A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With SCLC

NCT06745323 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 20240092
• Study Type: interventional
• Target: 252
• Locations: 16 countries
• Sites: 78

Brief Summary

The primary objective of this study is to describe the antitumor activity of tarlatamab in participants with small cell lung cancer (SCLC).

Conditions

Small Cell Lung Cancer (SCLC)

Keywords

Tarlatamab; AMG 757

Outcome Measures

Primary Outcomes (3)

• Proportion of participants with confirmed objective response to Tarlatamab

  Approximately 52 Months

• Proportion of participants with complete response to Tarlatamab

  Approximately 52 Months

• Proportion of participants with partial response to Tarlatamab

  Approximately 52 Months

Secondary Outcomes (10)

• Average serum concentrations of Tarlatamab

  Approximately 52 Weeks

• Duration of confirmed response, defined as the time from the first documentation of OR until the first documentation of disease progression or death

  Approximately 52 Months

• Disease control, defined as objective response or stable disease

  Approximately 52 Months

• Duration of disease control

  Approximately 52 Months

• Progression-free survival, defined as the time from randomization to the first documentation of disease progression or death due to any cause

  Approximately 52 Months

Study Arms (3)

Treatment Arm A: Dose 1 Tarlatamab

EXPERIMENTAL

Participants will receive dose 1 of Tarlatamab by intravenous (IV) infusion during the treatment period.

Drug: Tarlatamab

Treatment Arm B: Dose 2 Tarlatamab

EXPERIMENTAL

Participants will receive dose 2 of Tarlatamab by IV infusion during the treatment period.

Drug: Tarlatamab

Treatment Arm C: Dose 3 Tarlatamab

EXPERIMENTAL

Participants will receive dose 3 of Tarlatamab by IV infusion during the treatment period.

Drug: Tarlatamab

Interventions

Tarlatamab DRUG

Tarlatamab will be administered by IV infusion.

Also known as: AMG 757

Treatment Arm A: Dose 1 Tarlatamab; Treatment Arm B: Dose 2 Tarlatamab; Treatment Arm C: Dose 3 Tarlatamab

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has provided informed consent prior to initiation of any study specific activities/procedures.
• Age ≥ 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent.
• Histologically or cytologically confirmed SCLC with demonstrated progression or relapse.
• Participants who progressed or recurred following 1 platinum-based regimen.
• Measurable disease as defined per RECIST 1.1 within the 21-day screening period.
• Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
• Minimum life expectancy of 12 weeks.
• Adequate organ function as described per protocol.

You may not qualify if:

• Disease Related
• Previous diagnosis of transformed non-small cell lung cancer (NSCLC) including epidermal growth factor receptor activating mutation positive NSCLC that has transformed to SCLC.
• Symptomatic central nervous system (CNS) metastases with exceptions defined in the protocol.
• Other Medical Conditions
• History of other malignancy within the past 2 years, with exceptions defined in the protocol.
• Evidence of interstitial lung disease or active, non-infectious pneumonitis
• Diagnosis or evidence of leptomeningeal disease.
• Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study.
• History of solid organ transplantation.
• Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 6 months prior to first dose of study treatment.
• History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment
• Presence or history of viral infection based on criteria per protocol.
• Symptoms and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection requiring antibiotics within 7 days prior to the first dose study treatment.
• Known or active infection requiring parenteral antibiotic treatment.
• History of severe or life-threatening events from any immune-mediated therapy.

Sponsors & Collaborators

• Amgen: lead

Study Sites (78)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut

Plainville, Connecticut, 06062, United States

Location

AdventHealth Hematology and Oncology

Orlando, Florida, 32804, United States

Location

City of Hope Chicago

Rockford, Illinois, 61108, United States

Location

Health Partners Cancer Center at Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

New York Oncology Hematology PC

Albany, New York, 12206, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

FirstHealth Cancer Center

Pinehurst, North Carolina, 28374, United States

Location

Guthrie Medical Group

Sayre, Pennsylvania, 18840, United States

Location

Tennessee Oncology PLLC - Chattanooga

Chattanooga, Tennessee, 37404, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

Virginia Cancer Specialists PC

Fairfax, Virginia, 22031, United States

Location

Fundacion Respirar

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426ABP, Argentina

Location

Instituto de Investigaciones clinicas de Mar del Plata

Mar del Plata, Buenos Aires, B7600FZO, Argentina

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

Austin Health, Austin Hospital

Heidelberg, Victoria, 3084, Australia

Location

Grand Hopital de Charleroi - Site des Viviers

Charleroi, 6060, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

Jessa Ziekenhuis - Campus Virga Jesse

Hasselt, 3500, Belgium

Location

Liga Norte-Riograndense Contra O Cancer

Natal, Rio Grande do Norte, 59075-740, Brazil

Location

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Cipo - Centro Integrado de Pesquisa em Oncologia

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Hospital de Amor

Barretos, São Paulo, 14784-400, Brazil

Location

Hospital de Base de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, 350028, China

Location

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Affiliated Cancer Hospital of Harbin Medical University

Harbin, Heilongjiang, 150081, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

Shanxi Bethune Hospital

Taiyuan, Shanxi, 030032, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310016, China

Location

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, 317099, China

Location

Hopital Lyon sud

Pierre-Bénite, 69495, France

Location

Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

Rennes, 35033, France

Location

Hopital Foch

Suresnes, 92150, France

Location

Helios Kliniken Emil-von-Behring

Berlin, 14165, Germany

Location

Universitaetsklinikum des Saarlandes

Homburg, 66421, Germany

Location

Universitaetsklinikum Schleswig-Holstein - Kiel

Kiel, 24105, Germany

Location

Universitaetsklinikum Wuerzburg

Würzburg, 97078, Germany

Location

Henry Dunant Hospital Center

Athens, 11526, Greece

Location

Alexandra Hospital

Athens, 11528, Greece

Location

Metropolitan Hospital

Athens, 18547, Greece

Location

University Hospital of Heraklion

Heraklion - Crete, 71500, Greece

Location

University Hospital of Patras

Pátrai, 26504, Greece

Location

European Interbalkan Medical Center

Thessaloniki, 57001, Greece

Location

Azienda Ospedaliera San Giovanni Addolorata

Roma, 00144, Italy

Location

Kurume University Hospital

Kurume-shi, Fukuoka, 830-0011, Japan

Location

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, 003-0804, Japan

Location

Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

Yokohama, Kanagawa, 241-8515, Japan

Location

Niigata Cancer Center Hospital

Niigata, Niigata, 951-8566, Japan

Location

Kansai Medical University Hospital

Hirakata-shi, Osaka, 573-1191, Japan

Location

Osaka International Cancer Institute

Osaka, Osaka, 541-8567, Japan

Location

Shizuoka Cancer Center

Sunto-gun, Shizuoka, 411-8777, Japan

Location

The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Koto-ku, Tokyo, 135-8550, Japan

Location

Chungbuk National University Hospital

Cheongju Chungbuk, 28644, South Korea

Location

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

Location

Chonnam National University Hwasun Hospital

Hwasun-gun, Jeollanam-do, 58128, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Hospital Universitario Insular de Gran Canaria

Las Palmas de Gran Canaria, Canary Islands, 35016, Spain

Location

Hospital Universitari Vall d Hebron

Barcelona, Catalonia, 08035, Spain

Location

Complexo Hospitalario Universitario A Coruna Hospital Teresa Herrera

A Coruña, Galicia, 15006, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Kantonsspital Baden

Baden, 5404, Switzerland

Location

Universitaetsspital Zuerich

Zurich, 8091, Switzerland

Location

Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi

Adana, 01250, Turkey (Türkiye)

Location

Memorial Ankara Hastanesi

Ankara, 06520, Turkey (Türkiye)

Location

Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

Ankara, 06560, Turkey (Türkiye)

Location

Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

Istanbul, 34722, Turkey (Türkiye)

Location

Ege Universitesi Tip Fakultesi Hastanesi

Izmir, 35100, Turkey (Türkiye)

Location

Christie Hospital

Manchester, M20 4BX, United Kingdom

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

AMG 757

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: February 26, 2025
• Primary Completion (Estimated): February 9, 2029
• Study Completion (Estimated): February 9, 2029
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4); CN (12); GR (6); BE (3); BR (6); AU (2); IT (1); AR (2); TU (5); JP (8); US (12); KR (6); FR (3); GB (1); CH (2); ES (5)