei 430030, China

Hunan Cancer Hospital

Changsha, Hunan 410013, China

Subei Peoples Hospital

Yangzhou, Jiangsu 225009, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi 330006, China

Jilin Cancer Hospital

Changchun, Jilin 130012, China

Jinan Central Hospital

Jinan, Shandong 250013, China

Shandong Tumor Hospital

Jinan, Shandong 250117, China

Linyi Cancer Hospital

Linyi, Shandong 276034, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality 200030, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality 200032, China

Shanxi Province Cancer Hospital

Taiyuan, Shanxi 30009, China

West China Hospital of Sichuan University

Chengdu, Sichuan 610041, China

The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang 310003, China

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang 310003, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang 310005, China

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang 317099, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang 325015, China

Beijing Chest Hospital, Capital Medical University

Beijing, 101149, China

Fujian Cancer Hospital

Fuzhou, 350011, China

Tianjin Peoples Hospital

Tianjin, 300131, China

Weihai Municipal Hospital

Weihai, 264200, China

Fakultni nemocnice Brno

Brno, 625 00, Czechia

Masarykuv onkologicky ustav

Brno, 656 53, Czechia

Fakultni nemocnice Olomouc

Olomouc, 779 00, Czechia

Nemocnice Agel Ostrava-Vitkovice as

Ostrava-Vitkovice, 703 00, Czechia

Vseobecna fakultni nemocnice v Praze

Prague, 128 08, Czechia

Rigshospitalet

Copenhagen, 2100, Denmark

Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon

Grenoble, 38700, France

Centre Hospitalier Régional Universitaire de Lille - Institut Coeur Poumon

Lille, 59037, France

Centre Hospitalier Regional Universitaire de Limoges - Hopital Dupuytren

Limoges, 87042, France

Centre Leon Berard

Lyon, 69008, France

Centre Hospitalier Universitaire Nord

Marseille, 13915, France

Institut Curie

Paris, 75005, France

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

Rennes, 35033, France

Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil

Strasbourg, 67091, France

Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

Toulouse, 31059, France

Gustave Roussy

Villejuif, 94805, France

Charite Universitaetsmedizin Berlin, Campus Virchow

Berlin, 13353, Germany

Universitaetsklinikum Koeln

Cologne, 50937, Germany

Universitaetsklinikum Dresden

Dresden, 01307, Germany

Universitaetsklinikum Essen

Essen, 45147, Germany

Asklepios Fachkliniken Muenchen Gauting

Gauting, 82130, Germany

LungenClinic Grosshansdorf GmbH

Großhansdorf, 22927, Germany

Robert-Bosch-Krankenhaus

Stuttgart, 70376, Germany

Universitaetsklinikum Wuerzburg

Würzburg, 97078, Germany

Saint Savas Hospital

Athens, 11522, Greece

Henry Dunant Hospital Center

Athens, 11526, Greece

Thoracic General Hospital Of Athens Sotiria

Athens, 11527, Greece

Alexandra Hospital

Athens, 11528, Greece

University Hospital of Heraklion

Heraklion - Crete, 71500, Greece

Olympion Therapeftirio General Clinic Of Patras

Pátrai, 26443, Greece

Saint Luke Hospital

Thessaloniki, 55236, Greece

European Interbalkan Medical Center

Thessaloniki, 57001, Greece

Semmelweis Egyetem

Budapest, 1083, Hungary

Orszagos Koranyi Pulmonologiai Intezet

Budapest, 1121, Hungary

Matrai Gyogyintezet

Gyöngyös, 3200, Hungary

Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz

Székesfehérvár, 8000, Hungary

Komarom-Esztergom Varmegyei Szent Borbala Korhaz

Tatabánya, 2800, Hungary

Reformatus Pulmonologiai Centrum

Törökbálint, 2045, Hungary

Beaumont Hospital

Dublin, 9, Ireland

Rambam Medical Center

Haifa, 3109601, Israel

Hadassah Ein-Kerem Medical Center

Jerusalem, 9112001, Israel

Meir Medical Center

Kfar Saba, 4428164, Israel

Rabin Medical Center

Petah Tikva, 4941492, Israel

Humanitas Gavazzeni

Bergamo, 24125, Italy

Azienda Ospedaliera Universitaria Renato Dulbecco

Catanzaro, 88100, Italy

Ospedale Policlinico San Martino IRCCS

Genova, 16132, Italy

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

Meldola (FC), 47014, Italy

Azienda Ospedaliera Universitaria San Luigi Gonzaga

Orbassano, 10043, Italy

Azienda Ospedaliera San Giovanni Addolorata

Roma, 00144, Italy

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken 460-0001, Japan

Aichi Cancer Center

Nagoya, Aichi-ken 464-8681, 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

Hyogo Cancer Center

Akashi-shi, Hyōgo 673-8558, 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

Shizuoka Cancer Center

Sunto-gun, Shizuoka 411-8777, 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, Wakayama 641-8510, Japan

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur 59100, Malaysia

Hospital Tengku Ampuan Afzan

Kuantan, Pahang 25100, Malaysia

Sarawak General Hospital

Kuching, Sarawak 93586, Malaysia

coi Centro Oncologico Internacional sapi de cv

Tlajomulco de Zúñiga, Jalisco 45640, Mexico

Health Pharma Professional Research SA de CV

Mexico City, Mexico City 03100, Mexico

Oncare

Mexico City, Mexico City 03810, Mexico

Universitair Medisch Centrum Groningen

Groningen, 9713 GZ, Netherlands

Leids Universitair Medisch Centrum

Leiden, 2333 ZA, Netherlands

Erasmus Medisch Centrum

Rotterdam, 3015 GD, Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, 3584 CX, Netherlands

Centrum Pulmonologii i Torakochirurgii w Bystrej

Bystra, 43-360, Poland

Szpital Specjalistyczny imienia Ludwika Rydygiera w Krakowie Sp zoo

Krakow, 31-826, Poland

Wielkopolskie Centrum Pulmonologii i Torakochirurgii imienia Eugenii i Janusza Zeylandow

Poznan, 60-569, Poland

Hospital da Luz, SA

Lisbon, 1500-650, Portugal

Hospital Cuf Descobertas

Lisbon, 1998-018, Portugal

Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano

Matosinhos Municipality, 4464-513, Portugal

Hospital Cuf porto

Porto, 4100-180, Portugal

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

SC Oncomed SRL

Timișoara, 300239, Romania

National Cancer Centre Singapore

Singapore, 168583, Singapore

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Chungbuk National University Hospital

Cheongju Chungbuk, 28644, South Korea

National Cancer Center

Goyang-si Gyeonggi-do, 10408, South Korea

Gachon University Gil Hospital

Incheon, 21565, South Korea

Gyeongsang National University Hospital

Jinju, 52727, 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

The Catholic University of Korea Seoul St Marys Hospital

Seoul, 06591, South Korea

Ulsan University Hospital

Ulsan, 44033, South Korea

Hospital Regional Universitario de Malaga

Málaga, Andalusia 29011, Spain

Hospital Clinico Universitario Lozano Blesa

Zaragoza, Aragon 50009, Spain

Hospital del Mar

Barcelona, Catalonia 08003, Spain

Hospital Universitari Vall d Hebron

Barcelona, Catalonia 08035, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia 08041, Spain

Complexo Hospitalario Universitario A Coruna Hospital Teresa Herrera

A Coruña, Galicia 15006, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid 28222, Spain

Fundacion Jimenez Diaz

Madrid, 28040, Spain

Hospital Clinico San Carlos

Madrid, 28040, Spain

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Kantonsspital Graubuenden

Chur, 7000, Switzerland

Freiburg Spital

Fribourg, 1708, Switzerland

Hopitaux universitaires de Geneve

Geneva, 1211, Switzerland

Kantonsspital Sankt Gallen

Sankt Gallen, 9007, Switzerland

Kantonsspital Winterthur

Winterthur, 8401, Switzerland

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

Veterans General Hospital - Taichung

Taichung, 40705, Taiwan

National Cheng Kung University Hospital

Tainan, 70403, Taiwan

National Taiwan University Hospital

Taipei, 10002, Taiwan

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

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)

Pamukkale Universitesi Tip Fakultesi Hastanesi

Denizli, 20070, Turkey (Türkiye)

Bagcilar Medipol Mega Universite Hastanesi

Istanbul, 34214, Turkey (Türkiye)

Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

Istanbul, 34722, Turkey (Türkiye)

Ege Universitesi Tip Fakultesi Hastanesi

Izmir, 35100, Turkey (Türkiye)

Izmir Ekonomi Universitesi Medical Point Hastanesi

Izmir, 35575, Turkey (Türkiye)

Inonu Universitesi Turgut Ozal Tip Merkezi

Malatya, 44280, Turkey (Türkiye)

University College London Hospital

London, NW1 2PG, United Kingdom

Guys Hospital

London, SE1 9RT, United Kingdom

Christie Hospital

Manchester, M20 4BX, United Kingdom