Trial Title:
Tarlatamab (AMG 757) Expanded Access Protocol for Advanced Small Cell Lung Cancer
NCT ID:
NCT06064500
Condition:
Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
AMG 757
Conditions: Keywords:
Lung cancer
Extensive-stage small cell lung cancer
Tarlatamab
AMG 757
Bispecific T-Cell Engager
BiTE
Immunotherapy
Immuno-oncology
Delta-like ligand 3
Study type:
Expanded Access
Overall status:
Available
Intervention:
Intervention type:
Drug
Intervention name:
Tarlatamab
Description:
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
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).
EA may still be available in countries outside of the United States.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Yale School of Medicine
Address:
City:
New Haven
Zip:
06520
Country:
United States
Status:
Available
Facility:
Name:
Mount Sinai Comprehensive Cancer Center
Address:
City:
Miami Beach
Zip:
33140
Country:
United States
Status:
Available
Facility:
Name:
Martin Memorial Health System
Address:
City:
Stuart
Zip:
34994
Country:
United States
Status:
Available
Facility:
Name:
Nebraska Cancer Specialists
Address:
City:
Omaha
Zip:
68106
Country:
United States
Status:
Available
Facility:
Name:
Perlmutter Cancer Center at New York University Langone Hospital - 34th Street
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Available
Facility:
Name:
The University of North Carolina at Chapel Hill
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Available
Facility:
Name:
Fox Chase Cancer Center
Address:
City:
Philadelphia
Zip:
19111
Country:
United States
Status:
Available
Facility:
Name:
University of Virginia
Address:
City:
Charlottesville
Zip:
22903
Country:
United States
Status:
Available
Facility:
Name:
Cancer Care Northwest - South
Address:
City:
Spokane
Zip:
99202
Country:
United States
Status:
Available
Facility:
Name:
Associacao Hospitalar Moinhos de Vento
Address:
City:
Porto Alegre
Zip:
90035-000
Country:
Brazil
Status:
Available
Facility:
Name:
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
Address:
City:
Sao Paulo
Zip:
01308-050
Country:
Brazil
Status:
Available
Facility:
Name:
Shaare Zedek Medical Center
Address:
City:
Jerusalem
Zip:
9103102
Country:
Israel
Status:
Available
Facility:
Name:
Assuta Medical Center
Address:
City:
Petah Tikva
Zip:
4941492
Country:
Israel
Status:
Available
Facility:
Name:
Rabin Medical Center
Address:
City:
Petah Tikva
Zip:
4941492
Country:
Israel
Status:
Available
Facility:
Name:
Aichi Cancer Center
Address:
City:
Nagoya-shi
Zip:
464-8681
Country:
Japan
Status:
Available
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa-shi
Zip:
277-8577
Country:
Japan
Status:
Available
Facility:
Name:
Okayama University Hospital
Address:
City:
Okayama-shi
Zip:
700-8558
Country:
Japan
Status:
Available
Facility:
Name:
Kindai University Hospital
Address:
City:
Osakasayama-shi
Zip:
589-8511
Country:
Japan
Status:
Available
Facility:
Name:
Shizuoka Cancer Center
Address:
City:
Sunto-gun
Zip:
411-8777
Country:
Japan
Status:
Available
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Chuo-ku
Zip:
104-0045
Country:
Japan
Status:
Available
Facility:
Name:
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Address:
City:
Koto-ku
Zip:
135-8550
Country:
Japan
Status:
Available
Facility:
Name:
Wakayama Medical University Hospital
Address:
City:
Wakayama-shi
Zip:
641-8510
Country:
Japan
Status:
Available
Lead sponsor:
Agency:
Amgen
Agency class:
Industry
Source:
Amgen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06064500
http://www.amgentrials.com
