Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

Last updated: June 25, 2025
Sponsor: Amgen
Overall Status: Active - Recruiting

Phase

1

Condition

Small Cell Lung Cancer

Treatment

Tarlatamab

Clinical Study ID

NCT06598306
20230298
  • Ages > 18
  • All Genders

Study Summary

The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants ≥ 18 years of age (or ≥ legal adult age within country if it is olderthan 18 years) at time of signing informed consent.

  • Participants with histologically or cytologically confirmed ES-SCLC that progressedor recurred following at least one line of platinum-based anti-cancer therapy forSCLC.

Note: Participants with prior treatment for LS-SCLC should have also received another regimen for their recurrent, ES-SCLC disease.

  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.

  • Participants must have adequate organ function (cardiac, pulmonary, kidney, andliver).

  • Participants must be able to have SC injections administered in the abdomen (and/orthigh).

  • Participants without measurable disease or tumor tissue (fresh biopsy or archival)available may be permitted after discussion with and approval by Amgen MedicalMonitor.

Exclusion

Exclusion Criteria:

  • Participants that have received prior DLL3 targeted therapy.

  • Participants with untreated or symptomatic brain metastases or those requiringtherapy with steroids.

  • Note: Participants with asymptomatic brain metastatic lesions are allowed followingdefinitive treatment (Amgen Medical Monitor may approve untreated, asymptomaticbrain metastasis if local therapy is not required per investigator judgment).

  • Participants with leptomeningeal disease.

  • Participants with baseline oxygen requirement.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Tarlatamab
Phase: 1
Study Start date:
October 07, 2024
Estimated Completion Date:
March 27, 2030

Connect with a study center

  • Chris OBrien Lifehouse

    Camperdown, New South Wales 2050
    Australia

    Active - Recruiting

  • Calvary Mater Newcastle Hospital

    Waratah, New South Wales 2298
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Universitair Ziekenhuis Gent

    Gent, 9000
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    Liege, 4000
    Belgium

    Active - Recruiting

  • Universitaetsklinikum Regensburg

    Regensburg, 93053
    Germany

    Active - Recruiting

  • Universitaetsklinikum Wuerzburg

    Wuerzburg, 97078
    Germany

    Active - Recruiting

  • Okayama University Hospital

    Okayama-shi, Okayama 700-8558
    Japan

    Active - Recruiting

  • Wakayama Medical University Hospital

    Wakayama-shi, Wakayama 641-8510
    Japan

    Site Not Available

  • Wakayama Medical University Hospital

    Wakayama, 641-8509
    Japan

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214
    Poland

    Active - Recruiting

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93-338
    Poland

    Active - Recruiting

  • Wojewodzki Szpital im Sw Ojca Pio w Przemyslu

    Przemysl, 37-700
    Poland

    Active - Recruiting

  • Hospital Regional Universitario de Malaga

    Malaga, Andalucía 29011
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d Hebron

    Barcelona, Cataluña 08035
    Spain

    Active - Recruiting

  • Hospital Universitari i Politecnic La Fe

    Valencia, Comunidad Valenciana 46026
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Kantonsspital Graubuenden

    Chur, 7000
    Switzerland

    Active - Recruiting

  • Freiburg Spital

    Fribourg, 1708
    Switzerland

    Active - Recruiting

  • Kantonsspital Winterthur

    Winterthur, 8401
    Switzerland

    Active - Recruiting

  • Adana Sehir Egitim ve Arastirma Hastanesi

    Adana, 01370
    Turkey

    Active - Recruiting

  • Ankara Bilkent Sehir Hastanesi

    Ankara, 06800
    Turkey

    Active - Recruiting

  • Koc Universitesi Hastanesi

    Istanbul, 34010
    Turkey

    Active - Recruiting

  • University of Southern California, Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • University of Illinois Chicago

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • Trinity Health Saint Joseph Mercy Ann Arbor

    Ann Arbor, Michigan 48106
    United States

    Active - Recruiting

  • Avera Cancer Institute

    Sioux Falls, South Dakota 57105
    United States

    Active - Recruiting

  • University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Swedish Cancer Institute

    Seattle, Washington 98104
    United States

    Active - Recruiting

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