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

Recruiting now · Phase 1

Conditions studied: Extensive Stage Small Cell Lung Cancer

In brief

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

Key facts

Study ID

NCT06598306

Run by

Amgen

People needed

220

Starts

2024-10-07

Expected to finish

2030-04-24

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Southern California, Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
• University of Illinois Chicago — Chicago, Illinois, United States (enrolling)
• Trinity Health Saint Joseph Mercy Ann Arbor — Ann Arbor, Michigan, United States (enrolling)
• Avera Cancer Institute — Sioux Falls, South Dakota, United States (enrolling)
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Swedish Cancer Institute — Seattle, Washington, United States (enrolling)
• Chris OBrien Lifehouse — Camperdown, New South Wales, Australia (enrolling)
• Calvary Mater Newcastle Hospital — Waratah, New South Wales, Australia (enrolling)
• The Alfred Hospital — Melbourne, Victoria, Australia (enrolling)
• Universitair Ziekenhuis Gent — Ghent, Belgium (enrolling)
• Universitair Ziekenhuis Leuven - Campus Gasthuisberg — Leuven, Belgium (enrolling)
• Centre Hospitalier Universitaire de Liege - Sart Tilman — Liège, Belgium (enrolling)
• Jilin Cancer Hospital — Changchun, Jilin, China (enrolling)
• Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (enrolling)
• Universitaetsklinikum Regensburg — Regensburg, Germany (enrolling)
• Universitaetsklinikum Wuerzburg — Würzburg, Germany (enrolling)
• Okayama University Hospital — Okayama, Okayama-ken, Japan (enrolling)
• Wakayama Medical University Hospital — Wakayama, Wakayama, Japan (enrolling)
• Uniwersyteckie Centrum Kliniczne — Gdansk, Poland (enrolling)
• Instytut Centrum Zdrowia Matki Polki — Lodz, Poland (enrolling)
• Wojewodzki Szpital im Sw Ojca Pio w Przemyslu — Przemyśl, Poland (enrolling)
• Hospital Regional Universitario de Malaga — Málaga, Andalusia, Spain (enrolling)
• Hospital Universitari Vall d Hebron — Barcelona, Catalonia, Spain (enrolling)
• Hospital Universitari i Politecnic La Fe — Valencia, Valencia, Spain (enrolling)
• Hospital Universitario 12 de Octubre — Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

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