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New cocktail of immune drugs shows promise in lung cancer trial

NCT ID NCT04262856

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This phase 2 study tested three different drug combinations in 151 people with advanced non-small cell lung cancer that had not been treated before. The drugs help the immune system attack cancer cells. Researchers measured how many patients' tumors shrank or stopped growing, and how long they lived without the cancer getting worse.

What this could mean

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

Active substance
Zimberelimab, domvanalimab, and etrumadenant (three drugs that help the immune system fight cancer)
What this could lead to
If successful, this could point toward a more effective first-line treatment for advanced non-small cell lung cancer by combining immune-boosting drugs.
What could go wrong
This is a phase 2 trial with only 151 participants, so results are still early. The drug combinations may cause immune-related side effects and may not improve survival compared to existing treatments.

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

151 people

The number who actually took part.

Started

May 2020

Finished

Jul 2025

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: * Male or female participants; age ≥ 18 years * Histologically confirmed, treatment naive, metastatic squamous or non-squamous NSCLC with documented high PD-L1 expression, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Must have at least 1 measurable lesion per RECIST v1.1 * Adequate organ and marrow function Exclusion Criteria: * Use of any live vaccines against infectious diseases within 28 days of first dose of investigational medicinal products (IMPs) * Any gastrointestinal condition that would preclude the use of oral medications (eg, difficulty swallowing, nausea, vomiting, or malabsorption) * History of trauma or major surgery within 28 days prior to the first dose of IMP * Concurrent medical condition requiring the use of supra-physiologic doses of corticosteroids (\> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications * Positive test results for Hepatitis B surface antigen, Hepatitis C virus antibody with presence of Hepatitis C qualitative RNA or human immunodeficiency virus (HIV-1 and/or HIV-2) antibody at screening * Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy. * Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Adelaide Cancer Centre

    Elizabeth Vale, Australia

  • Allegheny General Hospital (AGH)-Alleghney Singer Research Institute

    Pittsburgh, Pennsylvania, 15224, United States

  • Asan Medical Center

    Seoul, South Korea

  • Baptist Health Lexington

    Lexington, Kentucky, 40503, United States

  • Border Medical Oncology

    Albury, Australia

  • Catholic University of Korea, Uijeongbu St. Mary's Hospital

    Uijeongbu-si, South Korea

  • Chang Gung Memorial Hospital at Linkou

    Taoyuan, Taiwan

  • Chi Mei Hospital

    Tainan, Taiwan

  • Chonbuk National University Hospital

    Jeonju, South Korea

  • Chonnam University Hospital

    Hwasun, South Korea

  • Chungbuk National University Hospital (CBNUH)

    Cheongju-si, South Korea

  • Clinical Research Alliance

    Lake Success, New York, 11042, United States

  • Coffs Harbour Health Campus

    Coffs Harbour, Australia

  • Curie Oncology

    Singapore, Singapore

  • Florida Cancer Specialists

    Englewood, Florida, 34223, United States

  • Florida Cancer Specialists

    Gainesville, Florida, 32605, United States

  • Florida Cancer Specialists - East

    West Palm Beach, Florida, 33401, United States

  • Florida Cancer Specialists - Panhandle

    Tallahassee, Florida, 32308, United States

  • Gachon University Gil Medical Center

    Incheon, South Korea

  • Hong Kong United Oncology Centre

    Hong Kong, Hong Kong

  • Innovative Clinical Research Institute (ICRI)

    Whittier, California, 90603, United States

  • Kangbuk Samsung Hospital

    Seoul, South Korea

  • Korea University Anam Hospital

    Seoul, South Korea

  • Kosin University Gospel Hospital

    Busan, South Korea

  • McGill University Health Centre (MUHC) - The Montreal Children's Hospital (MCH)

    Montreal, Canada

  • Millennium Oncology

    Houston, Texas, 77339, United States

  • National Cheng Kung University Hospital

    Tainan, Taiwan

  • National Taiwan University Hospital

    Taipei, Taiwan

  • Northwell Health Cancer Institute

    Lake Success, New York, 11042, United States

  • Norton Cancer Institute

    Louisville, Kentucky, 40202, United States

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121, United States

  • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    Blacksburg, Virginia, 24060, United States

  • Queen Elizabeth Hospital (Hong Kong)

    Hong Kong, Hong Kong

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Seoul National University Bundang Hospital

    Seongnam-si, South Korea

  • Shoalhaven Cancer Care Centre

    Nowra, Australia

  • St Vincent Hospital of the Catholic University of Korea

    Suwon, South Korea

  • Taipei Medical University - Shuang Ho Hospital

    New Taipei City, Taiwan

  • Taipei Medical University Hospital

    Taipei, Taiwan

  • The Center For Cancer And Blood Disorders (Texas Cancer Care)

    Fort Worth, Texas, 76104, United States

  • The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion

    Ridgewood, New Jersey, 07450, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157, United States

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