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New hope for tough lung cancer: tarlatamab trial shows promise

NCT ID NCT05060016

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 23, 2026 · Updated 2 times

Summary

This phase 2 study tests a drug called tarlatamab in 222 people with relapsed or refractory small cell lung cancer who have already tried at least two prior treatments. The goal is to see if tarlatamab can shrink tumors and how safe it is. Participants receive the drug through an IV infusion, and researchers will monitor side effects and tumor response.

What this could mean

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

Active substance
tarlatamab
What this could lead to
If successful, tarlatamab could offer a new treatment option for patients with advanced small cell lung cancer who have run out of standard therapies.
What could go wrong
This is a mid-stage trial with only 222 participants, so results may not apply to all patients. Side effects are possible, and the drug may not work for everyone.

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

222 people

The number who actually took part.

Started

Dec 2021

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/assent prior to initiation of any study specific activities/procedures. * Male and female participants ≥ 18 years of age (or legal adult age within country) at the time of signing the informed consent. * Histologically or cytologically confirmed relapsed/refractory SCLC * Participants who progressed or recurred following 1 platinum-based regimen and at least 1 other prior line of therapy. * Participants willing to provide archived tumor tissue samples or willing to undergo pretreatment tumor biopsy. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 1. * Minimum life expectancy of 12 weeks. * Measurable lesions as defined per RECIST 1.1 within 21 days prior to the first dose of tarlatamab. * Participants with treated brain metastases are eligible provided they meet defined criteria. Exclusion Criteria: Disease Related * Untreated or symptomatic brain metastases and leptomeningeal disease. * Has evidence of interstitial lung disease or active, non-infectious pneumonitis. * Participants who experienced recurrent pneumonitis (grade 2 or higher) or severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents. * Unresolved toxicity from prior anti-tumor therapy, defined as per protocol. Other Medical Conditions * History of other malignancy within the past 2 years, with exceptions * Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 12 months of first dose of tarlatamab. * History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of first dose of tarlatamab. * 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 tarlatamab. * Presence of any indwelling line or drain. * History of hypophysitis or pituitary dysfunction. * Exclusion of hepatitis infection based on the results and/or criteria per protocol. * Major surgery within 28 days of first dose of tarlatamab. * History or evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Subject is eligible if no acute symptoms of coronavirus disease 2019 (COVID-19) within 14 days prior to first dose of tarlatamab (counted from day of positive test for asymptomatic subjects). Prior/Concomitant Therapy * Participant received prior therapy with tarlatamab. * Prior anti-cancer therapy within 28 days prior to first dose of tarlatamab. * 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. * The following vaccines (live and live-attenuated vaccines) are excluded during the following study periods: 1. Screening and during study treatment: Live and live-attenuated vaccines are prohibited within 28 days prior to the first dose of tarlatamab and for the duration of the study. Live viral non-replicating vaccine (e.g. Jynneos) for Monkeypox infection is allowed during the study (except during cycle 1) in accordance with local standard of care and institutional guidelines. 2. End of study treatment: Live and live-attenuated vaccines can be used when at least 42 days (5X half-life of tarlatamab) have passed after the last dose of tarlatamab. 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 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 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. Specific Exclusions to Part 3 * Participants unable to remain within one hour of study site for 48 hours after infusion of tarlatamab on Cycle 1 Day 1 and Cycle 1 Day 8. * Participants unable to remain within one hour of any hospital for 72 hours after infusion of tarlatamab on Cycle 1 Day 1 and Cycle 1 Day 8. * Unable to identify home companion who will cohabitate with participant for 72 hours after infusion of tarlatamab on Cycle 1 Day 1 and Cycle 1 Day 8.

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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.

Relapsed/refractory small cell lung cancer

Contacts and locations

Locations

  • Agios Loukas Clinic

    Thessaloniki, 55236, Greece

  • Aichi Cancer Center

    Nagoya, Aichi-ken, 464-8681, Japan

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Azienda Ospedaliero-Universitaria di Parma

    Parma, 43126, Italy

  • Azienda Socio Sanitaria Territoriale dei Sette Laghi Ospedale di Circolo e Fondazione Macchi

    Varese, 21100, Italy

  • Centra Medyczne Medyceusz Sp zoo

    Lodz, 91-053, Poland

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495, France

  • Centre Hospitalier Universitaire Nord

    Marseille, 13915, France

  • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

    Rennes, 35033, France

  • Centre Hospitalier Universitaire de Strasbourg - Nouvel Hopital Civil

    Strasbourg, 67091, France

  • Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

    Toulouse, 31059, France

  • Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio

    Porto, 4099-001, Portugal

  • Christiana Care Health Services

    Newark, Delaware, 19713, United States

  • Christie Hospital

    Manchester, M20 4BX, United Kingdom

  • Dana Farber - Harvard Cancer Center

    Boston, Massachusetts, 02215, United States

  • Dartmouth Hitchcock Medical Center

    Hanover, New Hampshire, 03756, United States

  • Duke University Medical Center

    Durham, North Carolina, 27705, United States

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD, Netherlands

  • Euromedica General Clinic of Thessaloniki

    Thessaloniki, 54645, Greece

  • General Hospital of Patras Agios Andreas

    Pátrai, 26335, Greece

  • Grand Hopital de Charleroi - Site Saint Joseph

    Gilly, 6060, Belgium

  • Henry Dunant Hospital Center

    Athens, 11526, Greece

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Hopitaux Universitaires de Geneve

    Geneva, 1211, Switzerland

  • Hospital CUF Descobertas

    Lisbon, 1998-018, Portugal

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, Catalonia, 08036, Spain

  • Hospital Cuf porto

    Porto, 4100-180, Portugal

  • Hospital Regional Universitario de Malaga

    Málaga, Andalusia, 29011, Spain

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, Valencia, 46026, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222, Spain

  • Hospital da Luz, SA

    Lisbon, 1500-650, Portugal

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 08041, Spain

  • Institut Curie

    Paris, 75248, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Instituto Catalan de Oncologia Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Catalonia, 08908, Spain

  • Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

    Porto, 4200-072, Portugal

  • Istituti Fisioterapici Ospitalieri Regina Elena San Gallicano

    Rome, 00144, Italy

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301, Taiwan

  • Kindai University Hospital

    Osakasayama-shi, Osaka, 589-8511, Japan

  • Landeskrankenhaus Salzburg

    Salzburg, 5020, Austria

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZA, Netherlands

  • LungenClinic Grosshansdorf GmbH

    Großhansdorf, 22927, Germany

  • Mazowieckie centrum leczenia

    Otwock, 05-400, Poland

  • Metropolitan Hospital

    Athens, 18547, Greece

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • National Cancer Center

    Goyang-si Gyeonggi-do, 10408, South Korea

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Cancer Centre Singapore

    Singapore, 168583, Singapore

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-8558, Japan

  • Oncology Hematology Care Inc

    Cincinnati, Ohio, 45242, United States

  • Rigshospitalet

    Copenhagen, 2100, Denmark

  • Samsung medical center

    Seoul, 06351, South Korea

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Sarah Cannon Research Institute UK

    London, W1G 6AD, United Kingdom

  • Seoul National University Bundang Hospital

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

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka, 411-8777, Japan

  • Sotiria General Hospital

    Athens, 11527, Greece

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto-ku, Tokyo, 135-8550, Japan

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591, South Korea

  • Theagenion Cancer Hospital

    Thessaloniki, 54007, Greece

  • Universitaetsklinikum Koeln

    Cologne, 50937, Germany

  • Universitaetsklinikum Krems

    Krems, 3500, Austria

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97078, Germany

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, 3000, Belgium

  • University Hospital of Heraklion

    Heraklion - Crete, 71500, Greece

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249, United States

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Pittsburgh Medical Center Cancer Pavillion

    Pittsburgh, Pennsylvania, 15232, United States

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214, Poland

  • Wakayama Medical University Hospital

    Wakayama, Wakayama, 641-8510, Japan

  • Wake Forest Baptist Comprehensive Cancer Research Center

    Winston-Salem, North Carolina, 27157, United States

  • West Virginia University Health Sciences Center

    Morgantown, West Virginia, 26506, United States

  • Winship Cancer Institute

    Atlanta, Georgia, 30332, United States

  • Yonsei University Health System Severance Hospital

    Seoul, 03722, South Korea

More trials for these conditions

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