Active, not recruitingNCT06745323DeLLphi-309Updated Oct 6, 2026

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

A Phase 2 interventional study of Tarlatamab in Small Cell Lung Cancer (SCLC), sponsored by Amgen. Active, not recruiting at 78 sites in 16 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Amgen · Phase 2, Interventional, and Treatment

Updated Oct 6, 2026Primary completion movedStudy completion movedGo to Updates ↓

Phase: Phase 2
Study type: Interventional
Enrollment: 252
Allocation: Randomized
Ages: 18 Years to 99 Years
Sex: All

Study summary

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

Conditions studied

Small Cell Lung Cancer (SCLC)

Browse trials for

Small Cell Lung Carcinoma 1,203

Keywords

Tarlatamab
AMG 757

In context

Small Cell Lung Carcinoma

1,203 studies on the registry are indexed under Small Cell Lung Carcinoma; 342 are open to participants now.

This study's enrollment of 252 is above the median of 56 across 1,031 interventional studies indexed under Small Cell Lung Carcinoma.

Browse Small Cell Lung Carcinoma studies →

Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 99 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 252 participants (actual)

Study arms

Experimental
Treatment Arm A: Dose 1 Tarlatamab
Participants will receive dose 1 of Tarlatamab by intravenous (IV) infusion during the treatment period.
Drug: Tarlatamab
Experimental
Treatment Arm B: Dose 2 Tarlatamab
Participants will receive dose 2 of Tarlatamab by IV infusion during the treatment period.
Drug: Tarlatamab
Experimental
Treatment Arm C: Dose 3 Tarlatamab
Participants will receive dose 3 of Tarlatamab by IV infusion during the treatment period.
Drug: Tarlatamab

Interventions

DrugTarlatamab
Tarlatamab will be administered by IV infusion.
Also known as: AMG 757

What researchers measure

Primary outcomes

Proportion of participants with confirmed objective response to Tarlatamab
Time frame: Approximately 52 Months
Proportion of participants with complete response to Tarlatamab
Time frame: Approximately 52 Months
Proportion of participants with partial response to Tarlatamab
Time frame: Approximately 52 Months

Secondary outcomes

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

Study locations

78 sites

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

References and documents

Individual participant data

Plan to share: No

Updates

1 registry update since Sep 25, 2026

Primary completion

May 10, 2029→Aug 10, 2029

Oct 6, 2026

Study completion

May 10, 2029→Aug 10, 2029

Oct 6, 2026

Show all 1 update

Oct 6, 2026
Primary completion May 10, 2029→Aug 10, 2029
Study completion May 10, 2029→Aug 10, 2029
+ 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06745323
Lead sponsor: Amgen
Responsible party: Sponsor
First posted: Dec 20, 2024
Start date: Feb 26, 2025
Primary completion: Aug 10, 2029 (estimated)
Completion: Aug 10, 2029 (estimated)
Last update: Oct 6, 2026

Study contacts

study director · Amgen

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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