The primary objective of the study is to provide expanded access to and characterize thesafety 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-basedregimen).EA may still be available in countries outside of the United States.
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
- 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
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
Hadassah University Hospital-Ein Kerem
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
MD, Study Director
Amgen