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)
2 other identifiers
interventional
184
15 countries
44
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2022
Longer than P75 for phase_1
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2022
CompletedFirst Posted
Study publicly available on registry
May 4, 2022
CompletedStudy Start
First participant enrolled
August 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 28, 2028
March 3, 2026
February 1, 2026
6 years
April 29, 2022
February 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Number of Participants with a Dose Limiting Toxicity (DLT)
24 months
Number of Participants with Treatment-emergent Adverse Events (TEAE)
24 months
Number of Participants with Treatment-related Adverse Events
24 months
Number of Participants with Clinically Significant Changes in Vital Signs
24 months
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Measurements
24 months
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
24 months
Secondary Outcomes (6)
6-month Progression-free Survival (PFS)
24 months
Objective Response (OR)
24 months
Duration of Response (DOR)
24 months
Disease Control Rate(DCR)
24 months
Overall Survival (OS)
24 months
- +1 more secondary outcomes
Study Arms (9)
Part 1: Dose Exploration Combination Regimen 1
EXPERIMENTALTarlatamab+Atezolizumab+Carboplatin+Etoposide
Part 2: Dose Exploration Combination Regimen 2
EXPERIMENTALTarlatamab+Atezolizumab+Carboplatin+Etoposide
Part 3: Dose Exploration Combination Regimen 3
EXPERIMENTALTarlatamab+Atezolizumab+Carboplatin+Etoposide
Part 4: Dose Expansion
EXPERIMENTALExpansion of Part 1, Part 2, or Part 3 with Atezolizumab
Part 5: Dose Exploration Maintenance
EXPERIMENTALTarlatamab+Atezolizumab
Part 6: Dose Expansion Maintenance
EXPERIMENTALExpansion of Part 5 with Atezolizumab
Part 7: Dose Expansion
EXPERIMENTALExpansion of Part 1, 2, or 3 with Durvalumab
Part 8: Dose Expansion Maintenance
EXPERIMENTALExpansion of Part 5 with Durvalumab
Part 9: Dose Expansion Maintenance
EXPERIMENTALExpansion with Tarlatamab+Durvalumab
Interventions
Tarlatamab will be administered as an intravenous (IV) infusion.
Carboplatin will be administered as an intravenous (IV) infusion.
Etoposide will be administered as an intravenous (IV) infusion.
Atezolizumab will be administered as an intravenous (IV) infusion.
Durvalumab will be administered as an intravenous (IV) infusion.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- History of other malignancy within the past 2 years with exceptions.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (44)
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Christiana Care Health Services
Newark, Delaware, 19713, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
New York University Grossman School of Medicine and New York University Langone Hospitals
New York, New York, 10016, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Swedish Cancer Institute Medical Oncology
Seattle, Washington, 98104, United States
West Virginia University Health Sciences Center
Morgantown, West Virginia, 26506, United States
Chris OBrien Lifehouse
Camperdown, New South Wales, 2050, Australia
Universitair Ziekenhuis Antwerpen
Edegem, 2650, Belgium
Algemeen Ziekenhuis Maria Middelares
Ghent, 9000, Belgium
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, 3500, Belgium
AZ Delta Campus Rumbeke
Roeselare, 8800, Belgium
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
CHU de Quebec Hopital de l Enfant Jesus
Québec, Quebec, G1R 2J6, Canada
Rigshospitalet
Copenhagen, 2100, Denmark
Centre Leon Berard
Lyon, 69373, France
Centre Hospitalier Universitaire de Nantes, Hôpital Nord Laënnec
Saint-Herblain, 44800, France
Gustave Roussy
Villejuif, 94805, France
Universitaetsklinikum Dresden
Dresden, 01307, Germany
Universitaetsklinikum Essen
Essen, 45147, Germany
Universitaetsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Rambam Medical Center
Haifa, 3109601, Israel
Hadassah Ein-Kerem Medical Center
Jerusalem, 9112001, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
Sheba Medical Center
Ramat Gan, 5265601, Israel
Azienda Ospedaliera Universitaria Renato Dulbecco
Catanzaro, 88100, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza (MB), 20900, Italy
Istituto Nazionale Tumori Regina Elena
Rome, 00144, Italy
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, 135-8550, Japan
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ, Netherlands
Seoul National University Hospital
Seoul, 03080, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol
Badalona, Catalonia, 08916, Spain
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08035, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Universitaetsspital Basel
Basel, 4031, Switzerland
Inselspital Bern
Bern, 3010, Switzerland
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Related Publications (1)
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.
PMID: 40934933BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
April 29, 2022
First Posted
May 4, 2022
Study Start
August 24, 2022
Primary Completion (Estimated)
August 28, 2028
Study Completion (Estimated)
August 28, 2028
Last Updated
March 3, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
- Access Criteria
- Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request