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New drug combo shows promise in advanced lung cancer trial

NCT ID NCT04294810

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding a new drug called tiragolumab to the standard immunotherapy atezolizumab works better than atezolizumab alone for people with advanced non-small cell lung cancer that has not been treated before. About 620 participants with high levels of a protein called PD-L1 on their tumors were randomly assigned to receive either the combination or a placebo plus atezolizumab. The goal was to see if the combination could delay cancer growth and improve 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

620 people

The number who actually took part.

Started

Mar 2020

Finished

Dec 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 locally advanced or recurrent NSCLC not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic Stage IV non-squamous or squamous NSCLC * No prior systemic treatment for metastatic NSCLC * High tumor tissue PD-L1 expression * Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) * Adequate hematologic and end-organ function * For participants enrolled in the extended China enrollment phase: current resident of mainland China or Taiwan and of Chinese ancestry. Exclusion Criteria: * Known mutation in the EGFR gene or an ALK fusion oncogene * Symptomatic, untreated, or actively progressing central nervous system metastases * 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 * Malignancies other than NSCLC within 5 years, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome * Severe infection within 4 weeks prior to initiation of study treatment * Positive test result for human immunodeficiency virus (HIV) * Active hepatitis B or hepatitis C * Treatment with investigational therapy within 28 days prior to initiation of study treatment * Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA-4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies * Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug elimination half-lives prior to initiation of study treatment.

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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

Contacts and locations

Locations

  • AVIX Investigación Clínica S.C

    Monterrey, Nuevo León, 64710, Mexico

  • Adana Baskent University Hospital

    Adana, 01120, Turkey (Türkiye)

  • Aichi Cancer Center

    Aichi, 464-8681, Japan

  • Ajou University Medical Center

    Gyeonggi-do, 16499, South Korea

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Asst Di Monza

    Monza, Lombardy, 20900, Italy

  • Austin Hospital Olivia Newton John Cancer Centre

    Heidelberg, Victoria, 3084, Australia

  • Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia

    Perugia, Umbria, 06156, Italy

  • Azienda Ospedaliera San Camillo Forlanini

    Rome, Lazio, 00151, Italy

  • Azienda Ospedaliera San Giuseppe Moscati

    Avellino, Campania, 83100, Italy

  • Azienda Sanitaria Ospedaliera S Luigi Gonzaga

    Orbassano, Piedmont, 10043, Italy

  • Beijing Cancer Hospital

    Beijing, 100142, China

  • CHUV

    Lausanne, 1011, Switzerland

  • Chang Gung Memorial Hospital - Linkou Branch

    Guishan Dist., 33305, Taiwan

  • Chongqing Cancer Hospital

    Chongqing, 400030, China

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128, South Korea

  • Chulalongkorn Hospital

    Bangkok, 10330, Thailand

  • Chungbuk National University Hospital

    Cheongju-si, 28644, South Korea

  • City Clinical Hospital #4

    Dnipropetrovsk, 49102, Ukraine

  • Clinica Internacional, Sede San Borja

    Lima, Lima 41, Peru

  • Clinica Ricardo Palma

    San Isidro, Lima 27, Peru

  • Clinical Center of Serbia

    Belgrade, 11000, Serbia

  • Cryptex Investigacion Clinica SA de CV

    México, Mexico CITY (federal District), 06100, Mexico

  • Cuidados oncologicos

    Querétaro City, Querétaro, 76000, Mexico

  • Faculty of Med. Siriraj Hosp.

    Bangkok, 10700, Thailand

  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University

    Xi'an, 710061, China

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120, China

  • Fujian Cancer Hospital

    Fuzhou, 350014, China

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • Gemeinschaftspraxis für Hämatologie und Onkologie

    Münster, 48153, Germany

  • Goztepe Prof.Dr. Suleyman Yalcin City Hospital

    Kadiköy, 34722, Turkey (Türkiye)

  • HOCH Health Ostschweiz, Kantonsspital St. Gallen

    Sankt Gallen, 9000, Switzerland

  • Hacettepe University Medical Faculty

    Ankara, 06100, Turkey (Türkiye)

  • Hagaziekenhuis, locatie Leyweg

    The Hague, 2545 AA, Netherlands

  • Hainan General Hospital

    Haikou, 570311, China

  • Harbin Medical University Cancer Hospital

    Harbin, 150081, China

  • Health Pharma Professional Research

    CD Mexico, Mexico CITY (federal District), 03810, Mexico

  • Hosp Clinico Univ Lozano Blesa

    Zaragoza, 50009, Spain

  • Hospital 12 de Octubre

    Madrid, 28041, Spain

  • Hospital General Universitario de Alicante

    Alicante, 03010, Spain

  • Hospital Regional Universitario de Malaga

    Málaga, 29010, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Germans Trias i Pujol

    Badalona, Barcelona, 08916, Spain

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Madrid, 28222, Spain

  • Hospital Universitario Virgen del Rocío

    Madrid, 41013, Spain

  • Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400, Brazil

  • IOV - Istituto Oncologico Veneto - IRCCS

    Padova, Veneto, 35128, Italy

  • Inonu University Medical Faculty of Medicine

    Malatya, 44280, Turkey (Türkiye)

  • Inselspital Bern

    Bern, 3010, Switzerland

  • Institute of Oncology

    Saint Petersburg, Sankt-Peterburg, 189646, Russia

  • Instituto Nacional de Enfermedades Neoplasicas

    Lima, 15038, Peru

  • Instituto Regional de Enfermedades Neoplásicas del Sur

    Arequipa, 5154, Peru

  • Irccs Istituto Europeo di Oncologia (IEO)

    Milan, Lombardy, 20141, Italy

  • Istanbul University Cerrahpasa Faculty of Medicine

    Istanbul, 34098, Turkey (Türkiye)

  • Istituto Clinico Humanitas

    Rozzano, Lombardy, 20089, Italy

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

    Naples, Campania, 80131, Italy

  • Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi

    Izmir, 35110, Turkey (Türkiye)

  • Jinan Central Hospital

    Jinan, 250013, China

  • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház

    Szolnok, 5004, Hungary

  • Kangbuk Samsung Medical Center

    Seoul, 03181, South Korea

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301, Taiwan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807, Taiwan

  • Kindai University Hospital

    Osaka, 589-8511, Japan

  • Klinik Penzing

    Vienna, 1140, Austria

  • Klinik Schillerhöhe

    Stuttgart, 70376, Germany

  • Korea University Guro Hospital

    Seoul, 08308, South Korea

  • Krankenhaus Martha-Maria Halle-Doelau gGmbH

    Halle, 06120, Germany

  • Krankenhaus Nord - Klinik Floridsdorf

    Vienna, 1210, Austria

  • Krankenhaus Nordwest

    Frankfurt, 60488, Germany

  • Kyushu University Hospital

    Fukuoka, 812-8582, Japan

  • LungenClinic Großhansdorf GmbH

    Großhansdorf, 22927, Germany

  • ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council

    Kryvyi Rih, 50048, Ukraine

  • MEDSI Clinical Hospital on Pyatnitsky Highway

    Moscow, Moscow Oblast, 143422, Russia

  • Main Military Clinical Hospital named after N.N. Burdenko

    Moscow, Moscow Oblast, 105229, Russia

  • Matrai Gyogyintezet

    Mátraháza, 3233, Hungary

  • Medisch Centrum Leeuwarden

    Leeuwarden, 8934 AD, Netherlands

  • Meizhou People's Hospital

    Meizhou, 514031, China

  • Metropolitan Hospital

    Athens, 185 47, Greece

  • NHO Kinki-Chuo Chest Medical Center

    Sakaishi, 591-8555, Japan

  • Nantong Tumor Hospital

    Nantong, 226361, China

  • National Cancer Center Hospital

    Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Chiba, 277-8577, Japan

  • National Cheng Kung Uni Hospital

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    Zhongzheng Dist., 10048, Taiwan

  • Niigata Cancer Center Hospital

    Niigata, 951-8566, Japan

  • Northwest Cancer Specialists - Vancouver

    Vancouver, Washington, 98684, United States

  • Onc & Hem Assoc SW Virginia

    Salem, Virginia, 24153, United States

  • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

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

  • Ordensklinikum Linz Elisabethinen

    Linz, 4020, Austria

  • Orszagos Koranyi TBC es Pulmonologiai Intezet

    Budapest, 1121, Hungary

  • Osaka International Cancer Institute

    Osaka, 541-8567, Japan

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Policlinico Universitario "Agostino Gemelli"

    Rome, Lazio, 00168, Italy

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Ramathibodi Hospital

    Bangkok, 10400, Thailand

  • Rocky Mountain Cancer Center - Denver

    Denver, Colorado, 80220, United States

  • SCRI Florida Cancer Specialists North

    St. Petersburg, Florida, 33705, United States

  • SCRI Florida Cancer Specialists PAN

    Tallahassee, Florida, 32308, United States

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203, United States

  • SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein

    Löwenstein, 74245, Germany

  • Saitama Cancer Center

    Saitama, 362-0806, Japan

  • Samsung Medical Center

    Seoul, 6351, South Korea

  • Sendai Kousei Hospital

    Miyagi, 980-0873, Japan

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Shanghai Pulmonary Hospital

    Shanghai, 200433, China

  • Shizuoka Cancer Center

    Shizuoka, 411-8777, Japan

  • Sir Run Run Shaw Hospital Zhejiang University

    Hangzhou, 310016, China

  • Songklanagarind Hospital

    Songkhla, 90110, Thailand

  • Sotiria Hospital

    Athens, 104 31, Greece

  • St. Petersburg Clinical Scientific Center of special services medical assis (oncology)

    Saint Petersburg, Sankt-Peterburg, 197758, Russia

  • St. Petersburg Med Univ

    Saint Petersburg, Sankt-Peterburg, 197089, Russia

  • St. Vincent's Hospital

    Suwon, 442-723, South Korea

  • Taichung Veterans General Hospital

    Taichung, 407, Taiwan

  • Taipei Medical University ?Shuang Ho Hospital

    New Taipei City, 23561, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 112, Taiwan

  • The 1st Affiliated Hospital of Nanchang Unversity

    Nanchang, 330200, China

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550, Japan

  • The First Affiliated Hospital of Xiamen University

    Xiamen, 361003, China

  • The First Hospital of Jilin University

    Changchun, 130021, China

  • US oncology research at Minnesota Oncology

    Saint Paul, Minnesota, 55102, United States

  • University Hospital Medical Center Bezanijska kosa

    Belgrade, 11080, Serbia

  • University Hospital of Larissa

    Larissa, 411 10, Greece

  • Uniwersyteckie Centrum Kliniczne

    Gda?sk, 80-214, Poland

  • Uzhgorod Nat. University Central Municip Hosp

    Uzhhorod, 88000, Ukraine

  • Virginia Cancer Specialists (Fairfax) - USOR

    Fairfax, Virginia, 22031, United States

  • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie

    Olsztyn, 10-357, Poland

  • West China Hospital, Sichuan University

    Chengdu, 610041, China

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

    Poznan, 60-569, Poland

  • Yale Cancer Center

    New Haven, Connecticut, 06520, United States

  • Zhejiang Cancer Hospital

    Zhejiang, 310022, China

  • Zhongshan Hospital Fudan University

    Shanghai, 200032, China

  • Ziekenhuis Gelderse Vallei

    Ede, 6716 RP, Netherlands

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