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Experimental cocktail aims to outsmart tough lung cancer

NCT ID NCT07531095

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 21, 2026 · Updated 5 times

Summary

This early-phase trial is testing whether combining two experimental drugs, tarlatamab and ZL-1310, with or without the immunotherapy durvalumab, can safely shrink tumors in people with small cell lung cancer that has worsened after standard treatment. About 160 adults will take part to find the best dose and check for side effects. The goal is to see if this mix can control the disease longer than current options.

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) combined with ZL-1310 (another drug), with or without durvalumab (an immunotherapy)
What this could lead to
If successful, this could point toward a new combination treatment for small cell lung cancer that has stopped responding to standard chemotherapy.
What could go wrong
This is an early Phase 1 study with only 160 participants, so safety and the right dose are still being figured out. The combination may cause serious side effects or not shrink tumors as hoped.

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 160 people

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

Started

Apr 2026

Expected to finish

May 2031

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: * Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent. * Participants with Histologically or cytologically confirmed SCLC: * For Part 1, participants must have SCLC that has progressed or recurred following at least 1 line of platinum-based anti-cancer therapy. * For Parts 1 and 2, participants must have progressed or recurred following at least 1 line of platinum-based therapy. No prior tarlatamab is allowed in Cohort 2-1. * For Part 3, participants must have extensive-stage SCLC (ES-SCLC) with no prior systemic treatment other than 1 cycle of platinum-based chemotherapy. Note: Participants with prior treatment for limited-stage SCLC (LS-SCLC) before diagnosis of ES SCLC are permitted. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * At least 1 measurable lesion as defined per RECIST v1.1 within 21-day screening period, not previously irradiated. * Adequate organ function (hematological, coagulation, renal, hepatic, pulmonary, and cardiac function). Exclusion Criteria: * Symptomatic CNS metastases. Participants with treated brain metastases are eligible provided they meet the criteria specified in the protocol. * History of interstitial lung disease (ILD)/pneumonitis. * Received thoracic radiation therapy within 90 days prior to first dose of trial intervention. * Prior therapy with any delta-like ligand 3 (DLL3)-directed therapy. * Prior exposure to topoisomerase I inhibitors or antibody-drug conjugate (ADC) with topoisomerase I inhibitor payload. * Receiving strong CYP3A4 or CPY2D6 inhibitors within 14 days or 5 half-lives (whichever is longer) before the first dose of trial treatment. * Enrollment in any tarlatamab clinical trial.

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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

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

    27 sites in 9 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)

  • Baptist Cancer Center

    RECRUITING

    Memphis, Tennessee, 38120, United States

  • Centre Hospitalier Universitaire de Lyon Hopital Louis Pradel

    RECRUITING

    Bron, 69677, France

  • City of Hope Cancer Center Phoenix

    RECRUITING

    Goodyear, Arizona, 85338, United States

  • City of Hope Chicago

    RECRUITING

    Zion, Illinois, 60099, United States

  • Gustave Roussy

    RECRUITING

    Villejuif, 94805, France

  • Hacettepe Universitesi Tip Fakultesi Hastanesi

    RECRUITING

    Ankara, 06230, Turkey (Türkiye)

  • Health Partners Cancer Center at Regions Hospital

    RECRUITING

    Saint Paul, Minnesota, 55101, United States

  • Hopital de la Timone

    RECRUITING

    Marseille, 13005, France

  • Hospital Clinico Universitario Virgen de la Victoria

    RECRUITING

    Málaga, Andalusia, 29010, Spain

  • Hospital Clinico Universitario de Valencia

    RECRUITING

    Valencia, Valencia, 46010, Spain

  • Hospital Universitari Vall d Hebron

    RECRUITING

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Ramon y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Institut Jules Bordet

    RECRUITING

    Brussels, B-1070, Belgium

  • Izmir Ekonomi Universitesi Medical Point Hastanesi

    RECRUITING

    Izmir, 35575, Turkey (Türkiye)

  • Kantonsspital Sankt Gallen

    RECRUITING

    Sankt Gallen, 9007, Switzerland

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Monash Medical Centre

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

    RECRUITING

    Gliwice, 44-102, Poland

  • New York University Cancer Institute

    RECRUITING

    New York, New York, 10016, United States

  • Next Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Universitaetsklinikum Dresden

    RECRUITING

    Dresden, 01307, Germany

  • Universitaetsklinikum Wuerzburg

    RECRUITING

    Würzburg, 97078, Germany

  • Universitair Ziekenhuis Gent

    RECRUITING

    Ghent, 9000, Belgium

  • Uniwersyteckie Centrum Kliniczne

    RECRUITING

    Gdansk, 80-214, Poland

  • Ziekenhuis aan de Stroom Augustinus

    RECRUITING

    Wilrijk, 2610, Belgium

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