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New drug combo aims to keep stage III lung cancer in check

NCT ID NCT05211895

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 1 time

Summary

This study tests whether adding a second immunotherapy drug (domvanalimab) to the standard drug durvalumab can better control stage III lung cancer that hasn't grown after initial chemo-radiation. About 860 adults with a specific type of lung cancer will receive either the combo or durvalumab alone. The goal is to see if the combo delays cancer progression and improves survival.

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

791 people

The number who actually took part.

Started

Feb 2022

Expected to finish

Sep 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: 1. Participant must be ≥ 18 years at the time of screening. 2. Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease 3. Provision of a tumour tissue sample obtained prior to CRT 4. Documented tumour PD-L1 status ≥ 1% by central lab 5. Documented EGFR and ALK wild-type status (local or central). 6. Patients must not have progressed following definitive, platinum-based, concurrent chemoradiotherapy 7. Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy 8. Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy) as part of the chemoradiation therapy, to be randomised. Radiation therapy should be administered by intensity modulated RT (preferred) or 3D-conforming technique. 9. WHO performance status of 0 or 1 at randomization 10. Adequate organ and marrow function EXCLUSION CRITERIA: 1. History of another primary malignancy, except for: * Malignancies treated with curative intent and adequate follow-up with no known active disease and have not required active treatment within the past 3 years before the first dose of study intervention and of low potential risk of recurrence. * Adequately resected non melanoma skin cancer or lentigo maligna without evidence of disease . * Adequately treated carcinoma in situ, including Ta tumors without evidence of disease. 2. Mixed small cell and non-small cell lung cancer histology. 3. Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC. 4. Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT. 5. Any unresolved toxicity CTCAE \>Grade 2 from the prior chemoradiation therapy (excluding alopecia). 6. Participants with ≥ grade 2 pneumonitis from prior chemoradiation therapy. 7. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or idiopathic pneumonitis - regardless of time of onset prior to randomisation. Evidence of active non-CRT induced pneumonitis (≥ Grade 2), active pneumonia, active ILD, active or recently treated pleural effusion, or current pulmonary fibrosis 8. Active or prior documented autoimmune or inflammatory disorders (with exceptions) 9. Active EBV infection, or known or suspected chronic active EBV infection at screening 10. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.

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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

    Chandler, Arizona, 85224, United States

  • Research Site

    Phoenix, Arizona, 85054, United States

  • Research Site

    Fountain Valley, California, 92708, United States

  • Research Site

    Santa Rosa, California, 95403, United States

  • Research Site

    Washington D.C., District of Columbia, 20016, United States

  • Research Site

    Jacksonville, Florida, 32224, United States

  • Research Site

    Orlando, Florida, 32804, United States

  • Research Site

    Saint Augustine, Florida, 32086, United States

  • Research Site

    Macon, Georgia, 31217, United States

  • Research Site

    Elmhurst, Illinois, 60126, United States

  • Research Site

    Louisville, Kentucky, 40202, United States

  • Research Site

    Baltimore, Maryland, 21224, United States

  • Research Site

    Silver Spring, Maryland, 20910, United States

  • Research Site

    Ann Arbor, Michigan, 48106-0995, United States

  • Research Site

    Detroit, Michigan, 48202, United States

  • Research Site

    Minneapolis, Minnesota, 55407, United States

  • Research Site

    Rochester, Minnesota, 55905, United States

  • Research Site

    Reno, Nevada, 89511, United States

  • Research Site

    East Brunswick, New Jersey, 08816, United States

  • Research Site

    Columbus, Ohio, 43214, United States

  • Research Site

    Maumee, Ohio, 43537, United States

  • Research Site

    Oklahoma City, Oklahoma, 73102, United States

  • Research Site

    Pittsburgh, Pennsylvania, 15212, United States

  • Research Site

    Charleston, South Carolina, 29401, United States

  • Research Site

    Chattanooga, Tennessee, 37404, United States

  • Research Site

    Nashville, Tennessee, 37203, United States

  • Research Site

    Nashville, Tennessee, 37232, United States

  • Research Site

    Fort Sam Houston, Texas, 78234, United States

  • Research Site

    Fairfax, Virginia, 22031, United States

  • Research Site

    Fort Belvoir, Virginia, 22060, United States

  • Research Site

    Spokane Valley, Washington, 99216, United States

  • Research Site

    Appleton, Wisconsin, 54911, United States

  • Research Site

    Brussels, 1160, Belgium

  • Research Site

    Edegem, 2650, Belgium

  • Research Site

    Haine-Saint-Paul, 7100, Belgium

  • Research Site

    Leuven, 3000, Belgium

  • Research Site

    Liège, 4000, Belgium

  • Research Site

    Sint-Niklaas, 9100, Belgium

  • Research Site

    Barretos, 14784-400, Brazil

  • Research Site

    Londrina, 86015-520, Brazil

  • Research Site

    Porto Alegre, 91350200, Brazil

  • Research Site

    Porto Velho, 76834-899, Brazil

  • Research Site

    Rio de Janeiro, 20231-050, Brazil

  • Research Site

    Santo André, 09060-650, Brazil

  • Research Site

    São Paulo, 01221-900, Brazil

  • Research Site

    Taubaté, 12030-200, Brazil

  • Research Site

    Calgary, Alberta, T2N 5G2, Canada

  • Research Site

    Kelowna, British Columbia, V1Y 5L3, Canada

  • Research Site

    Laval, Quebec, H7M 3L9, Canada

  • Research Site

    Montreal, Quebec, H4A 3J1, Canada

  • Research Site

    Las Condes, 7560908, Chile

  • Research Site

    Port Montt, 5500243, Chile

  • Research Site

    Santiago, 7500713, Chile

  • Research Site

    Santiago, 7520426, Chile

  • Research Site

    Santiago, 7630370, Chile

  • Research Site

    Santiago, 8241479, Chile

  • Research Site

    Temuco, 4810218, Chile

  • Research Site

    Aix-en-Provence, 13616, France

  • Research Site

    Angers, 49055, France

  • Research Site

    Bobigny, 93000, France

  • Research Site

    Lille, 59000, France

  • Research Site

    Paris, 75014, France

  • Research Site

    Pau, 6400, France

  • Research Site

    Quimper, 29000, France

  • Research Site

    Saint-Grégoire, 35760, France

  • Research Site

    Saint-Quentin, 02321, France

  • Research Site

    Vantoux, 57070, France

  • Research Site

    Villeurbanne, 69100, France

  • Research Site

    Berlin, 12351, Germany

  • Research Site

    Berlin-Zehlendorf, 14165, Germany

  • Research Site

    Braunschweig, 38114, Germany

  • Research Site

    Chemnitz, 09116, Germany

  • Research Site

    Cologne, 51109, Germany

  • Research Site

    Erlangen, 91054, Germany

  • Research Site

    Essen, 45147, Germany

  • Research Site

    Giessen, 35392, Germany

  • Research Site

    Halle, 06120, Germany

  • Research Site

    Koblenz, 56073, Germany

  • Research Site

    Krefeld, 47805, Germany

  • Research Site

    Löwenstein, 74245, Germany

  • Research Site

    Moers, 47441, Germany

  • Research Site

    Regensburg, 93049, Germany

  • Research Site

    Regensburg, 93053, Germany

  • Research Site

    Tübingen, 72076, Germany

  • Research Site

    Athens, 11526, Greece

  • Research Site

    Athens, 11527, Greece

  • Research Site

    Athens, 12462, Greece

  • Research Site

    Athens, 18547, Greece

  • Research Site

    Holargos, Athens, 155 62, Greece

  • Research Site

    Thessaloniki, 55236, Greece

  • Research Site

    Thessaloniki, 56 429, Greece

  • Research Site

    Thessaloniki, 57001, Greece

  • Research Site

    Hong Kong, 150001, Hong Kong

  • Research Site

    Budapest, 1121, Hungary

  • Research Site

    Budapest, 1122, Hungary

  • Research Site

    Deszk, 6772, Hungary

  • Research Site

    Győr, 9024, Hungary

  • Research Site

    Salgótarján, 3100, Hungary

  • Research Site

    Székesfehérvár, 8000, Hungary

  • Research Site

    Törökbálint, 2045, Hungary

  • Research Site

    Ahmedabad, 380054, India

  • Research Site

    Bangalore, 560027, India

  • Research Site

    Bangalore, 560064, India

  • Research Site

    Delhi, 110085, India

  • Research Site

    Howrah, 711103, India

  • Research Site

    Hyderabad, 500032, India

  • Research Site

    Jaipur, 302004, India

  • Research Site

    Jaipur, 302022, India

  • Research Site

    Kolkata, 700160, India

  • Research Site

    Marg Jaipur, 302004, India

  • Research Site

    Mohali, 160055, India

  • Research Site

    Namakkal, 637001, India

  • Research Site

    New Delhi, 110005, India

  • Research Site

    New Delhi, 110029, India

  • Research Site

    Varanasi, 221005, India

  • Research Site

    Bergamo, 24127, Italy

  • Research Site

    Roma, 00144, Italy

  • Research Site

    Rozzano, 20089, Italy

  • Research Site

    Bunkyō City, 113-8431, Japan

  • Research Site

    Bunkyō City, 113-8603, Japan

  • Research Site

    Bunkyō City, 113-8677, Japan

  • Research Site

    Chiba, 260-8717, Japan

  • Research Site

    Fukuoka, 812-8582, Japan

  • Research Site

    Hidaka-shi, 350-1298, Japan

  • Research Site

    Hirosaki-shi, 036-8563, Japan

  • Research Site

    Itabashi-ku, 173-0003, Japan

  • Research Site

    Kashihara-shi, 634-8522, Japan

  • Research Site

    Kōtoku, 135-8550, Japan

  • Research Site

    Kumamoto, 860-8556, Japan

  • Research Site

    Matsuyama, 791-0280, Japan

  • Research Site

    Nagoya, 464-8681, Japan

  • Research Site

    Osaka, 545-8586, Japan

  • Research Site

    Osakasayama-shi, 589-8511, Japan

  • Research Site

    Sapporo, 003-0804, Japan

  • Research Site

    Sunto-gun, 411-8777, Japan

  • Research Site

    Tokyo, 104-0045, Japan

  • Research Site

    Yokohama, 221-0855, Japan

  • Research Site

    Yokohama, 241-8515, Japan

  • Research Site

    Johor Bahru, 81100, Malaysia

  • Research Site

    Kuala Lumpur, 59100, Malaysia

  • Research Site

    Kuala Selangor, 46050, Malaysia

  • Research Site

    Kuching, 93586, Malaysia

  • Research Site

    Chihuahua City, 31207, Mexico

  • Research Site

    Guadalajara, 44638, Mexico

  • Research Site

    Mexico City, 03810, Mexico

  • Research Site

    Oaxaca City, 68020, Mexico

  • Research Site

    Bodø, 8092, Norway

  • Research Site

    Gjøvik, 2819, Norway

  • Research Site

    Oslo, 0379, Norway

  • Research Site

    Trondheim, 0730, Norway

  • Research Site

    City of Muntinlupa, 1780, Philippines

  • Research Site

    Iloilo City, 5000, Philippines

  • Research Site

    Quezon City, 1100, Philippines

  • Research Site

    Quezon City, 1112, Philippines

  • Research Site

    Bialystok, 15-027, Poland

  • Research Site

    Gliwice, 44-102, Poland

  • Research Site

    Katowice, 40-074, Poland

  • Research Site

    Lodz, 93-513, Poland

  • Research Site

    Warsaw, 02-781, Poland

  • Research Site

    Wroclaw, 53-413, Poland

  • Research Site

    Bucharest, 022328, Romania

  • Research Site

    Bucharest, 050098, Romania

  • Research Site

    Craiova, 200542, Romania

  • Research Site

    Floreşti, Romania

  • Research Site

    Iași, 700483, Romania

  • Research Site

    Oradea, 410001, Romania

  • Research Site

    Sibiu, 550245, Romania

  • Research Site

    Suceava, 720214, Romania

  • Research Site

    eManzimtoti, 4126, South Africa

  • Research Site

    Parktown, 2193, South Africa

  • Research Site

    Pretoria, 0084, South Africa

  • Research Site

    Daegu, 42415, South Korea

  • Research Site

    Goyang-si, 10408, South Korea

  • Research Site

    Incheon, 21431, South Korea

  • Research Site

    Incheon, 21565, South Korea

  • Research Site

    Jinju, 52727, South Korea

  • Research Site

    Seoul, 03722, South Korea

  • Research Site

    Seoul, 06273, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Seoul, 07061, South Korea

  • Research Site

    Suwon, 16247, South Korea

  • Research Site

    Bilbao (Vizcaya), 48013, Spain

  • Research Site

    Castellon, 12002, Spain

  • Research Site

    Córdoba, 14004, Spain

  • Research Site

    El Palmar, 30120, Spain

  • Research Site

    Palma de Mallorca, 07010, Spain

  • Research Site

    Sabadell (Barcelona), 08208, Spain

  • Research Site

    Basel, 4031, Switzerland

  • Research Site

    Bern, CH-3010, Switzerland

  • Research Site

    Lausanne, 1011, Switzerland

  • Research Site

    Hsinchu, 300, Taiwan

  • Research Site

    New Taipei City, 220216, Taiwan

  • Research Site

    Taichung, 40447, Taiwan

  • Research Site

    Taichung, 40705, Taiwan

  • Research Site

    Tainan, 704, Taiwan

  • Research Site

    Taipei, 10002, Taiwan

  • Research Site

    Taipei, 10449, Taiwan

  • Research Site

    Taipei, 11217, Taiwan

  • Research Site

    Taoyuan, 333, Taiwan

  • Research Site

    Bangkok, 10300, Thailand

  • Research Site

    Bangkok, 10400, Thailand

  • Research Site

    Bangkok, 10700, Thailand

  • Research Site

    Hat Yai, 90110, Thailand

  • Research Site

    Adapazarı, 54290, Turkey (Türkiye)

  • Research Site

    Ankara, 06340, Turkey (Türkiye)

  • Research Site

    Ankara, 6100, Turkey (Türkiye)

  • Research Site

    Antalya, 07058, Turkey (Türkiye)

  • Research Site

    Çankaya, 06680, Turkey (Türkiye)

  • Research Site

    Edirne, 22030, Turkey (Türkiye)

  • Research Site

    Istanbul, 34098, Turkey (Türkiye)

  • Research Site

    Istanbul, 34662, Turkey (Türkiye)

  • Research Site

    Izmir, 35360, Turkey (Türkiye)

  • Research Site

    Konya, 42080, Turkey (Türkiye)

  • Research Site

    Birmingham, B9 5SS, United Kingdom

  • Research Site

    Brighton, BN2 5BE, United Kingdom

  • Research Site

    Cardiff, CF14 2TL, United Kingdom

  • Research Site

    Cheltenham, GL53 7AN, United Kingdom

  • Research Site

    Edinburgh, EH4 2XR, United Kingdom

  • Research Site

    High Heaton/Newcastle Upon Tyn, NE7 7DN, United Kingdom

  • Research Site

    Leeds, LS 9 7TF, United Kingdom

  • Research Site

    London, SE1 9RT, United Kingdom

  • Research Site

    Nottingham, NG5 1PB, United Kingdom

  • Research Site

    Truro, TR1 3LJ, United Kingdom

  • Research Site

    Hanoi, 100000, Vietnam

  • Research Site

    Hanoi, 10000, Vietnam

  • Research Site

    Ho Chi Minh City, 700000, Vietnam

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