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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Atezolizumab
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Banner MD Anderson Cancer Center
  • HonorHealth Research Institute - Bisgrove
  • City of Hope Comprehensive Cancer Center
  • Angeles Clinic & Rsch Inst
  • City of Hope National Medical Group
  • Stanford Cancer Center
  • University of Colorado Health Science Center; Biomedical Research Bldg. Room 511
  • Yale Cancer Center; Medical Oncology
  • Georgetown University Medical Center Lombardi Cancer Center
  • Florida Cancer Specialists; SCRI
  • Florida Hospital Cancer Inst
  • Hematology Oncology Associates of the Treasure Coast
  • Florida Cancer Specialists.
  • Emory Uni - Winship Cancer Center; Hematology/Oncology
  • Northwest Georgia Oncology Centers PC - Marietta
  • Northwestern University; Robert H. Lurie Comp Can Ctr
  • University Of Chicago Medical Center; Section Of Hematology/Oncology
  • Uni of Maryland; Greenebaum Cancer Center
  • Massachusetts General Hospital
  • Beth Israel Deaconess Med Ctr; Hem/Onc
  • Dana Farber Cancer Institute
  • Washington University School of Medicine
  • Dartmouth Hitchcock Medical Center
  • Monter Cancer Center
  • Memorial Sloan Kettering Cancer Center
  • Carolina BioOncology Institute, PLCC
  • Oncology Hematology Care Inc
  • The Cleveland Clinic Foundation
  • Ohio State University; B406 Starling-Loving Hall
  • Penn State Milton S. Hershey Medical Center
  • Fox Chase Cancer Center; Hematology/Oncology
  • Tennessee Oncology PLLC - Nashville (20th Ave)
  • MD Anderson Cancer Center
  • Huntsman Cancer Institute; University of Utah
  • University of Virginia; Office of Sponsored Programs
  • University of Washington Seattle Cancer Care Alliance
  • University of Wisconsin
  • Royal North Shore Hospital; Oncology
  • Princess AleXandra Hospital; Department of Medical Oncology
  • Austin Health
  • Peter Maccallum Cancer Institute; Medical Oncology
  • Sir Charles Gairdner Hospital; Medical Oncology
  • Cliniques Universitaires St-Luc
  • GHdC Site Saint-Joseph
  • UZ Leuven Gasthuisberg
  • Sint Augustinus Wilrijk
  • University Clinical Centre of the Republic of Srpska
  • University Clinical Center Sarajevo;Clinic for Pulmonary disease
  • University Clinical Center Sarajevo;Institute of oncology
  • Complex Oncology Center (COC)-Plovidiv
  • Specialized Hospital for Active Treatment of Oncology
  • BCCA-Vancouver Cancer Centre
  • Lakeridge Health Oshawa; Oncology
  • The Ottawa Hospital Cancer Centre; Oncology
  • Sunnybrook Odette Cancer Centre
  • University Health Network; Princess Margaret Hospital; Medical Oncology Dept
  • Hopital Augustin Morvan; Oncologie Thoracique
  • Hopital Cote De Nacre; Pneumologie
  • CHU Limoges - Dupuytren; Oncologie Thoracique Cutanee
  • Centre Leon Berard; Departement Oncologie Medicale
  • Hopital Arnaud De Villeneuve; Maladies Respiratoires
  • Centre René Gauducheau - cancer Nantes - Atlantique; Service Oncologie Médicale
  • Nouvel Hopital Civil; Pneumologie
  • Institut Gustave Roussy; Departement Oncologie Medicale
  • Research institute for Clinical Medicine
  • Cancer Research Centre
  • MediClab Georgia
  • Chemotherapy and Immunotherapy Clinic Medulla
  • Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung
  • LungenClinic Großhansdorf GmbH
  • Klinikum Nuernberg Nord; Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie, Schlafmedizin
  • Pius-Hospital; Klinik fuer Haematologie und Onkologie
  • Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie
  • Queen Elizabeth Hospital; Clinical Oncology
  • Queen Mary Hospital; Dept. of Clinical Oncology
  • Prince of Wales Hosp; Dept. Of Clinical Onc
  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
  • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
  • Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico
  • National Hospital Organization Kyushu Medical Center; Respiratory Internal Medicine
  • Kanagawa Cardiovascular and Respiratory Center; Respiratory Medicine
  • Yokohama Municipal Citizen'S Hospital; Respiratory Medicine
  • Kitasato University Hospital; Respiratory Medicine
  • Kyoto University Hospital, Respiratory Medicine
  • Sendai Kousei Hospital; Pulmonary Medicine
  • Osaka International Cancer Institute; Thoracic Oncology
  • Kansai Medical university Hospital; Thoracic Oncology
  • Osaka Habikino Medical Center
  • National Cancer Center Hospital; Thoracic Medical Oncology
  • Toranomon Hospital; Respiratory Medicine
  • Antoni Van Leeuwenhoek Ziekenhuis; Thoracic Oncology
  • Amphia Ziekenhuis; Afdeling Longziekten
  • Academ Ziekenhuis Groningen; Medical Oncology
  • National University Hospital; National University Cancer Institute, Singapore (NCIS)
  • National Cancer Centre; Medical Oncology
  • Institute of Oncology Ljubljana
  • Hospital Univ Vall d'Hebron; Servicio de Oncologia
  • ICO Badalona - Hospital Germans Trias i Pujol
  • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
  • Universitaetsspital Basel; Onkologie
  • CHUV; Departement d'Oncologie
  • Kantonsspital St. Gallen; Onkologie/Hämatologie
  • UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
  • Hacettepe Uni Medical Faculty Hospital; Oncology Dept
  • Ankara Ataturk Chest Diseases Training and Research Hospital
  • Ege University School of Medicine; Chest Diseases Department
  • Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
  • Barts & London School of Med; Medical Oncology
  • Royal Marsden Hospital - London
  • Royal Marsden NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Atezolizumab

Arm Description

Outcomes

Primary Outcome Measures

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)
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

Percentage of Participants Achieving Objective Response Per RECIST v1.1 as Assessed by the Investigator (INV)
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).
Percentage of Participants Achieving Objective Response Per Modified RECIST as Assessed by the INV
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).
Duration of Response (DOR) Assessed by IRF Per RECIST v1.1
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).
DOR as Assessed by INV Per RECIST v1.1
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).
DOR as Assessed by INV Per Modified RECIST
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).
Progression Free Survival (PFS) as Assessed by IRF Per RECIST v1.1
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.
PFS as Assessed by INV Per RECIST v1.1
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.
PFS as Assessed by INV Per Modified RECIST
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.
Overall Survival : Percentage of Participants Without Event (Death)
Overall Survival : Median Time to Event (Death)
Overall survival is measured as interval between the first dose of atezolizumab and date of death from any cause.
Percentage of Participants Without an Event (Death) at 6 Months
Percentage of Participants Without an Event (Death) at 12 Months
PFS: Percentage of Participants Alive and Progression Free at 6 Months
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: Percentage of Participants Alive and Progression Free at 12 Months
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.
Time in Response (TIR) as Assessed by INV Per RECIST v1.1
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.
TIR as Assessed by INV Per Modified RECIST
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.
TIR as Assessed by IRF Per RECIST v1.1
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.
Atezolizumab Serum Concentrations
Serum concentrations were determined for all participants after administration of atezolizumab up to Cycle 8. Time (T) = time from first dose in days.
Percentage of Participants With Positive Anti-Therapeutic Antibody (Anti-Atezolizumab Antibody) Status
Anti-therapeutic antibodies is a measurement to explore the potential relationship of immunogenicity response with pharmacokinetics, safety and efficacy.
Percentage of Participants With Event (Disease Progression or Death) as Assessed by IRF Per RECIST v1.1
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.
Percentage of Participants With Event (Disease Progression or Death) as Assessed by INV Per RECIST v1.1
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.
Percentage of Participants With Event (Disease Progression or Death) as Assessed by INV Per Modified RECIST v1.1
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).

Full Information

First Posted
December 16, 2013
Last Updated
December 17, 2019
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02031458
Brief Title
A Study of Atezolizumab in Participants With Programmed Death - Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Acronym
BIRCH
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
January 22, 2014 (Actual)
Primary Completion Date
May 28, 2015 (Actual)
Study Completion Date
January 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. 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.

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 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
667 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atezolizumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Intervention Description
1200 mg IV every 3 weeks
Primary Outcome Measure Information:
Title
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)
Description
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).
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)
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Objective Response Per RECIST v1.1 as Assessed by the Investigator (INV)
Description
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).
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)
Title
Percentage of Participants Achieving Objective Response Per Modified RECIST as Assessed by the INV
Description
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).
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)
Title
Duration of Response (DOR) Assessed by IRF Per RECIST v1.1
Description
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).
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)
Title
DOR as Assessed by INV Per RECIST v1.1
Description
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).
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)
Title
DOR as Assessed by INV Per Modified RECIST
Description
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).
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)
Title
Progression Free Survival (PFS) as Assessed by IRF Per RECIST v1.1
Description
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.
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)
Title
PFS as Assessed by INV Per RECIST v1.1
Description
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.
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)
Title
PFS as Assessed by INV Per Modified RECIST
Description
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.
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)
Title
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)
Title
Overall Survival : Median Time to Event (Death)
Description
Overall survival is measured as interval between the first dose of atezolizumab and date of death from any cause.
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)
Title
Percentage of Participants Without an Event (Death) at 6 Months
Time Frame
Month 6
Title
Percentage of Participants Without an Event (Death) at 12 Months
Time Frame
Month 12
Title
PFS: Percentage of Participants Alive and Progression Free at 6 Months
Description
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.
Time Frame
Month 6
Title
PFS: Percentage of Participants Alive and Progression Free at 12 Months
Description
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.
Time Frame
Month 12
Title
Time in Response (TIR) as Assessed by INV Per RECIST v1.1
Description
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.
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)
Title
TIR as Assessed by INV Per Modified RECIST
Description
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.
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)
Title
TIR as Assessed by IRF Per RECIST v1.1
Description
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.
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)
Title
Atezolizumab Serum Concentrations
Description
Serum concentrations were determined for all participants after administration of atezolizumab up to Cycle 8. Time (T) = time from first dose in days.
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
Title
Percentage of Participants With Positive Anti-Therapeutic Antibody (Anti-Atezolizumab Antibody) Status
Description
Anti-therapeutic antibodies is a measurement to explore the potential relationship of immunogenicity response with pharmacokinetics, safety and efficacy.
Time Frame
Baseline, post-baseline (up to 16 months)
Title
Percentage of Participants With Event (Disease Progression or Death) as Assessed by IRF Per RECIST v1.1
Description
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.
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)
Title
Percentage of Participants With Event (Disease Progression or Death) as Assessed by INV Per RECIST v1.1
Description
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.
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)
Title
Percentage of Participants With Event (Disease Progression or Death) as Assessed by INV Per Modified RECIST v1.1
Description
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).
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. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
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
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
HonorHealth Research Institute - Bisgrove
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Angeles Clinic & Rsch Inst
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
City of Hope National Medical Group
City
South Pasadena
State/Province
California
ZIP/Postal Code
91030
Country
United States
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5820
Country
United States
Facility Name
University of Colorado Health Science Center; Biomedical Research Bldg. Room 511
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale Cancer Center; Medical Oncology
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Georgetown University Medical Center Lombardi Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Florida Cancer Specialists; SCRI
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Florida Hospital Cancer Inst
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Hematology Oncology Associates of the Treasure Coast
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
Florida Cancer Specialists.
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Emory Uni - Winship Cancer Center; Hematology/Oncology
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwest Georgia Oncology Centers PC - Marietta
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Northwestern University; Robert H. Lurie Comp Can Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University Of Chicago Medical Center; Section Of Hematology/Oncology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Uni of Maryland; Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Med Ctr; Hem/Onc
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Monter Cancer Center
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Carolina BioOncology Institute, PLCC
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Oncology Hematology Care Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University; B406 Starling-Loving Hall
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Fox Chase Cancer Center; Hematology/Oncology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Tennessee Oncology PLLC - Nashville (20th Ave)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Huntsman Cancer Institute; University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
University of Virginia; Office of Sponsored Programs
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
Facility Name
University of Washington Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Royal North Shore Hospital; Oncology
City
St. Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Princess AleXandra Hospital; Department of Medical Oncology
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Peter Maccallum Cancer Institute; Medical Oncology
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Sir Charles Gairdner Hospital; Medical Oncology
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Cliniques Universitaires St-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
GHdC Site Saint-Joseph
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Sint Augustinus Wilrijk
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
University Clinical Centre of the Republic of Srpska
City
Banja Luka
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
University Clinical Center Sarajevo;Clinic for Pulmonary disease
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
University Clinical Center Sarajevo;Institute of oncology
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
Complex Oncology Center (COC)-Plovidiv
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Specialized Hospital for Active Treatment of Oncology
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
BCCA-Vancouver Cancer Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Lakeridge Health Oshawa; Oncology
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
The Ottawa Hospital Cancer Centre; Oncology
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Sunnybrook Odette Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Hopital Augustin Morvan; Oncologie Thoracique
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Hopital Cote De Nacre; Pneumologie
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
CHU Limoges - Dupuytren; Oncologie Thoracique Cutanee
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Centre Leon Berard; Departement Oncologie Medicale
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Hopital Arnaud De Villeneuve; Maladies Respiratoires
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Centre René Gauducheau - cancer Nantes - Atlantique; Service Oncologie Médicale
City
Nantes
ZIP/Postal Code
44805
Country
France
Facility Name
Nouvel Hopital Civil; Pneumologie
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Institut Gustave Roussy; Departement Oncologie Medicale
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Research institute for Clinical Medicine
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
Cancer Research Centre
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
MediClab Georgia
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Chemotherapy and Immunotherapy Clinic Medulla
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
LungenClinic Großhansdorf GmbH
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Klinikum Nuernberg Nord; Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie, Schlafmedizin
City
Nürnberg
ZIP/Postal Code
90419
Country
Germany
Facility Name
Pius-Hospital; Klinik fuer Haematologie und Onkologie
City
Oldenburg
ZIP/Postal Code
26121
Country
Germany
Facility Name
Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie
City
Villingen-Schwenningen
ZIP/Postal Code
78052
Country
Germany
Facility Name
Queen Elizabeth Hospital; Clinical Oncology
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Mary Hospital; Dept. of Clinical Oncology
City
Hong Kong
Country
Hong Kong
Facility Name
Prince of Wales Hosp; Dept. Of Clinical Onc
City
Shatin
Country
Hong Kong
Facility Name
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
City
Meldola
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Facility Name
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico
City
Orbassano
State/Province
Piemonte
ZIP/Postal Code
10043
Country
Italy
Facility Name
National Hospital Organization Kyushu Medical Center; Respiratory Internal Medicine
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
Kanagawa Cardiovascular and Respiratory Center; Respiratory Medicine
City
Kanagawa
ZIP/Postal Code
236-0051
Country
Japan
Facility Name
Yokohama Municipal Citizen'S Hospital; Respiratory Medicine
City
Kanagawa
ZIP/Postal Code
240-8555
Country
Japan
Facility Name
Kitasato University Hospital; Respiratory Medicine
City
Kanagawa
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
Kyoto University Hospital, Respiratory Medicine
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Sendai Kousei Hospital; Pulmonary Medicine
City
Miyagi
ZIP/Postal Code
980-0873
Country
Japan
Facility Name
Osaka International Cancer Institute; Thoracic Oncology
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Kansai Medical university Hospital; Thoracic Oncology
City
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
Osaka Habikino Medical Center
City
Osaka
ZIP/Postal Code
583-8588
Country
Japan
Facility Name
National Cancer Center Hospital; Thoracic Medical Oncology
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Toranomon Hospital; Respiratory Medicine
City
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
Antoni Van Leeuwenhoek Ziekenhuis; Thoracic Oncology
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Amphia Ziekenhuis; Afdeling Longziekten
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Academ Ziekenhuis Groningen; Medical Oncology
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
National University Hospital; National University Cancer Institute, Singapore (NCIS)
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
National Cancer Centre; Medical Oncology
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Institute of Oncology Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Hospital Univ Vall d'Hebron; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
ICO Badalona - Hospital Germans Trias i Pujol
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Universitaetsspital Basel; Onkologie
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
CHUV; Departement d'Oncologie
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Kantonsspital St. Gallen; Onkologie/Hämatologie
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Ankara Ataturk Chest Diseases Training and Research Hospital
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Ege University School of Medicine; Chest Diseases Department
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Facility Name
Barts & London School of Med; Medical Oncology
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Royal Marsden Hospital - London
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33241650
Citation
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.
Results Reference
derived

Learn more about this trial

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

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