Tarlatamab (AMG 757) Expanded Access Protocol for Advanced Small Cell Lung Cancer

Study summary

The primary objective of the study is to provide expanded access to and characterize the safety profile of tarlatamab in participants with advanced small cell lung cancer (SCLC) after two or more prior lines of treatment (including at least one platinum-based regimen). EA may still be available in countries outside of the United States.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedTarlatamab

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 10, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Approved For Marketing

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Expanded Access

Where is it offered?23 U.S. locations

Locations may change over time.

Who runs it?Amgen

Study sponsor

Study overview

What this study is about

Purpose: Not specified
Study type: Expanded Access
Phase: Not applicable
Sponsor: Amgen
Interventions being studied: Drug: Tarlatamab

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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)→

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

Age ≥ 18 years
Histologically or cytologically confirmed SCLC
Extensive-stage, unable to be encompassed in a tolerable radiation plan
Progressed or recurred following 1 platinum-based regimen and at least 1 other prior line of therapy
Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1
Minimum life expectancy of 12 weeks

Reasons someone may not be able to joinExclusion criteria

Any previous diagnosis of transformed non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that has transformed to SCLC, or mixed SCLC NSCLC histology
Symptomatic central nervous system (CNS) metastases
Active hepatitis B or hepatitis C virus infection
Eligible for participation in any Amgen-sponsored ongoing clinical study of the investigational product
Currently or previously enrolled in a prior tarlatamab study
Female participants and/or male participants with female partners who are pregnant, breastfeeding, planning to become pregnant or donate eggs while on study through 60 days after the last dose of tarlatamab
Male and female participants unwilling to practice abstinence and/or use protocol specified method of contraception

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

Study sites

U.S. locations

Yale School of MedicineNew Haven, Connecticut
Mount Sinai Comprehensive Cancer CenterMiami Beach, Florida
Martin Memorial Health SystemStuart, Florida
Nebraska Cancer SpecialistsOmaha, Nebraska
Perlmutter Cancer Center at New York University Langone Hospital - 34th StreetNew York, New York
The University of North Carolina at Chapel HillChapel Hill, North Carolina
Fox Chase Cancer CenterPhiladelphia, Pennsylvania
University of VirginiaCharlottesville, Virginia
Cancer Care Northwest - SouthSpokane, Washington
Associacao Hospitalar Moinhos de VentoPorto Alegre, Rio Grande do Sul
Sociedade Beneficente de Senhoras Hospital Sirio LibanesSão Paulo, São Paulo
Shaare Zedek Medical CenterJerusalem

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 10, 2025. Always confirm current availability with the study team.

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