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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

Full criteria on ClinicalTrials.gov

Sites (42)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Chris Obrien Lifehouse
Coordinator of this site? Confirm its status
CamperdownAustraliaUnknown status
Antwerp University Hospital
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EdegemBelgiumActive, not recruiting
Az Maria Middelares Gent
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GentBelgiumActive, not recruiting
JESSA Ziekenhuis
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HasseltBelgiumActive, not recruiting
Algemeen Ziekenhuis Delta
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RoeselareBelgiumActive, not recruiting
CHU de Quebec - Hôpital de l' Enfant Jésus
Coordinator of this site? Confirm its status
QuébecCanadaUnknown status
Princess Margaret Cancer Centre
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TorontoCanadaUnknown status
Universitaetsspital Basel
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BaselSwitzerlandUnknown status
Inselspital Bern
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BernSwitzerlandUnknown status
Technische Universitaet Dresden
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DresdenGermanyActive, not recruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyActive, not recruiting
Medical Center - University Of Freiburg
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FreiburgGermanyActive, not recruiting
Rigshospitalet
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CopenhagenDenmarkUnknown status
Hospital Germans Trias i Pujol
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BadalonaSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Centre Leon Berard
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LyonFranceActive, not recruiting
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceActive, not recruiting
Institut Gustave Roussy
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VillejuifFranceActive, not recruiting
Rambam Medical Center
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HaifaIsraelUnknown status
Hadassah Ein-Kerem Medical Center
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JerusalemIsraelUnknown status
Rabin Medical Center
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Petah TikvaIsraelUnknown status
Sheba medical center
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Ramat GanIsraelUnknown status
Fondazione IRCCS San Gerardo dei Tintori
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MonzaItalyActive, not recruiting
National Cancer Center Hospital East
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Kashiwa-shiJapanUnknown status
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
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Koto-kuJapanUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Universitair Medisch Centrum Groningen
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GroningenNetherlandsActive, not recruiting
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
The University of North Carolina at Chapel Hill
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Chapel HillUnited StatesUnknown status
Henry Ford Health System
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DetroitUnited StatesUnknown status
University of Southern California Norris Comprehensive Cancer Center
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Los AngelesUnited StatesUnknown status
West Virginia University Health Sciences Center
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MorgantownUnited StatesUnknown status
Christiana Care Health Services
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NewarkUnited StatesUnknown status
Rutgers Cancer Institute of New Jersey
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New BrunswickUnited StatesUnknown status
New York University Grossman School of Medicine and New York University Langone Hospitals
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New YorkUnited StatesUnknown status
Swedish Cancer Institute Medical Oncology
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SeattleUnited StatesUnknown status
Avera Cancer Institute
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Sioux FallsUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.