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Active, not recruitingNCT05361395Updated Sep 9, 2026

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 1 interventional study of Tarlatamab and Carboplatin in Extensive Stage Small Cell Lung Cancer, sponsored by Amgen. Active, not recruiting at 44 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Amgen · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
184
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Extensive Stage Small Cell Lung Cancer

Keywords

  • Extensive Stage Small Cell Lung Cancer
  • ES-SCLC
  • SCLC
  • Lung Cancer
  • AMG 757
  • Bi-Specific T-Cell Engager
  • BiTE
  • Inmunotherapy
  • Immunooncology
  • Inmuno-oncology
  • DLL3
  • Delta Like Protein 3
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 184 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
184 participants (actual)

Study arms

  • Experimental
    Part 1: Dose Exploration Combination Regimen 1

    Tarlatamab+Atezolizumab+Carboplatin+Etoposide

    Drug: Tarlatamab · Drug: Carboplatin · Drug: Etoposide · Drug: Atezolizumab

  • Experimental
    Part 2: Dose Exploration Combination Regimen 2

    Tarlatamab+Atezolizumab+Carboplatin+Etoposide

    Drug: Tarlatamab · Drug: Carboplatin · Drug: Etoposide · Drug: Atezolizumab

  • Experimental
    Part 3: Dose Exploration Combination Regimen 3

    Tarlatamab+Atezolizumab+Carboplatin+Etoposide

    Drug: Tarlatamab · Drug: Carboplatin · Drug: Etoposide · Drug: Atezolizumab

  • Experimental
    Part 4: Dose Expansion

    Expansion of Part 1, Part 2, or Part 3 with Atezolizumab

    Drug: Tarlatamab · Drug: Carboplatin · Drug: Etoposide · Drug: Atezolizumab

  • Experimental
    Part 5: Dose Exploration Maintenance

    Tarlatamab+Atezolizumab

    Drug: Tarlatamab · Drug: Atezolizumab

  • Experimental
    Part 6: Dose Expansion Maintenance

    Expansion of Part 5 with Atezolizumab

    Drug: Tarlatamab · Drug: Atezolizumab

  • Experimental
    Part 7: Dose Expansion

    Expansion of Part 1, 2, or 3 with Durvalumab

    Drug: Tarlatamab · Drug: Carboplatin · Drug: Etoposide · Drug: Durvalumab

  • Experimental
    Part 8: Dose Expansion Maintenance

    Expansion of Part 5 with Durvalumab

    Drug: Tarlatamab · Drug: Durvalumab

  • Experimental
    Part 9: Dose Expansion Maintenance

    Expansion with Tarlatamab+Durvalumab

    Drug: Tarlatamab · Drug: Durvalumab

Interventions

  • DrugTarlatamab

    Tarlatamab will be administered as an intravenous (IV) infusion.

    Also known as: AMG 757

  • DrugCarboplatin

    Carboplatin will be administered as an intravenous (IV) infusion.

  • DrugEtoposide

    Etoposide will be administered as an intravenous (IV) infusion.

  • DrugAtezolizumab

    Atezolizumab will be administered as an intravenous (IV) infusion.

    Also known as: Tecentriq

  • DrugDurvalumab

    Durvalumab will be administered as an intravenous (IV) infusion.

06

What researchers measure

Primary outcomes

  1. Number of Participants with a Dose Limiting Toxicity (DLT)

    Time frame: 24 months

  2. Number of Participants with Treatment-emergent Adverse Events (TEAE)

    Time frame: 24 months

  3. Number of Participants with Treatment-related Adverse Events

    Time frame: 24 months

  4. Number of Participants with Clinically Significant Changes in Vital Signs

    Time frame: 24 months

  5. Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Measurements

    Time frame: 24 months

  6. Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests

    Time frame: 24 months

Secondary outcomes

  1. 6-month Progression-free Survival (PFS)

    Time frame: 24 months

  2. Objective Response (OR)

    Per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

    Time frame: 24 months

  3. Duration of Response (DOR)

    Time frame: 24 months

  4. Disease Control Rate(DCR)

    Time frame: 24 months

  5. Overall Survival (OS)

    Time frame: 24 months

  6. Serum Concentration of Tarlatamab

    Time frame: 24 months

07

Study locations

44 sites
  • 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
08

References and documents

Publications

  • 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. PubMed 40934933 ↗

Individual participant data

Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Supporting information: Study protocol, Sap, Icf, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05361395
Lead sponsor
Amgen
Responsible party
Sponsor
First posted
May 4, 2022
Start date
Aug 24, 2022
Primary completion
May 30, 2030 (estimated)
Completion
May 30, 2030 (estimated)
Last update
Sep 9, 2026

Study contacts

MD
study director · Amgen

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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