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ACTIVE NOT RECRUITING

NCT05740566

PHASE3

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

Sponsor: Amgen

View on ClinicalTrials.gov

Summary

The main objective is to compare the efficacy of tarlatamab with standard of care (SOC) on prolonging overall survival (OS).

Official title: A Randomized, Open-label, Phase 3 Study of Tarlatamab Compared With Standard of Care in Subjects With Relapsed Small Cell Lung Cancer After Platinum-based First-line Chemotherapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

509

Start Date

2023-05-31

Completion Date

2028-03-26

Last Updated

2026-01-05

Healthy Volunteers

Conditions

Small Cell Lung Cancer (SCLC)

Interventions

DRUG

Tarlatamab

Tarlatamab will be administered as an IV infusion.

DRUG

Lurbinectedin

Lurbinectedin will be administered per local SOC.

DRUG

Topotecan

Topotecan will be administered per local SOC.

DRUG

Amrubicin

Amrubicin will be administered per local SOC.

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..

Locations (223)

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States

Alaska Oncology and Hematology

Anchorage, Alaska, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

University of California Los Angeles

Santa Monica, California, United States

Northwestern University

Chicago, Illinois, United States

University of Illinois Chicago

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

Pikeville Medical Center

Pikeville, Kentucky, United States

Our Lady of the Lake Cancer Institute

Baton Rouge, Louisiana, United States

Trinity Health Saint Joseph Mercy Ann Arbor

Ann Arbor, Michigan, United States

University of Minnesota Cancer Center

Minneapolis, Minnesota, United States

University of Missouri Health Care

Columbia, Missouri, United States

Summit Medical Group, Overlook Oncology Center

Summit, New Jersey, United States

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

New York, New York, United States

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

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Northport Veterans Affairs Medical Center

Northport, New York, United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Sanford Oncology Clinic and Pharmacy

Sioux Falls, South Dakota, United States

University of Tennessee Medical Center Knoxville

Knoxville, Tennessee, United States

Baptist Cancer Center

Memphis, Tennessee, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Swedish Cancer Institute Medical Oncology

Edmonds, Washington, United States

The Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Cemic

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Hospital Universitario Austral

Pilar, Buenos Aires, Argentina

Sociedad de Beneficencia Hospital Italiano

Córdoba, Córdoba Province, Argentina

Clinica Viedma

Viedma, Río Negro Province, Argentina

Sanatorio Parque SA

Rosario, Santa Fe Province, Argentina

Instituto Argentino de Diagnostico y Tratamiento IADT

Buenos Aires, Argentina

Sanatorio Allende

Córdoba, Argentina

Liverpool Hospital

Liverpool, New South Wales, Australia

Calvary Mater Newcastle Hospital

Waratah, New South Wales, Australia

Monash Medical Centre

Clayton, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Medizinische Universitaet Graz

Graz, Austria

Universitaetsklinikum Krems

Krems, Austria

Universitair Ziekenhuis Gent

Ghent, Belgium

Jessa Ziekenhuis - Campus Virga Jesse

Hasselt, Belgium

AZ Delta Campus Rumbeke

Roeselare, Belgium

Vitaz campus Sint-Niklaas Moerland

Sint-Niklaas, Belgium

Hospital Santa Izabel

Salvador, Estado de Bahia, 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, Brazil

Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda

Ijuí, Rio Grande do Sul, Brazil

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

Porto Alegre, Rio Grande do Sul, Brazil

Hospital de Amor da Amazonia

Porto Velho, Rondônia, Brazil

Hospital de Base de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Beneficencia Portuguesa de Sao Paulo - Bp

São Paulo, São Paulo, Brazil

Oncologia Rede D Or

São Paulo, São Paulo, Brazil

Instituto Coi

Rio de Janeiro, Brazil

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

São Paulo, Brazil

London Health Sciences Centre

London, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Anhui Chest Hospital

Hefei, Anhui, China

Beijing Tongren Hospital affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

The Second Affiliated Hospital of Army Medical University, PLA

Chongqing, Chongqing Municipality, China

Army Special Medical Center of Peoples Liberation Army

Chongqing, Chongqing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, China

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Jiangmen Central Hospital

Jiangmen, Guangdong, China

The 4th Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Affiliated Cancer Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Subei Peoples Hospital

Yangzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Jilin Cancer Hospital

Changchun, Jilin, China

Jinan Central Hospital

Jinan, Shandong, China

Shandong Tumor Hospital

Jinan, Shandong, China

Linyi Cancer Hospital

Linyi, Shandong, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Shanxi Province Cancer Hospital

Taiyuan, Shanxi, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Beijing Chest Hospital, Capital Medical University

Beijing, China

Fujian Cancer Hospital

Fuzhou, China

Tianjin Peoples Hospital

Tianjin, China

Weihai Municipal Hospital

Weihai, China

Fakultni nemocnice Brno

Brno, Czechia

Masarykuv onkologicky ustav

Brno, Czechia

Fakultni nemocnice Olomouc

Olomouc, Czechia

Nemocnice Agel Ostrava-Vitkovice as

Ostrava-Vitkovice, Czechia

Vseobecna fakultni nemocnice v Praze

Prague, Czechia

Rigshospitalet

Copenhagen, Denmark

Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon

Grenoble, France

Centre Hospitalier Régional Universitaire de Lille - Institut Coeur Poumon

Lille, France

Centre Hospitalier Regional Universitaire de Limoges - Hopital Dupuytren

Limoges, France

Centre Leon Berard

Lyon, France

Centre Hospitalier Universitaire Nord

Marseille, France

Institut Curie

Paris, France

And 123 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (223)