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

Sponsor

Amgen (Industry)

Overall Status

Available

CT.gov ID

NCT06064500

Collaborator

(none)

Study Details

Study Description

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	Phase
Small Cell Lung Cancer	Drug: Tarlatamab

Study Design

Study Type:

Expanded Access

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

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