Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab
Extensive-Stage Small-Cell Lung CancerSmall-Cell Lung Cancer
Investigational drug(s) / intervention(s)
TarlatamabDurvalumab
Tarlatamab: Intravenous (IV) infusion
Durvalumab: IV infusion
Study summary
The primary objective of this study is to compare the efficacy of tarlatamab plus durvalumab with durvalumab alone on prolonging overall survival (OS).
Eligibility
Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
OS — Up to approximately 3 years
Trial sites (219)
Facility
City
Region
Status
Infirmary Cancer Center
Mobile
Alabama
University of Southern California
Los Angeles
California
Yale New Haven Hospital
New Haven
Connecticut
University Cancer and Blood Center LLC
Athens
Georgia
Emory University
Atlanta
Georgia
Northeast Georgia Medical Center
Gainesville
Georgia
University of Illinois Chicago
Chicago
Illinois
Franciscan Health Indianapolis
Indianapolis
Indiana
Our Lady of the Lake Cancer Institute
Baton Rouge
Louisiana
Dana-Farber Cancer Institute
Boston
Massachusetts
Cancer and Hematology Centers of Western Michigan
Grand Rapids
Michigan
Mayo Clinic
Rochester
Minnesota
Allina Health System dba Allina Health Cancer Institute
Saint Paul
Minnesota
Oncology Hematology Associates
Springfield
Missouri
Nebraska Cancer Specialists
Omaha
Nebraska
Astera Cancer Care
East Brunswick
New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick
New Jersey
Montefiore Medical Center - Bronx
The Bronx
New York
Duke University
Durham
North Carolina
Wake Forest University Health Sciences
Winston-Salem
North Carolina
Oncology Hematology Care Incorporated
Cincinnati
Ohio
University Hospitals Cleveland Medical Center
Cleveland
Ohio
The Ohio State University
Columbus
Ohio
Oncology Associates of Oregon, PC
Eugene
Oregon
Oregon Health and Science University
Portland
Oregon
Allegheny Health Network
Pittsburgh
Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh
Pennsylvania
Medical University of South Carolina
Charleston
South Carolina
Baptist Cancer Center Memphis Thoracic
Memphis
Tennessee
Sarah Cannon Research Institute
Nashville
Tennessee
Texas Oncology - Dallas Fort Worth
Dallas
Texas
US Oncology Research Investigational Products Center
Dallas
Texas
University of Texas MD Anderson Cancer Center
Houston
Texas
Virginia Oncology Associates
Newport News
Virginia
Virginia Commonwealth University Massey Cancer Center
Richmond
Virginia
Swedish Cancer Institute
Seattle
Washington
The Medical College of Wisconsin
Milwaukee
Wisconsin
Hospital Britanico de Buenos Aires
CABA
Buenos Aires
Instituto Alexander Fleming
Capital Federal
Buenos Aires
Fundacion Medica de Rio Negro y Neuquen
Cipolletti
Río Negro Province
+ 179 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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