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Active Not RecruitingPhase 1NCT03319940
Official study title

Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)

Study summary

A study to assess the safety, tolerability, and PK of tarlatamab in participants with SCLC

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedTarlatamab and Pembrolizumab

Plus 1 other study approaches.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 19, 2025 · 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?39 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: Pembrolizumab; Drug: CRS Mitigation Strategies
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)→
Treatment approach
Immunotherapy→
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 time of signing the informed consent
  • Histologically or cytologically confirmed SCLC. For parts A, C, D, E, F, and G: relapsed/refractory small cell lung cancer (R/R SCLC) who progressed or recurred following platinum-based regimen
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Participants with treated 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 prior to first dose of tarlatamab with exceptions
  • Major surgery within 28 days of first dose tarlatamab
  • Untreated (includes new lesions or progression in previously treated lesions) or symptomatic brain metastases and leptomeningeal disease (regardless of symptomatic or not).
  • Prior anti-cancer therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and first dose of tarlatamab with the following exceptions: participants who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to Grade less than or equal to 1; and prior palliative radiotherapy must have been completed at least 7 days before the first dose of tarlatamab
  • Participants who experienced severe, life-threatening or recurrent (Grade 2 or higher) immune-mediated AEs or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immune-oncology agents
  • Has 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 tarlatamab
  • Part C only: history of solid organ transplantation or active autoimmune disease that has required systemic treatment within the past 2 years
  • Participant 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 investigational product administration

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

  • City of Hope National Medical CenterDuarte, California
  • Yale New Haven HospitalNew Haven, Connecticut
  • Moffitt Cancer CenterTampa, Florida
  • Winship Cancer InstituteAtlanta, Georgia
  • University of ChicagoChicago, Illinois
  • Ochsner Clinic FoundationNew Orleans, Louisiana
  • John Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimore, Maryland
  • Henry Ford Health SystemDetroit, Michigan
  • Washington UniversitySt Louis, Missouri
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • University Hospitals Cleveland Medical CenterCleveland, Ohio
  • The Ohio State University Wexner Medical Center - Thoracic Oncology ClinicColumbus, Ohio

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 19, 2025. Always confirm current availability with the study team.

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