Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)
Recruiting · NCT06598306 · Interventional (participants receive a specific treatment) · Lead sponsor: Amgen
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
31 locations listed across 6 US states.
- 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
- Adana Sehir Egitim ve Arastirma Hastanesi - Adana, Turkey (Türkiye)
- Ankara Bilkent Sehir Hastanesi - Ankara, Turkey (Türkiye)
- Kantonsspital Graubuenden - Chur, Switzerland
- Freiburg Spital - Fribourg, Switzerland
- Uniwersyteckie Centrum Kliniczne - Gdansk, Poland
- Universitair Ziekenhuis Gent - Ghent, Belgium
- Koc Universitesi Hastanesi - Istanbul, Turkey (Türkiye)
- Universitair Ziekenhuis Leuven - Campus Gasthuisberg - Leuven, Belgium
- Centre Hospitalier Universitaire de Liege - Sart Tilman - Liège, Belgium
- Instytut Centrum Zdrowia Matki Polki - Lodz, Poland
- Hospital Universitario 12 de Octubre - Madrid, Spain
- Wojewodzki Szpital im Sw Ojca Pio w Przemyslu - Przemyśl, Poland
- Universitaetsklinikum Regensburg - Regensburg, Germany
- Kantonsspital Winterthur - Winterthur, Switzerland
- Universitaetsklinikum Wuerzburg - Würzburg, Germany
- Hospital Regional Universitario de Malaga - Málaga, Andalusia, Spain
- Hospital Universitari Vall d Hebron - Barcelona, Catalonia, Spain
- Jilin Cancer Hospital - Changchun, Jilin, China
- Chris OBrien Lifehouse - Camperdown, New South Wales, Australia
- Calvary Mater Newcastle Hospital - Waratah, New South Wales, Australia
- Okayama University Hospital - Okayama, Okayama-ken, Japan
- Shanghai Pulmonary Hospital - Shanghai, Shanghai Municipality, China
- Hospital Universitari i Politecnic La Fe - Valencia, Valencia, Spain
- The Alfred Hospital - Melbourne, Victoria, Australia
- Wakayama Medical University Hospital - Wakayama, Wakayama, Japan