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Active Not RecruitingPhase 1NCT05361395
Official study title

First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedTarlatamab and Carboplatin

Plus 3 other study approaches.

Who it may be forSmall cell lung cancer (SCLC) · PD-L1

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 9, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 1

Interventional

Where is it offered?44 U.S. locations

Locations may change over time.

Who runs it?Amgen

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Amgen
Interventions being studied
Drug: Tarlatamab; Drug: Carboplatin; Drug: Etoposide; Drug: Atezolizumab; Drug: Durvalumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Small cell lung cancer (SCLC)→
Biomarkers
PD-L1→
Treatment approach
Immunotherapy→Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Southern California, Norris Comprehensive Cancer CenterLos Angeles, California
  • Christiana Care Health ServicesNewark, Delaware
  • Henry Ford Health SystemDetroit, Michigan
  • Rutgers Cancer Institute of New JerseyNew Brunswick, New Jersey
  • New York University Grossman School of Medicine and New York University Langone HospitalsNew York, New York
  • The University of North Carolina at Chapel HillChapel Hill, North Carolina
  • Avera Cancer InstituteSioux Falls, South Dakota
  • Swedish Cancer Institute Medical OncologySeattle, Washington
  • West Virginia University Health Sciences CenterMorgantown, West Virginia
  • Chris OBrien LifehouseCamperdown, New South Wales
  • Universitair Ziekenhuis AntwerpenEdegem
  • Algemeen Ziekenhuis Maria MiddelaresGhent

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 9, 2026. Always confirm current availability with the study team.

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