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NCT06598306PHASE1Recruiting

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

Amgen

Start Date

10/7/2024

Completion Date

4/24/2030

Summary

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

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Participants ≥ 18 years of age (or ≥ legal adult age within country if it is older than 18 years) at time of signing informed consent. * Participants with histologically or cytologically confirmed ES-SCLC that progressed or recurred following at least one line of platinum-based anti-cancer therapy for SCLC. 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, and liver). * Participants must be able to have SC injections administered in the abdomen. * Participants without measurable disease or tumor tissue (fresh biopsy or archival) available may be permitted after discussion with and approval by Amgen Medical Monitor. Exclusion Criteria: * Participants that have received prior DLL3 targeted therapy. * Participants with untreated or symptomatic brain metastases or those requiring therapy with steroids. * Note: Participants with asymptomatic brain metastatic lesions are allowed following definitive treatment (Amgen Medical Monitor may approve untreated, asymptomatic brain metastasis if local therapy is not required per investigator judgment). * Participants with leptomeningeal disease. * Participants with baseline oxygen requirement.

Interventions

DRUG

Tarlatamab

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Conditions

Extensive Stage Small Cell Lung Cancer

Locations

University of Southern California, Norris Comprehensive Cancer Center

Los Angeles, California 90033

United States

University of Illinois Chicago

Chicago, Illinois 60612

United States

Trinity Health Saint Joseph Mercy Ann Arbor

Ann Arbor, Michigan 48106

United States

Avera Cancer Institute

Sioux Falls, South Dakota 57105

United States

University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

Swedish Cancer Institute

Seattle, Washington 98104

United States

Chris OBrien Lifehouse

Camperdown, New South Wales 2050

Australia

Calvary Mater Newcastle Hospital

Waratah, New South Wales 2298

Australia

The Alfred Hospital

Melbourne, Victoria 3004

Australia

Universitair Ziekenhuis Gent

Ghent, 9000

Belgium

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, 3000

Belgium

Centre Hospitalier Universitaire de Liege - Sart Tilman

Liège, 4000

Belgium

Jilin Cancer Hospital

Changchun, Jilin 130012

China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality 200433

China

Universitaetsklinikum Regensburg

Regensburg, 93053

Germany

Universitaetsklinikum Wuerzburg

Würzburg, 97078

Germany

Okayama University Hospital

Okayama, Okayama-ken 700-8558

Japan

Wakayama Medical University Hospital

Wakayama, Wakayama 641-8510

Japan

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214

Poland

Instytut Centrum Zdrowia Matki Polki

Lodz, 93-338

Poland

Wojewodzki Szpital im Sw Ojca Pio w Przemyslu

Przemyśl, 37-700

Poland

Hospital Regional Universitario de Malaga

Málaga, Andalusia 29011

Spain

Hospital Universitari Vall d Hebron

Barcelona, Catalonia 08035

Spain

Hospital Universitari i Politecnic La Fe

Valencia, Valencia 46026

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Kantonsspital Graubuenden

Chur, 7000

Switzerland

Freiburg Spital

Fribourg, 1708

Switzerland

Kantonsspital Winterthur

Winterthur, 8401

Switzerland

Adana Sehir Egitim ve Arastirma Hastanesi

Adana, 01370

Turkey (Türkiye)

Ankara Bilkent Sehir Hastanesi

Ankara, 06800

Turkey (Türkiye)

Koc Universitesi Hastanesi

Istanbul, 34010

Turkey (Türkiye)