NCT05361395Active, not recruitingPhase 1
First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)
A Phase 1b Study Evaluating the Safety and Efficacy of First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung (DeLLphi-303)
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
This is a phase 1b study to assess the safety and tolerability of tarlatamab in combination with programmed death ligand (PD-L1) inhibition with and without chemotherapy.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 184 (actual)
- First submitted
- 29 Apr 2022
- Start date
- 24 Aug 2022
- Primary completion date
- 30 May 2030
- Lead sponsor
- Amgen
- Diseases
- Lung cancer
- NCT number
- NCT05361395
- EU CT number
- 2024-511021-58-00
- EudraCT number
- 2021-005462-17
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 184
- From 24 Aug 2022 to the primary completion date, 30 May 2030
- 42 sites in 15 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 study day 1.
- Participants who experienced recurrent grade 2 pneumonitis or severe or life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-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 study treatment.
- Participants 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 study treatment
Other illness
- History of other malignancy within the past 2 years with exceptions.
- Untreated or symptomatic brain metastases and leptomeningeal disease.
- History of immune-related colitis.
- History or evidence of interstitial lung disease or active, non-infectious pneumonitis.
- Participant has known active infection requiring parenteral antibiotic treatment. Upon completion of parenteral antibiotics and resolution of symptoms, the participant may be considered eligible for the study from an infection standpoint
- NOTE: Simple urinary tract infections and uncomplicated bacterial pharyngitis are permitted if responding to an active treatment and after consultation with Medical Monitor. Participants requiring oral antibiotics who have been afebrile for \>24 hours, have no leukocytosis, nor clinical signs of infection are eligible. Screening for chronic infectious conditions is not required.
- History of hypophysitis or pituitary dysfunction.
- History of solid organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study. Participants with Type I diabetes, vitiligo, psoriasis, hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are permitted.
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 same time of signing the informed consent.
- Histologically or cytologically confirmed Extensive Stage Small Cell Lung Cancer (ES-SCLC) and no prior systemic treatment for ES-SCLC.
- Participants with prior treatment for limited-stage SCLC (LS-SCLC) are permitted.
- Eastern Cooperative Oncology Group (ECOG) 0 to 1.
- Participants with treated asymptomatic 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 (42)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chris Obrien Lifehouse Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| Antwerp University Hospital Coordinator of this site? Confirm its status | Edegem | Belgium | Active, not recruiting |
| Az Maria Middelares Gent Coordinator of this site? Confirm its status | Gent | Belgium | Active, not recruiting |
| JESSA Ziekenhuis Coordinator of this site? Confirm its status | Hasselt | Belgium | Active, not recruiting |
| Algemeen Ziekenhuis Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Active, not recruiting |
| CHU de Quebec - Hôpital de l' Enfant Jésus Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Universitaetsspital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Inselspital Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| Technische Universitaet Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Active, not recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Active, not recruiting |
| Medical Center - University Of Freiburg Coordinator of this site? Confirm its status | Freiburg | Germany | Active, not recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron 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 |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Saint-Herblain | France | Active, not recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Active, not recruiting |
| Rambam Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Hadassah Ein-Kerem Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Rabin Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Active, not recruiting |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Kashiwa-shi | Japan | Unknown status |
| The Cancer Institute Hospital of Japanese Foundation for Cancer Research Coordinator of this site? Confirm its status | Koto-ku | Japan | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Active, not recruiting |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| The University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Henry Ford Health System Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| University of Southern California Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| West Virginia University Health Sciences Center Coordinator of this site? Confirm its status | Morgantown | United States | Unknown status |
| Christiana Care Health Services Coordinator of this site? Confirm its status | Newark | United States | Unknown status |
| Rutgers Cancer Institute of New Jersey Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| New York University Grossman School of Medicine and New York University Langone Hospitals Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Swedish Cancer Institute Medical Oncology Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Avera Cancer Institute Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.