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Small Cell Lung Cancer (SCLC)Phase 2DeLLphi-309NCT06745323

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

A Phase 2 study testing Tarlatamab in people with Small Cell Lung Cancer (SCLC), run by Amgen at 78 sites in 16 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Small Cell Lung Cancer (SCLC)
What is being tested?
Tarlatamab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
252 participants
Where
78 sitesin 16 countries
Study dates
26 Feb 2025to 10 Aug 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 35Show fewer
  • 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.

Trial locations and contacts

78 sites in 16 countries.

78 sites in 16 countries

United States12 sites

  • New York Oncology Hematology PC

    Albany, New York, 12206

  • Tennessee Oncology PLLC - Chattanooga

    Chattanooga, Tennessee, 37404

  • Duke University

    Durham, North Carolina, 27705

  • Virginia Cancer Specialists PC

    Fairfax, Virginia, 22031

  • University of California Los Angeles

    Los Angeles, California, 90095

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • AdventHealth Hematology and Oncology

    Orlando, Florida, 32804

  • FirstHealth Cancer Center

    Pinehurst, North Carolina, 28374

  • Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut

    Plainville, Connecticut, 06062

  • City of Hope Chicago

    Rockford, Illinois, 61108

  • Health Partners Cancer Center at Regions Hospital

    Saint Paul, Minnesota, 55101

  • Guthrie Medical Group

    Sayre, Pennsylvania, 18840

Other trials in United States

China12 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian, 350028

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang, 310016

  • Affiliated Cancer Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150081

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030032

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang, 317099

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

Other trials in China

Japan8 sites

  • Kansai Medical University Hospital

    Hirakata-shi, Osaka, 573-1191

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto-ku, Tokyo, 135-8550

  • Kurume University Hospital

    Kurume-shi, Fukuoka, 830-0011

  • Niigata Cancer Center Hospital

    Niigata, Niigata, 951-8566

  • Osaka International Cancer Institute

    Osaka, Osaka, 541-8567

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka, 411-8777

  • Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

Brazil6 sites

  • Hospital de Amor

    Barretos, São Paulo, 14784-400

  • Liga Norte-Riograndense Contra O Cancer

    Natal, Rio Grande do Norte, 59075-740

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-003

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

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Cipo - Centro Integrado de Pesquisa em Oncologia

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Hospital de Base de Sao Jose do Rio Preto

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

Other trials in Brazil

Greece6 sites

  • Henry Dunant Hospital Center

    Athens, 11526

  • Alexandra Hospital

    Athens, 11528

  • Metropolitan Hospital

    Athens, 18547

  • University Hospital of Heraklion

    Heraklion - Crete, 71500

  • University Hospital of Patras

    Pátrai, 26504

  • European Interbalkan Medical Center

    Thessaloniki, 57001

Other trials in Greece

South Korea6 sites

  • Chungbuk National University Hospital

    Cheongju Chungbuk, 28644

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

  • Chonnam National University Hwasun Hospital

    Hwasun-gun, Jeollanam-do, 58128

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Korea University Guro Hospital

    Seoul, 08308

Other trials in South Korea

Spain5 sites

  • Complexo Hospitalario Universitario A Coruna Hospital Teresa Herrera

    A Coruña, Galicia, 15006

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035

  • Hospital Universitario Insular de Gran Canaria

    Las Palmas de Gran Canaria, Canary Islands, 35016

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

Other trials in Spain

Turkey (Türkiye)5 sites

  • Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi

    Adana, 01250

  • Memorial Ankara Hastanesi

    Ankara, 06520

  • Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

    Ankara, 06560

  • Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

    Istanbul, 34722

  • Ege Universitesi Tip Fakultesi Hastanesi

    Izmir, 35100

Other trials in Turkey (Türkiye)

Germany4 sites

  • Helios Kliniken Emil-von-Behring

    Berlin, 14165

  • Universitaetsklinikum des Saarlandes

    Homburg, 66421

  • Universitaetsklinikum Schleswig-Holstein - Kiel

    Kiel, 24105

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97078

Other trials in Germany

Belgium3 sites

  • Grand Hopital de Charleroi - Site des Viviers

    Charleroi, 6060

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • Jessa Ziekenhuis - Campus Virga Jesse

    Hasselt, 3500

Other trials in Belgium

France3 sites

  • Hopital Lyon sud

    Pierre-Bénite, 69495

  • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

    Rennes, 35033

  • Hopital Foch

    Suresnes, 92150

Other trials in France

Argentina2 sites

  • Fundacion Respirar

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426ABP

  • Instituto de Investigaciones clinicas de Mar del Plata

    Mar del Plata, Buenos Aires, B7600FZO

Other trials in Argentina

Australia2 sites

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Austin Health, Austin Hospital

    Heidelberg, Victoria, 3084

Other trials in Australia

Switzerland2 sites

  • Kantonsspital Baden

    Baden, 5404

  • Universitaetsspital Zuerich

    Zurich, 8091

Other trials in Switzerland

Italy1 site

  • Azienda Ospedaliera San Giovanni Addolorata

    Roma, 00144

Other trials in Italy

United Kingdom1 site

  • Christie Hospital

    Manchester, M20 4BX

Other trials in United Kingdom

About this study

Official title: 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).

Being tested
Tarlatamab
Keywords
Tarlatamab, AMG 757
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TarlatamabDrug

    Also called AMG 757

    Tarlatamab will be administered by IV infusion.

Study groups in NCT06745323
Study groupRoleWhat they receive
Treatment Arm A: Dose 1 TarlatamabExperimentalParticipants will receive dose 1 of Tarlatamab by intravenous (IV) infusion during the treatment period.
Receives: Drug: Tarlatamab
Treatment Arm B: Dose 2 TarlatamabExperimentalParticipants will receive dose 2 of Tarlatamab by IV infusion during the treatment period.
Receives: Drug: Tarlatamab
Treatment Arm C: Dose 3 TarlatamabExperimentalParticipants will receive dose 3 of Tarlatamab by IV infusion during the treatment period.
Receives: Drug: Tarlatamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants with confirmed objective response to Tarlatamab

    Measured: Approximately 52 Months

  2. Proportion of participants with complete response to Tarlatamab

    Measured: Approximately 52 Months

  3. Proportion of participants with partial response to Tarlatamab

    Measured: Approximately 52 Months

Secondary outcomes (10)

  1. Average serum concentrations of Tarlatamab

    Measured: Approximately 52 Weeks

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

    Measured: Approximately 52 Months

  3. Disease control, defined as objective response or stable disease

    Measured: Approximately 52 Months

  4. Duration of disease control

    Measured: Approximately 52 Months

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

    Measured: Approximately 52 Months

  6. Objective response, defined as best overall response of CR or PR

    Measured: Approximately 52 Months

  7. Overall survival, defined as the time from randomization to death due to any cause

    Measured: Approximately 52 Months

  8. Overall Survival rate at 6 months and 1 year from randomization

    Measured: Approximately 52 Months

  9. Number of participants with treatment-emergent adverse events

    Measured: Approximately 52 Months

  10. Number of participants with anti-tarlatamab antibody formation

    Measured: Approximately 52 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2024
  2. Study start26 Feb 2025
  3. Primary completion10 Aug 2029 (estimated)
  4. Study completion10 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
252 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06745323
Sponsor's protocol ID
20240092
Acronym
DeLLphi-309
Status last verified
Oct 2026
First submitted
17 Dec 2024
Last updated
6 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tarlatamab in people with Small Cell Lung Cancer (SCLC), run by Amgen at 78 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United States, China, Japan, Brazil, Greece and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with confirmed objective response to Tarlatamab (time frame: Approximately 52 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06745323.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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