ACTIVE_NOT_RECRUITING

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

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Conditions

Extensive-Stage Small-Cell Lung CancerSmall-Cell Lung CancerES-SCLCPlatinumEtoposideDurvalumabTarlatamabAMG 757

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2024-06-05
Study Completion:2028-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06211036

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

MD
STUDY_DIRECTOR
Amgen

Study Locations (Sites)

Infirmary Cancer Center
Mobile, Alabama, 36607
United States
University of Southern California
Los Angeles, California, 90033
United States
Yale New Haven Hospital
New Haven, Connecticut, 06510
United States
University Cancer and Blood Center LLC
Athens, Georgia, 30607
United States
Emory University
Atlanta, Georgia, 30322
United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
United States
University of Illinois Chicago
Chicago, Illinois, 60612
United States
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237
United States
Our Lady of the Lake Cancer Institute
Baton Rouge, Louisiana, 70808
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Allina Health System dba Allina Health Cancer Institute
Saint Paul, Minnesota, 55102
United States
Oncology Hematology Associates
Springfield, Missouri, 65807
United States
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
United States
Astera Cancer Care
East Brunswick, New Jersey, 08816
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
Montefiore Medical Center - Bronx
The Bronx, New York, 10461
United States
Duke University
Durham, North Carolina, 27710
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States
Oncology Hematology Care Incorporated
Cincinnati, Ohio, 45242
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
The Ohio State University
Columbus, Ohio, 43210
United States
Oncology Associates of Oregon, PC
Eugene, Oregon, 97401
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Baptist Cancer Center Memphis Thoracic
Memphis, Tennessee, 38120
United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
United States
Texas Oncology - Dallas Fort Worth
Dallas, Texas, 75246
United States
US Oncology Research Investigational Products Center
Dallas, Texas, 75246
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
Virginia Oncology Associates
Newport News, Virginia, 23606
United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298
United States
Swedish Cancer Institute
Seattle, Washington, 98104
United States
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Amgen

  • MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-05
Study Completion Date2028-09-30

Study Record Updates

Study Start Date2024-06-05
Study Completion Date2028-09-30

Terms related to this study

Keywords Provided by Researchers

  • Extensive-Stage Small-Cell Lung Cancer
  • ES-SCLC
  • Platinum
  • Etoposide
  • Durvalumab
  • Tarlatamab
  • AMG 757

Additional Relevant MeSH Terms

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