A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With SCLC (DeLLphi-309)

A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With Small Cell Lung Cancer (SCLC) (DeLLphi-309)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Small Cell Lung Cancer (SCLC)
• Intervention / Treatment: Drug: Tarlatamab

• Study Type: Interventional
• Enrollment (Actual): 252
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1426ABP
      • Fundación Respirar
    • Mar del Plata, Buenos Aires, Argentina, B7600FZO
      • Instituto de Investigaciones clinicas de Mar del Plata
• Australia
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Medical Centre
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health, Austin Hospital
• Belgium
  • Charleroi, Belgium, 6060
    • Grand Hopital de Charleroi - Site des Viviers
  • Edegem, Belgium, 2650
    • Universitair Ziekenhuis Antwerpen
  • Hasselt, Belgium, 3500
    • Jessa Ziekenhuis - Campus Virga Jesse
• Brazil
  • Rio Grande do Norte
    • Natal, Rio Grande do Norte, Brazil, 59075-740
      • Liga Norte-Riograndense Contra O Cancer
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
      • Hospital de Clínicas de Porto Alegre
    • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
      • Cipo - Centro Integrado de Pesquisa em Oncologia
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784-400
      • Hospital de Amor
    • São José do Rio Preto, São Paulo, Brazil, 15090-000
      • Hospital de Base de Sao Jose do Rio Preto
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Beijing Cancer Hospital
    • Beijing, Beijing Municipality, China, 100730
      • Peking Union Medical College Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Fujian Cancer Hospital
    • Fuzhou, Fujian, China, 350028
      • Mengchao Hepatobiliary Hospital of Fujian Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Center
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Affiliated Cancer Hospital of Harbin Medical University
  • Hunan
    • Changsha, Hunan, China, 410011
      • The second Xiangya hospital of central south university
  • Shanxi
    • Taiyuan, Shanxi, China, 030032
      • Shanxi Bethune Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Tianjin Medical University Cancer Institute and Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310016
      • Sir Run Run Shaw Hospital
    • Taizhou, Zhejiang, China, 317099
      • Taizhou Hospital of Zhejiang Province
• France
  • Pierre-Bénite, France, 69495
    • Hôpital Lyon Sud
  • Rennes, France, 35033
    • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
  • Suresnes, France, 92150
    • Hopital Foch
• Germany
  • Berlin, Germany, 14165
    • Helios Kliniken Emil-von-Behring
  • Homburg, Germany, 66421
    • Universitaetsklinikum des Saarlandes
  • Kiel, Germany, 24105
    • Universitaetsklinikum Schleswig-Holstein - Kiel
  • Würzburg, Germany, 97078
    • Universitaetsklinikum Wuerzburg
• Greece
  • Athens, Greece, 18547
    • Metropolitan Hospital
  • Athens, Greece, 11528
    • Alexandra Hospital
  • Athens, Greece, 11526
    • Henry Dunant Hospital Center
  • Heraklion - Crete, Greece, 71500
    • University Hospital of Heraklion
  • Pátrai, Greece, 26504
    • University Hospital of Patras
  • Thessaloniki, Greece, 57001
    • European Interbalkan Medical Center
• Italy
  • Roma, Italy, 00144
    • Azienda Ospedaliera San Giovanni Addolorata
• Japan
  • Fukuoka
    • Kurume-shi, Fukuoka, Japan, 830-0011
      • Kurume University Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 003-0804
      • National Hospital Organization Hokkaido Cancer Center
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 241-8515
      • Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
  • Niigata
    • Niigata, Niigata, Japan, 951-8566
      • Niigata Cancer Center Hospital
  • Osaka
    • Hirakata-shi, Osaka, Japan, 573-1191
      • Kansai Medical University Hospital
    • Osaka, Osaka, Japan, 541-8567
      • Osaka International Cancer Institute
  • Shizuoka
    • Sunto-gun, Shizuoka, Japan, 411-8777
      • Shizuoka Cancer Center
  • Tokyo
    • Koto-ku, Tokyo, Japan, 135-8550
      • The Cancer Institute Hospital of Japanese Foundation for Cancer Research
• South Korea
  • Cheongju Chungbuk, South Korea, 28644
    • Chungbuk National University Hospital
  • Daegu, South Korea, 41404
    • Kyungpook National University Chilgok Hospital
  • Hwasun-gun, Jeollanam-do, South Korea, 58128
    • Chonnam National University Hwasun Hospital
  • Seongnam-si, Gyeonggi-do, South Korea, 13620
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 03722
    • Severance Hospital Yonsei University Health System
  • Seoul, South Korea, 08308
    • Korea University Guro Hospital
• Spain
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Canary Islands
    • Las Palmas de Gran Canaria, Canary Islands, Spain, 35016
      • Hospital Universitario Insular de Gran Canaria
  • Catalonia
    • Barcelona, Catalonia, Spain, 08035
      • Hospital Universitari Vall D Hebron
  • Galicia
    • A Coruña, Galicia, Spain, 15006
      • Complexo Hospitalario Universitario A Coruna Hospital Teresa Herrera
• Switzerland
  • Baden, Switzerland, 5404
    • Kantonsspital Baden
  • Zurich, Switzerland, 8091
    • UniversitaetsSpital Zuerich
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01250
    • Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi
  • Ankara, Turkey (Türkiye), 06520
    • Memorial Ankara Hastanesi
  • Ankara, Turkey (Türkiye), 06560
    • Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
  • Istanbul, Turkey (Türkiye), 34722
    • Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi
  • Izmir, Turkey (Türkiye), 35100
    • Ege Universitesi Tip Fakultesi Hastanesi
• United Kingdom
  • Manchester, United Kingdom, M20 4BX
    • Christie Hospital
• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles
  • Connecticut
    • Plainville, Connecticut, United States, 06062
      • Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut
  • Florida
    • Orlando, Florida, United States, 32804
      • AdventHealth Hematology and Oncology
  • Illinois
    • Rockford, Illinois, United States, 61108
      • City of Hope Chicago
  • Minnesota
    • Saint Paul, Minnesota, United States, 55101
      • Health Partners Cancer Center at Regions Hospital
  • New York
    • Albany, New York, United States, 12206
      • New York Oncology Hematology PC
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University
    • Pinehurst, North Carolina, United States, 28374
      • FirstHealth Cancer Center
  • Pennsylvania
    • Sayre, Pennsylvania, United States, 18840
      • Guthrie Medical Group
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Tennessee Oncology PLLC - Chattanooga
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology, PLLC
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
  • Major surgical procedures within 21 days of prior to first dose of study treatment.

• Prior/Concomitant Therapy

  • Prior anticancer therapy within 30 days of enrollment (14 days for conventional chemotherapy).
  • Prior enrollment on a tarlatamab clinical trial OR prior therapy with any selective inhibitor of the DLL3 pathway.
  • Current anti-cancer therapy such as chemotherapy, immunotherapy, or targeted therapy with exceptions.
  • Receiving systemic corticosteroid therapy or any other immunosuppressive therapy within 7 days prior to first dose as described per protocol.
  • Live and live-attenuated vaccines within 14 days prior to the start of study treatment. Inactive vaccines and live viral non-replicating vaccines within 3 days prior to the first dose of study treatment.

• Prior/Concurrent Clinical Study Experience

  • Currently receiving treatment in another investigational device or drug study, or less than 30 days or 5 half-lives since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.

• Other Exclusions

  • Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 60 days after the last dose of tarlatamab.
  • Female participants who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of tarlatamab.
  • Female participants planning to become pregnant or donate eggs while on study through 60 days after the last dose of tarlatamab.
  • Female participants of childbearing potential with a positive pregnancy test assessed at screening and/or day 1 by a highly sensitive urine or serum pregnancy test.
  • Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 60 days after the last dose of tarlatamab.
  • Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 60 days after the last dose of tarlatamab.
  • Male participants unwilling to abstain from donating sperm during treatment and for an additional 60 days after the last dose of tarlatamab.
  • Participant has known sensitivity or is contraindicated to any of the products or components to be administered during dosing.
  • Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures.
  • History or evidence of any other clinically significant disorder, condition or disease determined by the investigator or Amgen physician, if consulted, would pose a risk to the subject safety or interfere with the study evaluation procedure or completion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm A: Dose 1 Tarlatamab; Participants will receive dose 1 of Tarlatamab by intravenous (IV) infusion during the treatment period.	Drug: Tarlatamab; Tarlatamab will be administered by IV infusion.; Other Names: AMG 757
Experimental: Treatment Arm B: Dose 2 Tarlatamab; Participants will receive dose 2 of Tarlatamab by IV infusion during the treatment period.	Drug: Tarlatamab; Tarlatamab will be administered by IV infusion.; Other Names: AMG 757
Experimental: Treatment Arm C: Dose 3 Tarlatamab; Participants will receive dose 3 of Tarlatamab by IV infusion during the treatment period.	Drug: Tarlatamab; Tarlatamab will be administered by IV infusion.; Other Names: AMG 757

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Average serum concentrations of Tarlatamab	Approximately 52 Weeks
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
Objective response, defined as best overall response of CR or PR	Approximately 52 Months
Overall survival, defined as the time from randomization to death due to any cause	Approximately 52 Months
Overall Survival rate at 6 months and 1 year from randomization	Approximately 52 Months
Number of participants with treatment-emergent adverse events	Approximately 52 Months
Number of participants with anti-tarlatamab antibody formation	Approximately 52 Months
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

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2025
• Primary Completion (Estimated): February 9, 2029
• Study Completion (Estimated): February 9, 2029

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): December 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: AMG 757; Tarlatamab
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Small Cell Lung Carcinoma; Antineoplastic Agents; AMG 757
• Other Study ID Numbers: 20240092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No