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New drug tarlatatamab shows promise in lung cancer trial

NCT ID NCT06745323

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 18, 2026 · Updated 3 times

Summary

This phase 2 trial is testing tarlatamab, an experimental drug given by IV, in 252 adults with small cell lung cancer that has worsened after platinum-based chemotherapy. The main goal is to see if the drug can shrink tumors (partial or complete response). Researchers will also monitor how long any response lasts and track drug levels in the blood. The study is active but no longer recruiting participants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tarlatamab (a drug given by IV infusion)
What this could lead to
If successful, this could lead to a new treatment option that helps control small cell lung cancer by shrinking tumors or slowing disease progression.
What could go wrong
This is a mid-stage trial with no placebo group, so results may not be definitive. The drug may cause side effects, and not all participants may respond.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

252 people

The number who actually took part.

Started

Feb 2025

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Small cell lung cancer ( SCLC )

Contacts and locations

Locations

  • AdventHealth Hematology and Oncology

    Orlando, Florida, 32804, United States

  • Affiliated Cancer Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150081, China

  • Alexandra Hospital

    Athens, 11528, Greece

  • Austin Health, Austin Hospital

    Heidelberg, Victoria, 3084, Australia

  • Azienda Ospedaliera San Giovanni Addolorata

    Roma, 00144, Italy

  • Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi

    Adana, 01250, Turkey (Türkiye)

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

    Rennes, 35033, France

  • Chonnam National University Hwasun Hospital

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

  • Christie Hospital

    Manchester, M20 4BX, United Kingdom

  • Chungbuk National University Hospital

    Cheongju Chungbuk, 28644, South Korea

  • Cipo - Centro Integrado de Pesquisa em Oncologia

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

  • City of Hope Chicago

    Rockford, Illinois, 61108, United States

  • Complexo Hospitalario Universitario A Coruna Hospital Teresa Herrera

    A Coruña, Galicia, 15006, Spain

  • Duke University

    Durham, North Carolina, 27705, United States

  • Ege Universitesi Tip Fakultesi Hastanesi

    Izmir, 35100, Turkey (Türkiye)

  • European Interbalkan Medical Center

    Thessaloniki, 57001, Greece

  • FirstHealth Cancer Center

    Pinehurst, North Carolina, 28374, United States

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014, China

  • Fundacion Respirar

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

  • Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

    Ankara, 06560, Turkey (Türkiye)

  • Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

    Istanbul, 34722, Turkey (Türkiye)

  • Grand Hopital de Charleroi - Site des Viviers

    Charleroi, 6060, Belgium

  • Guthrie Medical Group

    Sayre, Pennsylvania, 18840, United States

  • Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut

    Plainville, Connecticut, 06062, United States

  • Health Partners Cancer Center at Regions Hospital

    Saint Paul, Minnesota, 55101, United States

  • Helios Kliniken Emil-von-Behring

    Berlin, 14165, Germany

  • Henry Dunant Hospital Center

    Athens, 11526, Greece

  • Hopital Foch

    Suresnes, 92150, France

  • Hopital Lyon sud

    Pierre-Bénite, 69495, France

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

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

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Insular de Gran Canaria

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

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • 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

  • Hospital de Clinicas de Porto Alegre

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

  • Instituto de Investigaciones clinicas de Mar del Plata

    Mar del Plata, Buenos Aires, B7600FZO, Argentina

  • Jessa Ziekenhuis - Campus Virga Jesse

    Hasselt, 3500, Belgium

  • Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515, Japan

  • Kansai Medical University Hospital

    Hirakata-shi, Osaka, 573-1191, Japan

  • Kantonsspital Baden

    Baden, 5404, Switzerland

  • Korea University Guro Hospital

    Seoul, 08308, South Korea

  • Kurume University Hospital

    Kurume-shi, Fukuoka, 830-0011, Japan

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404, South Korea

  • Liga Norte-Riograndense Contra O Cancer

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

  • Memorial Ankara Hastanesi

    Ankara, 06520, Turkey (Türkiye)

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian, 350028, China

  • Metropolitan Hospital

    Athens, 18547, Greece

  • Monash Medical Centre

    Clayton, Victoria, 3168, Australia

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804, Japan

  • New York Oncology Hematology PC

    Albany, New York, 12206, United States

  • Niigata Cancer Center Hospital

    Niigata, Niigata, 951-8566, Japan

  • Osaka International Cancer Institute

    Osaka, Osaka, 541-8567, Japan

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730, China

  • Seoul National University Bundang Hospital

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

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030032, China

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka, 411-8777, Japan

  • Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang, 310016, China

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang, 317099, China

  • Tennessee Oncology PLLC - Chattanooga

    Chattanooga, Tennessee, 37404, United States

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203, United States

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto-ku, Tokyo, 135-8550, Japan

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011, China

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060, China

  • Universitaetsklinikum Schleswig-Holstein - Kiel

    Kiel, 24105, Germany

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97078, Germany

  • Universitaetsklinikum des Saarlandes

    Homburg, 66421, Germany

  • Universitaetsspital Zuerich

    Zurich, 8091, Switzerland

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650, Belgium

  • University Hospital of Heraklion

    Heraklion - Crete, 71500, Greece

  • University Hospital of Patras

    Pátrai, 26504, Greece

  • University of California Los Angeles

    Los Angeles, California, 90095, United States

  • Virginia Cancer Specialists PC

    Fairfax, Virginia, 22031, United States

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041, China

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Other studies related to the condition(s) this trial covers.