First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)
NCT ID: NCT05361395
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
184 participants
INTERVENTIONAL
2022-08-24
2028-08-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1: Dose Exploration Combination Regimen 1
Tarlatamab+Atezolizumab+Carboplatin+Etoposide
Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Carboplatin
Carboplatin will be administered as an intravenous (IV) infusion.
Etoposide
Etoposide will be administered as an intravenous (IV) infusion.
Atezolizumab
Atezolizumab will be administered as an intravenous (IV) infusion.
Part 2: Dose Exploration Combination Regimen 2
Tarlatamab+Atezolizumab+Carboplatin+Etoposide
Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Carboplatin
Carboplatin will be administered as an intravenous (IV) infusion.
Etoposide
Etoposide will be administered as an intravenous (IV) infusion.
Atezolizumab
Atezolizumab will be administered as an intravenous (IV) infusion.
Part 3: Dose Exploration Combination Regimen 3
Tarlatamab+Atezolizumab+Carboplatin+Etoposide
Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Carboplatin
Carboplatin will be administered as an intravenous (IV) infusion.
Etoposide
Etoposide will be administered as an intravenous (IV) infusion.
Atezolizumab
Atezolizumab will be administered as an intravenous (IV) infusion.
Part 4: Dose Expansion
Expansion of Part 1, Part 2, or Part 3 with Atezolizumab
Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Carboplatin
Carboplatin will be administered as an intravenous (IV) infusion.
Etoposide
Etoposide will be administered as an intravenous (IV) infusion.
Atezolizumab
Atezolizumab will be administered as an intravenous (IV) infusion.
Part 5: Dose Exploration Maintenance
Tarlatamab+Atezolizumab
Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Atezolizumab
Atezolizumab will be administered as an intravenous (IV) infusion.
Part 6: Dose Expansion Maintenance
Expansion of Part 5 with Atezolizumab
Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Atezolizumab
Atezolizumab will be administered as an intravenous (IV) infusion.
Part 7: Dose Expansion
Expansion of Part 1, 2, or 3 with Durvalumab
Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Carboplatin
Carboplatin will be administered as an intravenous (IV) infusion.
Etoposide
Etoposide will be administered as an intravenous (IV) infusion.
Durvalumab
Durvalumab will be administered as an intravenous (IV) infusion.
Part 8: Dose Expansion Maintenance
Expansion of Part 5 with Durvalumab
Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Durvalumab
Durvalumab will be administered as an intravenous (IV) infusion.
Part 9: Dose Expansion Maintenance
Expansion with Tarlatamab+Durvalumab
Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Durvalumab
Durvalumab will be administered as an intravenous (IV) infusion.
Interventions
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Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Carboplatin
Carboplatin will be administered as an intravenous (IV) infusion.
Etoposide
Etoposide will be administered as an intravenous (IV) infusion.
Atezolizumab
Atezolizumab will be administered as an intravenous (IV) infusion.
Durvalumab
Durvalumab will be administered as an intravenous (IV) infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Major surgery within 28 days of study day 1.
* Untreated or symptomatic brain metastases and leptomeningeal disease.
* 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.
* History of immune-related colitis.
* History or evidence of interstitial lung disease or active, non-infectious pneumonitis.
* 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
* 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.
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California, United States
Christiana Care Health Services
Newark, Delaware, United States
Henry Ford Health System
Detroit, Michigan, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
New York University Grossman School of Medicine and New York University Langone Hospitals
New York, New York, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Swedish Cancer Institute Medical Oncology
Seattle, Washington, United States
West Virginia University Health Sciences Center
Morgantown, West Virginia, United States
Chris OBrien Lifehouse
Camperdown, New South Wales, Australia
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Algemeen Ziekenhuis Maria Middelares
Ghent, , Belgium
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, , Belgium
AZ Delta Campus Rumbeke
Roeselare, , Belgium
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
CHU de Quebec Hopital de l Enfant Jesus
Québec, Quebec, Canada
Rigshospitalet
Copenhagen, , Denmark
Centre Leon Berard
Lyon, , France
Centre Hospitalier Universitaire de Nantes, Hôpital Nord Laënnec
Saint-Herblain, , France
Gustave Roussy
Villejuif, , France
Universitaetsklinikum Dresden
Dresden, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Universitaetsklinikum Freiburg
Freiburg im Breisgau, , Germany
Rambam Medical Center
Haifa, , Israel
Hadassah Ein-Kerem Medical Center
Jerusalem, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Azienda Ospedaliera Universitaria Renato Dulbecco
Catanzaro, , Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza (MB), , Italy
Istituto Nazionale Tumori Regina Elena
Rome, , Italy
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, Japan
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol
Badalona, Catalonia, Spain
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Universitaetsspital Basel
Basel, , Switzerland
Inselspital Bern
Bern, , Switzerland
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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References
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Paulson KG, Lau SCM, Ahn MJ, Moskovitz M, Pogorzelski M, Hafliger S, Parkes A, Zhang Y, Hamidi A, Thompson CG, Wermke M. Safety and activity of tarlatamab in combination with a PD-L1 inhibitor as first-line maintenance therapy after chemo-immunotherapy in patients with extensive-stage small-cell lung cancer (DeLLphi-303): a multicentre, non-randomised, phase 1b study. Lancet Oncol. 2025 Oct;26(10):1300-1311. doi: 10.1016/S1470-2045(25)00480-2. Epub 2025 Sep 8.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2024-511021-58
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20200469
Identifier Type: -
Identifier Source: org_study_id
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