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

March 6, 2025 updated by: Amgen

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

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.

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-000
        • Associação Hospitalar Moinhos de Vento
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01308-050
        • Sociedade Beneficente de Senhoras Hospital Sirio Libanes
  • Israel
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
      • Jerusalem, Israel, 9112001
        • Hadassah University Hospital-ein Kerem
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center
      • Petah Tikva, Israel, 4941492
        • Assuta Medical Center
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Aichi Cancer Center
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
    • Okayama-ken
      • Okayama, Okayama-ken, Japan, 700-8558
        • Okayama University Hospital
    • Osaka
      • Osakasayama-shi, Osaka, Japan, 589-8511
        • Kindai University Hospital
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 411-8777
        • Shizuoka Cancer Center
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
      • Koto-ku, Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital of Japanese Foundation for Cancer Research
    • Wakayama
      • Wakayama, Wakayama, Japan, 641-8510
        • Wakayama Medical University Hospital
  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale School of Medicine
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Comprehensive Cancer Center
      • Stuart, Florida, United States, 34994
        • Martin Memorial Health System
    • Nebraska
      • Omaha, Nebraska, United States, 68106
        • Nebraska Cancer Specialists
    • New York
      • New York, New York, United States, 10016
        • Perlmutter Cancer Center at New York University Langone Hospital - 34th Street
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • The University of North Carolina at Chapel Hill
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia
    • Washington
      • Spokane, Washington, United States, 99202
        • Cancer Care Northwest - South

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Investigators

  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 26, 2023

First Submitted That Met QC Criteria

September 26, 2023

First Posted (Actual)

October 3, 2023

Study Record Updates

Last Update Posted (Actual)

March 10, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20220100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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