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
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).

Detailed Description

Not Provided

Treatment IND/Protocol
Small Cell Lung Cancer

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

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

Eligibility Gender
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
United States

Yale School of Medicine
New Haven, Connecticut, United States

Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States

Martin Memorial Health System
Stuart, Florida, United States

Nebraska Cancer Specialists
Omaha, Nebraska, United States

Perlmutter Cancer Center at New York University Langone Hospital - 34th Street
New York, New York, United States

Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States

University of Virginia
Charlottesville, Virginia, United States

Cancer Care Northwest - South
Spokane, Washington, United States

Associacao Hospitalar Moinhos de Vento
Porto Alegre, Rio Grande Do Sul, Brazil

Sociedade Beneficente de Senhoras Hospital Sirio Libanes
Sao Paulo, São Paulo, Brazil

Okayama University Hospital
Okayama-shi, Okayama, Japan


Amgen Call Center

MD, Study Director

NCT Number
lung cancer
Extensive-stage small cell lung cancer
AMG 757
Bispecific T-Cell Engager
Delta-like ligand 3
MeSH Terms
Lung Neoplasms
Small Cell Lung Carcinoma
AMG 757