Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)

Running, not enrolling · Phase 1

Conditions studied: Small Cell Lung Carcinoma

In brief

A study to assess the safety, tolerability, and PK of tarlatamab in participants with SCLC

Key facts

Study ID

NCT03319940

Run by

Amgen

People needed

269

Starts

2017-12-26

Expected to finish

2027-12-31

Last updated by the study team

2025-11-19

Who can join

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

You may qualify if…

• Participant has provided informed consent prior to initiation of any study-specific activities/procedures
• Age greater than or equal to 18 years old at the time of signing the informed consent
• Histologically or cytologically confirmed SCLC. For parts A, C, D, E, F, and G: relapsed/refractory small cell lung cancer (R/R SCLC) who progressed or recurred following platinum-based regimen
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Participants with treated brain metastases are eligible provided they meet defined criteria
• Adequate organ function as defined in protocol

You may not qualify if…

• History of other malignancy within the past 2 years prior to first dose of tarlatamab with exceptions
• Major surgery within 28 days of first dose tarlatamab
• Untreated (includes new lesions or progression in previously treated lesions) or symptomatic brain metastases and leptomeningeal disease (regardless of symptomatic or not).
• Prior anti-cancer therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and first dose of tarlatamab with the following exceptions: participants who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to Grade less than or equal to 1; and prior palliative radiotherapy must have been completed at least 7 days before the first dose of tarlatamab
• Participants who experienced severe, life-threatening or recurrent (Grade 2 or higher) immune-mediated AEs or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immune-oncology agents
• Has evidence of interstitial lung disease or active, non-infectious pneumonitis
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of tarlatamab
• Part C only: history of solid organ transplantation or active autoimmune disease that has required systemic treatment within the past 2 years
• Participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of investigational product administration

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Winship Cancer Institute — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• John Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Washington University — St Louis, Missouri, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• The Ohio State University Wexner Medical Center - Thoracic Oncology Clinic — Columbus, Ohio, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center Cancer Pavillion — Pittsburgh, Pennsylvania, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• Chris OBrien Lifehouse — Camperdown, New South Wales, Australia
• Medizinische Universitaet Graz — Graz, Austria
• Landeskrankenhaus Salzburg — Salzburg, Austria
• Gustave Roussy — Villejuif, France
• Universitaetsklinikum Wuerzburg — Würzburg, Germany
• Prince of Wales Hospital — Shatin, New Territories, Hong Kong
• National Cancer Center Hospital East — Kashiwa-shi, Chiba, Japan
• National Cancer Center Hospital — Chuo-ku, Tokyo, Japan
• Wakayama Medical University Hospital — Wakayama, Wakayama, Japan
• Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis — Amsterdam, Netherlands

Full record on ClinicalTrials.gov

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