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).
Not Provided
Drug: Tarlatamab
Tarlatamab will be administered as a 60-minute intravenous infusion with 1 mg step dose on cycle 1 day 1 followed by a 10 mg target dose on cycle 1 day 8 and cycle 1 day 15 in a 28-day cycle. Subsequent doses (10 mg) will be administered every 2 weeks.
Other Name: AMG 757
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
- Untreated or 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 72
days after the last dose of tarlatamab
- Male and female participants unwilling to practice abstinence and/or use protocol
specified method of contraception
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
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
Okayama University Hospital
Okayama-shi, Okayama, Japan
Amgen Call Center
866-572-6436
medinfo@amgen.com
MD, Study Director
Amgen