Tarlatamab (AMG 757) Expanded Access Protocol for Advanced Small Cell Lung Cancer
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.
Checked against the public recordLast updated Mar 10, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Not specified
- Study type
- Expanded Access
- Phase
- Not applicable
- Sponsor
- Amgen
- Interventions being studied
- Drug: Tarlatamab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion 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 Exclusion 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.
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.