Non-Small Cell Lung CancerPhase 2BIRCHNCT02031458
A Study of Atezolizumab in Participants With Programmed Death - Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
A Phase 2 study testing Atezolizumab in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 110 sites in 19 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Atezolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 667 participants
- Where
- 110 sitesin 19 countries
- Study dates
- 22 Jan 2014to 11 Jan 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
110 sites in 19 countries.
110 sites in 19 countries
United States37 sites
Emory Uni - Winship Cancer Center; Hematology/Oncology
Atlanta, Georgia, 30322
University of Colorado Health Science Center; Biomedical Research Bldg. Room 511
Aurora, Colorado, 80045
Uni of Maryland; Greenebaum Cancer Center
Baltimore, Maryland, 21201
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Med Ctr; Hem/Onc
Boston, Massachusetts, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
University of Virginia; Office of Sponsored Programs
Charlottesville, Virginia, 22902
Northwestern University; Robert H. Lurie Comp Can Ctr
Chicago, Illinois, 60611
University Of Chicago Medical Center; Section Of Hematology/Oncology
Chicago, Illinois, 60637
Oncology Hematology Care Inc
Cincinnati, Ohio, 45242
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State University; B406 Starling-Loving Hall
Columbus, Ohio, 43210
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Florida Cancer Specialists; SCRI
Fort Myers, Florida, 33901
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
MD Anderson Cancer Center
Houston, Texas, 77030
Carolina BioOncology Institute, PLCC
Huntersville, North Carolina, 28078
Monter Cancer Center
Lake Success, New York, 11042
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Angeles Clinic & Rsch Inst
Los Angeles, California, 90025
University of Wisconsin
Madison, Wisconsin, 53792
Northwest Georgia Oncology Centers PC - Marietta
Marietta, Georgia, 30060
Tennessee Oncology PLLC - Nashville (20th Ave)
Nashville, Tennessee, 37203
Yale Cancer Center; Medical Oncology
New Haven, Connecticut, 06520
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Florida Hospital Cancer Inst
Orlando, Florida, 32804
Fox Chase Cancer Center; Hematology/Oncology
Philadelphia, Pennsylvania, 19111
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952
Huntsman Cancer Institute; University of Utah
Salt Lake City, Utah, 84112
HonorHealth Research Institute - Bisgrove
Scottsdale, Arizona, 85258
University of Washington Seattle Cancer Care Alliance
Seattle, Washington, 98195
City of Hope National Medical Group
South Pasadena, California, 91030
Washington University School of Medicine
St Louis, Missouri, 63110
Florida Cancer Specialists.
St. Petersburg, Florida, 33705
Stanford Cancer Center
Stanford, California, 94305-5820
Georgetown University Medical Center Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
Japan11 sites
National Hospital Organization Kyushu Medical Center; Respiratory Internal Medicine
Fukuoka, 810-8563
Kanagawa Cardiovascular and Respiratory Center; Respiratory Medicine
Kanagawa, 236-0051
Yokohama Municipal Citizen'S Hospital; Respiratory Medicine
Kanagawa, 240-8555
Kitasato University Hospital; Respiratory Medicine
Kanagawa, 252-0375
Kyoto University Hospital, Respiratory Medicine
Kyoto, 606-8507
Sendai Kousei Hospital; Pulmonary Medicine
Miyagi, 980-0873
Osaka International Cancer Institute; Thoracic Oncology
Osaka, 541-8567
Kansai Medical university Hospital; Thoracic Oncology
Osaka, 573-1191
Osaka Habikino Medical Center
Osaka, 583-8588
National Cancer Center Hospital; Thoracic Medical Oncology
Tokyo, 104-0045
Toranomon Hospital; Respiratory Medicine
Tokyo, 105-8470
France8 sites
Hopital Augustin Morvan; Oncologie Thoracique
Brest, 29609
Hopital Cote De Nacre; Pneumologie
Caen, 14000
CHU Limoges - Dupuytren; Oncologie Thoracique Cutanee
Limoges, 87042
Centre Leon Berard; Departement Oncologie Medicale
Lyon, 69373
Hopital Arnaud De Villeneuve; Maladies Respiratoires
Montpellier, 34295
Centre René Gauducheau - cancer Nantes - Atlantique; Service Oncologie Médicale
Nantes, 44805
Nouvel Hopital Civil; Pneumologie
Strasbourg, 67091
Institut Gustave Roussy; Departement Oncologie Medicale
Villejuif, 94805
Australia5 sites
Austin Health
Heidelberg, Victoria, 3084
Peter Maccallum Cancer Institute; Medical Oncology
Melbourne, Victoria, 3000
Sir Charles Gairdner Hospital; Medical Oncology
Nedlands, Western Australia, 6009
Royal North Shore Hospital; Oncology
St Leonards, New South Wales, 2065
Princess AleXandra Hospital; Department of Medical Oncology
Woolloongabba, Queensland, 4102
Canada5 sites
Lakeridge Health Oshawa; Oncology
Oshawa, Ontario, L1G 2B9
The Ottawa Hospital Cancer Centre; Oncology
Ottawa, Ontario, K1H 8L6
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N 3M5
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto, Ontario, M5G 2M9
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6
Germany5 sites
Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung
Essen, 45122
LungenClinic Großhansdorf GmbH
Großhansdorf, 22927
Klinikum Nuernberg Nord; Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie, Schlafmedizin
Nuremberg, 90419
Pius-Hospital; Klinik fuer Haematologie und Onkologie
Oldenburg, 26121
Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie
Villingen-Schwenningen, 78052
Belgium4 sites
Cliniques Universitaires St-Luc
Brussels, 1200
GHdC Site Saint-Joseph
Charleroi, 6000
UZ Leuven Gasthuisberg
Leuven, 3000
Sint Augustinus Wilrijk
Wilrijk, 2610
Georgia4 sites
Research institute for Clinical Medicine
Tbilisi, 0112
Cancer Research Centre
Tbilisi, 0159
MediClab Georgia
Tbilisi, 0160
Chemotherapy and Immunotherapy Clinic Medulla
Tbilisi, 0186
Switzerland4 sites
Universitaetsspital Basel; Onkologie
Basel, 4031
CHUV; Departement d'Oncologie
Lausanne, 1011
Kantonsspital St. Gallen; Onkologie/Hämatologie
Sankt Gallen, 9007
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
Zurich, 8091
Turkey (Türkiye)4 sites
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Ankara, 06100
Ankara Ataturk Chest Diseases Training and Research Hospital
Ankara, 06500
Ege University School of Medicine; Chest Diseases Department
Izmir, 35100
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
Malatya, 44280
Bosnia and Herzegovina3 sites
University Clinical Centre of the Republic of Srpska
Banja Luka, 78000
University Clinical Center Sarajevo;Clinic for Pulmonary disease
Sarajevo, 71000
University Clinical Center Sarajevo;Institute of oncology
Sarajevo, 71000
Hong Kong3 sites
Queen Elizabeth Hospital; Clinical Oncology
Hong Kong
Queen Mary Hospital; Dept. of Clinical Oncology
Hong Kong
Prince of Wales Hosp; Dept. Of Clinical Onc
Shatin
Italy3 sites
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola, Emilia-Romagna, 47014
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
Milan, Lombardy, 20133
Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico
Orbassano, Piedmont, 10043
Netherlands3 sites
Antoni Van Leeuwenhoek Ziekenhuis; Thoracic Oncology
Amsterdam, 1066 CX
Amphia Ziekenhuis; Afdeling Longziekten
Breda, 4818 CK
Academ Ziekenhuis Groningen; Medical Oncology
Groningen, 9713 GZ
Spain3 sites
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, 08035
ICO Badalona - Hospital Germans Trias i Pujol
Barcelona, 08916
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Seville, 41013
United Kingdom3 sites
Barts & London School of Med; Medical Oncology
London, EC1A 7BE
Royal Marsden Hospital - London
London, SW3 6JJ
Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT
Bulgaria2 sites
Complex Oncology Center (COC)-Plovidiv
Plovdiv, 4000
Specialized Hospital for Active Treatment of Oncology
Sofia, 1756
Singapore2 sites
National University Hospital; National University Cancer Institute, Singapore (NCIS)
Singapore, 119228
National Cancer Centre; Medical Oncology
Singapore, 169610
About this study
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
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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Atezolizumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabDrug
1200 mg IV every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Atezolizumab | Experimental | Not described Receives: Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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
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).
Measured: 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)
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.
Measured: 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 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.
Measured: 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 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.
Measured: 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 : Percentage of Participants Without Event (Death)
Measured: 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 : Median Time to Event (Death)
Overall survival is measured as interval between the first dose of atezolizumab and date of death from any cause.
Measured: 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 Without an Event (Death) at 6 Months
Measured: Month 6
Percentage of Participants Without an Event (Death) at 12 Months
Measured: Month 12
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.
Measured: Month 6
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.
Measured: Month 12
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.
Measured: 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 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.
Measured: 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 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.
Measured: 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)
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.
Measured: 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
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.
Measured: Baseline, post-baseline (up to 16 months)
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.
Measured: 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 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.
Measured: 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 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).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study start22 Jan 2014
- Primary completion28 May 2015
- Study completion11 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 667 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031458
- Sponsor's protocol ID
- GO28754
- Other IDs
- 2013-003330-32
- Acronym
- BIRCH
- Status last verified
- Dec 2019
- First submitted
- 16 Dec 2013
- Last updated
- 6 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 38367405Shemesh 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.
PubMed 33241650
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02031458
- Acronym / sponsor ID
- BIRCH / GO28754
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 667 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2014 (actual)
- Primary completion
- 28 May 2015 (actual)
- Study completion
- 11 Jan 2019 (actual)
- First posted
- 9 Jan 2014 (estimated)
- Results
- Posted 23 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atezolizumab | Experimental | Drug: Atezolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atezolizumab1200 mg IV every 3 weeks | Drug | Atezolizumab |
Primary outcome
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).
22 secondary outcomes
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)
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)
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 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 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)
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 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 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)
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)
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)
Percentage of Participants Without an Event (Death) at 6 Months
Time frame: Month 6
Percentage of Participants Without an Event (Death) at 12 Months
Time frame: Month 12
PFS: Percentage of Participants Alive and Progression Free at 6 Months
Time frame: Month 6
PFS: Percentage of Participants Alive and Progression Free at 12 Months
Time frame: Month 12
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 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 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)
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
Percentage of Participants With Positive Anti-Therapeutic Antibody (Anti-Atezolizumab Antibody) Status
Time frame: Baseline, post-baseline (up to 16 months)
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)
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38367405Saal 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.
- Derived from this study: PubMed 33241650Shemesh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
110 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atezolizumab in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 110 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 110 sites in United States, Japan, France, Australia, Canada and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02031458, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2020.