Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)
NCT ID: NCT06598306
Last Updated: 2025-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
220 participants
INTERVENTIONAL
2024-10-07
2030-03-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
NONE
Study Groups
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Part 1 Dose Exploration
Tarlatamab will be administered as a SC injection in Part 1.
Tarlatamab
Administered by SC injection.
Part 2 Dose Expansion
Following the selection of a SC dosing regimen in Part 1, tarlatamab will be administered in Part 2 at the dose deemed safe and tolerable in Part 1.
Tarlatamab
Administered by SC injection.
Part 3 Alternative Dosing
Following the selection of a SC dosing regimen from Part 1 that will be used in Part 2 dose expansion, Part 3 may open to test alternative dosing of SC tarlatamab.
Tarlatamab
Administered by SC injection.
Interventions
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Tarlatamab
Administered by SC injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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BeOne Medicines
INDUSTRY
Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of Illinois Chicago
Chicago, Illinois, United States
Trinity Health Saint Joseph Mercy Ann Arbor
Ann Arbor, Michigan, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Swedish Cancer Institute
Seattle, Washington, United States
Chris OBrien Lifehouse
Camperdown, New South Wales, Australia
Calvary Mater Newcastle Hospital
Waratah, New South Wales, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Universitair Ziekenhuis Gent
Ghent, , Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, , Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, , Belgium
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Universitaetsklinikum Regensburg
Regensburg, , Germany
Universitaetsklinikum Wuerzburg
Würzburg, , Germany
Okayama University Hospital
Okayama, Okayama-ken, Japan
Wakayama Medical University Hospital
Wakayama, , Japan
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, , Poland
Wojewodzki Szpital im Sw Ojca Pio w Przemyslu
Przemyśl, , Poland
Hospital Regional Universitario de Malaga
Málaga, Andalusia, Spain
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Kantonsspital Graubuenden
Chur, , Switzerland
Freiburg Spital
Fribourg, , Switzerland
Kantonsspital Winterthur
Winterthur, , Switzerland
Adana Sehir Egitim ve Arastirma Hastanesi
Adana, , Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Ankara, , Turkey (Türkiye)
Koc Universitesi Hastanesi
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20230298
Identifier Type: -
Identifier Source: org_study_id
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