A Study of Atezolizumab in Participants With Programmed Death - Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (BIRCH)

• ClinicalTrials.gov Identifier: NCT02031458
• Recruitment Status: Completed
• First Posted: January 9, 2014
• Results First Posted: March 23, 2017
• Last Update Posted: January 6, 2020
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Study Description

Brief Summary:

This multicenter, single-arm study will evaluate the efficacy and safety of Atezolizumab in participants with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Participants will receive Atezolizumab 1200 milligrams (mg) intravenously every 3 weeks as long as participants are experiencing clinical benefit as assessed by the investigator, that is , in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.

Condition or disease	Intervention/treatment	Phase
Non-Small Cell Lung Cancer	Drug: Atezolizumab	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 667 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II, Multicenter, Single-Arm Study OF Atezolizumab In Patients With PD-L1-Positive Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
• Actual Study Start Date: January 22, 2014
• Actual Primary Completion Date: May 28, 2015
• Actual Study Completion Date: January 11, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Atezolizumab	Drug: Atezolizumab; 1200 mg IV every 3 weeks

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants Achieving Objective Response (ORR) Per Response Evaluation Criteria In Solid Tumors (RECIST) Version (v) 1.1 as Assessed by Independent Review Facility (IRF) [ Time Frame: Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) ]
   ORR was the percentage of participants whose confirmed best overall response was either a Partial Response (PR) or a Complete Response (CR) based upon the IRF assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm); PR:greater than (>) or equal to (=) 30 percent (%) decrease from baseline in sum of diameters of target lesions, non-progressive disease (PD) non-target lesions and no new lesions. Results were reported by line of therapy and programmed death-ligand 1 (PD-L1) Expression Subgroup (tumor cell [TC]3 [TC3] or tumor-infiltrating immune cell [IC] 3 [IC3], TC3 or IC2/3, TC2/3 or IC2/3).

Secondary Outcome Measures :

1. Percentage of Participants Achieving Objective Response Per RECIST v1.1 as Assessed by the Investigator (INV) [ Time Frame: Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) ]
   ORR was the percentage of participants whose confirmed best overall response was either a PR or a CR based upon the Investigator assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10mm; PR: > or = 30 % decrease from baseline in sum of diameters of target lesions, non-PD non-target lesions and no new lesions. Results were reported by line of therapy (reporting arms) and PD-L1 Expression Subgroup (TC3 or IC3, TC3 or IC2/3, TC2/3 or IC2/3).
2. Percentage of Participants Achieving Objective Response Per Modified RECIST as Assessed by the INV [ Time Frame: Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) ]
   ORR was the percentage of participants whose confirmed best overall response was either a PR or a CR based upon the Investigator assessment per modified RECIST. CR: disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10mm; PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. Results were reported by line of therapy (reporting arms) and PD-L1 Expression Subgroup (TC3 or IC3, TC3 or IC2/3, TC2/3 or IC2/3).
3. Duration of Response (DOR) Assessed by IRF Per RECIST v1.1 [ Time Frame: Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) ]
   DOR is interval between date of first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and the first date that PD or death is documented, whichever occurs first as measured by RECIST v1.1. CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10mm; PR: > or = 30 % decrease from baseline in sum of diameters of target lesions, non-PD non-target lesions and no new lesions; PD: one or more of the following: at least 20% increase from nadir in sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions. DOR was assessed by Kaplan-Meier estimates. Results were reported by line of therapy (reporting arms) and PD-L1 Expression Subgroup (TC3 or IC3, TC3 or IC2/3, TC2/3 or IC2/3).
4. DOR as Assessed by INV Per RECIST v1.1 [ Time Frame: Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) ]
   DOR is interval between date of the first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and first date that PD or death is documented, whichever occurs first as measured by RECIST v1.1. CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10mm; PR: > or = 30 % decrease from baseline in sum of diameters of target lesions, non-PD non-target lesions and no new lesions; PD: one or more of the following: at least 20% increase from nadir in sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions. DOR was assessed by Kaplan-Meier estimates. Results were reported by line of therapy (reporting arms) and PD-L1 Expression Subgroup (TC3 or IC3, TC3 or IC2/3, TC2/3 or IC2/3).
5. DOR as Assessed by INV Per Modified RECIST [ Time Frame: Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) ]
   DOR is the interval between the date of the first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and the first date that PD or death is documented, whichever occurs first as measured by modified RECIST. CR: disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10mm; PR: at least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR; PD: one or more of the following: at least 20% increase from nadir in the sum of diameters of existing and/or new target lesions (with an absolute increase of at least 5mm). DOR was assessed by Kaplan-Meier estimates. Results were reported by line of therapy (reporting arms) and PD-L1 Expression Subgroup (TC3 or IC3, TC3 or IC2/3, TC2/3 or IC2/3).
6. Progression Free Survival (PFS) as Assessed by IRF Per RECIST v1.1 [ Time Frame: Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) ]
   PFS is the interval between the first dose of atezolizumab and date of disease progression or death due to any cause, whichever occurred first as measured by RECIST v1.1. PD is defined as one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions. PFS was assessed by Kaplan-Meier estimates.
7. PFS as Assessed by INV Per RECIST v1.1 [ Time Frame: Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) ]
   PFS is the interval between the first dose of atezolizumab and date of disease progression or death due to any cause, whichever occurred first as measured by RECIST v1.1. PD: one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions. PFS was assessed by Kaplan-Meier estimates.
8. PFS as Assessed by INV Per Modified RECIST [ Time Frame: Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) ]
   PFS is the interval between the first dose of atezolizumab and date of disease progression or death due to any cause, whichever occurred first as measured by modified RECIST. PD: at least 20% increase from nadir in the sum of diameters of new and/or existing target lesions (with an absolute increase of at least 5mm). PFS was assessed by Kaplan-Meier estimates.
9. Overall Survival : Percentage of Participants Without Event (Death) [ Time Frame: Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) ]
10. Overall Survival : Median Time to Event (Death) [ Time Frame: Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) ]
    Overall survival is measured as interval between the first dose of atezolizumab and date of death from any cause.
11. Percentage of Participants Without an Event (Death) at 6 Months [ Time Frame: Month 6 ]
12. Percentage of Participants Without an Event (Death) at 12 Months [ Time Frame: Month 12 ]
13. PFS: Percentage of Participants Alive and Progression Free at 6 Months [ Time Frame: Month 6 ]
    PD is defined as one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions.
14. PFS: Percentage of Participants Alive and Progression Free at 12 Months [ Time Frame: Month 12 ]
    PD is defined as one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions.
15. Time in Response (TIR) as Assessed by INV Per RECIST v1.1 [ Time Frame: Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) ]
    TIR is interval between date of first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and first date that PD or death is documented, whichever occurs first as measured by RECIST v1.1. For responders, TIR was the same as DOR; for non-responders, TIR was considered as an event and defined as the date of first treatment plus one day. TIR was assessed by Kaplan-Meier estimates.
16. TIR as Assessed by INV Per Modified RECIST [ Time Frame: Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) ]
    TIR is interval between date of first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and first date that PD or death is documented, whichever occurs first as measured by modified RECIST. For responders, TIR was the same as DOR; for non-responders, TIR was considered as an event and defined as the date of first treatment plus one day. TIR was assessed by Kaplan-Meier estimates.
17. TIR as Assessed by IRF Per RECIST v1.1 [ Time Frame: Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) ]
    TIR is interval between date of first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and first date that PD or death is documented, whichever occurs first as measured by RECIST v1.1. For responders, TIR was the same as DOR; for non-responders, TIR was considered as an event and defined as the date of first treatment plus one day. TIR was assessed by Kaplan-Meier estimates.
18. Atezolizumab Serum Concentrations [ Time Frame: Pre-dose (hour 0) and 0.5 hours post dose on Cycle 1 Day 1 (Cycle length = 21days), Cycle 1 Days 2, 4, 8, 15, and 21, Cycle 2 Day 21, Cycle 3 Day 21, Cycle 7 Day 21 ]
    Serum concentrations were determined for all participants after administration of atezolizumab up to Cycle 8. Time (T) = time from first dose in days.
19. Percentage of Participants With Positive Anti-Therapeutic Antibody (Anti-Atezolizumab Antibody) Status [ Time Frame: Baseline, post-baseline (up to 16 months) ]
    Anti-therapeutic antibodies is a measurement to explore the potential relationship of immunogenicity response with pharmacokinetics, safety and efficacy.
20. Percentage of Participants With Event (Disease Progression or Death) as Assessed by IRF Per RECIST v1.1 [ Time Frame: Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) ]
    PD was defined as one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5 mm), appearance of new lesions, and/or unequivocal progression of non-target lesions.
21. Percentage of Participants With Event (Disease Progression or Death) as Assessed by INV Per RECIST v1.1 [ Time Frame: Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) ]
    PD was defined as one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5 mm), appearance of new lesions, and/or unequivocal progression of non-target lesions.
22. Percentage of Participants With Event (Disease Progression or Death) as Assessed by INV Per Modified RECIST v1.1 [ Time Frame: Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months) ]
    PD was defined as at least 20% increase from nadir in the sum of diameters of new and/or existing target lesions (with an absolute increase of at least 5 mm).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Adult participants greater than or equal to 18 years of age
• Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) NSCLC
• Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens
• PD-L1-positive tumor status as determined by an immunohistochemistry (IHC) assay based on PD-L1 expression on tumor infiltrating immune cells and/or tumor cells performed by a central laboratory
• Measurable disease, as defined by RECIST version 1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

• Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment; the following exception are allowed:

Hormone-replacement therapy or oral contraceptives tyrosine-kinase inhibitors (TKIs) approved for treatment of NSCLC discontinued >7 days prior to Cycle 1, Day 1

• Central nervous system (CNS) disease, including treated brain metastases
• Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with negligible risk of metastases or death and treated with expected curative outcome
• History of autoimmune disease
• History of idiopathic pulmonary fibrosis (including pneumonia), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening CT scan. History of radiation pneumonitis in the radiation field (fibrosis) id permitted
• Active hepatitis B or hepatitis C
• Human Immunodeficiency virus (HIV) positive
• Prior treatment with CD137 agonists, anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents

Contacts and Locations

Locations

United States, Arizona

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States, 85234

HonorHealth Research Institute - Bisgrove

Scottsdale, Arizona, United States, 85258

United States, California

City of Hope Comprehensive Cancer Center

Duarte, California, United States, 91010

Angeles Clinic & Rsch Inst

Los Angeles, California, United States, 90025

City of Hope National Medical Group

South Pasadena, California, United States, 91030

Stanford Cancer Center

Stanford, California, United States, 94305-5820

United States, Colorado

University of Colorado Health Science Center; Biomedical Research Bldg. Room 511

Aurora, Colorado, United States, 80045

United States, Connecticut

Yale Cancer Center; Medical Oncology

New Haven, Connecticut, United States, 06520

United States, District of Columbia

Georgetown University Medical Center Lombardi Cancer Center

Washington, District of Columbia, United States, 20007

United States, Florida

Florida Cancer Specialists; SCRI

Fort Myers, Florida, United States, 33901

Florida Hospital Cancer Inst

Orlando, Florida, United States, 32804

Hematology Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, United States, 34952

Florida Cancer Specialists.

Saint Petersburg, Florida, United States, 33705

United States, Georgia

Emory Uni - Winship Cancer Center; Hematology/Oncology

Atlanta, Georgia, United States, 30322

Northwest Georgia Oncology Centers PC - Marietta

Marietta, Georgia, United States, 30060

United States, Illinois

Northwestern University; Robert H. Lurie Comp Can Ctr

Chicago, Illinois, United States, 60611

University Of Chicago Medical Center; Section Of Hematology/Oncology

Chicago, Illinois, United States, 60637

United States, Maryland

Uni of Maryland; Greenebaum Cancer Center

Baltimore, Maryland, United States, 21201

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Beth Israel Deaconess Med Ctr; Hem/Onc

Boston, Massachusetts, United States, 02215

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

United States, Missouri

Washington University School of Medicine

Saint Louis, Missouri, United States, 63110

United States, New Hampshire

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

United States, New York

Monter Cancer Center

Lake Success, New York, United States, 11042

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

United States, North Carolina

Carolina BioOncology Institute, PLCC

Huntersville, North Carolina, United States, 28078

United States, Ohio

Oncology Hematology Care Inc

Cincinnati, Ohio, United States, 45242

The Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Ohio State University; B406 Starling-Loving Hall

Columbus, Ohio, United States, 43210

United States, Pennsylvania

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

Fox Chase Cancer Center; Hematology/Oncology

Philadelphia, Pennsylvania, United States, 19111

United States, Tennessee

Tennessee Oncology PLLC - Nashville (20th Ave)

Nashville, Tennessee, United States, 37203

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030

United States, Utah

Huntsman Cancer Institute; University of Utah

Salt Lake City, Utah, United States, 84112

United States, Virginia

University of Virginia; Office of Sponsored Programs

Charlottesville, Virginia, United States, 22902

United States, Washington

University of Washington Seattle Cancer Care Alliance

Seattle, Washington, United States, 98195

United States, Wisconsin

University of Wisconsin

Madison, Wisconsin, United States, 53792

Australia, New South Wales

Royal North Shore Hospital; Oncology

St. Leonards, New South Wales, Australia, 2065

Australia, Queensland

Princess AleXandra Hospital; Department of Medical Oncology

Woolloongabba, Queensland, Australia, 4102

Australia, Victoria

Austin Health

Heidelberg, Victoria, Australia, 3084

Peter Maccallum Cancer Institute; Medical Oncology

Melbourne, Victoria, Australia, 3000

Australia, Western Australia

Sir Charles Gairdner Hospital; Medical Oncology

Nedlands, Western Australia, Australia, 6009

Belgium

Cliniques Universitaires St-Luc

Bruxelles, Belgium, 1200

GHdC Site Saint-Joseph

Charleroi, Belgium, 6000

UZ Leuven Gasthuisberg

Leuven, Belgium, 3000

Sint Augustinus Wilrijk

Wilrijk, Belgium, 2610

Bosnia and Herzegovina

University Clinical Centre of the Republic of Srpska

Banja Luka, Bosnia and Herzegovina, 78000

University Clinical Center Sarajevo;Clinic for Pulmonary disease

Sarajevo, Bosnia and Herzegovina, 71000

University Clinical Center Sarajevo;Institute of oncology

Sarajevo, Bosnia and Herzegovina, 71000

Bulgaria

Complex Oncology Center (COC)-Plovidiv

Plovdiv, Bulgaria, 4000

Specialized Hospital for Active Treatment of Oncology

Sofia, Bulgaria, 1756

Canada, British Columbia

BCCA-Vancouver Cancer Centre

Vancouver, British Columbia, Canada, V5Z 4E6

Canada, Ontario

Lakeridge Health Oshawa; Oncology

Oshawa, Ontario, Canada, L1G 2B9

The Ottawa Hospital Cancer Centre; Oncology

Ottawa, Ontario, Canada, K1H 8L6

Sunnybrook Odette Cancer Centre

Toronto, Ontario, Canada, M4N 3M5

University Health Network; Princess Margaret Hospital; Medical Oncology Dept

Toronto, Ontario, Canada, M5G 2M9

France

Hopital Augustin Morvan; Oncologie Thoracique

Brest, France, 29609

Hopital Cote De Nacre; Pneumologie

Caen, France, 14000

CHU Limoges - Dupuytren; Oncologie Thoracique Cutanee

Limoges, France, 87042

Centre Leon Berard; Departement Oncologie Medicale

Lyon, France, 69373

Hopital Arnaud De Villeneuve; Maladies Respiratoires

Montpellier, France, 34295

Centre René Gauducheau - cancer Nantes - Atlantique; Service Oncologie Médicale

Nantes, France, 44805

Nouvel Hopital Civil; Pneumologie

Strasbourg, France, 67091

Institut Gustave Roussy; Departement Oncologie Medicale

Villejuif, France, 94805

Georgia

Research institute for Clinical Medicine

Tbilisi, Georgia, 0112

Cancer Research Centre

Tbilisi, Georgia, 0159

MediClab Georgia

Tbilisi, Georgia, 0160

Chemotherapy and Immunotherapy Clinic Medulla

Tbilisi, Georgia, 0186

Germany

Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung

Essen, Germany, 45122

LungenClinic Großhansdorf GmbH

Großhansdorf, Germany, 22927

Klinikum Nuernberg Nord; Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie, Schlafmedizin

Nürnberg, Germany, 90419

Pius-Hospital; Klinik fuer Haematologie und Onkologie

Oldenburg, Germany, 26121

Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie

Villingen-Schwenningen, Germany, 78052

Hong Kong

Queen Elizabeth Hospital; Clinical Oncology

Hong Kong, Hong Kong

Queen Mary Hospital; Dept. of Clinical Oncology

Hong Kong, Hong Kong

Prince of Wales Hosp; Dept. Of Clinical Onc

Shatin, Hong Kong

Italy

IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

Meldola, Emilia-Romagna, Italy, 47014

Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

Milano, Lombardia, Italy, 20133

Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico

Orbassano, Piemonte, Italy, 10043

Japan

National Hospital Organization Kyushu Medical Center; Respiratory Internal Medicine

Fukuoka, Japan, 810-8563

Kanagawa Cardiovascular and Respiratory Center; Respiratory Medicine

Kanagawa, Japan, 236-0051

Yokohama Municipal Citizen'S Hospital; Respiratory Medicine

Kanagawa, Japan, 240-8555

Kitasato University Hospital; Respiratory Medicine

Kanagawa, Japan, 252-0375

Kyoto University Hospital, Respiratory Medicine

Kyoto, Japan, 606-8507

Sendai Kousei Hospital; Pulmonary Medicine

Miyagi, Japan, 980-0873

Osaka International Cancer Institute; Thoracic Oncology

Osaka, Japan, 541-8567

Kansai Medical university Hospital; Thoracic Oncology

Osaka, Japan, 573-1191

Osaka Habikino Medical Center

Osaka, Japan, 583-8588

National Cancer Center Hospital; Thoracic Medical Oncology

Tokyo, Japan, 104-0045

Toranomon Hospital; Respiratory Medicine

Tokyo, Japan, 105-8470

Netherlands

Antoni Van Leeuwenhoek Ziekenhuis; Thoracic Oncology

Amsterdam, Netherlands, 1066 CX

Amphia Ziekenhuis; Afdeling Longziekten

Breda, Netherlands, 4818 CK

Academ Ziekenhuis Groningen; Medical Oncology

Groningen, Netherlands, 9713 GZ

Singapore

National University Hospital; National University Cancer Institute, Singapore (NCIS)

Singapore, Singapore, 119228

National Cancer Centre; Medical Oncology

Singapore, Singapore, 169610

Slovenia

Institute of Oncology Ljubljana

Ljubljana, Slovenia, 1000

Spain

Hospital Univ Vall d'Hebron; Servicio de Oncologia

Barcelona, Spain, 08035

ICO Badalona - Hospital Germans Trias i Pujol

Barcelona, Spain, 08916

Hospital Universitario Virgen del Rocio; Servicio de Oncologia

Sevilla, Spain, 41013

Switzerland

Universitaetsspital Basel; Onkologie

Basel, Switzerland, 4031

CHUV; Departement d'Oncologie

Lausanne, Switzerland, 1011

Kantonsspital St. Gallen; Onkologie/Hämatologie

St. Gallen, Switzerland, 9007

UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie

Zürich, Switzerland, 8091

Turkey

Hacettepe Uni Medical Faculty Hospital; Oncology Dept

Ankara, Turkey, 06100

Ankara Ataturk Chest Diseases Training and Research Hospital

Ankara, Turkey, 06500

Ege University School of Medicine; Chest Diseases Department

Izmir, Turkey, 35100

Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

Malatya, Turkey, 44280

United Kingdom

Barts & London School of Med; Medical Oncology

London, United Kingdom, EC1A 7BE

Royal Marsden Hospital - London

London, United Kingdom, SW3 6JJ

Royal Marsden NHS Foundation Trust

Sutton, United Kingdom, SM2 5PT

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT02031458
• Other Study ID Numbers: GO28754; 2013-003330-32 ( EudraCT Number )
• First Posted: January 9, 2014
• Results First Posted: March 23, 2017
• Last Update Posted: January 6, 2020
• Last Verified: December 2019

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Atezolizumab; Immune Checkpoint Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents, Immunological; Antineoplastic Agents