Lung Cancer Clinical Trial
Tarlatamab (AMG 757) Expanded Access Protocol for Advanced Small Cell Lung Cancer
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).
Eligibility Criteria
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
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There are 12 Locations for this study
New Haven Connecticut, 06520, United States
Miami Beach Florida, 33140, United States
Stuart Florida, 34994, United States
Omaha Nebraska, 68106, United States
New York New York, 10016, United States
Chapel Hill North Carolina, 27599, United States
Philadelphia Pennsylvania, 19111, United States
Charlottesville Virginia, 22903, United States
Spokane Washington, 99202, United States
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Sao Paulo São Paulo, 01308, Brazil
Okayama-shi Okayama, 700-8, Japan
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