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

NCT06064500 | Unknown

• 1 other identifier: 20220100
• Study Type: expanded_access
• Target: N/A
• Locations: 4 countries
• Sites: 23

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.

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

Interventions

Tarlatamab DRUG

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.

Also known as: AMG 757

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (23)

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

Location

Martin Memorial Health System

Stuart, Florida, 34994, United States

Location

Nebraska Cancer Specialists

Omaha, Nebraska, 68106, United States

Location

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

New York, New York, 10016, United States

Location

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Cancer Care Northwest - South

Spokane, Washington, 99202, United States

Location

Associacao Hospitalar Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90035-000, Brazil

Location

Sociedade Beneficente de Senhoras Hospital Sirio Libanes

São Paulo, São Paulo, 01308-050, Brazil

Location

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

Location

Hadassah University Hospital-Ein Kerem

Jerusalem, 9112001, Israel

Location

Assuta Medical Center

Petah Tikva, 4941492, Israel

Location

Rabin Medical Center

Petah Tikva, 4941492, Israel

Location

Aichi Cancer Center

Nagoya, Aichi-ken, 464-8681, Japan

Location

National Cancer Center Hospital East

Kashiwa-shi, Chiba, 277-8577, Japan

Location

Okayama University Hospital

Okayama, Okayama-ken, 700-8558, Japan

Location

Kindai University Hospital

Osakasayama-shi, Osaka, 589-8511, Japan

Location

Shizuoka Cancer Center

Sunto-gun, Shizuoka, 411-8777, Japan

Location

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

Location

The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Koto-ku, Tokyo, 135-8550, Japan

Location

Wakayama Medical University Hospital

Wakayama, Wakayama, 641-8510, Japan

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Lung Neoplasms; Bites and Stings

Interventions

AMG 757

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 3, 2023
• Last Updated: March 10, 2025

Record last verified: 2025-03

Locations

JP (8); US (9); BR (2); IL (4)