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New immune drug aims to keep lung cancer away after surgery

NCT ID NCT02486718

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 30, 2026 · Updated 3 times

Summary

This phase 3 study tests whether the immune-boosting drug atezolizumab can delay or prevent lung cancer from coming back in patients who have already had surgery and chemotherapy. About 1,280 people with stage IB to IIIA non-small cell lung cancer are taking part. Half receive atezolizumab for about a year, while the other half get standard follow-up care.

What this could mean

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

Active substance
atezolizumab (a drug that helps the immune system fight cancer)
What this could lead to
If it works, this could offer a new option to help prevent lung cancer from coming back after surgery and chemotherapy.
What could go wrong
This is a large phase 3 trial, but results may not apply to all patients. Atezolizumab can cause immune-related side effects, and it may not improve survival for everyone.

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

1,280 people

The number who actually took part.

Started

Oct 2015

Expected to finish

Aug 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: Inclusion Criteria for Enrollment Phase * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Histological or cytological diagnosis of Stage IB (tumors greater than or equal to \[\>/=\] 4 centimeters \[cm\])-IIIA (T2-3 N0, T1-3 N1, T1-3 N2, T4 N0-1) NSCLC (per the Union Internationale Contre le Cancer staging system (UICC)/American Joint Committee on Cancer staging system (AJCC) staging system, 7th edition; Detterbeck et al. 2009) * Participants must have had complete resection of NSCLC 4-12 weeks (\>/=28 days and less than or equal to \[\</=\] 84 days) prior to enrollment and must be adequately recovered from surgery * If mediastinoscopy was not performed preoperatively, it is required that, at a minimum, mediastinal lymph node systematic sampling will have occurred. Systematic sampling is defined as removal of at least one representative lymph node at specified levels. MLND entails resection of all lymph nodes at those same levels. For a right thoracotomy, sampling or MLND is required at levels 4 and 7 and for a left thoracotomy, levels 5 and/or 6 and 7. Exceptions will be granted if there is clear documentation in the operative report or in a separately submitted addendum by the surgeon of exploration of the required lymph node areas, the participant will be considered eligible if no lymph nodes are found in those areas; if participants have documented N2 disease in one level (per the UICC/AJCC staging system, 7th edition; Detterbeck et al. 2009), not all levels need to be sampled; if the preoperative staging imaging results (contrast computed tomography \[CT\] and positron emission tomography \[PET\] scans) do not suggest evidence of disease in the mediastinum, the participant will be considered eligible if N2 nodal sampling is not performed per surgeon's decision * Eligible to receive a cisplatin-based chemotherapy regimen * Adequate hematologic and end-organ function * Women who are not postmenopausal (\>/=12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of cisplatin-based chemotherapy Inclusion Criteria for Randomized Phase - Women who are not postmenopausal (\>/=12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of atezolizumab or BSC Exclusion Criteria: Exclusion Criteria for Enrollment Phase * Illness or condition that may interfere with a participant's capacity to understand, follow, and/or comply with study procedures * Pregnant and lactating women * Treatment with prior systemic chemotherapy: Chemotherapy for early stage of malignancy with curative intent, provided that the last dose received was more than 5 years prior to enrollment and low-dose chemotherapy for non-malignant conditions may be allowed upon approval by the Medical Monitor * Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years before enrollment * Treatment with any other investigational agent with therapeutic intent within 28 days prior to enrollment * Participants with hearing impairment * Known sensitivity to any component of the chemotherapy regimen the participant will be assigned to, or to mannitol * Prior treatment with cluster of differentiation (CD) 137 (CD137) agonists or immune checkpoint blockade therapies, anti-programmed death-1 (PD-1), and anti programmed death ligand 1 (PD-L1) therapeutic antibodies * Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS greater than \[\>\] 90 percent \[%\]) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent) * History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins * Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation * History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis * Positive test for human immunodeficiency virus (HIV) * Participants with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen \[HBsAg\] test at screening) or hepatitis C * Active tuberculosis * Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within the previous 3 months, unstable arrhythmias, or unstable angina * History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan * Prior allogeneic bone marrow transplantation or solid organ transplant * Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications * Known tumor PD-L1 expression status as determined by an immunohistochemistry (IHC) assay from other clinical studies (e.g., participants whose PD-L1 expression status was determined during screening for entry into a study with anti-PD-1 or anti-PD-L1 antibodies but were not eligible are excluded) Specific Exclusions for Pemetrexed Treatment \- Participants with squamous cell histology Exclusion Criteria for Randomized Phase * Signs or symptoms of infection within 14 days prior to randomization (severe infection within 28 days prior to randomization), including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia * Received therapeutic oral or intravenous (IV) antibiotics within 14 days prior to randomization * Major surgical procedure within 28 days prior to randomization or anticipation of need for a major surgical procedure during the course of the study * Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation that such a live attenuated vaccine will be required during the study * Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to randomization: Prior treatment with cancer vaccines is allowed * Treatment with systemic corticosteroids or other immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] agents) within 14 days prior to randomization

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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

  • ASST Spedali Civili di Brescia

    Brescia, Lombardy, 25123, Italy

  • Aichi Cancer Center Hospital

    Aichi, 464-8681, Japan

  • Anhui Province Cancer Hospital

    Hefei, China

  • Asst Papa Giovanni XXIII

    Bergamo, Lombardy, 24127, Italy

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Turin, Piedmont, 10126, Italy

  • Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi

    Catania, Sicily, 95122, Italy

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, Veneto, 37126, Italy

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Tuscany, 56124, Italy

  • Azienda Sanitaria Ospedaliera S Luigi Gonzaga

    Orbassano, Piedmont, 10043, Italy

  • Azienda per l'Assistenza Sanitaria N° 5 - Friuli Occidentale

    Pordenone, Friuli Venezia Giulia, 33170, Italy

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS, United Kingdom

  • C.H. Regional Reina Sofia

    Córdoba, 14004, Spain

  • CE Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council

    Kryvyi Rih, 50048, Ukraine

  • CHU de Liège (Sart Tilman)

    Liège, 4000, Belgium

  • Cabrini Hospital Malvern

    Malvern, Victoria, 3144, Australia

  • California Cancer Associates for Research & Excellence, Inc.

    Encinitas, California, 92024, United States

  • Cancer Institute and Hospital Chinese Academy of Medical Sciences

    Beijing, 100021, China

  • Centre Hospitalier Regional Sud Reunion

    Saint-Pierre, 97448, France

  • Centre Hospitalier de Mont de Marsan - Hopital Layne

    Mont-de-Marsan, 40000, France

  • Centre Hospitalier de Saint-Quentin

    Saint-Quentin, 02321, France

  • Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque

    Montpellier, 34298, France

  • Centre René Gauducheau Centre de Lutte Contre Le Cancer Nantes Atlantique

    Nantes, 44093, France

  • Centro Hospitalar E Universitário de Coimbra EPE

    Coimbra, 3000-602, Portugal

  • Chaim Sheba Medical Center

    Tel Litwinsky, 52621, Israel

  • Chang Gung Medical Foundation Linkou Branch

    Taoyuan City, 333, Taiwan

  • Chang Gung Memorial Hospital Chiayi

    Putzui City, 61363, Taiwan

  • Changhua Christian Hospital

    Changhua, 500, Taiwan

  • Chonnam National University Hwasun Hospital

    Jeonnam, 519-763, South Korea

  • City Clinical Hospital #1

    Novosibirsk, 630047, Russia

  • Clinical Research Alliance

    Lake Success, New York, 11042, United States

  • Clinique Clémentville

    Montpellier, 34070, France

  • Cliniques Universitaires St-Luc

    Brussels, 1200, Belgium

  • Colchester General Hospital

    Colchester, Essex, CO4 5JL, United Kingdom

  • Communal Non profit Enterprise Regional Center of Oncology

    Kharkiv, Kharkiv Governorate, 61070, Ukraine

  • Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council

    Vinnytsia, Vinnytsia Oblast, 21018, Ukraine

  • Compassionate Cancer Care Medical Group, Inc

    Fountain Valley, California, 92708, United States

  • Complejo Hospitalario de Jaen

    Jaén, 23007, Spain

  • Consorcio Hospitalario Provincial de Castellon

    Castellon, Castellon, 12002, Spain

  • Eastern Connecticut Hematology and Oncology Associates

    Norwich, Connecticut, 06360, United States

  • Edith Wolfson Medical Center

    Holon, 58100, Israel

  • Ev.Krankenhaus Bielefeld gGmbH

    Bielefeld, North Rhine-Westphalia, 33611, Germany

  • Evang. Lungenklinik Berlin Klinik für Pneumologie

    Berlin, 13125, Germany

  • Fachklinik für Lungenerkrankungen

    Immenhausen, 34376, Germany

  • First Affiliated Hospital of Soochow University

    Suzhou, 215006, China

  • First Hospital of China Medical University

    Shenyang, 110001, China

  • GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)

    Saint Petersburg, Sankt-Peterburg, 197758, Russia

  • Gemeinschaftspraxis für Hämatologie und Onkologie

    Münster, 48149, Germany

  • Hematology Oncology Associates of Fredericksburg, Inc.

    Fredericksburg, Virginia, 22408, United States

  • Hematology Oncology Associates of Northern New Jersey

    Florham Park, New Jersey, 07932, United States

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703, United States

  • Hiroshima University Hospital

    Hiroshima, 734-8551, Japan

  • Hopital d Instruction des Armees de Sainte Anne

    Toulon, 83041, France

  • Hosp Clinico Univ Lozano Blesa

    Zaragoza, 50009, Spain

  • Hospital Lucus Augusti

    Lugo, 27003, Spain

  • Hospital Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08025, Spain

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026, Spain

  • Hospital Universitario HM Sanchinarro-CIOCC

    Madrid, 28050, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Virgen de La Arrixaca

    El Palmar, Murcia, 30120, Spain

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Tenerife, 3820, Spain

  • Hospital de Sao Joao

    Porto, 4200-319, Portugal

  • Hospital del Mar

    Barcelona, 08003, Spain

  • Hospital of the University of Occupational and Environmental Health,Japan

    Kitakyushu-shi, 807-8555, Japan

  • Houston Methodist Cancer Center

    Houston, Texas, 77030, United States

  • Hyogo Cancer Center

    Akashi, 673-0021, Japan

  • Illinois Cancer Care

    Peoria, Illinois, 61615, United States

  • Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe

    Porto, 4200-072, Portugal

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.

    Szolnok, 5004, Hungary

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, North Brabant, 5223 GZ, Netherlands

  • Juntendo University Hospital

    Bunkyō City, 113-8431, Japan

  • Kaiser Permanente

    Vallejo, California, 94589, United States

  • Kaiser Permanente - Walnut Creek

    Walnut Creek, California, 94596, United States

  • Kanagawa Cancer Center

    Yokohama-shi, Asahi-ku, 241-8515, Japan

  • Katholisches Klinikum Marienhof

    Koblenz Am Rhein, 56073, Germany

  • Klinikum Bogenhausen

    München, 81925, Germany

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09113, Germany

  • Krankenhaus Barmherzige Bruder Regensburg

    Regensburg, 93049, Germany

  • Krankenhaus Nordwest

    Frankfurt am Main, 60488, Germany

  • Kumamoto University Hospital

    Kumamoto, 860-8556, Japan

  • Kyiv City Clinical Oncological Center

    Kyiv, 03115, Ukraine

  • Kyorin University Hospital

    Mitaka-shi, 181-0004, Japan

  • Kyoto University Hospital

    Kyoto, 606-8507, Japan

  • Kyushu University Hospital

    Fukuoka, 812-8582, Japan

  • Leningrad Regional Clinical Hospital

    Saint Petersburg, Sankt-Peterburg, 194291, Russia

  • Lewis Hall Singletary Oncology Center

    Thomasville, Georgia, 31792, United States

  • Liaoning Provincial Cancer Hospital

    Shengyang, 110042, China

  • LungenClinic Grosshansdorf GmbH

    Großhansdorf, 22927, Germany

  • Lungenklinik Hemer

    Hemer, 58675, Germany

  • Lynn Cancer Institute - West

    Boca Raton, Florida, 33486, United States

  • MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council

    Dnipropetrovsk, Katerynoslav Governorate, 49102, Ukraine

  • MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology

    Zaporizhzhya, 69040, Ukraine

  • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

    Otwock, 05-400, Poland

  • Meir Medical Center

    Kfar Saba, 44281, Israel

  • MultiCare Regional Cancer Center - Auburn

    Auburn, Washington, 98002-4117, United States

  • Municipal Institution Odesa Regional Oncology Dispensary

    Odesa, KIEV Governorate, 65055, Ukraine

  • Municipal Institution SubCarpathian ClinicalOncological Centre

    Ivano-Frankivsk, Poltava Governorate, 76018, Ukraine

  • National Cancer Center Hospital

    Chūō, 104-0045, Japan

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, 003-0804, Japan

  • Niigata Cancer Center Hospital

    Niigata, 951-8566, Japan

  • Norton Cancer Institute

    Louisville, Kentucky, 40402, United States

  • Okayama University Hospital

    Okayama, 700-8558, Japan

  • Oncology Center Sf. Nectarie

    Craiova, 200542, Romania

  • Oncology Hematology Care - SCRI

    Cincinnati, Ohio, 45242, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Ospedale Clinicizzato SS Annunziata

    Chieti, Abruzzo, 66013, Italy

  • Ospedale Santa Chiara

    Trento, Trentino-Alto Adige, 38100, Italy

  • Ospedale Silvestrini

    Perugia, Umbria, 06132, Italy

  • Overlook Medical Center

    Summit, New Jersey, 07901, United States

  • Pius-Hospital Oldenburg

    Oldenburg, 26121, Germany

  • Policlinico Universitario Campus Biomedico Di Roma

    Rome, Lazio, 00128, Italy

  • Presbyterian Hospital

    Charlotte, North Carolina, 28204, United States

  • Prince of Wales Hosp

    Shatin, Hong Kong

  • Principal Military Clinical Hospital n.a. N.N. Burdenko

    Moscow, Moscow Oblast, 105229, Russia

  • Providence Everett Med Ctr

    Everett, Washington, 98201, United States

  • Rambam Medical Center

    Haifa, 31096, Israel

  • Regional Clinical Oncology Hospital

    Yaroslavl, 150040, Russia

  • Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

    Sumy, 40022, Ukraine

  • SCRI Florida Cancer Specialists North

    St. Petersburg, Florida, 33705, United States

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039, United States

  • Saitama Cancer Center

    Kitaadachi-gun, 362-0806, Japan

  • Scientific Research Institute of Oncology n.a. N.N. Petrov

    Saint Petersburg, Sankt-Peterburg, 197758, Russia

  • Shanghai Chest Hospital

    Shanghai, 200030, China

  • Shanghai Pulmonary Hospital

    Shanghai, 200433, China

  • Shikoku Cancer Center

    Matsuyama, 791-0280, Japan

  • St Bartholomew's Hospital

    London, EC1A 7BE, United Kingdom

  • St. Antonius Ziekenhuis Nieuwegein

    Nieuwegein, 3430 EM, Netherlands

  • St. Luke's Cancer Institute

    Kansas City, Missouri, 64111, United States

  • Stadtisches Klinikum Braunschweig

    Braunschweig, 38114, Germany

  • Swedish Medical Center

    Seattle, Washington, 98122, United States

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 00112, Taiwan

  • Tel Aviv Sourasky Medical Ctr

    Tel Aviv, 64239, Israel

  • The Catholic University of Korea St. Vincent's Hospital

    Suwon, 442-723, South Korea

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120, China

  • Tokyo Medical University Hospital

    Tokyo, 160-0023, Japan

  • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

    Bunkyō City, 113-8677, Japan

  • Toranomon Hospital

    Tokyo, 105-8470, Japan

  • Townsville Hospital

    Douglas, Queensland, 4814, Australia

  • University Oncology Associates

    Chattanooga, Tennessee, 37403, United States

  • University of California Los Angeles

    Los Angeles, California, 90024, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45219, United States

  • University of Illinois at Chicago

    Chicago, Illinois, 60612, United States

  • University of Miami School of Medicine - Sylvester at Deerfield

    Deerfield Beach, Florida, 33442, United States

  • University of Pecs, I st Dept of Internal Medicine

    Pécs, 7624, Hungary

  • Universität Des Saarlandes

    Homburg, 66421, Germany

  • Vall d'Hebron Institute of Oncology (VHIO), Barcelona

    Barcelona, 08035, Spain

  • Valley Hospital

    Paramus, New Jersey, 07652, United States

  • Vincentius-Diakonissen-Kliniken gAG

    Karlsruhe, 76137, Germany

  • Volgograd Regional Clinical Oncology Dispensary

    Volgograd, 400138, Russia

  • Weill Cornell Medical College

    New York, New York, 10065, United States

  • Wellmont Medical Associates

    Bristol, Virginia, 24201, United States

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

    Poznan, 60569, Poland

  • Zhejiang Cancer Hospital

    Hangzhou, 310022, China

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