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Sponsor ID
20220100

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

Sponsor ID
20220100
Clinicaltrials.gov ID
NCT06064500
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
Tarlatamab
Type
Expanded Access
Masking
N/A
Enrollment
N/A
Additional Study Details

Protocol Summary

Primary Outcome Measures
Not Available
Secondary Outcome Measures
Not Available

Locations

Location
Status
Contact Us
Location
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
Sao Paulo, São Paulo, Brazil, 01308-050
Status
Recruiting
Location
Associacao Hospitalar Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil, 90035-000
Status
Recruiting
Location
Martin Memorial Health System
Stuart, FL, United States, 34994
Status
Completed
Location
Nebraska Cancer Specialists
Omaha, NE, United States, 68106
Status
Recruiting
Location
University of Virginia
Charlottesville, VA, United States, 22903
Status
Recruiting
Location
Yale School of Medicine
New Haven, CT, United States, 06520
Status
Recruiting
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Study Info
Age
18+ years
Condition
  • Lung Cancer - Small Cell
    • Sex
    All
    Trial Dates
    N/A - N/A
    Inclusion and Exclusion 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 – 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