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New injectable drug shows promise for tough lung cancer

NCT ID NCT06598306

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This early-phase trial is testing a drug called tarlatamab, given as a shot under the skin, for people with extensive stage small cell lung cancer that has worsened after standard chemotherapy. The main goals are to check safety and side effects, and to see how the drug behaves in the body. About 220 adults will take part in this study.

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 as a shot under the skin)
What this could lead to
If it works, this could offer a more convenient way to treat small cell lung cancer that has spread and stopped responding to standard chemotherapy.
What could go wrong
This is an early Phase 1b trial focused on safety, not yet on effectiveness. The drug may cause side effects or not shrink tumors. Results are preliminary and may not lead to a new treatment.

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

About 220 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Apr 2030

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: * Participants ≥ 18 years of age (or ≥ legal adult age within country if it is older than 18 years) at time of signing informed consent. * Participants with histologically or cytologically confirmed ES-SCLC that progressed or recurred following at least one line of platinum-based anti-cancer therapy for SCLC. Note: Participants with prior treatment for LS-SCLC should have also received another regimen for their recurrent, ES-SCLC disease. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1. * Participants must have adequate organ function (cardiac, pulmonary, kidney, and liver). * Participants must be able to have SC injections administered in the abdomen. * Participants without measurable disease or tumor tissue (fresh biopsy or archival) available may be permitted after discussion with and approval by Amgen Medical Monitor. Exclusion Criteria: * Participants that have received prior DLL3 targeted therapy. * Participants with untreated or symptomatic brain metastases or those requiring therapy with steroids. * Note: Participants with asymptomatic brain metastatic lesions are allowed following definitive treatment (Amgen Medical Monitor may approve untreated, asymptomatic brain metastasis if local therapy is not required per investigator judgment). * Participants with leptomeningeal disease. * Participants with baseline oxygen requirement.

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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.

Extensive-stage small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    31 sites in 10 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Adana Sehir Egitim ve Arastirma Hastanesi

    RECRUITING

    Adana, 01370, Turkey (Türkiye)

  • Ankara Bilkent Sehir Hastanesi

    RECRUITING

    Ankara, 06800, Turkey (Türkiye)

  • Avera Cancer Institute

    RECRUITING

    Sioux Falls, South Dakota, 57105, United States

  • Calvary Mater Newcastle Hospital

    RECRUITING

    Waratah, New South Wales, 2298, Australia

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    RECRUITING

    Liège, 4000, Belgium

  • Chris OBrien Lifehouse

    RECRUITING

    Camperdown, New South Wales, 2050, Australia

  • Freiburg Spital

    RECRUITING

    Fribourg, 1708, Switzerland

  • Hospital Regional Universitario de Malaga

    RECRUITING

    Málaga, Andalusia, 29011, Spain

  • Hospital Universitari Vall d Hebron

    RECRUITING

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitari i Politecnic La Fe

    RECRUITING

    Valencia, Valencia, 46026, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Instytut Centrum Zdrowia Matki Polki

    RECRUITING

    Lodz, 93-338, Poland

  • Jilin Cancer Hospital

    RECRUITING

    Changchun, Jilin, 130012, China

  • Kantonsspital Graubuenden

    RECRUITING

    Chur, 7000, Switzerland

  • Kantonsspital Winterthur

    RECRUITING

    Winterthur, 8401, Switzerland

  • Koc Universitesi Hastanesi

    RECRUITING

    Istanbul, 34010, Turkey (Türkiye)

  • Okayama University Hospital

    RECRUITING

    Okayama, Okayama-ken, 700-8558, Japan

  • Shanghai Pulmonary Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200433, China

  • Swedish Cancer Institute

    RECRUITING

    Seattle, Washington, 98104, United States

  • The Alfred Hospital

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • Trinity Health Saint Joseph Mercy Ann Arbor

    RECRUITING

    Ann Arbor, Michigan, 48106, United States

  • Universitaetsklinikum Regensburg

    RECRUITING

    Regensburg, 93053, Germany

  • Universitaetsklinikum Wuerzburg

    RECRUITING

    Würzburg, 97078, Germany

  • Universitair Ziekenhuis Gent

    RECRUITING

    Ghent, 9000, Belgium

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    RECRUITING

    Leuven, 3000, Belgium

  • University of Illinois Chicago

    RECRUITING

    Chicago, Illinois, 60612, United States

  • University of Southern California, Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Uniwersyteckie Centrum Kliniczne

    RECRUITING

    Gdansk, 80-214, Poland

  • Wakayama Medical University Hospital

    RECRUITING

    Wakayama, Wakayama, 641-8510, Japan

  • Wojewodzki Szpital im Sw Ojca Pio w Przemyslu

    RECRUITING

    Przemyśl, 37-700, Poland

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