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Immunotherapy combo shows promise in lung cancer before surgery

NCT ID NCT03456063

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 the immunotherapy drug atezolizumab to standard chemotherapy before surgery helps people with stage II to IIIB non-small cell lung cancer live longer without the cancer coming back. About 453 participants received either atezolizumab plus chemo or a placebo plus chemo, followed by surgery and optional post-surgery treatment. The main goal was to see if the combination delays cancer progression or recurrence.

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

453 people

The number who actually took part.

Started

Apr 2018

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 0 or 1 * Histologically or cytologically confirmed, resectable Stage II, IIIA, or Select IIIB (T3N2 only) NSCLC of squamous or non-squamous histology. Staging should be based on the 8th edition of the AJCC/UICC staging system * Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent * Adequate pulmonary and cardiac function to undergo surgical resection * Measurable disease as defined by RECIST v1.1 * Adequate hematologic and end organ function * Negative HIV test at screening * Negative for active HBV and HCV at screening * Adequate tissue for PD-L1 IHC assessment Exclusion criteria: * NSCLC with histology of large cell neuroendocrine carcinoma or sarcomatoid carcinoma * Mixed NSCLC and small cell lung cancer histology * Any prior therapy for lung cancer * Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated expected curative outcome * Non-squamous NSCLC histology with activating ALK and EGFR mutation * Pregnant or lactating women * History of autoimmune disease * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or evidence of active of active pneumonitis on screening chest Computed Tomography (CT) scan * Prior treatment with cluster of differentiation 137 (CD137) agonist or immune checkpoint blockade therapies, anti-programmed-death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibody * Severe infection within 4 weeks prior to randomization * Significant history of cardiovascular disease

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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

Contacts and locations

Locations

  • A.O. Universitaria Pisana-Ospedale Cisanello

    Pisa, Tuscany, 56124, Italy

  • Aichi Cancer Center Hospital

    Aichi, 464-8681, Japan

  • Arizona Oncology

    Tucson, Arizona, 85711, United States

  • Asklepios-Fachkliniken Muenchen-Gauting

    Gauting, 82131, Germany

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Barts and the London NHS Trust.

    London, EC1A 7BE, United Kingdom

  • Box Hill Hospital

    Box Hill, Victoria, 3128, Australia

  • Brighton Center for Specialty Care

    Brighton, Michigan, 48116, United States

  • CHU Angers

    Angers, 49933, France

  • CHU Strasbourg - Nouvel Hopital Civil

    Strasbourg, 67091, France

  • CHUV

    Lausanne, 1011, Switzerland

  • Cenantron - Centro Avancado de Tratamento Oncologico

    Belo Horizonte, Minas Gerais, 30130-090, Brazil

  • Centre Hospitalier Saint Quentin

    Saint-Quentin, 02321, France

  • Centre Léon Bérard

    Lyon, 69008, France

  • Chemotherapy SI Dnipropetrovsk MA of MOHU

    Dnipropetrovsk, 49102, Ukraine

  • Chulalongkorn Hospital

    Bangkok, 10330, Thailand

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008, Spain

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Corporacio Sanitaria Parc Tauli

    Sabadell, Barcelona, 08208, Spain

  • Eugene Marais Hospital

    Pretoria, South Africa

  • FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

    Moscow, Moscow Oblast, 115478, Russia

  • Fukushima Medical University Hospital

    Miyagi, 960-1295, Japan

  • Gangnam Severance Hospital

    Seoul, 06273, South Korea

  • Georgetown University

    Washington D.C., District of Columbia, 20007, United States

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, 730-8518, Japan

  • Hiroshima University Hospital

    Hiroshima, 734-8551, Japan

  • Hopital d'Instruction des Armees de Begin

    Saint-Mandé, 94160, France

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

  • Hospital Regional Universitario Carlos Haya

    Málaga, 29010, Spain

  • Hospital Son Llatzer

    Palma de Mallorca, Balearic Islands, 07198, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital Universitario la Fe

    Valencia, 46026, Spain

  • Hospital de Basurto

    Bilbao, Vizcaya, 48013, Spain

  • Hyogo Medical University Hospital

    Hyōgo, 663-8501, Japan

  • Hôpital d'Instruction des Armées de Sainte Anne

    Toulon, 83000, France

  • IOV - Istituto Oncologico Veneto - IRCCS

    Padova, Veneto, 35128, Italy

  • Illinois Cancer Care

    Peoria, Illinois, 61615, United States

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000, Brazil

  • Irccs Istituto Europeo Di Oncologia (IEO)

    Milan, Lombardy, 20141, Italy

  • Irccs Istituto Nazionale Dei Tumori (Int)

    Milan, Lombardy, 20133, Italy

  • Juntendo University Hospital

    Tokyo, 113-8431, Japan

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 00833, Taiwan

  • Karolinska Universitetssjukhuset, Solna

    Solna, 171 64, Sweden

  • Kepler Universitätskliniken GmbH - Med Campus III

    Linz, 4020, Austria

  • Klinik Penzing

    Vienna, 1140, Austria

  • Klinikum der Univer Regenburg

    Regensburg, 93053, Germany

  • Kobe University Hospital

    Hyōgo, 650-0017, Japan

  • Korea University Guro Hospital

    Seoul, 08308, South Korea

  • Kosin University Gospel Hospital

    Busan, 49267, South Korea

  • Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II

    Krakow, 31-202, Poland

  • Krankenhaus Martha-Maria Halle-Doelau gGmbH

    Halle, 06120, Germany

  • Krankenhaus Nord - Klinik Floridsdorf

    Vienna, 1210, Austria

  • Kurashiki Central Hospital

    Okayama, 710-8602, Japan

  • Kyoto University Hospital

    Kyoto, 606-8507, Japan

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18103, United States

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • LungenClinic Großhansdorf GmbH

    Großhansdorf, 22927, Germany

  • Lungmedicinska kliniken, Centrum för kirurgi, ortopedi och cancervård, Universitetssjukhuset

    Linköping, 58185, Sweden

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 50200, Thailand

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

    Moscow, Moscow Oblast, 105229, Russia

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905, United States

  • Medical Oncology Centre of Rosebank

    Johannesburg, 2196, South Africa

  • Meir Medical Center

    Kfar Saba, 4428164, Israel

  • Mercy Clinic Cancer & Hematology

    Springfield, Missouri, 65804, United States

  • Minnesota Oncology Minneapolis

    Minneapolis, Minnesota, 55404, United States

  • Missionsärztliche Klinik, Gemeinnützige Gesellschaft mbH

    Würzburg, 97074, Germany

  • NYU Langone Medical Center

    New York, New York, 10016, United States

  • NYU Winthrop Hospital

    Mineola, New York, 11501, United States

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

    Warsaw, 02-781, Poland

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395, Japan

  • National Jewish Health

    Denver, Colorado, 80206, United States

  • Nebraska Methodist Estabrook Cancer Center

    Omaha, Nebraska, 68114, United States

  • Northwell Health

    Lake Success, New York, 11042, United States

  • Northwest Cancer Specialists - Vancouver

    Vancouver, Washington, 98684, United States

  • Okayama University Hospital

    Okayama, 700-8558, Japan

  • Ordensklinikum Linz Elisabethinen

    Linz, 4020, Austria

  • Osaka City General Hospital

    Osaka, 534-0021, Japan

  • Osaka International Cancer Institute

    Osaka, 541-8567, Japan

  • Peter MacCallum Cancer Center

    Melbourne, Victoria, 3000, Australia

  • Pius-Hospital Oldenburg

    Oldenburg, 26121, Germany

  • Policlinico Universitario Campus Biomedico

    Rome, Lazio, 00128, Italy

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH, United Kingdom

  • Rambam Health Care Campus

    Haifa, 3109601, Israel

  • Robert Bosch Krankenhaus

    Stuttgart, 70376, Germany

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80218, United States

  • S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

    Saint Petersburg, Sankt-Peterburg, 197758, Russia

  • Sarah Cannon Research Institute / Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • Scientific Research Oncology Institute named after N.N. Petrov

    Saint Petersburg, Sankt-Peterburg, 197758, Russia

  • Scripps Clinic

    San Diego, California, 92037, United States

  • Semmelweis Egyetem X

    Budapest, 1083, Hungary

  • Sendai Kousei Hospital

    Miyagi, 981-0914, Japan

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Shanghai Chest Hospital

    Shanghai, 200030, China

  • Soroka Medical Center

    Beersheba, 8410101, Israel

  • Sourasky / Ichilov Hospital

    Tel Aviv, 6423906, Israel

  • St George Hospital

    Kogarah, New South Wales, 2217, Australia

  • St. Vincent's Hospital

    Gyeonggi-do, 16247, South Korea

  • Taichung Veterans General Hospital

    Xitun Dist., 40705, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 112, Taiwan

  • Texas Oncology - South Austin

    Austin, Texas, 78745, United States

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550, Japan

  • The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange

    Orange, California, 92868, United States

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

  • Tokyo Medical University Hospital

    Tokyo, 160-0023, Japan

  • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

    Tokyo, 113-8677, Japan

  • UC Davis Cancer Center

    Sacramento, California, 95817, United States

  • USC Norris Cancer Center

    Los Angeles, California, 90033, United States

  • UT Health East Texas HOPE Cancer Center

    Tyler, Texas, 75701, United States

  • Uni Hospital in Lund

    Lund, 22185, Sweden

  • Uni of Maryland Cancer Center

    Baltimore, Maryland, 21201, United States

  • University Clinic Golnik

    Golnik, 4204, Slovenia

  • University Hospital Medical Center Bezanijska kosa

    Belgrade, 11080, Serbia

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • UniversitätsSpital Zürich

    Zurich, 8091, Switzerland

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106, Germany

  • Uniwersyteckie Centrum Kliniczne

    Gda?sk, 80-214, Poland

  • Uppsala University Hospital

    Uppsala, SE-75185, Sweden

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031, United States

  • Washington Cancer Institute

    Washington D.C., District of Columbia, 20010, United States

More trials for these conditions

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