NCT06064500
Approved For Marketing
Not Applicable
A Phase 3b, Multicenter, Single-arm, Expanded Access Protocol of Tarlatamab (AMG 757) for the Treatment of Subjects With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment
ConditionsSmall Cell Lung Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Small Cell Lung Cancer
- Sponsor
- Amgen
- Locations
- 23
- Status
- Approved For Marketing
- Last Updated
- last year
Overview
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.
Investigators
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
- •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
Outcomes
Primary Outcomes
Not specified
Study Sites (23)
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