TrialPath
Recruiting

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

NCT06598306 · Amgen
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Official title
A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of Subcutaneous Tarlatamab in Subjects With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)
About this study
The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.
Eligibility criteria
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.
Study design
Enrollment target: 220 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-10-07
Estimated completion: 2030-04-24
Last updated: 2026-06-26
Interventions
Drug: Tarlatamab
Primary outcomes
  • Number of Participants with Dose-limiting toxicities (DLTs) (Up to day 21)
  • Number of Participants with Treatment-emergent Adverse Events (TEAEs) (Up to approximately 24 months)
  • Number of Participants with Changes in Vital Signs (Up to approximately 24 months)
Sponsor
Amgen · industry
With: BeOne Medicines
Contacts & investigators
ContactAmgen Call Center · contact · medinfo@amgen.com · 866-572-6436
InvestigatorMD · study_director, Amgen
All locations (31)
University of Southern California, Norris Comprehensive Cancer CenterRecruiting
Los Angeles, California, United States
University of Illinois ChicagoRecruiting
Chicago, Illinois, United States
Trinity Health Saint Joseph Mercy Ann ArborRecruiting
Ann Arbor, Michigan, United States
Avera Cancer InstituteRecruiting
Sioux Falls, South Dakota, United States
University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Swedish Cancer InstituteRecruiting
Seattle, Washington, United States
Chris OBrien LifehouseRecruiting
Camperdown, New South Wales, Australia
Calvary Mater Newcastle HospitalRecruiting
Waratah, New South Wales, Australia
The Alfred HospitalRecruiting
Melbourne, Victoria, Australia
Universitair Ziekenhuis GentRecruiting
Ghent, Belgium
Universitair Ziekenhuis Leuven - Campus GasthuisbergRecruiting
Leuven, Belgium
Centre Hospitalier Universitaire de Liege - Sart TilmanRecruiting
Liège, Belgium
Jilin Cancer HospitalRecruiting
Changchun, Jilin, China
Shanghai Pulmonary HospitalRecruiting
Shanghai, Shanghai Municipality, China
Universitaetsklinikum RegensburgRecruiting
Regensburg, Germany
Universitaetsklinikum WuerzburgRecruiting
Würzburg, Germany
Okayama University HospitalRecruiting
Okayama, Okayama-ken, Japan
Wakayama Medical University HospitalRecruiting
Wakayama, Wakayama, Japan
Uniwersyteckie Centrum KliniczneRecruiting
Gdansk, Poland
Instytut Centrum Zdrowia Matki PolkiRecruiting
Lodz, Poland
Wojewodzki Szpital im Sw Ojca Pio w PrzemysluRecruiting
Przemyśl, Poland
Hospital Regional Universitario de MalagaRecruiting
Málaga, Andalusia, Spain
Hospital Universitari Vall d HebronRecruiting
Barcelona, Catalonia, Spain
Hospital Universitari i Politecnic La FeRecruiting
Valencia, Valencia, Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Spain
Kantonsspital GraubuendenRecruiting
Chur, Switzerland
Freiburg SpitalRecruiting
Fribourg, Switzerland
Kantonsspital WinterthurRecruiting
Winterthur, Switzerland
Adana Sehir Egitim ve Arastirma HastanesiRecruiting
Adana, Turkey (Türkiye)
Ankara Bilkent Sehir HastanesiRecruiting
Ankara, Turkey (Türkiye)
Koc Universitesi HastanesiRecruiting
Istanbul, Turkey (Türkiye)