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

APPROVED_FOR_MARKETING

Conditions studied: Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT06064500

Run by

Amgen

Last updated by the study team

2025-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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 — São 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, Aichi-ken, Japan
• National Cancer Center Hospital East — Kashiwa-shi, Chiba, Japan
• Okayama University Hospital — Okayama, Okayama-ken, 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, Wakayama, Japan

Full record on ClinicalTrials.gov

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