Clinical Trials in Australia / NCT06598306
Recruiting
Phase 1
Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)
NCT06598306 · tracked via the Priya Life Science Australia tracker
Condition(s) studied
Extensive Stage Small Cell Lung Cancer
Study summary
The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.
Eligibility
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.
Primary outcome measure(s)
- 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
- Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests — Up to approximately 24 months
Trial sites (31)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Southern California, Norris Comprehensive Cancer Center | Los Angeles | California | Recruiting |
| University of Illinois Chicago | Chicago | Illinois | Recruiting |
| Trinity Health Saint Joseph Mercy Ann Arbor | Ann Arbor | Michigan | Recruiting |
| Avera Cancer Institute | Sioux Falls | South Dakota | Recruiting |
| University of Texas MD Anderson Cancer Center | Houston | Texas | Recruiting |
| Swedish Cancer Institute | Seattle | Washington | Recruiting |
| Chris OBrien Lifehouse | Camperdown | New South Wales | Recruiting |
| Calvary Mater Newcastle Hospital | Waratah | New South Wales | Recruiting |
| The Alfred Hospital | Melbourne | Victoria | Recruiting |
| Universitair Ziekenhuis Gent | Ghent | Belgium | Recruiting |
| Universitair Ziekenhuis Leuven - Campus Gasthuisberg | Leuven | Belgium | Recruiting |
| Centre Hospitalier Universitaire de Liege - Sart Tilman | Liège | Belgium | Recruiting |
| Jilin Cancer Hospital | Changchun | Jilin | Recruiting |
| Shanghai Pulmonary Hospital | Shanghai | Shanghai Municipality | Recruiting |
| Universitaetsklinikum Regensburg | Regensburg | Germany | Recruiting |
| Universitaetsklinikum Wuerzburg | Würzburg | Germany | Recruiting |
| Okayama University Hospital | Okayama | Okayama-ken | Recruiting |
| Wakayama Medical University Hospital | Wakayama | Wakayama | Recruiting |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Poland | Recruiting |
| Instytut Centrum Zdrowia Matki Polki | Lodz | Poland | Recruiting |
| Wojewodzki Szpital im Sw Ojca Pio w Przemyslu | Przemyśl | Poland | Recruiting |
| Hospital Regional Universitario de Malaga | Málaga | Andalusia | Recruiting |
| Hospital Universitari Vall d Hebron | Barcelona | Catalonia | Recruiting |
| Hospital Universitari i Politecnic La Fe | Valencia | Valencia | Recruiting |
| Hospital Universitario 12 de Octubre | Madrid | Spain | Recruiting |
| Kantonsspital Graubuenden | Chur | Switzerland | Recruiting |
| Freiburg Spital | Fribourg | Switzerland | Recruiting |
| Kantonsspital Winterthur | Winterthur | Switzerland | Recruiting |
| Adana Sehir Egitim ve Arastirma Hastanesi | Adana | Turkey (Türkiye) | Recruiting |
| Ankara Bilkent Sehir Hastanesi | Ankara | Turkey (Türkiye) | Recruiting |
| Koc Universitesi Hastanesi | Istanbul | Turkey (Türkiye) | Recruiting |
More Amgen trials in Australia
A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)
Active, not recruiting
First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Active, not recruiting
Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight
Active, not recruiting
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06598306 on ClinicalTrials.gov ↗ ← All trials in Australia