Back to resultsStudy to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]
Primary Purpose
Non-Small Cell Lung Cancer
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atezolizumab
Cisplatin
Vinorelbine
Docetaxel
Gemcitabine
Pemetrexed
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer
Eligibility Criteria
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
Sites / Locations
- Highlands Oncology Group
- Southern California Permanente Medical Group Bellflower
- Compassionate Cancer Care Medical Group, Inc
- Stanford University
- California Cancer Associates for Research & Excellence, Inc.
- University of California Los Angeles
- Kaiser Permanente; Oncology Clinical Trials
- Kaiser Permanente - Walnut Creek
- Praxair Cancer Center at Danbury Hospital
- Eastern Connecticut Hematology and Oncology Associates; (ECHO)
- Lynn Cancer Institute - West
- University of Miami School of Medicine - Sylvester at Deerfield
- Holy Cross Hospital Inc
- Florida Cancer Specialists-Broadway, Fort Myers
- SCRI Florida Cancer Specialists North; Research Office North Region.
- SCRI Florida Cancer Specialists East
- University Cancer & Blood Center, LLC; Research
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
- Lewis Hall Singletary Oncology Center
- Rush University Medical Center
- University of Illinois at Chicago
- Ingalls Memorial Hospital
- Illinois Cancer Care
- Quincy Medical Group; Canc Ctr at Blessing Hosp
- Southern Illinois University, Simmons Cancer Institute
- Norton Cancer Institute
- New England Cancer Specialists
- Karmanos Cancer Institute
- Cancer and Hematology Centers of Western Michigan
- Hematology and Oncology Associates at Bridgepoint
- St. Luke's Cancer Institute
- Comprehensive Cancer Centers of Nevada
- Hematology Oncology Associates of Northern New Jersey
- Saint Barnabas Medical Center
- Valley Hospital; Oncology Research
- Overlook Medical Center; Medical Diagnostic Associates
- Weill Cornell Medical College
- Clinical Research Alliance
- Presbyterian Hospital
- University of Cincinnati
- Oncology Hematology Care - SCRI
- SCRI Mark H. Zangmeister Center
- Oregon Health and Science University
- St. Luke's Cancer Care Associates
- Pinnacle Health
- Allegheny General Hospital
- Rhode Island Hospital
- Greenville Health System
- University Oncology Associates
- SCRI Tennessee Oncology Chattanooga
- Sarah Cannon Cancer Center
- Houston Methodist Cancer Center
- Wellmont Medical Associates
- Hematology Oncology Associates of Fredericksburg, Inc.
- MultiCare Regional Cancer Center - Auburn
- Providence Everett Med Ctr
- Swedish Medical Center
- Townsville Hospital
- Cabrini Hospital Malvern
- Cliniques Universitaires St-Luc
- CHU Sart-Tilman
- William Osler Health Centre
- Cite de La Sante de Laval; Hemato-Oncologie
- Cancer Institute and Hospital Chinese Academy of Medical Sciences
- Beijing Cancer Hospital
- Chinese People's Liberation Army (PLA) General Hospital (301 Hospital)
- Affiliated Hospital of Guangdong Medical University
- The First Affiliated Hospital of Guangzhou Medical University
- Anhui Province Cancer Hospital
- Shanghai Chest Hospital
- Shanghai Pulmonary Hospital
- Liaoning Provincial Cancer Hospital
- First Hospital of China Medical University
- First Affiliated Hospital of Soochow University
- Zhejiang Cancer Hospital
- Hôpital Universitaire Dupuytren
- Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
- Hôpital Saint Joseph; Oncologie Medicale
- Centre Hospitalier de Mont de Marsan - Hopital Layne
- Clinique Clémentville
- Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque; Service d oncologie
- Centre René Gauducheau Centre de Lutte Contre Le Cancer Nantes Atlantique
- Centre Hospitalier Regional Sud Reunion; Service de Pneumologie
- Hopital d'Instruction des Armees de Begin
- Centre Hospitalier de Saint-Quentin; Pharmacie-URCC
- Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
- Hopital d Instruction des Armees de Sainte Anne
- Evang. Lungenklinik Berlin Klinik für Pneumologie
- Ev.Krankenhaus Bielefeld gGmbH; Klinik für Innere Medizin und Geriatrie
- Stadtisches Klinikum Braunschweig
- Klinikum Chemnitz gGmbH
- Krankenhaus Nordwest
- LungenClinic Großhansdorf GmbH
- Krankenhaus Martha-Maria; Halle-Dolau gGmbH
- Universitätsklinikum Hamburg-Eppendorf
- Asklepios Klinik Harburg
- Thoraxklinik Heidelberg gGmbH
- Lungenklinik Hemer
- Universität Des Saarlandes
- Fachklinik für Lungenerkrankungen
- Vincentius-Diakonissen-Kliniken gAG
- Katholisches Klinikum Marienhof
- Kliniken der Stadt Koln gGmbH; Lungenklinik Onkologische Ambulanz
- SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein; Onk & Pal
- Klinikum Bogenhausen
- Gemeinschaftspraxis für Hämatologie und Onkologie
- Pius-Hospital Oldenburg
- Krankenhaus Barmherzige Bruder Regensburg
- Praxis fur Hamatologie und internistische Onkologie
- Prince of Wales Hosp; Dept. Of Clinical Onc
- Semmelweis Egyetem
- University of Pecs, I st Dept of Internal Medicine
- Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
- Tudogyogyintezet Torokbalint
- Rambam Medical Center; Oncology
- Edith Wolfson Medical Center
- Meir Medical Center; Oncology
- Rabin Medical Center
- Chaim Sheba Medical Center; Oncology Dept
- Tel Aviv Sourasky Medical Ctr; Oncology
- Ospedale Clinicizzato SS Annunziata
- Azienda per l'Assistenza Sanitaria N° 5 - Friuli Occidentale; S.C. Oncologia Pordenone
- Policlinico Universitario Campus Biomedico Di Roma; U.O.Oncologia Medica
- Asst Papa Giovanni XXIII; Oncologia Medica
- ASST Spedali Civili di Brescia
- Ospedale San Raffaele
- Azienda Sanitaria Ospedaliera s. Croce e Carle; Oncologia Medica
- A.O.U. Maggiore della Carità
- Azienda Sanitaria Ospedaliera S Luigi Gonzaga
- Azienda Ospedaliera Città della Salute e della Scienza di Torino
- Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi
- Azienda Ospedaliero Universitaria Pisana
- Ospedale Santa Chiara; Oncologia Medica
- Ospedale Silvestrini
- Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia
- Aichi Cancer Center Hospital
- Nagoya University Hospital
- National Cancer Center East
- Shikoku Cancer Center
- Kyushu University Hospital
- Hiroshima University Hospital
- National Hospital Organization Hokkaido Cancer Center
- Hyogo Cancer Center
- Kanagawa Cancer Center
- Hospital of the University of Occupational and Environmental Health,Japan
- Kumamoto University Hospital
- Kyoto University Hospital
- Sendai Kousei Hospital
- Niigata Cancer Center Hospital
- Okayama University Hospital
- Saitama Cancer Center
- Shizuoka Cancer Center
- National Cancer Center Hospital
- Toranomon Hospital
- Juntendo University Hospital
- Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
- Tokyo Medical University Hospital
- Kyorin University Hospital
- Wakayama Medical University Hospital
- Chonnam National University Hwasun Hospital
- The Catholic University of Korea St. Vincent's Hospital
- Jeroen Bosch Ziekenhuis
- Martini Ziekenhuis
- St. Antonius Ziekenhuis Nieuwegein
- Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
- Centro Hospitalar E Universitário de Coimbra EPE
- Centro Hospitalar de Lisboa Norte E.P.E ? Hospital Pulido Valente
- Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe
- Hospital de Sao Joao; Servico de Pneumologia
- Oncology Center Sf. Nectarie
- Mordovia State University
- Moscow City Oncology Hospital #62
- Principal Military Clinical Hospital n.a. N.N. Burdenko
- Russian Oncology Research Center n a N N Blokhin
- Evromedservis LCC
- GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
- City Clinical Oncology Dispensary
- Leningrad Regional Clinical Hospital
- St. Petersburg Med Univ; n.a. I.P. Pavlov; Pulmonology Research
- Scientific Research Institute of Oncology n.a. N.N. Petrov; Department of Oncogynecology
- Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
- City Clinical Hospital #1; Dpt of Oncology
- Volgograd Regional Clinical Oncology Dispensary
- Regional Clinical Oncology Hospital
- Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
- Hospital Univ Vall d'Hebron; Servicio de Oncologia
- Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
- Consorcio Hospitalario Provincial de Castellon
- Hospital Universitario Son Espases
- Centro Oncologico de Galicia COG; Medical Oncology
- Hospital Universitario Virgen de La Arrixaca; Servicio De Oncologia
- Hospital Universitario de Canarias
- Hospital del Mar
- Hospital Santa Creu i Sant Pau
- C.H. Regional Reina Sofia
- Complejo Hospitalario de Jaen
- Hospital Lucus Augusti; Servicio de Oncologia
- Hospital Universitario La Paz
- Hospital Ramon y Cajal; Servicio de Oncologia
- Hosp. Clinico San Carlos
- Hospital Universitario HM Sanchinarro-CIOCC; Oncología Médica
- Hospital Clinico Universitario de Valencia
- Hospital NisA 9 de Octubre
- Hospital Universitari i Politecnic La Fe de Valencia
- Hosp Clinico Univ Lozano Blesa
- Changhua Christian Hospital
- Kaohsiung Medical University Hospital; Department of Urology
- Chi Mei Medical Center Liou Ying Campus
- Chang Gung Memorial Hospital Chiayi
- National Taiwan Uni Hospital
- Taipei Veterans General Hospital
- Mackay Memorial Hospital
- Chang Gung Medical Foundation Linkou Branch
- Taichung Veterans General Hospital
- MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council
- Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs
- Kyiv Railway Clinical Hospital #3 of Branch Health Center of the PJSC Ukrainian Railway
- Municipal Institution Odesa Regional Oncology Dispensary
- Municipal Institution Podilskiy Regional Center of Oncology; Department of Chemotherapy
- Municipal Institution SubCarpathian ClinicalOncological Centre; Chemotherapy department
- Private Enterprise Private Manufacturing Company Acinus
- ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department
- Kyiv City Clinical Oncological Center
- Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary
- MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology
- Birmingham Heartlands Hospital
- Colchester General Hospital
- St Bartholomew's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Atezolizumab
Best Supportive Care
Arm Description
Enrollment Phase: Participants will receive four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed [non-squamous cell NSCLC only]), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occur. Randomization Phase: Participants will receive atezolizumab 1200 milligrams (mg) intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles and will undergo periodic chest X-ray and CT scan.
Enrollment Phase: Participants will receive four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed [non-squamous cell NSCLC only]), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occur. Randomization Phase: After enrollment phase participants will receive only the best supportive care and will undergo periodic chest X-ray and CT scan.
Outcomes
Primary Outcome Measures
Disease-Free Survival (DFS), Assessed Using Computed Tomography (CT)/Magnetic Resonance Imaging (MRI)/X-Ray
DFS will be assessed by the investigator in PD-L1 subpopulation within the Stage II-IIIA population, in all randomized patients with Stage II-IIIA NSCLC, and in the ITT population.
Secondary Outcome Measures
Overall Survival (OS) in the ITT Population
Percentage of Participants Who are Disease-Free at Year 3, Assessed Using CT/MRI/X-Ray
DFS rates will be measured in the PD-L1 subpopulation within the Stage II-IIIA population, in all randomized patients with Stage II-IIIA NSCLC, and in the ITT population.
Percentage of Participants Who are Disease-Free at Year 5, Assessed Using CT/MRI/X-Ray
DFS rates will be measured in the PD-L1 subpopulation within the Stage II-IIIA population, in all randomized patients with Stage II-IIIA NSCLC, and in the ITT population.
DFS Within Selected Populations
DFS rates will be measured within the PD-L1 subpopulation in patients with Stage II-IIIA NSCLC.
Percentage of Participants with Adverse Events
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
Maximum Plasma Concentration (Cmax) of Atezolizumab
Minimum Serum Concentration (Cmin) at Steady-State Within a Dosing Interval of Atezolizumab
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02486718
Brief Title
Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]
Official Title
A Phase III, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Best Supportive Care Following Adjuvant Cisplatin-Based Chemotherapy in Patients With Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 31, 2015 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
August 30, 2035 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This is a Phase III, global, multicenter, open-label, randomized study to compare the efficacy and safety of 16 cycles (1 cycle duration=21 days) of atezolizumab (MPDL3280A) treatment compared with best supportive care (BSC) in participants with Stage IB-Stage IIIA non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy, as measured by disease-free survival (DFS) as assessed by the investigator and overall survival (OS). Participants, after completing up to 4 cycles of adjuvant cisplatin-based chemotherapy, will be randomized in a 1:1 ratio to receive atezolizumab for 16 cycles or BSC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atezolizumab
Arm Type
Experimental
Arm Description
Enrollment Phase: Participants will receive four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed [non-squamous cell NSCLC only]), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occur. Randomization Phase: Participants will receive atezolizumab 1200 milligrams (mg) intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles and will undergo periodic chest X-ray and CT scan.
Arm Title
Best Supportive Care
Arm Type
Active Comparator
Arm Description
Enrollment Phase: Participants will receive four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed [non-squamous cell NSCLC only]), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occur. Randomization Phase: After enrollment phase participants will receive only the best supportive care and will undergo periodic chest X-ray and CT scan.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
MPDL3280A; TECENTRIQ
Intervention Description
Participants will receive atezolizumab (1200 mg IV) Q3W for 16 cycles (cycle length=21 days).
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Participants will receive cisplatin 75 milligrams per square meter (mg/m^2) IV on Day 1 of up to four 21-day cycles.
Intervention Type
Drug
Intervention Name(s)
Vinorelbine
Intervention Description
Participants will receive vinorelbine 30 mg/m^2 IV on Days 1 and 8 of each of the four 21-day cycles.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Participants will receive docetaxel 75 mg/m^2 IV on Day 1 of each of the four 21-day cycles.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Participants will receive gemcitabine 1250 mg/m^2 IV on Days 1 and 8 of each of the four 21-day cycles.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Participants will receive pemetrexed 500 mg/m^2 IV on Day 1 of each of the four 21-day cycles. Pemetrexed will be administered only in participants with non-squamous cell NSCLC.
Primary Outcome Measure Information:
Title
Disease-Free Survival (DFS), Assessed Using Computed Tomography (CT)/Magnetic Resonance Imaging (MRI)/X-Ray
Description
DFS will be assessed by the investigator in PD-L1 subpopulation within the Stage II-IIIA population, in all randomized patients with Stage II-IIIA NSCLC, and in the ITT population.
Time Frame
From randomization to the date of first recurrence of NSCLC, occurrence of new primary NSCLC, or death from any cause, whichever occurs first (up to approximately 131 months)
Secondary Outcome Measure Information:
Title
Overall Survival (OS) in the ITT Population
Time Frame
Baseline up to death from any cause (up to approximately 131 months)
Title
Percentage of Participants Who are Disease-Free at Year 3, Assessed Using CT/MRI/X-Ray
Description
DFS rates will be measured in the PD-L1 subpopulation within the Stage II-IIIA population, in all randomized patients with Stage II-IIIA NSCLC, and in the ITT population.
Time Frame
Year 3
Title
Percentage of Participants Who are Disease-Free at Year 5, Assessed Using CT/MRI/X-Ray
Description
DFS rates will be measured in the PD-L1 subpopulation within the Stage II-IIIA population, in all randomized patients with Stage II-IIIA NSCLC, and in the ITT population.
Time Frame
Year 5
Title
DFS Within Selected Populations
Description
DFS rates will be measured within the PD-L1 subpopulation in patients with Stage II-IIIA NSCLC.
Time Frame
From randomization to the date of first recurrence of NSCLC, occurrence of new primary NSCLC, or death from any cause, whichever occurs first (up to approximately 67 months)
Title
Percentage of Participants with Adverse Events
Time Frame
Baseline up to approximately 131 months
Title
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
Time Frame
Predose (Hour 0) on Day (D) 1 of Cycles (Cy) 1, 2, 3, 4, 8, 16 (Cy length=21 days), at treatment discontinuation (TD) (up to 12 months), 120 days after last atezolizumab administration (up to 16 months)
Title
Maximum Plasma Concentration (Cmax) of Atezolizumab
Time Frame
Post-infusion on Day 1 of Cycle 1 (cy length = 21 days)
Title
Minimum Serum Concentration (Cmin) at Steady-State Within a Dosing Interval of Atezolizumab
Time Frame
Prior to infusion on D1 of Cy2, 3, 4, 8, 16 (Cy length = 21 days), and at study termination (up to approximately 131 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Highlands Oncology Group
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Facility Name
Southern California Permanente Medical Group Bellflower
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
Compassionate Cancer Care Medical Group, Inc
City
Corona
State/Province
California
ZIP/Postal Code
92882
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
California Cancer Associates for Research & Excellence, Inc.
City
San Marcos
State/Province
California
ZIP/Postal Code
92069
Country
United States
Facility Name
University of California Los Angeles
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Kaiser Permanente; Oncology Clinical Trials
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Kaiser Permanente - Walnut Creek
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94596
Country
United States
Facility Name
Praxair Cancer Center at Danbury Hospital
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Eastern Connecticut Hematology and Oncology Associates; (ECHO)
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Lynn Cancer Institute - West
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428
Country
United States
Facility Name
University of Miami School of Medicine - Sylvester at Deerfield
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
Suite 200
Country
United States
Facility Name
Holy Cross Hospital Inc
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Florida Cancer Specialists-Broadway, Fort Myers
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
Facility Name
SCRI Florida Cancer Specialists North; Research Office North Region.
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
SCRI Florida Cancer Specialists East
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
University Cancer & Blood Center, LLC; Research
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
City
Carrollton
State/Province
Georgia
ZIP/Postal Code
30117
Country
United States
Facility Name
Lewis Hall Singletary Oncology Center
City
Thomasville
State/Province
Georgia
ZIP/Postal Code
31792
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Illinois Cancer Care
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Quincy Medical Group; Canc Ctr at Blessing Hosp
City
Quincy
State/Province
Illinois
ZIP/Postal Code
62301
Country
United States
Facility Name
Southern Illinois University, Simmons Cancer Institute
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
New England Cancer Specialists
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Cancer and Hematology Centers of Western Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Hematology and Oncology Associates at Bridgepoint
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
St. Luke's Cancer Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89014
Country
United States
Facility Name
Hematology Oncology Associates of Northern New Jersey
City
Florham Park
State/Province
New Jersey
ZIP/Postal Code
07932
Country
United States
Facility Name
Saint Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Valley Hospital; Oncology Research
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Facility Name
Overlook Medical Center; Medical Diagnostic Associates
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Clinical Research Alliance
City
Westbury
State/Province
New York
ZIP/Postal Code
11590
Country
United States
Facility Name
Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45203-0542
Country
United States
Facility Name
Oncology Hematology Care - SCRI
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
SCRI Mark H. Zangmeister Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
St. Luke's Cancer Care Associates
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Pinnacle Health
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17110
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Greenville Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
University Oncology Associates
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
SCRI Tennessee Oncology Chattanooga
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Sarah Cannon Cancer Center
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Houston Methodist Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Wellmont Medical Associates
City
Bristol
State/Province
Virginia
ZIP/Postal Code
24201
Country
United States
Facility Name
Hematology Oncology Associates of Fredericksburg, Inc.
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22408
Country
United States
Facility Name
MultiCare Regional Cancer Center - Auburn
City
Auburn
State/Province
Washington
ZIP/Postal Code
98002-4117
Country
United States
Facility Name
Providence Everett Med Ctr
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104-1360
Country
United States
Facility Name
Townsville Hospital
City
Townsville
State/Province
Queensland
ZIP/Postal Code
4810
Country
Australia
Facility Name
Cabrini Hospital Malvern
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Cliniques Universitaires St-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
CHU Sart-Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
William Osler Health Centre
City
Etobicoke
State/Province
Ontario
ZIP/Postal Code
M9V 1R8
Country
Canada
Facility Name
Cite de La Sante de Laval; Hemato-Oncologie
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7M 3L9
Country
Canada
Facility Name
Cancer Institute and Hospital Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Chinese People's Liberation Army (PLA) General Hospital (301 Hospital)
City
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Affiliated Hospital of Guangdong Medical University
City
Guangdong
ZIP/Postal Code
524023
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Facility Name
Anhui Province Cancer Hospital
City
Hefei City
ZIP/Postal Code
230031
Country
China
Facility Name
Shanghai Chest Hospital
City
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Liaoning Provincial Cancer Hospital
City
Shengyang
ZIP/Postal Code
110042
Country
China
Facility Name
First Hospital of China Medical University
City
Shenyang
ZIP/Postal Code
110001
Country
China
Facility Name
First Affiliated Hospital of Soochow University
City
Suzhou
ZIP/Postal Code
215006
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Hôpital Universitaire Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Hôpital Saint Joseph; Oncologie Medicale
City
Marseille
ZIP/Postal Code
13285
Country
France
Facility Name
Centre Hospitalier de Mont de Marsan - Hopital Layne
City
Mont De Marsan
ZIP/Postal Code
40024
Country
France
Facility Name
Clinique Clémentville
City
Montpellier
ZIP/Postal Code
34070
Country
France
Facility Name
Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque; Service d oncologie
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre René Gauducheau Centre de Lutte Contre Le Cancer Nantes Atlantique
City
Nantes
ZIP/Postal Code
44805
Country
France
Facility Name
Centre Hospitalier Regional Sud Reunion; Service de Pneumologie
City
Saint Pierre
ZIP/Postal Code
97448
Country
France
Facility Name
Hopital d'Instruction des Armees de Begin
City
Saint-Mande
ZIP/Postal Code
94160
Country
France
Facility Name
Centre Hospitalier de Saint-Quentin; Pharmacie-URCC
City
Saint-Quentin
ZIP/Postal Code
02321
Country
France
Facility Name
Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
City
Toulon
ZIP/Postal Code
83000
Country
France
Facility Name
Hopital d Instruction des Armees de Sainte Anne
City
Toulon
ZIP/Postal Code
83041
Country
France
Facility Name
Evang. Lungenklinik Berlin Klinik für Pneumologie
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Ev.Krankenhaus Bielefeld gGmbH; Klinik für Innere Medizin und Geriatrie
City
Bielefeld
ZIP/Postal Code
33611
Country
Germany
Facility Name
Stadtisches Klinikum Braunschweig
City
Braunschweig
ZIP/Postal Code
38114
Country
Germany
Facility Name
Klinikum Chemnitz gGmbH
City
Chemnitz
ZIP/Postal Code
09116
Country
Germany
Facility Name
Krankenhaus Nordwest
City
Frankfurt am Main
ZIP/Postal Code
60488
Country
Germany
Facility Name
LungenClinic Großhansdorf GmbH
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Krankenhaus Martha-Maria; Halle-Dolau gGmbH
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Asklepios Klinik Harburg
City
Hamburg
ZIP/Postal Code
21075
Country
Germany
Facility Name
Thoraxklinik Heidelberg gGmbH
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Lungenklinik Hemer
City
Hemer
ZIP/Postal Code
58675
Country
Germany
Facility Name
Universität Des Saarlandes
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
Fachklinik für Lungenerkrankungen
City
Immenhausen
ZIP/Postal Code
34376
Country
Germany
Facility Name
Vincentius-Diakonissen-Kliniken gAG
City
Karlsruhe
ZIP/Postal Code
76137
Country
Germany
Facility Name
Katholisches Klinikum Marienhof
City
Koblenz Am Rhein
ZIP/Postal Code
56073
Country
Germany
Facility Name
Kliniken der Stadt Koln gGmbH; Lungenklinik Onkologische Ambulanz
City
Koln
ZIP/Postal Code
51109
Country
Germany
Facility Name
SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein; Onk & Pal
City
Löwenstein
ZIP/Postal Code
74245
Country
Germany
Facility Name
Klinikum Bogenhausen
City
München
ZIP/Postal Code
81925
Country
Germany
Facility Name
Gemeinschaftspraxis für Hämatologie und Onkologie
City
Münster
ZIP/Postal Code
48153
Country
Germany
Facility Name
Pius-Hospital Oldenburg
City
Oldenburg
ZIP/Postal Code
26121
Country
Germany
Facility Name
Krankenhaus Barmherzige Bruder Regensburg
City
Regensburg
ZIP/Postal Code
93049
Country
Germany
Facility Name
Praxis fur Hamatologie und internistische Onkologie
City
Velbert
ZIP/Postal Code
42551
Country
Germany
Facility Name
Prince of Wales Hosp; Dept. Of Clinical Onc
City
Shatin
Country
Hong Kong
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
University of Pecs, I st Dept of Internal Medicine
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Tudogyogyintezet Torokbalint
City
Torokbalint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Rambam Medical Center; Oncology
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Edith Wolfson Medical Center
City
Holon
ZIP/Postal Code
5822012
Country
Israel
Facility Name
Meir Medical Center; Oncology
City
Kfar-Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Rabin Medical Center
City
Petach Tikva
ZIP/Postal Code
4922297
Country
Israel
Facility Name
Chaim Sheba Medical Center; Oncology Dept
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Ctr; Oncology
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Ospedale Clinicizzato SS Annunziata
City
Chieti
State/Province
Abruzzo
ZIP/Postal Code
66100
Country
Italy
Facility Name
Azienda per l'Assistenza Sanitaria N° 5 - Friuli Occidentale; S.C. Oncologia Pordenone
City
Pordenone
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33170
Country
Italy
Facility Name
Policlinico Universitario Campus Biomedico Di Roma; U.O.Oncologia Medica
City
Roma
State/Province
Lazio
ZIP/Postal Code
00128
Country
Italy
Facility Name
Asst Papa Giovanni XXIII; Oncologia Medica
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24127
Country
Italy
Facility Name
ASST Spedali Civili di Brescia
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
Azienda Sanitaria Ospedaliera s. Croce e Carle; Oncologia Medica
City
Cuneo
State/Province
Piemonte
ZIP/Postal Code
12100
Country
Italy
Facility Name
A.O.U. Maggiore della Carità
City
Novara
State/Province
Piemonte
ZIP/Postal Code
28100
Country
Italy
Facility Name
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
City
Orbassano
State/Province
Piemonte
ZIP/Postal Code
10043
Country
Italy
Facility Name
Azienda Ospedaliera Città della Salute e della Scienza di Torino
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90127
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56126
Country
Italy
Facility Name
Ospedale Santa Chiara; Oncologia Medica
City
Trento
State/Province
Trentino-Alto Adige
ZIP/Postal Code
38100
Country
Italy
Facility Name
Ospedale Silvestrini
City
Perugia
State/Province
Umbria
ZIP/Postal Code
06122
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia
City
Verona
State/Province
Veneto
ZIP/Postal Code
37126
Country
Italy
Facility Name
Aichi Cancer Center Hospital
City
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Nagoya University Hospital
City
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
National Cancer Center East
City
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Shikoku Cancer Center
City
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
National Hospital Organization Hokkaido Cancer Center
City
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
Hyogo Cancer Center
City
Hyogo
ZIP/Postal Code
673-0021
Country
Japan
Facility Name
Kanagawa Cancer Center
City
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Hospital of the University of Occupational and Environmental Health,Japan
City
Kitakyushu-shi
ZIP/Postal Code
807-8556
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Sendai Kousei Hospital
City
Miyagi
ZIP/Postal Code
980-0873
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Saitama Cancer Center
City
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Shizuoka Cancer Center
City
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
National Cancer Center Hospital
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Toranomon Hospital
City
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
Juntendo University Hospital
City
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
City
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Kyorin University Hospital
City
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Wakayama Medical University Hospital
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Facility Name
Chonnam National University Hwasun Hospital
City
Jeollanam-do
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
The Catholic University of Korea St. Vincent's Hospital
City
Suwon-si
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Jeroen Bosch Ziekenhuis
City
'S Hertogenbosch
ZIP/Postal Code
5223 GZ
Country
Netherlands
Facility Name
Martini Ziekenhuis
City
Groningen
ZIP/Postal Code
9728 MG
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis Nieuwegein
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Centro Hospitalar E Universitário de Coimbra EPE
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Centro Hospitalar de Lisboa Norte E.P.E ? Hospital Pulido Valente
City
Lisboa
ZIP/Postal Code
1769-001
Country
Portugal
Facility Name
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Hospital de Sao Joao; Servico de Pneumologia
City
Porto
ZIP/Postal Code
4200
Country
Portugal
Facility Name
Oncology Center Sf. Nectarie
City
Craiova
ZIP/Postal Code
200347
Country
Romania
Facility Name
Mordovia State University
City
Saransk
State/Province
Mordovija
ZIP/Postal Code
430032
Country
Russian Federation
Facility Name
Moscow City Oncology Hospital #62
City
Moscovskaya Oblast
State/Province
Moskovskaja Oblast
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
Principal Military Clinical Hospital n.a. N.N. Burdenko
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Russian Oncology Research Center n a N N Blokhin
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Evromedservis LCC
City
Pushkin
State/Province
Sankt Petersburg
ZIP/Postal Code
196603
Country
Russian Federation
Facility Name
GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)
City
Saint Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
City Clinical Oncology Dispensary
City
Saint-Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Leningrad Regional Clinical Hospital
City
St Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
St. Petersburg Med Univ; n.a. I.P. Pavlov; Pulmonology Research
City
St Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
Facility Name
Scientific Research Institute of Oncology n.a. N.N. Petrov; Department of Oncogynecology
City
St. Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
City
Kazan
State/Province
Tatarstan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
City Clinical Hospital #1; Dpt of Oncology
City
Novosibirsk
ZIP/Postal Code
630047
Country
Russian Federation
Facility Name
Volgograd Regional Clinical Oncology Dispensary
City
Volgograd
ZIP/Postal Code
400138
Country
Russian Federation
Facility Name
Regional Clinical Oncology Hospital
City
Yaroslavl
ZIP/Postal Code
150040
Country
Russian Federation
Facility Name
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Univ Vall d'Hebron; Servicio de Oncologia
City
Sant Andreu de La Barca
State/Province
Barcelona
ZIP/Postal Code
08740
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Consorcio Hospitalario Provincial de Castellon
City
Castellon DE LA Plana/castello DE LA Plana
State/Province
Castellon
ZIP/Postal Code
12002
Country
Spain
Facility Name
Hospital Universitario Son Espases
City
Palma De Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07014
Country
Spain
Facility Name
Centro Oncologico de Galicia COG; Medical Oncology
City
A Coruna
State/Province
LA Coruña
ZIP/Postal Code
15009
Country
Spain
Facility Name
Hospital Universitario Virgen de La Arrixaca; Servicio De Oncologia
City
El Palmar
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital Universitario de Canarias
City
S. Cristobal De La Laguna
State/Province
Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
C.H. Regional Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Complejo Hospitalario de Jaen
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Facility Name
Hospital Lucus Augusti; Servicio de Oncologia
City
Lugo
ZIP/Postal Code
27003
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
280146
Country
Spain
Facility Name
Hospital Ramon y Cajal; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hosp. Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario HM Sanchinarro-CIOCC; Oncología Médica
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital NisA 9 de Octubre
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hosp Clinico Univ Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Changhua Christian Hospital
City
Chang Hua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Kaohsiung Medical University Hospital; Department of Urology
City
Kaohsiung City
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Chi Mei Medical Center Liou Ying Campus
City
Liuying Township
ZIP/Postal Code
736
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital Chiayi
City
Putzu
ZIP/Postal Code
613
Country
Taiwan
Facility Name
National Taiwan Uni Hospital
City
Taipei City
ZIP/Postal Code
10041
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
104
Country
Taiwan
Facility Name
Chang Gung Medical Foundation Linkou Branch
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Xitun Dist.
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council
City
Dnipropetrovsk
State/Province
Katerynoslav Governorate
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs
City
Kharkiv
State/Province
Kharkiv Governorate
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Kyiv Railway Clinical Hospital #3 of Branch Health Center of the PJSC Ukrainian Railway
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
02096
Country
Ukraine
Facility Name
Municipal Institution Odesa Regional Oncology Dispensary
City
Odesa
State/Province
KIEV Governorate
ZIP/Postal Code
65055
Country
Ukraine
Facility Name
Municipal Institution Podilskiy Regional Center of Oncology; Department of Chemotherapy
City
Vinnytsia
State/Province
Podolia Governorate
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Municipal Institution SubCarpathian ClinicalOncological Centre; Chemotherapy department
City
Ivano-Frankivsk
State/Province
Poltava Governorate
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Private Enterprise Private Manufacturing Company Acinus
City
Kirovograd
ZIP/Postal Code
25006
Country
Ukraine
Facility Name
ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department
City
Kryvyi Rih
ZIP/Postal Code
50048
Country
Ukraine
Facility Name
Kyiv City Clinical Oncological Center
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary
City
Sumy
ZIP/Postal Code
40005
Country
Ukraine
Facility Name
MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology
City
Zaporizhzhya
ZIP/Postal Code
69040
Country
Ukraine
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Colchester General Hospital
City
Colchester, Essex
ZIP/Postal Code
CO4 5JL
Country
United Kingdom
Facility Name
St Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
35947027
Citation
Mohindra NA, Patel JD. Top advances in lung cancer, 2021. Cancer. 2022 Oct 1;128(19):3434-3437. doi: 10.1002/cncr.34406. Epub 2022 Aug 10.
Results Reference
derived
PubMed Identifier
34555333
Citation
Felip E, Altorki N, Zhou C, Csoszi T, Vynnychenko I, Goloborodko O, Luft A, Akopov A, Martinez-Marti A, Kenmotsu H, Chen YM, Chella A, Sugawara S, Voong D, Wu F, Yi J, Deng Y, McCleland M, Bennett E, Gitlitz B, Wakelee H; IMpower010 Investigators. Adjuvant atezolizumab after adjuvant chemotherapy in resected stage IB-IIIA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase 3 trial. Lancet. 2021 Oct 9;398(10308):1344-1357. doi: 10.1016/S0140-6736(21)02098-5. Epub 2021 Sep 20. Erratum In: Lancet. 2021 Sep 23;:
Results Reference
derived
Learn more about this trial
Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]
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