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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06064500
Expanded Access Status : Available
First Posted : October 3, 2023
Last Update Posted : May 1, 2024
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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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).

Condition or disease Intervention/treatment
Small Cell Lung Cancer Drug: Tarlatamab

Study Design
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Study Type : Expanded Access
Expanded Access Type : Treatment IND/Protocol
  See clinical trials of the intervention/treatment in this expanded access record.
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Interventions
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Intervention Details:
  • 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.
    Other Name: AMG 757
Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06064500


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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United States, Connecticut
Yale School of Medicine Available
New Haven, Connecticut, United States, 06520
United States, Florida
Mount Sinai Comprehensive Cancer Center Available
Miami Beach, Florida, United States, 33140
Martin Memorial Health System Available
Stuart, Florida, United States, 34994
United States, Nebraska
Nebraska Cancer Specialists Available
Omaha, Nebraska, United States, 68106
United States, New York
Perlmutter Cancer Center at New York University Langone Hospital - 34th Street Available
New York, New York, United States, 10016
United States, Pennsylvania
Fox Chase Cancer Center Available
Philadelphia, Pennsylvania, United States, 19111
United States, Virginia
University of Virginia Available
Charlottesville, Virginia, United States, 22903
United States, Washington
Cancer Care Northwest - South Available
Spokane, Washington, United States, 99202
Brazil
Associacao Hospitalar Moinhos de Vento Available
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-000
Sociedade Beneficente de Senhoras Hospital Sirio Libanes Available
Sao Paulo, São Paulo, Brazil, 01308-050
Japan
Okayama University Hospital Available
Okayama-shi, Okayama, Japan, 700-8558
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT06064500    
Other Study ID Numbers: 20220100
First Posted: October 3, 2023    Key Record Dates
Last Update Posted: May 1, 2024
Last Verified: April 2024
Keywords provided by Amgen:
Lung cancer
Extensive-stage small cell lung cancer
Tarlatamab
AMG 757
Bispecific T-Cell Engager
 BiTE
Immunotherapy
Immuno-oncology
Delta-like ligand 3
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
AMG 757
Antineoplastic Agents