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

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Amgen
Study ID
NCT06211036
Phase
PHASE3
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Jun 5, 2024
Status verified
Dec 2025
Primary completion
Jul 5, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
563 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tarlatamab in Combination With Durvalumab
    Participants will receive tarlatamab once every 2 weeks (Q2W) and durvalumab once every 4 weeks (Q4W).
  • Active Comparator: Durvalumab Alone
    Participants will receive durvalumab Q4W alone.

Primary Outcome Measure

OS [ Time Frame: Up to approximately 3 years ]

Locations (37)

FacilityCityStateZIPSite coordinators
Infirmary Cancer CenterMobileAlabama36607-
University of Southern CaliforniaLos AngelesCalifornia90033-
Yale New Haven HospitalNew HavenConnecticut06510-
University Cancer and Blood Center LLCAthensGeorgia30607-
Emory UniversityAtlantaGeorgia30322-
Northeast Georgia Medical CenterGainesvilleGeorgia30501-
University of Illinois ChicagoChicagoIllinois60612-
Franciscan Health IndianapolisIndianapolisIndiana46237-
Our Lady of the Lake Cancer InstituteBaton RougeLouisiana70808-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Cancer and Hematology Centers of Western MichiganGrand RapidsMichigan49503-
Mayo ClinicRochesterMinnesota55905-
Allina Health System dba Allina Health Cancer InstituteSaint PaulMinnesota55102-
Oncology Hematology AssociatesSpringfieldMissouri65807-
Nebraska Cancer SpecialistsOmahaNebraska68130-
Astera Cancer CareEast BrunswickNew Jersey08816-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901-
Montefiore Medical Center - BronxThe BronxNew York10461-
Duke UniversityDurhamNorth Carolina27710-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-
Oncology Hematology Care IncorporatedCincinnatiOhio45242-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
The Ohio State UniversityColumbusOhio43210-
Oncology Associates of Oregon, PCEugeneOregon97401-
Oregon Health and Science UniversityPortlandOregon97239-
Allegheny Health NetworkPittsburghPennsylvania15212-
University of Pittsburgh Medical CenterPittsburghPennsylvania15232-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Baptist Cancer Center Memphis ThoracicMemphisTennessee38120-
Sarah Cannon Research InstituteNashvilleTennessee37203-
Texas Oncology - Dallas Fort WorthDallasTexas75246-
US Oncology Research Investigational Products CenterDallasTexas75246-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Virginia Oncology AssociatesNewport NewsVirginia23606-
Virginia Commonwealth University Massey Cancer CenterRichmondVirginia23298-
Swedish Cancer InstituteSeattleWashington98104-
The Medical College of WisconsinMilwaukeeWisconsin53226-

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