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New drug cocktail aims to tackle tough lung cancer

NCT ID NCT05361395

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 10, 2026 · Updated 3 times

Summary

This early-stage trial is testing a new drug called tarlatamab, which helps the immune system find and attack cancer cells, when given together with standard chemotherapy and immunotherapy. The study includes about 184 people with extensive-stage small cell lung cancer who have not had prior treatment for this stage. The main goal is to check safety and side effects, while also looking at whether the combination helps shrink tumors or delay cancer progression.

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 that helps the immune system attack cancer cells) combined with chemotherapy (carboplatin, etoposide) and an immunotherapy (atezolizumab or durvalumab)
What this could lead to
If this combination proves safe and effective, it could offer a new first-line treatment option for people with extensive-stage small cell lung cancer, potentially improving how long they live or delaying cancer growth.
What could go wrong
This is an early phase 1b trial focused on safety, so it is too soon to know if the combination works better than current treatments. Side effects from combining multiple drugs could be significant, and the results may not lead to a standard therapy.

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

184 people

The number who actually took part.

Started

Aug 2022

Expected to finish

May 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: * 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 same time of signing the informed consent. * Histologically or cytologically confirmed Extensive Stage Small Cell Lung Cancer (ES-SCLC) and no prior systemic treatment for ES-SCLC. * Participants with prior treatment for limited-stage SCLC (LS-SCLC) are permitted. * Eastern Cooperative Oncology Group (ECOG) 0 to 1. * Participants with treated asymptomatic 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 with exceptions. * Major surgery within 28 days of study day 1. * Untreated or symptomatic brain metastases and leptomeningeal disease. * Participants who experienced recurrent grade 2 pneumonitis or severe or life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents. * History of immune-related colitis. * History or 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 study treatment. * Participants 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 study treatment * Participant has known active infection requiring parenteral antibiotic treatment. Upon completion of parenteral antibiotics and resolution of symptoms, the participant may be considered eligible for the study from an infection standpoint * NOTE: Simple urinary tract infections and uncomplicated bacterial pharyngitis are permitted if responding to an active treatment and after consultation with Medical Monitor. Participants requiring oral antibiotics who have been afebrile for \>24 hours, have no leukocytosis, nor clinical signs of infection are eligible. Screening for chronic infectious conditions is not required. * History of hypophysitis or pituitary dysfunction. * History of solid organ transplantation or allogeneic hematopoietic stem cell transplantation. * Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study. Participants with Type I diabetes, vitiligo, psoriasis, hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are permitted.

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Conditions

The condition(s) this trial relates to.

Bites and Stings lung neoplasm 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

Contacts and locations

Locations

  • AZ Delta Campus Rumbeke

    Roeselare, 8800, Belgium

  • Algemeen Ziekenhuis Maria Middelares

    Ghent, 9000, Belgium

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105, United States

  • Azienda Ospedaliera Universitaria Renato Dulbecco

    Catanzaro, 88100, Italy

  • CHU de Quebec Hopital de l Enfant Jesus

    Québec, Quebec, G1R 2J6, Canada

  • Centre Hospitalier Universitaire de Nantes, Hôpital Nord Laënnec

    Saint-Herblain, 44800, France

  • Centre Leon Berard

    Lyon, 69373, France

  • Chris OBrien Lifehouse

    Camperdown, New South Wales, 2050, Australia

  • Christiana Care Health Services

    Newark, Delaware, 19713, United States

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza (MB), 20900, Italy

  • Gustave Roussy

    Villejuif, 94805, France

  • Hadassah Ein-Kerem Medical Center

    Jerusalem, 9112001, Israel

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Inselspital Bern

    Bern, 3010, Switzerland

  • Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol

    Badalona, Catalonia, 08916, Spain

  • Istituto Nazionale Tumori Regina Elena

    Rome, 00144, Italy

  • Jessa Ziekenhuis - Campus Virga Jesse

    Hasselt, 3500, Belgium

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Cheng Kung University Hospital

    Tainan, 70403, Taiwan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • New York University Grossman School of Medicine and New York University Langone Hospitals

    New York, New York, 10016, United States

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • Rabin Medical Center

    Petah Tikva, 4941492, Israel

  • Rambam Medical Center

    Haifa, 3109601, Israel

  • Rigshospitalet

    Copenhagen, 2100, Denmark

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901, United States

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Sheba Medical Center

    Ramat Gan, 5265601, Israel

  • Swedish Cancer Institute Medical Oncology

    Seattle, Washington, 98104, United States

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto-ku, Tokyo, 135-8550, Japan

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • Universitaetsklinikum Dresden

    Dresden, 01307, Germany

  • Universitaetsklinikum Essen

    Essen, 45147, Germany

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, 79106, Germany

  • Universitaetsspital Basel

    Basel, 4031, Switzerland

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ, Netherlands

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650, Belgium

  • University of Southern California, Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • West Virginia University Health Sciences Center

    Morgantown, West Virginia, 26506, United States

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