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New immunotherapy cocktail takes on lung cancer in major trial

NCT ID NCT04513925

Disease control Sponsor: Hoffmann-La Roche 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tested whether combining two immunotherapy drugs, atezolizumab and tiragolumab, works better than the standard drug durvalumab for people with stage III lung cancer that cannot be surgically removed. The 829 participants had already received chemotherapy and radiation without their cancer growing. The goal was to see if the combo could delay cancer progression or improve survival.

What this could mean

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

Active substance
Atezolizumab and tiragolumab (immunotherapy drugs)
What this could lead to
If this combination works better than durvalumab, it could offer a new standard treatment to keep stage III lung cancer from growing after chemoradiation.
What could go wrong
This is a large phase 3 trial, but the combination may not improve outcomes over the current drug durvalumab. Immunotherapy can cause immune-related side effects like inflammation of the lungs or other organs.

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

829 people

The number who actually took part.

Started

Aug 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: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Histologically or cytologically documented NSCLC with locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology * Whole-body Positron Emission Tomography-Computed Tomography (PET-CT) scan, performed prior and within 42 days of the first dose of concurrent chemoradiotherapy (cCRT) * At least two prior cycles of platinum-based chemotherapy administered concurrently with radiotherapy (RT), which must be completed within 1 to 42 days prior to randomization in the study (one cycle of cCRT is defined as 21 or 28 days) * The radiotherapy (RT) component in the cCRT must have been at a total dose of radiation of 60 (±10 percent \[%\]) gray (Gy) (54 Gy to 66 Gy) administered by intensity modulated RT (preferred) or 3D-conforming technique * No progression during or following concurrent platinum-based CRT * A known PD-L1 result * Life expectancy \>/= 12 weeks * Adequate hematologic and end-organ function * Female participants must be willing to avoid pregnancy for 90 days after the final dose of tiragolumab and 5 months after the final dose of atezolizumab, or for 3 months after the final dose of durvalumab * Male participants must remain abstinent or use a condom during the treatment period and for 90 days after the final dose of tiragolumab * Male participants must not donate sperm during the treatment period and for 90 days after the final dose of tiragolumab Exclusion Criteria: * Any history of prior NSCLC and/or any history of prior treatment for NSCLC (participants must be newly diagnosed with unresectable Stage III disease) * NSCLC known to have a mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene * Any evidence of Stage IV disease * Treatment with sequential CRT for locally advanced NSCLC * Participants with locally advanced NSCLC who have progressed during or after the definitive cCRT prior to randomization * Any Grade \>2 unresolved toxicity from previous CRT * Grade \>= 2 pneumonitis from prior CRT * Active or history of autoimmune disease or immune deficiency * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis or evidence of active pneumonitis * History of malignancy other than NSCLC within 5 years prior to screening with the exception of malignancies with a negligible risk of metastasis or death * Prior allogeneic stem cell or solid organ transplantation * Active Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection at screening * Treatment with investigational therapy within 28 days prior to initiation of study treatment * Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated protein 4, anti-T-cell immunoreceptor with Ig and ITIM domains (anti-TIGIT), anti-PD-1 and anti-PD-L1 * Any prior Grade \>/= 3 immune-mediated adverse event or any unresolved Grade \> 1 immune-mediated adverse event while receiving any previous immunotherapy agent other than immune checkpoint blockade agents * Treatment with systemic immunosuppressive medication * Women who are pregnant, or breastfeeding

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

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

Non-small cell lung cancer (NSCLC)

Contacts and locations

Locations

  • A.O. Spedali Civili Di Brescia-P.O. Spedali Civili

    Brescia, Lombardy, 25123, Italy

  • AZ Maria Middelares

    Ghent, 9000, Belgium

  • Adana Baskent University Medical Faculty

    Adana, 01220, Turkey (Türkiye)

  • Addenbrooke's NHS Trust

    Cambridge, CB2 0QQ, United Kingdom

  • Agioi Anargyroi Cancer Hospital

    Kifissia, 145 64, Greece

  • Aichi Cancer Center

    Aichi, 464-8681, Japan

  • Ajou University Medical Center

    Gyeonggi-do, 16499, South Korea

  • Amphia Ziekenhuis

    Breda, 4819 EV, Netherlands

  • Ankara University Medical Faculty

    Ankara, 06100, Turkey (Türkiye)

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Auckland City Hospital, Cancer and Blood Research

    Auckland, 1023, New Zealand

  • Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello

    Pisa, Tuscany, 56124, Italy

  • Azienda Ospedaliero Universitaria di Parma

    Parma, Emilia-Romagna, 43100, Italy

  • Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)

    Milan, Lombardy, DUMMY_VALUE, Italy

  • Azienda ULSS 8 Berica

    Vicenza, Veneto, 36100, Italy

  • BC Cancer - Victoria

    Victoria, British Columbia, V8R 6V5, Canada

  • BC Cancer ? Abbotsford

    Abbotsford British Columbia, British Columbia, V2S 0C2, Canada

  • Banner MD Anderson Cancer Center

    Greeley, Colorado, 80631, United States

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN, United Kingdom

  • Beijing Cancer Center

    Beijing, 100142, China

  • Beijing Chest Hospital

    Beijing, 101149, China

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS, United Kingdom

  • Blacktown Hospital

    Blacktown, New South Wales, 2148, Australia

  • CEMIC

    Buenos Aires, C1431FWO, Argentina

  • CHU Angers

    Angers, 49933, France

  • Calderdale & Huddersfield Nhs Trust

    Huddersfield, HD3 3EA, United Kingdom

  • Cancer Care Centers of Brevard

    Palm Bay, Florida, 32901, United States

  • Cancer Center, Sun Yat-sen University of Medical Sciences

    Guangzhou, 510060, China

  • Cancer Hospital of Shantou University Medical College

    Shantou, 515041, China

  • Centre Francois Baclesse

    Caen, 14000, France

  • Centro Integrado de Oncologia de Curitiba

    Curitiba, Paraná, 80810-050, Brazil

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Chongqing Cancer Hospital

    Chongqing, 400030, China

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128, South Korea

  • Christie Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • Chungbuk National University Hospital

    Cheongju-si, 28644, South Korea

  • Clinica Universitaria Reina Fabiola

    Córdoba, X5004FHP, Argentina

  • Clinique Clémentville

    Montpellier, 34070, France

  • Complejo Hospitalario Universitario A Coruña (CHUAC)

    A Coruña, 15006, Spain

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89128, United States

  • Cox Health Systems

    Springfield, Missouri, 65807, United States

  • Crio - Centro Regional Integrado de Oncologia

    Fortaleza, Ceará, 60336-550, Brazil

  • Dicle University Faculty of Medicine

    Diyarbakır, 21280, Turkey (Türkiye)

  • Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii

    Wroc?aw, 53-413, Poland

  • Ege University Medical Faculty

    Bornova, ?zm?r, 35100, Turkey (Türkiye)

  • Fiona Stanley Hospital

    Bull Creek, Western Australia, 6149, Australia

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042, Australia

  • Florida Cancer Specialist, North Region

    St. Petersburg, Florida, 33705, United States

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901-8101, United States

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, Lombardy, 27100, Italy

  • Fujian Medical University Union Hospital

    Fujian, 350001, China

  • Fujian Provincial Cancer Hospital

    Fuzhou, 350014, China

  • GHdC Site Les Viviers

    Charleroi, 6000, Belgium

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • Gazi University Medical Faculty, Oncology Hospital

    Ankara, 06500, Turkey (Türkiye)

  • General Hospital "G.Papanikolaou"

    Asvestochóri, 570 10, Greece

  • HCA Midwest Health

    Kansas City, Missouri, 64132, United States

  • Hacettepe Universitesi Tip Fakultesi Hastanesi

    Ankara, 06100, Turkey (Türkiye)

  • Hangzhou Cancer Hospital

    Hangzhou, 310002, China

  • Henan Cancer Hospital

    Zhengzhou, 450008, China

  • Hopital Nord AP-HM

    Marseille, 13015, France

  • Hopital Robert Schuman

    Vantoux, 57070, France

  • Hospital Britanico de Buenos Aires

    Ciudad Autonoma Buenos Aires, C1284AEB, Argentina

  • Hospital CUF Porto

    Porto, 4100-180, Portugal

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28009, Spain

  • Hospital Provincial de Castellon

    Castellon, Castellon, 12002, Spain

  • Hospital Regional Universitario Carlos Haya

    Málaga, 29010, Spain

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Hospital Son Llatzer

    Palma de Mallorca, Balearic Islands, 07198, Spain

  • Hospital Univ. Nuestra Señora de Valme

    Seville, 41014, Spain

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital da Luz

    Lisbon, 1500-650, Portugal

  • Hospital de Base de Sao Jose do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000, Brazil

  • Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400, Brazil

  • IPO de Coimbra

    Coimbra, 3000-075, Portugal

  • IPO do Porto

    Porto, 4200-072, Portugal

  • IRCCS AOU San Martino - IST

    Genoa, Liguria, 16132, Italy

  • IRCCS Istituto Regina Elena (IFO)

    Rome, Lazio, 00144, Italy

  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola

    Meldola, Emilia-Romagna, 47014, Italy

  • Illinois Cancer Care

    Peoria, Illinois, 61615, United States

  • Inonu University Faculty of Medicine Turgut Ozal Medical Center

    Malatya, 44280, Turkey (Türkiye)

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000, Brazil

  • Istanbul University Cerrahpasa Faculty of Medicine

    Istanbul, 34098, Turkey (Türkiye)

  • Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

    Naples, Campania, 80131, Italy

  • Jessa Zkh (Campus Virga Jesse)

    Hasselt, 3500, Belgium

  • Jilin Cancer Hospital

    Changchun, 132013, China

  • Kepler Universitätskliniken GmbH - Med Campus III

    Linz, 4020, Austria

  • Kindai University Hospital

    Osaka, 589-8511, Japan

  • Kitasato University Hospital

    Kanagawa, 252-0375, Japan

  • Klinik Penzing

    Vienna, 1140, Austria

  • Klinikum Bogenhausen

    München, 81925, Germany

  • Klinikum Braunschweig

    Braunschweig, 38114, Germany

  • Klinikum Koeln-Merheim

    Cologne, 51109, Germany

  • Korea University Guro Hospital

    Seoul, 08308, South Korea

  • Kyoto University Hospital

    Kyoto, 606-8507, Japan

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404, South Korea

  • Leicester Royal Infirmary

    Leicester, LE1 5WW, United Kingdom

  • Macarthur Cancer Therapy Centre

    Campbelltown, New South Wales, 2560, Australia

  • Maidstone & Tonbridge Wells Hospital

    Maidstone, ME16 9QQ, United Kingdom

  • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy

    Otwock, 05-400, Poland

  • Meander Medisch Centrum

    Amersfoort, 3813 TZ, Netherlands

  • Medipol University Medical Faculty

    Istanbul, 34214, Turkey (Türkiye)

  • Medisch Centrum Haaglanden, locatie Antoniushove

    Leidschendam, 2262 BA, Netherlands

  • Minnesota Oncology Hematology

    Minneapolis, Minnesota, 55404, United States

  • Monash Health Translational Precinct

    Victoria, Victoria, 3168, Australia

  • Montefiore Medical Center

    The Bronx, New York, 10461, United States

  • Mount Sinai Medical Center

    New York, New York, 10029, United States

  • Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad

    Warsaw, 02-781, Poland

  • National Cancer Center

    Gyeonggi-do, 10408, South Korea

  • National Cancer Center East

    Chiba, 277-8577, Japan

  • National Cancer Center Hospital

    Tokyo, 104-0045, Japan

  • National Hospital Organization Himeji Medical Center

    Hyōgo, 670-8520, Japan

  • New England Cancer Specialists

    Brunswick, Maine, 04011, United States

  • New York Oncology Hematology,P.C.-Albany

    Albany, New York, 12208, United States

  • Niigata Cancer Center Hospital

    Niigata, 951-8566, Japan

  • Northwest Georgia Oncology Centers PC - Marietta

    Marietta, Georgia, 30060, United States

  • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

    Ijuí, Rio Grande do Sul, 98700-000, Brazil

  • Optum Health Care

    Las Vegas, Nevada, 89106, United States

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6, Canada

  • Pamela Youde Nethersole Eastern Hospital

    Hong Kong, Hong Kong

  • Policlinico Universitario Campus Biomedico

    Rome, Lazio, 00128, Italy

  • Princess Margaret Hospital, Oncology

    Hong Kong, DUMMY_VALUE, Hong Kong

  • Prisma Health ? Upstate

    Greenville, South Carolina, 29615, United States

  • Pusan National University Yangsan Hospital

    Gyeongsangnam-do, 50612, South Korea

  • Pécsi Tudományegyetem

    Pécs, 7623, Hungary

  • Queen Elizabeth Hospital

    Hong Kong, DUMMY_VALUE, Hong Kong

  • Queen Mary Hospital

    Pokfulam, DUMMY_VALUE, Hong Kong

  • Rabin Medical Center

    Petah Tikva, 4941492, Israel

  • Rajavithi Hospital

    Bangkok, 10400, Thailand

  • Ramathibodi Hospital;Medicine/Oncology

    Bangkok, 10400, Thailand

  • Rambam Medical Center

    Haifa, 3109601, Israel

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2, Canada

  • Saitama Cancer Center

    Saitama, 362-0806, Japan

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • San Juan Oncology Associates

    Farmington, New Mexico, 87401, United States

  • Sanatorio Parque S.A.

    Rosario, S2000QGB, Argentina

  • Sarah Cannon Research Institute / Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • Sendai Kousei Hospital

    Miyagi, 981-0914, Japan

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Seoul St Mary's Hospital

    Seoul, 06591, South Korea

  • Shaare Zedek Medical Center

    Jerusalem, 9103102, Israel

  • Shandong Cancer Hospital

    Jinan, 250117, China

  • Shanghai Chest Hospital

    Shanghai, 200000, China

  • Shanxi Provincial Cancer Hospital

    Taiyuan, 030013, China

  • Shizuoka Cancer Center

    Shizuoka, 411-8777, Japan

  • Sichuan Provincial Cancer Hospital

    Chengdu, 610041, China

  • Songklanagarind Hospital

    Songkhla, 90110, Thailand

  • Soroka Medical Center

    Beersheba, 8410100, Israel

  • Sotiria Hospital

    Athens, 11527, Greece

  • Southcoast Health System

    Fairhaven, Massachusetts, 02719, United States

  • St George Hospital

    Kogarah, New South Wales, 2217, Australia

  • St. Vincent's Hospital

    Gyeonggi-do, 16247, South Korea

  • Stanford University

    Palo Alto, California, 94305, United States

  • Szent Borbala Korhaz

    Tatabánya, 2800, Hungary

  • Szpital Kliniczny MSWiA z Warmi?sko-Mazurskim Centrum Onkologii

    Olsztyn, 10-228, Poland

  • Taipei Veterans General Hospital

    Taipei, 112, Taiwan

  • Tennessee Oncology Chattanooga

    Chattanooga, Tennessee, 37403, United States

  • The 2nd School of Medicine, WMU

    Wenzhou, 325000, China

  • The Affiliated Hospital of Xuzhou Medical College

    Xuzhou, 221000, China

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550, Japan

  • The First Affiliated Hospital of Xiamen University

    Xiamen, 361003, China

  • The affiliated hospital of Qingdao university

    Qingdao, 266042, China

  • Thoraxklinik Heidelberg gGmbH

    Heidelberg, 69126, Germany

  • Tianjin Cancer Hospital

    Tianjin, 300060, China

  • Tiroler Landeskrankenanstalten Ges.M.B.H.

    Innsbruck, 6020, Austria

  • Titan Health Partners LLC, d/b/a Astera Cancer Care

    East Brunswick, New Jersey, 08816, United States

  • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

    Edirne, 22030, Turkey (Türkiye)

  • Tudogyogyintezet Torokbalint

    Törökbálint, 2045, Hungary

  • Tuen Mun Hospital

    Hong Kong, Hong Kong

  • Ulsan University Hosiptal

    Ulsan, 44033, South Korea

  • Universitaetsmedizin Goettingen

    Göttingen, 37075, Germany

  • Universitätsklinikum Regensburg

    Regensburg, 93053, Germany

  • Uniwersyteckie Centrum Kliniczne

    Gda?sk, 80-214, Poland

  • Vajira Hospital

    Bangkok, 10300, Thailand

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502, United States

  • Wakayama Medical University Hospital

    Wakayama, 641-8510, Japan

  • Weston Park Hospital

    Sheffield, S10 2SJ, United Kingdom

  • William Osler Health System Brampton Civic Hospital

    Brampton, Ontario, L6R 3J7, Canada

  • Woodlands Medical Specialists, P.A.

    Pensacola, Florida, 32503, United States

  • Xiangya Hospital Central South University

    Changsha, 410008, China

  • Zhongda Hospital Affiliated to Southeast University

    Nanjing, 210009, China

  • Zuyderland Medisch Centrum - Sittard Geleen

    Sittard-Geleen, 6162 BG, Netherlands

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