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New combo therapy targets tough lung cancer

NCT ID NCT06898957

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This early-phase trial tests a combination of three drugs—tarlatamab, YL201, and durvalumab—in 29 adults with extensive stage small cell lung cancer that has progressed after prior treatment. The main goal is to check safety and side effects, while also measuring how well the tumors respond. It's a small, early study, so results will guide future research rather than offer a new treatment right away.

What this could mean

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

Active substance
Tarlatamab, YL201, and Durvalumab (anti-PD-L1)
What this could lead to
If successful, this could point toward a new combination treatment option for people with advanced small cell lung cancer.
What could go wrong
This is a very early, small phase 1b study focused on safety, not proof of effectiveness. The combination may cause serious side effects or fail to shrink tumors.

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

29 people

The number who actually took part.

Started

May 2025

Expected to finish

Jun 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: * Participants ≥ 18 years of age (or legal adult age within country) at time of signing informed consent. * Participants with histologically or cytologically confirmed ES-SCLC. * For Parts 1 and 2, subjects must have ES-SCLC that has progressed or recurred following at least 1 prior line of platinum-based anti-cancer therapy received either for LS-SCLC or ES-SCLC. * For Part 3, subjects must have ES-SCLC and no prior systemic treatment for ES SCLC other than 1 cycle of platinum-based chemotherapy, and etoposide, and with or without PD-(L)1 inhibitor in the first-line setting. * At least 1 measurable lesion as defined by RECIST 1.1. * Participants must have adequate organ function (cardiac, pulmonary, kidney, bone marrow, and liver). Exclusion Criteria: * Prior delta-like ligand 3 (DLL3) or B7 homolog 3 (B7-H3) targeted therapy. * Prior exposure to topoisomerase I inhibitors or antibody-drug conjugate (ADC) with topoisomerase I inhibitor payload. * Symptomatic central nervous system (CNS) metastases. Note: Participants with asymptomatic brain metastases are eligible as defined in the protocol. * History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. * Baseline requirement of supplemental oxygen.

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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

Contacts and locations

Locations

  • Alexandra Hospital

    Athens, 11528, Greece

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • CHU de Quebec Hopital de l Enfant Jesus

    Québec, Quebec, G1J 1Z4, Canada

  • Centre Leon Berard

    Lyon, 69373, France

  • City of Hope Orange County Lennar Foundation Cancer Center

    Irvine, California, 92618, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Clinexpert Kft Bugat Pal Korhaz

    Gyöngyös, 3200, Hungary

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • European Interbalkan Medical Center

    Thessaloniki, 57001, Greece

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, United States

  • Fujian Cancer Hospital

    Fuzhou, 350011, China

  • Gustave Roussy

    Villejuif, 94805, France

  • Henry Dunant Hospital Center

    Athens, 11526, Greece

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 08041, Spain

  • Iatriko Diavalkaniko Thessalonikis

    Thessaloniki, 57001, Greece

  • Institut Bergonie

    Bordeaux, 33000, France

  • Institut Universitaire du Cancer Toulouse Oncopole

    Toulouse, 31059, France

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

    Meldola (FC), 47014, Italy

  • Istituto di Candiolo Fondazione del Piemonte per l Oncologia IRCCS

    Candiolo to, 10060, Italy

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Sanford Oncology Clinic and Pharmacy

    Sioux Falls, South Dakota, 54104, United States

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122, United States

  • Semmelweis Egyetem

    Budapest, 1083, Hungary

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117, China

  • Siteman Cancer Center

    St Louis, Missouri, 63110, United States

  • Swedish Medical Center

    Seattle, Washington, 98104, United States

  • Universitaetsklinikum Essen

    Essen, 45147, Germany

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 611135, China

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510, United States

More trials for these conditions

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