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NCT06064500 Clinical Trial

Tarlatamab (AMG 757) Expanded Access Protocol for Advanced Small Cell Lung Cancer

Small Cell Lung Cancer Clinical Trial

Official title:
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

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT06064500
Other study ID # 20220100
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date June 2024
Source Amgen
Contact Amgen Call Center
Phone 866-572-6436
Email medinfo@amgen.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Brazil Associacao Hospitalar Moinhos de Vento Porto Alegre Rio Grande Do Sul
Brazil Sociedade Beneficente de Senhoras Hospital Sirio Libanes Sao Paulo São Paulo
Japan Okayama University Hospital Okayama-shi Okayama
United States The University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States University of Virginia Charlottesville Virginia
United States Mount Sinai Comprehensive Cancer Center Miami Beach Florida
United States Yale School of Medicine New Haven Connecticut
United States Perlmutter Cancer Center at New York University Langone Hospital - 34th Street New York New York
United States Nebraska Cancer Specialists Omaha Nebraska
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Cancer Care Northwest - South Spokane Washington
United States Martin Memorial Health System Stuart Florida

Sponsors (1)
Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Brazil,  Japan, 

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