A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)
Recruiting · NCT07005128 · Interventional (participants receive a specific treatment) · Lead sponsor: Amgen
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The main objective of the study is to compare the efficacy of tarlatamab in combination with durvalumab, carboplatin and etoposide to the combination of durvalumab, carboplatin and etoposide on prolonging overall survival (OS).
Who can take part
Age range
18 Years to 99 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Participant has provided informed consent before 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 documented ES-SCLC (American Joint Committee on Cancer, 2017, Stage IV 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.
- Measurable disease as defined per RECIST 1.1.
- Suitable to receive carboplatin, etoposide and durvalumab regimen as first-line treatment per investigator clinical assessment.
- Minimum life expectancy ≥ 12 weeks.
Exclusion criteria
- Participants can have no history of other malignancy in the last 2 years.
- Any symptomatic central nervous system (CNS) metastases, or leptomeningeal disease.
- They will have no history of severe or life-threatening events to immune-mediated therapy.
- History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.
- They will have no active autoimmune or inflammatory disorders.
- Presence of active human immunodeficiency virus (HIV) or active Hepatitis (B/C) infection.
- Evidence or interstitial lung disease (ILD) or active, non-infectious pneumonitis.
- History of solid organ transplant.
- They will not have had a myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 6 months prior to first dose of study treatment.
Where it is running
60 locations listed across 23 US states.
- Cancer and Blood Specialists of Arizona - Casa Grande, Arizona, United States
- City of Hope Cancer Center Phoenix - Goodyear, Arizona, United States
- Genesis Cancer Center - Hot Springs, Arkansas, United States
- Saint Bernards Medical Center - Jonesboro, Arkansas, United States
- Providence Saint Jude Medical Center - Fullerton, California, United States
- Translational Research in Oncology US Inc, Trio Central Pharmacy - Los Angeles, California, United States
- University of California Los Angeles - Santa Monica, California, United States
- Presbyterian Intercommunity Hospital Health Whitter Hospital - Whittier, California, United States
- Colorado West Healthcare System dba Grand Valley Oncology - Grand Junction, Colorado, United States
- Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut - New Britain, Connecticut, United States
- Yale New Haven Hospital - New Haven, Connecticut, United States
- Eastern Connecticut Hematology and Oncology Associates - Norwich, Connecticut, United States
- Florida Oncology and Hematology - Fort Myers, Florida, United States
- Cancer Specialists of North Florida - Southpoint - Jacksonville, Florida, United States
- Orlando Health Cancer Institute - Kissimmee, Florida, United States
- Central Georgia Cancer Care PC - Macon, Georgia, United States
- City of Hope Atlanta - Newnan, Georgia, United States
- University of Illinois Chicago - Chicago, Illinois, United States
- Cancer Care Specialists of Illinois - Decatur, Illinois, United States
- Midwestern Regional Medical Center dba City of Hope Chicago - Rockford, Illinois, United States
- Indiana University Melvin and Bren Simon Cancer Center - Indianapolis, Indiana, United States
- Hematology Oncology of Indiana - Indianapolis, Indiana, United States
- Cancer Center of Kansas, Heritage Plaza Medical Building - Wichita, Kansas, United States
- New England Cancer Specialists - Westbrook, Maine, United States
- Dana Farber Cancer Institute - Boston, Massachusetts, United States
- Minnesota Oncology Hematology PA - Edina, Minnesota, United States
- Allina Health System dba Allina Health Cancer Institute - Minneapolis, Minnesota, United States
- Mayo Clinic - Rochester, Minnesota, United States
- Hattiesburg Clinic Hematology/Oncology - Hattiesburg, Mississippi, United States
- Cancer Partners of Nebraska - Lincoln, Nebraska, United States
- Nebraska Cancer Specialists - Omaha, Nebraska, United States
- New York Oncology Hematology PC - Albany, New York, United States
- Hematology Oncology Association of Central New York - East Syracuse, New York, United States
- New York Cancer and Blood Specialists - Shirley, New York, United States
- Oncology Hematology Care, Inc - Cincinnati, Ohio, United States
- University Hospitals Cleveland Medical Center - Cleveland, Ohio, United States
- Willamette Valley Cancer Institute and Research Center - Eugene - Eugene, Oregon, United States
- Kaiser Permanente Medical Center - Portland, Oregon, United States
- Baptist Cancer Center - Memphis, Tennessee, United States
- United States Oncology Regulatory Affairs Corporate Office - Nashville, Tennessee, United States
- Texas Oncology - Dallas Fort Worth - Dallas, Texas, United States
- Oncology Consultants - Houston, Texas, United States
- US Oncology Research Investigational Products Center - Irving, Texas, United States
- University of Texas Health Science Center at Tyler - Tyler, Texas, United States
- Texas Oncology Northeast Texas - Tyler, Texas, United States
- Virginia Cancer Specialists PC - Fairfax, Virginia, United States
- Virginia Oncology Associates - Norfolk, Virginia, United States
- Swedish Cancer Institute Medical Oncology - Seattle, Washington, United States
- Northwest Medical Specialties, PLLC - Tacoma, Washington, United States
- West Virginia University Health Sciences Center - Morgantown, West Virginia, United States
- Memorial Ankara Hastanesi - Ankara, Turkey (Türkiye)
- Ankara Bilkent Sehir Hastanesi - Ankara, Turkey (Türkiye)
- Henry Dunant Hospital Center - Athens, Greece
- Alexandra Hospital - Athens, Greece
- IRCCS Istituto Tumori Giovanni Paolo II - Bari, Italy
- Universitaetsspital Basel - Basel, Switzerland
- Humanitas Gavazzeni - Bergamo, Italy
- Centrum Pulmonologii i Torakochirurgii w Bystrej - Bystra, Poland
- Klinikum Chemnitz GmbH - Chemnitz, Germany
- Chungbuk National University Hospital - Cheongju Chungbuk, South Korea
Showing 60 of 164 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →