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Experimental drug tarlatamab targets tough lung cancer

NCT ID NCT03319940

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study is testing a new drug, tarlatamab, in 269 people with small cell lung cancer that has worsened after standard treatment. Tarlatamab is designed to help the body's immune cells find and attack cancer cells. The main goals are to check the drug's safety, find the right dose, and see how the body processes it.

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 bispecific antibody that helps immune cells attack cancer cells)
What this could lead to
If successful, this could lead to a new treatment option for people with small cell lung cancer that has come back after standard therapy.
What could go wrong
This is an early Phase 1 trial focused on safety and dosing, so it is too soon to know if tarlatamab will work. Side effects, including cytokine release syndrome, are possible.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

269 people

The number who actually took part.

Started

Dec 2017

Expected to finish

Dec 2027

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 years and older

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 greater than or equal to 18 years old at the time of signing the informed consent * Histologically or cytologically confirmed SCLC. For parts A, C, D, E, F, and G: relapsed/refractory small cell lung cancer (R/R SCLC) who progressed or recurred following platinum-based regimen * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Participants with treated brain metastases are eligible provided they meet defined criteria * Adequate organ function as defined in protocol Exclusion Criteria: * History of other malignancy within the past 2 years prior to first dose of tarlatamab with exceptions * Major surgery within 28 days of first dose tarlatamab * Untreated (includes new lesions or progression in previously treated lesions) or symptomatic brain metastases and leptomeningeal disease (regardless of symptomatic or not). * Prior anti-cancer therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and first dose of tarlatamab with the following exceptions: participants who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to Grade less than or equal to 1; and prior palliative radiotherapy must have been completed at least 7 days before the first dose of tarlatamab * Participants who experienced severe, life-threatening or recurrent (Grade 2 or higher) immune-mediated AEs or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immune-oncology agents * Has evidence of interstitial lung disease or active, non-infectious pneumonitis * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of tarlatamab * Part C only: history of solid organ transplantation or active autoimmune disease that has required systemic treatment within the past 2 years * Participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of investigational product administration

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Conditions

The condition(s) this trial relates to.

Bites and Stings neoplasm small cell lung carcinoma

As listed by the trial registrant

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

Small cell lung carcinoma

Contacts and locations

Locations

  • Biokinetica SA

    Józefów, 05-410, Poland

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, 1011, Switzerland

  • Chris OBrien Lifehouse

    Camperdown, New South Wales, 2050, Australia

  • Christie Hospital

    Manchester, M20 4BX, United Kingdom

  • City of Hope National Medical Center

    Duarte, California, 91010, United States

  • Europejskie Centrum Zdrowia Otwock Szpital imienia Fryderyka Chopina

    Otwock, 05-400, Poland

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Gustave Roussy

    Villejuif, 94805, France

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, Catalonia, 08036, Spain

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • John Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21287, United States

  • Kantonsspital St Gallen

    Sankt Gallen, 9007, Switzerland

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756, Taiwan

  • Landeskrankenhaus Salzburg

    Salzburg, 5020, Austria

  • Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

    Taoyuan, 33305, Taiwan

  • Maastricht Universitair Medisch Centrum

    Maastricht, 6229 HX, Netherlands

  • Medizinische Universitaet Graz

    Graz, 8036, Austria

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577, Japan

  • Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis

    Amsterdam, 1066 CX, Netherlands

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121, United States

  • Prince of Wales Hospital

    Shatin, New Territories, Hong Kong

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • The Ohio State University Wexner Medical Center - Thoracic Oncology Clinic

    Columbus, Ohio, 43210, United States

  • Tri-Service General Hospital

    Taipei, 11490, Taiwan

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97078, Germany

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Pittsburgh Medical Center Cancer Pavillion

    Pittsburgh, Pennsylvania, 15232, United States

  • Wakayama Medical University Hospital

    Wakayama, Wakayama, 641-8510, Japan

  • Washington University

    St Louis, Missouri, 63110-1093, United States

  • Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510, United States

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