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New hope for mesothelioma patients: experimental combo enters final testing

NCT ID NCT06097728

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 29, 2026 · Updated 2 times

Summary

This study tests a new drug called volrustomig combined with chemotherapy against standard treatments for people with advanced pleural mesothelioma that cannot be removed by surgery. About 861 adults with this rare lung cancer will be randomly assigned to receive either the experimental combo or one of two standard therapies. The main goal is to see if the new combination helps people live longer.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

863 people

The number who actually took part.

Started

Nov 2023

Expected to finish

Nov 2028

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.

Key Inclusion Criteria: * Participant must be ≥ 18 years at the time of screening * Histologically proven diagnosis of pleural mesothelioma with known histology (epithelioid vs. non-epithelioid) * Advanced unresectable disease that cannot be treated with curative surgery (with or without chemotherapy) * WHO/ECOG performance status of 0 or 1 with no deterioration (that is, ECOG PS\>1) over the previous 2 weeks prior to day of first dosing * Has measurable disease per modified RECIST1.1 * Has adequate bone marrow reserve and organ function at baseline Key Exclusion Criteria: * As judged by the investigator, any condition that would interfere with evaluation of the investigational product or interpretation of participant safety or study results. * Active or prior documented autoimmune or inflammatory disorders * History of another primary malignancy with exceptions. * Uncontrolled intercurrent illness * Tuberculosis, hepatitis B (HBV) or hepatitis C (HCV), human immunodeficiency virus (HIV) infection that is not well controlled * Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment * Untreated or progressive CNS metastatic disease

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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

  • Research Site

    Santa Rosa, California, 95403, United States

  • Research Site

    Aurora, Colorado, 80045, United States

  • Research Site

    Jacksonville, Florida, 32224, United States

  • Research Site

    Atlanta, Georgia, 30322, United States

  • Research Site

    Chicago, Illinois, 60637, United States

  • Research Site

    Rochester, Minnesota, 55905, United States

  • Research Site

    St Louis, Missouri, 63110, United States

  • Research Site

    Commack, New York, 11725, United States

  • Research Site

    Columbus, Ohio, 43210, United States

  • Research Site

    Portland, Oregon, 97213, United States

  • Research Site

    Portland, Oregon, 97225, United States

  • Research Site

    Philadelphia, Pennsylvania, 19104, United States

  • Research Site

    Houston, Texas, 77030, United States

  • Research Site

    Fairfax, Virginia, 22031, United States

  • Research Site

    Chermside, 4032, Australia

  • Research Site

    Clayton, 3168, Australia

  • Research Site

    Melbourne, 3000, Australia

  • Research Site

    Nedlands, 6009, Australia

  • Research Site

    Westmead, 2145, Australia

  • Research Site

    Anderlecht, 1070, Belgium

  • Research Site

    Antwerp, 2020, Belgium

  • Research Site

    Ghent, 9000, Belgium

  • Research Site

    Hasselt, 3500, Belgium

  • Research Site

    Sint-Niklaas, 9100, Belgium

  • Research Site

    Barretos, 14784-400, Brazil

  • Research Site

    Fortaleza, 60336-045, Brazil

  • Research Site

    Porto Alegre, 91350-200, Brazil

  • Research Site

    Rio de Janeiro, 22281-100, Brazil

  • Research Site

    Santo André, 09060-650, Brazil

  • Research Site

    São Paulo, 01246-000, Brazil

  • Research Site

    Edmonton, Alberta, T6G 1Z2, Canada

  • Research Site

    Ottawa, Ontario, K1H 8L6, Canada

  • Research Site

    Toronto, Ontario, M5G 1X6, Canada

  • Research Site

    Montreal, Quebec, H2X 0C1, Canada

  • Research Site

    Québec, Quebec, G1V 4G5, Canada

  • Research Site

    Beijing, 100142, China

  • Research Site

    Beijing, 100210, China

  • Research Site

    Changsha, 410013, China

  • Research Site

    Chengdu, 610042, China

  • Research Site

    Guangzhou, 510100, China

  • Research Site

    Hangzhou, 310022, China

  • Research Site

    Harbin, 150049, China

  • Research Site

    Kunming, 650118, China

  • Research Site

    Lanzhou, 730000, China

  • Research Site

    Ningbo, 315100, China

  • Research Site

    Qingdao, 266003, China

  • Research Site

    Shandong, China

  • Research Site

    Shanghai, 200032, China

  • Research Site

    Shenyang, 110044, China

  • Research Site

    Taiyuan, 030000, China

  • Research Site

    Taiyuan, 030032, China

  • Research Site

    Tianjin, 300050, China

  • Research Site

    Tianjin, 300060, China

  • Research Site

    Wuhan, 430030, China

  • Research Site

    Xi'an, 710061, China

  • Research Site

    Zhengzhou, 450008, China

  • Research Site

    Zhengzhou, 450052, China

  • Research Site

    Aarhus N, 8200, Denmark

  • Research Site

    Copenhagen, 2100, Denmark

  • Research Site

    Brest, 29200, France

  • Research Site

    Créteil, 94010, France

  • Research Site

    Le Mans, 72037, France

  • Research Site

    Lille, 59037, France

  • Research Site

    Lyon, 69373, France

  • Research Site

    Marseille, 13015, France

  • Research Site

    Montpellier, 34298, France

  • Research Site

    Paris, 75877, France

  • Research Site

    Rouen, 76031, France

  • Research Site

    Saint-Herblain, 44800, France

  • Research Site

    Strasbourg, 67091, France

  • Research Site

    Toulouse, 31059, France

  • Research Site

    Berlin, 13125, Germany

  • Research Site

    Berlin, 14109, Germany

  • Research Site

    Bochum, 44791, Germany

  • Research Site

    Cologne, 51109, Germany

  • Research Site

    Essen, 45122, Germany

  • Research Site

    Gauting, 82131, Germany

  • Research Site

    Georgsmarienhütte, 49124, Germany

  • Research Site

    Großhansdorf, 22927, Germany

  • Research Site

    Hamburg, 21075, Germany

  • Research Site

    Heidelberg, 69126, Germany

  • Research Site

    Kiel, 24105, Germany

  • Research Site

    Münster, 48153, Germany

  • Research Site

    Regensburg, 93049, Germany

  • Research Site

    Alessandria, 15100, Italy

  • Research Site

    Bari, 70124, Italy

  • Research Site

    Bergamo, 24125, Italy

  • Research Site

    Milan, 20141, Italy

  • Research Site

    Monza, 20052, Italy

  • Research Site

    Orbassano, 10043, Italy

  • Research Site

    Padova, 35128, Italy

  • Research Site

    Parma, 43100, Italy

  • Research Site

    Rozzano, 20089, Italy

  • Research Site

    Varese, 21100, Italy

  • Research Site

    Amagasaki-shi, 660-8550, Japan

  • Research Site

    Hakodate-shi, 040-8611, Japan

  • Research Site

    Hiroshima, 734-8551, Japan

  • Research Site

    Kitaadachi-gun, 362-0806, Japan

  • Research Site

    Kitakyushu-shi, 807-8555, Japan

  • Research Site

    Matsuyama, 791-0280, Japan

  • Research Site

    Nagoya, 466-8560, Japan

  • Research Site

    Nishinomiya-shi, 663-8501, Japan

  • Research Site

    Okayama, 702-8055, Japan

  • Research Site

    Osakasayama-shi, 589-8511, Japan

  • Research Site

    Tokyo, 104-0045, Japan

  • Research Site

    Ube-shi, 755-0241, Japan

  • Research Site

    Amsterdam, 1066CX, Netherlands

  • Research Site

    Eindhoven, 5623EJ, Netherlands

  • Research Site

    Rotterdam, 3015 GD, Netherlands

  • Research Site

    Lørenskog, 1478, Norway

  • Research Site

    Oslo, 450, Norway

  • Research Site

    Bystra, 43-360, Poland

  • Research Site

    Olsztyn, 10-357, Poland

  • Research Site

    Poznan, 60-569, Poland

  • Research Site

    Warsaw, 02-781, Poland

  • Research Site

    Cape Town, 7570, South Africa

  • Research Site

    eManzimtoti, 4126, South Africa

  • Research Site

    Johannesburg, 2013, South Africa

  • Research Site

    Johannesburg, 2193, South Africa

  • Research Site

    Kimberly, 8301, South Africa

  • Research Site

    Pretoria, 0002, South Africa

  • Research Site

    Pretoria, 0081, South Africa

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Seoul, 06591, South Korea

  • Research Site

    Barakaldo, 48903, Spain

  • Research Site

    Barcelona, 8035, Spain

  • Research Site

    Madrid, 28041, Spain

  • Research Site

    Oviedo, 33011, Spain

  • Research Site

    Baden, CH-5405, Switzerland

  • Research Site

    Basel, 4031, Switzerland

  • Research Site

    Bern, 3010, Switzerland

  • Research Site

    Fribourg, 1700, Switzerland

  • Research Site

    Sankt Gallen, 9007, Switzerland

  • Research Site

    Kaohsiung City, 80756, Taiwan

  • Research Site

    Taichung, 40705, Taiwan

  • Research Site

    Taipei, 10002, Taiwan

  • Research Site

    Ankara, 06280, Turkey (Türkiye)

  • Research Site

    Ankara, 06800, Turkey (Türkiye)

  • Research Site

    Diyarbakır, 21280, Turkey (Türkiye)

  • Research Site

    Izmir, 35110, Turkey (Türkiye)

  • Research Site

    Cambridge, CB20QQ, United Kingdom

  • Research Site

    Leeds, LS9 7TF, United Kingdom

  • Research Site

    Leicester, LE1 5WW, United Kingdom

  • Research Site

    London, NW1 2PG, United Kingdom

  • Research Site

    London, SE1 9RT, United Kingdom

  • Research Site

    London, SW3 6JJ, United Kingdom

  • Research Site

    Manchester, M23 9LT, United Kingdom

  • Research Site

    Newcastle upon Tyne, NE2 4HH, United Kingdom

  • Research Site

    Portsmouth, PO6 3LY, United Kingdom

  • Research Site

    Taunton, TA1 5DA, United Kingdom

More trials for these conditions

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