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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 : November 13, 2023
Sponsor:
Information provided by (Responsible Party):
Amgen

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

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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



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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (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

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

Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
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: November 13, 2023
Last Verified: November 2023
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