Clinical trial NCT06064500: Tarlatamab (AMG 757) Expanded Access Protocol for Advanced Small Cell Lung Cancer
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
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Small Cell Lung Cancer
Keywords: Lung cancer
Extensive-stage small cell lung cancer
Tarlatamab
AMG 757
Bispecific T-Cell Engager
BiTE
Immunotherapy
Immuno-oncology
Delta-like ligand 3
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2023-10-03
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

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).

EA may still be available in countries outside of the United States.


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
* 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Miami Beach
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: Stuart
country: United States
facility: Martin Memorial Health System
state: Florida
city: Omaha
country: United States
facility: Nebraska Cancer Specialists
state: Nebraska
city: New York
country: United States
facility: Perlmutter Cancer Center at New York University Langone Hospital - 34th Street
state: New York
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Spokane
country: United States
facility: Cancer Care Northwest - South
state: Washington
city: Porto Alegre
country: Brazil
facility: Associacao Hospitalar Moinhos de Vento
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes
state: São Paulo
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah University Hospital-Ein Kerem
city: Petah Tikva
country: Israel
facility: Assuta Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center
state: Aichi
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Okayama-shi
country: Japan
facility: Okayama University Hospital
state: Okayama
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research
state: Tokyo
city: Wakayama-shi
country: Japan
facility: Wakayama Medical University Hospital
state: Wakayama
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: