Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)

Last updated: February 12, 2025
Sponsor: Amgen
Overall Status: Active - Not Recruiting

Phase

1

Condition

Small Cell Lung Cancer

Treatment

CRS Mitigation Strategies

Pembrolizumab

Tarlatamab

Clinical Study ID

NCT03319940
20160323
  • Ages > 18
  • All Genders

Study Summary

A study to assess the safety, tolerability, and PK of tarlatamab in participants with SCLC

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant has provided informed consent prior to initiation of any study-specificactivities/procedures

  • Age greater than or equal to 18 years old at the time of signing the informedconsent

  • Histologically or cytologically confirmed SCLC. For parts A, C, D, E, F, and G:relapsed/refractory small cell lung cancer (R/R SCLC) who progressed or recurredfollowing platinum-based regimen

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

  • Participants with treated brain metastases are eligible provided they meet definedcriteria

  • Adequate organ function as defined in protocol

Exclusion

Exclusion Criteria:

  • History of other malignancy within the past 2 years prior to first dose oftarlatamab with exceptions

  • Major surgery within 28 days of first dose tarlatamab

  • Untreated (includes new lesions or progression in previously treated lesions) orsymptomatic brain metastases and leptomeningeal disease (regardless of symptomaticor not).

  • Prior anti-cancer therapy: at least 28 days must have elapsed between any prioranti-cancer therapy and first dose of tarlatamab with the following exceptions:participants who received conventional chemotherapy are eligible if at least 14 dayshave elapsed and if all treatment-related toxicity has been resolved to Grade lessthan or equal to 1; and prior palliative radiotherapy must have been completed atleast 7 days before the first dose of tarlatamab

  • Participants who experienced severe, life-threatening or recurrent (Grade 2 orhigher) immune-mediated AEs or infusion-related reactions including those that leadto permanent discontinuation while on treatment with immune-oncology agents

  • Has evidence of interstitial lung disease or active, non-infectious pneumonitis

  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or anyother form of immunosuppressive therapy within 7 days prior to the first dose oftarlatamab

  • Part C only: history of solid organ transplantation or active autoimmune diseasethat has required systemic treatment within the past 2 years

  • Participant with symptoms and/or clinical signs and/or radiographic signs thatindicate an acute and/or uncontrolled active systemic infection within 7 days priorto the first dose of investigational product administration

Study Design

Total Participants: 269
Treatment Group(s): 3
Primary Treatment: CRS Mitigation Strategies
Phase: 1
Study Start date:
December 26, 2017
Estimated Completion Date:
October 18, 2026

Study Description

This is an open-label, ascending, multiple doses, phase 1 study evaluating tarlatamab monotherapy, in combination with anti-PD1 therapy and with additional cytokine release syndrome (CRS) mitigation strategies. Tarlatamab will be administered as a short term intravenous (IV) infusion in participants with SCLC. Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)

Connect with a study center

  • Chris OBrien Lifehouse

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Medizinische Universitaet Graz

    Graz, 8036
    Austria

    Site Not Available

  • Landeskrankenhaus Salzburg

    Salzburg, 5020
    Austria

    Site Not Available

  • Universitaetsklinikum Salzburg

    Salzburg, 5020
    Austria

    Active - Recruiting

  • Gustave Roussy

    Villejuif, 94805
    France

    Site Not Available

  • Universitaetsklinikum Wuerzburg

    Wuerzburg, 97078
    Germany

    Site Not Available

  • Universitätsklinikum Würzburg

    Wuerzburg, 97078
    Germany

    Active - Recruiting

  • Comprehensive Cancer Center Mainfranken

    Wurzburg, 97080
    Germany

    Site Not Available

  • Universitätsklinikum Würzburg

    Würzburg, 97078
    Germany

    Site Not Available

  • Prince of Wales Hospital

    Shatin, New Territories,
    Hong Kong

    Site Not Available

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba 277-8577
    Japan

    Site Not Available

  • Research Site

    Chuo Ku, Tokyo 104-0045
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Chuo-ku, Tokyo 104-0045
    Japan

    Site Not Available

  • Wakayama Medical University Hospital

    Wakayama-shi, Wakayama 641-8510
    Japan

    Site Not Available

  • Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis

    Amsterdam, 1066 CX
    Netherlands

    Site Not Available

  • Nederlands Kanker Instituut, Antoni van Leeuwenhoek Ziekenhuis

    Amsterdam, 1066 CX
    Netherlands

    Active - Recruiting

  • Maastricht Universitair Medisch Centrum

    Maastricht, 6229 HX
    Netherlands

    Site Not Available

  • Biokinetica SA

    Jozefow, 05-410
    Poland

    Site Not Available

  • Europejskie Centrum Zdrowia Otwock Szpital imienia Fryderyka Chopina

    Otwock, 05-400
    Poland

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Sevilla, Andalucía 41013
    Spain

    Site Not Available

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, Cataluña 08036
    Spain

    Site Not Available

  • Hospital Universitari Vall d Hebron

    Barcelona, Cataluña 08035
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, 1011
    Switzerland

    Site Not Available

  • Kantonsspital St Gallen

    Sankt Gallen, 9007
    Switzerland

    Site Not Available

  • Kantonsspital St Gallen

    St. Gallen, 9007
    Switzerland

    Site Not Available

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung, 80756
    Taiwan

    Site Not Available

  • Tri-Service General Hospital

    Taipei, 11490
    Taiwan

    Site Not Available

  • Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

    Taoyuan, 33305
    Taiwan

    Site Not Available

  • Christie Hospital

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • City of Hope National Medical Center

    Duarte, California 91010
    United States

    Site Not Available

  • Yale New Haven Hospital

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Winship Cancer Institute

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Ochsner Clinic Foundation

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • John Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63110-1093
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10021
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • The Ohio State University Wexner Medical Center - Thoracic Oncology Clinic

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

  • University of Pittsburgh Medical Center Cancer Pavillion

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Site Not Available

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