NCT03319940Active, not recruitingPhase 1
Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)
A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of Tarlatamab in Subjects With Small Cell Lung Cancer (DeLLphi-300)
Source: ClinicalTrials.gov · Last updated 19 Nov 2025
Brief summary (registry, in English)
A study to assess the safety, tolerability, and PK of tarlatamab in participants with SCLC
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 269 (actual)
- First submitted
- 5 Oct 2017
- Start date
- 26 Dec 2017
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Amgen
- Diseases
- Lung cancer
- NCT number
- NCT03319940
- EU CT number
- 2023-506541-39-00
- EudraCT number
- 2017-003421-15
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 269
- From 26 Dec 2017 to the primary completion date, 31 Dec 2026
- 35 sites in 13 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major surgery within 28 days of first dose tarlatamab
- Untreated (includes new lesions or progression in previously treated lesions) or symptomatic brain metastases and leptomeningeal disease (regardless of symptomatic or not).
- Prior anti-cancer therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and first dose of tarlatamab with the following exceptions: participants who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to Grade less than or equal to 1; and prior palliative radiotherapy must have been completed at least 7 days before the first dose of tarlatamab
- Participants who experienced severe, life-threatening or recurrent (Grade 2 or higher) immune-mediated AEs or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immune-oncology agents
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of tarlatamab
- Participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of investigational product administration
Other illness
- History of other malignancy within the past 2 years prior to first dose of tarlatamab with exceptions
- Has evidence of interstitial lung disease or active, non-infectious pneumonitis
- Part C only: history of solid organ transplantation or active autoimmune disease that has required systemic treatment within the past 2 years
Who the study is looking for
- Participant has provided informed consent prior to initiation of any study-specific activities/procedures
- Age greater than or equal to 18 years old at the time of signing the informed consent
- Histologically or cytologically confirmed SCLC. For parts A, C, D, E, F, and G: relapsed/refractory small cell lung cancer (R/R SCLC) who progressed or recurred following platinum-based regimen
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Participants with treated brain metastases are eligible provided they meet defined criteria
- Adequate organ function as defined in protocol
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (35)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Completed |
| Chris Obrien Lifehouse Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| Centre Hospitalier Universitaire Vaudois Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
| Kantonsspital St. Gallen Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Unknown status |
| Universitaetsklinikum Wuerzburg AöR Coordinator of this site? Confirm its status | Wuerzburg | Germany | Active, not recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Active, not recruiting |
| Christie Hospital Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Shatin, New Territories | Hong Kong SAR China | Unknown status |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Chuo Ku | Japan | Unknown status |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Kashiwa-shi | Japan | Unknown status |
| Wakayama Medical University Hospital Coordinator of this site? Confirm its status | Wakayama | Japan | Unknown status |
| Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Completed |
| Biokinetica S.A. Coordinator of this site? Confirm its status | Jozefow | Poland | Active, not recruiting |
| Europejskie Centrum Zdrowia Otwock Sp. Z.o.o. Coordinator of this site? Confirm its status | Otwock | Poland | Active, not recruiting |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Tri-Service General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
| Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| John Hopkins Sidney Kimmel Comprehensive Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University Hospitals Cleveland Medical Center* Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| The Ohio State University Wexner Medical Center - Thoracic Oncology Clinic Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Henry Ford Health System Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| City of Hope National Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Sarah Cannon Research Institute Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Yale New Haven Hospital Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Ochsner Clinic Foundation Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Fox Chase Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of Pittsburgh Medical Center Cancer Pavillion Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.