Tarlatamab (AMG 757) Expanded Access Protocol for Advanced Small Cell Lung Cancer
- Conditions
- Small Cell Lung Cancer
- Registration Number
- NCT06064500
- Lead Sponsor
- Amgen
- 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 prior lines of treatment (including at least one platinum-based regimen).
EA may still be available in countries outside of the United States.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- APPROVED_FOR_MARKETING
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
Hadassah University Hospital-Ein Kerem
🇮🇱Jerusalem, Israel
Yale School of Medicine
🇺🇸New Haven, Connecticut, United States
Mount Sinai Comprehensive Cancer Center
🇺🇸Miami Beach, Florida, United States
Martin Memorial Health System
🇺🇸Stuart, Florida, United States
Nebraska Cancer Specialists
🇺🇸Omaha, Nebraska, United States
Perlmutter Cancer Center at New York University Langone Hospital - 34th Street
🇺🇸New York, New York, United States
The University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Cancer Care Northwest - South
🇺🇸Spokane, Washington, United States
Associacao Hospitalar Moinhos de Vento
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
🇧🇷Sao Paulo, São Paulo, Brazil
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Assuta Medical Center
🇮🇱Petah Tikva, Israel
Rabin Medical Center
🇮🇱Petah Tikva, Israel
Aichi Cancer Center
🇯🇵Nagoya-shi, Aichi, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa-shi, Chiba, Japan
Okayama University Hospital
🇯🇵Okayama-shi, Okayama, Japan
Kindai University Hospital
🇯🇵Osakasayama-shi, Osaka, Japan
Shizuoka Cancer Center
🇯🇵Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital
🇯🇵Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
🇯🇵Koto-ku, Tokyo, Japan
Wakayama Medical University Hospital
🇯🇵Wakayama-shi, Wakayama, Japan