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ACTIVE NOT RECRUITING

NCT06211036

PHASE3

Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab

Sponsor: Amgen

View on ClinicalTrials.gov

Summary

The primary objective of this study is to compare the efficacy of tarlatamab plus durvalumab with durvalumab alone on prolonging overall survival (OS).

Official title: A Phase 3, Open-label, Multicenter, Randomized Study of Tarlatamab in Combination With Durvalumab vs Durvalumab Alone in Subjects With Extensive-Stage Small-Cell Lung Cancer Following Platinum, Etoposide and Durvalumab (DeLLphi-305)

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

563

Start Date

2024-06-05

Completion Date

2028-09-30

Last Updated

2025-12-17

Healthy Volunteers

Conditions

Extensive-Stage Small-Cell Lung Cancer Small-Cell Lung Cancer

Interventions

DRUG

Tarlatamab

Intravenous (IV) infusion

DRUG

Durvalumab

IV infusion

Inclusion: * Participant has provided informed consent prior to initiation of any study specific activities/procedures. * Age \>= 18 years (or \>= legal adult age within the country if it is older than 18 years). * Completed 3-4 cycles of platinum-etoposide chemotherapy with concurrent durvalumab as first-line treatment of extensive-stage (ES)-SCLC prior to enrollment, without disease progression (ongoing response or stable disease) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1. * Minimum life expectancy \> 12 weeks. * Toxicities attributed to prior anti-cancer therapy resolved to grade ≤ 1, unless otherwise specified, excluding alopecia or fatigue. * Adequate organ function. * Histologically or cytologically documented extensive-stage disease (American Joint Committee on Cancer, 2017, IV small-cell lung cancer (SCLC) \[T any, N any, M1 a/b/c\]), or T3 to T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan. Participants with prior limited-stage (LS)-SCLC are allowed if the interval is \> 6 months since the end of previous therapy and progression, in discussion with the medical monitor. Exclusion * Symptomatic central nervous system (CNS) metastases, or leptomeningeal disease. Participants with treated brain metastases are eligible as per protocol. * Prior history of severe or life-threatening events from any immune-mediated therapy. * History of other malignancy within the past 2 years, with some exceptions as per protocol. * Active or prior documented autoimmune or inflammatory disorders as per protocol. * Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 6 months of first dose of study treatment. * History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 6 months of first dose of study treatment. * Evidence of interstitial lung disease (ILD) or active, non-infectious pneumonitis. * History of solid organ transplant. * Major surgical procedures within 28 days of first dose of study treatment. * Known human immunodeficiency virus (HIV) infection (participants with HIV infection on antiviral therapy and undetectable viral load are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on study), hepatitis C infection (participants with hepatitis C that achieve a sustained virologic response after antiviral therapy are allowed), or hepatitis B infection (participants with hepatitis B surface antigen \[HBsAg\] or core antibody that achieve sustained virologic response with antiviral therapy are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on the study). * Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 14 days prior to first dose of study treatment. * History of allergic reactions or acute hypersensitivity reaction to antibody therapies, platinum chemotherapy, or etoposide. * 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. * Participant has known active infection requiring parenteral antibiotic treatment. Upon completion of parenteral antibiotics and resolution of symptoms, the participant may be considered eligible for the study from an infection standpoint. * Treatment with live virus, including live-attenuated vaccination, within 4 weeks prior to the first dose of study treatment. Inactive vaccines (e.g., non-live or non-replicating agent) and live viral non-replicating vaccines (e.g., Jynneos for Monkeypox infection) within 30 days prior to first dose of study treatment. * Prior therapy with any selective inhibitor of the delta-like ligand 3 (DLL3) pathway. * Receiving another anti-cancer therapy. Adjuvant hormonal therapy for resected breast cancer is permitted. * Treatment in an alternative investigational trial within 28 days prior to enrollment. * Has received or is planning to receive consolidative chest radiation for extensive stage disease. * Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment as per protocol. * Female participants who are breastfeeding or who plan to breastfeed while on study as per protocol. * Female participants planning to become pregnant or donate eggs while on study as per protocol. * 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 as per protocol. * Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment as per protocol. * Male participants unwilling to abstain from donating sperm during treatment as per protocol. * Participant has known sensitivity to any of the products or components to be administered during dosing. * Participant has known sensitivity to any of the products or components to be administered during dosing. * History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or physician if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion. * 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. Participants who are unable to complete clinical outcome assessments are eligible.

Locations (219)

Infirmary Cancer Center

Mobile, Alabama, United States

University of Southern California

Los Angeles, California, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

University Cancer and Blood Center LLC

Athens, Georgia, United States

Emory University

Atlanta, Georgia, United States

Northeast Georgia Medical Center

Gainesville, Georgia, United States

University of Illinois Chicago

Chicago, Illinois, United States

Franciscan Health Indianapolis

Indianapolis, Indiana, United States

Our Lady of the Lake Cancer Institute

Baton Rouge, Louisiana, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Cancer and Hematology Centers of Western Michigan

Grand Rapids, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Allina Health System dba Allina Health Cancer Institute

Saint Paul, Minnesota, United States

Oncology Hematology Associates

Springfield, Missouri, United States

Nebraska Cancer Specialists

Omaha, Nebraska, United States

Astera Cancer Care

East Brunswick, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Montefiore Medical Center - Bronx

The Bronx, New York, United States

Duke University

Durham, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Oncology Hematology Care Incorporated

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Oncology Associates of Oregon, PC

Eugene, Oregon, United States

Oregon Health and Science University

Portland, Oregon, United States

Allegheny Health Network

Pittsburgh, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Baptist Cancer Center Memphis Thoracic

Memphis, Tennessee, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Texas Oncology - Dallas Fort Worth

Dallas, Texas, United States

US Oncology Research Investigational Products Center

Dallas, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Virginia Oncology Associates

Newport News, Virginia, United States

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, United States

Swedish Cancer Institute

Seattle, Washington, United States

The Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Hospital Britanico de Buenos Aires

CABA, Buenos Aires, Argentina

Instituto Alexander Fleming

Capital Federal, Buenos Aires, Argentina

Fundacion Medica de Rio Negro y Neuquen

Cipolletti, Río Negro Province, Argentina

Exelsus Oncologia Clinica

San Miguel de Tucumán, Tucumán Province, Argentina

Fundacion Centro Oncológico Riojano Integral para la Investigación y Prevención del Cáncer

La Rioja, Argentina

Chris OBrien Lifehouse

Camperdown, New South Wales, Australia

Wollongong Hospital

Wollongong, New South Wales, Australia

Greenslopes Private Hospital

Greenslopes, Queensland, Australia

Cancer Research South Australia

Adelaide, South Australia, Australia

Monash Medical Centre

Clayton, Victoria, Australia

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Medizinische Universitaet Graz

Graz, Austria

Universitaetsklinikum Krems

Krems, Austria

Landeskrankenhaus Feldkirch

Rankweil, Austria

Azorg Campus Aalst - Moorselbaan

Aalst, Belgium

Universitair Ziekenhuis Brussel

Brussels, Belgium

Universite Catholique de Louvain Cliniques Universitaires Saint Luc

Brussels, Belgium

Institut Jules Bordet

Brussels, Belgium

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

Ziekenhuis Oost-Limburg

Genk, Belgium

Algemeen Ziekenhuis Maria Middelares

Ghent, Belgium

Centres Hospitaliers Universitaires - Helora - Hopital de Mons - Site Kennedy

Mons, Belgium

Centre Hospitalier Universitaire-Universite Catholique de Louvain Namur-Site Godinne

Yvoir, Belgium

Hospital Sao Rafael-Idor

Salvador, Estado de Bahia, Brazil

Cenantron Centro Avançado de Tratamento Oncologico Ltda

Belo Horizonte, Minas Gerais, Brazil

Santa Casa de Misericordia de Passos

Passos, Minas Gerais, Brazil

Hospital Uopeccan

Cascavel, Paraná, Brazil

Hospital de Clinicas de Ijui

Ijuí, Rio Grande do Sul, Brazil

Hospital de Clinicas de Passo Fundo

Passo Fundo, Rio Grande do Sul, Brazil

Irmandade da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Fundacao Antonio Prudente AC Camargo Cancer Center

São Paulo, São Paulo, Brazil

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

Oncoclinicas Rio de Janeiro S A

Rio de Janeiro, Brazil

London Health Sciences Centre

London, Ontario, Canada

CHU de Quebec Hopital de l Enfant Jesus

Québec, Quebec, Canada

Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Xinqiao Hospital

Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

The Second Attached Hospital Of Fujian Medical University

Quanzhou, Fujian, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, China

Guangxi Medical University Affiliated Tumor Hospital

Nanning, Guangxi, China

Cangzhou Peoples Hospital

Cangzhou, Hebei, China

Jiamusi Cancer Hospital

Jiamusi, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Hubei Cancer Hospital

Wuhan, Hubei, China

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

Nanjing Chest Hospital

Nanjing, Jiangsu, China

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Jiangxi Cancer hospital

Nanchang, Jiangxi, China

Jilin Cancer Hospital

Changchun, Jilin, China

The Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

Linyi Cancer Hospital

Linyi, Shandong, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, China

The First Affiliated Hospital of Xian Jiaotong University

Xi’an, Shanxi, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Tianjin Peoples Hospital

Tianjin, Tianjin Municipality, China

Affiliated Cancer Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

the First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

And 119 more locations on ClinicalTrials.gov

Clinical Research Directory

Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (219)