Status:
APPROVED_FOR_MARKETING
Tarlatamab (AMG 757) Expanded Access Protocol for Advanced Small Cell Lung Cancer
Lead Sponsor:
Amgen
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Brief 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 prio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06064500
Last Update
March 10 2025
Active Locations (23)
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1
Yale School of Medicine
New Haven, Connecticut, United States, 06520
2
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
3
Martin Memorial Health System
Stuart, Florida, United States, 34994
4
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68106