A Study of Atezolizumab in Participants With Programmed Death - Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
BIRCH
A Phase II, Multicenter, Single-Arm Study OF Atezolizumab In Patients With PD-L1-Positive Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
2 other identifiers
interventional
667
19 countries
110
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 nonsmall-cell-lung-cancer
Started Jan 2014
Typical duration for phase_2 nonsmall-cell-lung-cancer
110 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2013
CompletedFirst Posted
Study publicly available on registry
January 9, 2014
CompletedStudy Start
First participant enrolled
January 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2015
CompletedResults Posted
Study results publicly available
March 23, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 11, 2019
CompletedJanuary 6, 2020
December 1, 2019
1.3 years
December 16, 2013
October 24, 2016
December 17, 2019
Conditions
Outcome Measures
Primary Outcomes (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)
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).
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 Outcomes (22)
Percentage of Participants Achieving Objective Response Per RECIST v1.1 as Assessed by the Investigator (INV)
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)
Percentage of Participants Achieving Objective Response Per Modified RECIST as Assessed by the INV
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)
Duration of Response (DOR) Assessed by IRF Per RECIST v1.1
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 as Assessed by INV Per RECIST v1.1
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 as Assessed by INV Per Modified RECIST
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)
- +17 more secondary outcomes
Study Arms (1)
Atezolizumab
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (110)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
HonorHealth Research Institute - Bisgrove
Scottsdale, Arizona, 85258, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
Angeles Clinic & Rsch Inst
Los Angeles, California, 90025, United States
City of Hope National Medical Group
South Pasadena, California, 91030, United States
Stanford Cancer Center
Stanford, California, 94305-5820, United States
University of Colorado Health Science Center; Biomedical Research Bldg. Room 511
Aurora, Colorado, 80045, United States
Yale Cancer Center; Medical Oncology
New Haven, Connecticut, 06520, United States
Georgetown University Medical Center Lombardi Cancer Center
Washington D.C., District of Columbia, 20007, United States
Florida Cancer Specialists; SCRI
Fort Myers, Florida, 33901, United States
Florida Hospital Cancer Inst
Orlando, Florida, 32804, United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952, United States
Florida Cancer Specialists.
St. Petersburg, Florida, 33705, United States
Emory Uni - Winship Cancer Center; Hematology/Oncology
Atlanta, Georgia, 30322, United States
Northwest Georgia Oncology Centers PC - Marietta
Marietta, Georgia, 30060, United States
Northwestern University; Robert H. Lurie Comp Can Ctr
Chicago, Illinois, 60611, United States
University Of Chicago Medical Center; Section Of Hematology/Oncology
Chicago, Illinois, 60637, United States
Uni of Maryland; Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Med Ctr; Hem/Onc
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Monter Cancer Center
Lake Success, New York, 11042, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Carolina BioOncology Institute, PLCC
Huntersville, North Carolina, 28078, United States
Oncology Hematology Care Inc
Cincinnati, Ohio, 45242, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University; B406 Starling-Loving Hall
Columbus, Ohio, 43210, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Fox Chase Cancer Center; Hematology/Oncology
Philadelphia, Pennsylvania, 19111, United States
Tennessee Oncology PLLC - Nashville (20th Ave)
Nashville, Tennessee, 37203, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Huntsman Cancer Institute; University of Utah
Salt Lake City, Utah, 84112, United States
University of Virginia; Office of Sponsored Programs
Charlottesville, Virginia, 22902, United States
University of Washington Seattle Cancer Care Alliance
Seattle, Washington, 98195, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Royal North Shore Hospital; Oncology
St Leonards, New South Wales, 2065, Australia
Princess AleXandra Hospital; Department of Medical Oncology
Woolloongabba, Queensland, 4102, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
Peter Maccallum Cancer Institute; Medical Oncology
Melbourne, Victoria, 3000, Australia
Sir Charles Gairdner Hospital; Medical Oncology
Nedlands, Western Australia, 6009, Australia
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
GHdC Site Saint-Joseph
Charleroi, 6000, Belgium
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
Sint Augustinus Wilrijk
Wilrijk, 2610, Belgium
University Clinical Centre of the Republic of Srpska
Banja Luka, 78000, Bosnia and Herzegovina
University Clinical Center Sarajevo;Clinic for Pulmonary disease
Sarajevo, 71000, Bosnia and Herzegovina
University Clinical Center Sarajevo;Institute of oncology
Sarajevo, 71000, Bosnia and Herzegovina
Complex Oncology Center (COC)-Plovidiv
Plovdiv, 4000, Bulgaria
Specialized Hospital for Active Treatment of Oncology
Sofia, 1756, Bulgaria
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
Lakeridge Health Oshawa; Oncology
Oshawa, Ontario, L1G 2B9, Canada
The Ottawa Hospital Cancer Centre; Oncology
Ottawa, Ontario, K1H 8L6, Canada
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto, Ontario, M5G 2M9, Canada
Hopital Augustin Morvan; Oncologie Thoracique
Brest, 29609, France
Hopital Cote De Nacre; Pneumologie
Caen, 14000, France
CHU Limoges - Dupuytren; Oncologie Thoracique Cutanee
Limoges, 87042, France
Centre Leon Berard; Departement Oncologie Medicale
Lyon, 69373, France
Hopital Arnaud De Villeneuve; Maladies Respiratoires
Montpellier, 34295, France
Centre René Gauducheau - cancer Nantes - Atlantique; Service Oncologie Médicale
Nantes, 44805, France
Nouvel Hopital Civil; Pneumologie
Strasbourg, 67091, France
Institut Gustave Roussy; Departement Oncologie Medicale
Villejuif, 94805, France
Research institute for Clinical Medicine
Tbilisi, 0112, Georgia
Cancer Research Centre
Tbilisi, 0159, Georgia
MediClab Georgia
Tbilisi, 0160, Georgia
Chemotherapy and Immunotherapy Clinic Medulla
Tbilisi, 0186, Georgia
Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung
Essen, 45122, Germany
LungenClinic Großhansdorf GmbH
Großhansdorf, 22927, Germany
Klinikum Nuernberg Nord; Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie, Schlafmedizin
Nuremberg, 90419, Germany
Pius-Hospital; Klinik fuer Haematologie und Onkologie
Oldenburg, 26121, Germany
Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie
Villingen-Schwenningen, 78052, Germany
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
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola, Emilia-Romagna, 47014, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
Milan, Lombardy, 20133, Italy
Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico
Orbassano, Piedmont, 10043, Italy
National Hospital Organization Kyushu Medical Center; Respiratory Internal Medicine
Fukuoka, 810-8563, Japan
Kanagawa Cardiovascular and Respiratory Center; Respiratory Medicine
Kanagawa, 236-0051, Japan
Yokohama Municipal Citizen'S Hospital; Respiratory Medicine
Kanagawa, 240-8555, Japan
Kitasato University Hospital; Respiratory Medicine
Kanagawa, 252-0375, Japan
Kyoto University Hospital, Respiratory Medicine
Kyoto, 606-8507, Japan
Sendai Kousei Hospital; Pulmonary Medicine
Miyagi, 980-0873, Japan
Osaka International Cancer Institute; Thoracic Oncology
Osaka, 541-8567, Japan
Kansai Medical university Hospital; Thoracic Oncology
Osaka, 573-1191, Japan
Osaka Habikino Medical Center
Osaka, 583-8588, Japan
National Cancer Center Hospital; Thoracic Medical Oncology
Tokyo, 104-0045, Japan
Toranomon Hospital; Respiratory Medicine
Tokyo, 105-8470, Japan
Antoni Van Leeuwenhoek Ziekenhuis; Thoracic Oncology
Amsterdam, 1066 CX, Netherlands
Amphia Ziekenhuis; Afdeling Longziekten
Breda, 4818 CK, Netherlands
Academ Ziekenhuis Groningen; Medical Oncology
Groningen, 9713 GZ, Netherlands
National University Hospital; National University Cancer Institute, Singapore (NCIS)
Singapore, 119228, Singapore
National Cancer Centre; Medical Oncology
Singapore, 169610, Singapore
Institute of Oncology Ljubljana
Ljubljana, 1000, Slovenia
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, 08035, Spain
ICO Badalona - Hospital Germans Trias i Pujol
Barcelona, 08916, Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Seville, 41013, Spain
Universitaetsspital Basel; Onkologie
Basel, 4031, Switzerland
CHUV; Departement d'Oncologie
Lausanne, 1011, Switzerland
Kantonsspital St. Gallen; Onkologie/Hämatologie
Sankt Gallen, 9007, Switzerland
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
Zurich, 8091, Switzerland
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Ankara, 06100, Turkey (Türkiye)
Ankara Ataturk Chest Diseases Training and Research Hospital
Ankara, 06500, Turkey (Türkiye)
Ege University School of Medicine; Chest Diseases Department
Izmir, 35100, Turkey (Türkiye)
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
Malatya, 44280, Turkey (Türkiye)
Barts & London School of Med; Medical Oncology
London, EC1A 7BE, United Kingdom
Royal Marsden Hospital - London
London, SW3 6JJ, United Kingdom
Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT, United Kingdom
Related Publications (2)
Saal J, Bald T, Eckstein M, Ralser DJ, Brossart P, Ellinger J, Holzel M, Klumper N. Integration of on-treatment modified Glasgow prognostic score (mGPS) to improve imaging-based prediction of outcomes in patients with non-small cell lung cancer on immune checkpoint inhibition. Lung Cancer. 2024 Mar;189:107505. doi: 10.1016/j.lungcan.2024.107505. Epub 2024 Feb 15.
PMID: 38367405DERIVEDShemesh 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.
PMID: 33241650DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2013
First Posted
January 9, 2014
Study Start
January 22, 2014
Primary Completion
May 28, 2015
Study Completion
January 11, 2019
Last Updated
January 6, 2020
Results First Posted
March 23, 2017
Record last verified: 2019-12