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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003330-32 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | 1200 mg IV every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Hormone-replacement therapy or oral contraceptives tyrosine-kinase inhibitors (TKIs) approved for treatment of NSCLC discontinued >7 days prior to Cycle 1, Day 1
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | United States | ||
| HonorHealth Research Institute - Bisgrove |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38367405 | Derived | 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. | |
| 33241650 |
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Screening was performed from Day -28 to Day -1.
Since the primary cut-off date May 8, 2015 one participant in Cohort 1 has moved to Cohort 2 and one participant in Cohort 3 was moved to Cohort 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: First Line Atezolizumab | Participants received 1200 milligrams (mg) atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by intravenous (IV) infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| May 8, 2015 to January 11, 2019 |
|
Not provided
Not provided
Not provided
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| 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). | 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). | 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). | 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). | 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. | 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. | 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. | 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) | 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. | 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 | Month 6 |
| Percentage of Participants Without an Event (Death) at 12 Months | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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) |
| 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 |
| 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. |
| Cohort 2: Second Line Atezolizumab |
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in Eastern Cooperative Oncology Group (ECOG) performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting. |
| FG002 | Cohort 3: Third Line and Beyond Atezolizumab | Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Baseline to May 8, 2015 |
|
|
Efficacy evaluable population included all enrolled participants who received any dose of the study drug (atezolizumab) during the study treatment period.
Since the primary CSR one patient in Cohort 1 has moved to Cohort 2 and one patient in Cohort 3 was moved to Cohort 2.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: First Line Atezolizumab | Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting. |
| BG001 | Cohort 2: Second Line Atezolizumab | Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting. |
| BG002 | Cohort 3: Third Line and Beyond Atezolizumab | Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Efficacy evaluable population; Number (n) equals (=) number of participants analyzed within the specified group. | Posted | Number | 95% Confidence Interval | percentage of participants | 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) |
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| Secondary | 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). | Efficacy evaluable population; n = number of participants analyzed within the specified group. | Posted | Number | 95% Confidence Interval | percentage of participants | 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) |
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| Secondary | 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). | Efficacy evaluable population; n= number of participants analyzed within the specified group. | Posted | Number | 95% Confidence Interval | percentage of participants | 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) |
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| Secondary | 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). | Efficacy evaluable population; n = number of participants analyzed within the specified group. Number of participants analyzed = overall number of participants who were evaluable for this outcome. | Posted | Median | 95% Confidence Interval | months | 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) |
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| Secondary | 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). | Efficacy evaluable population; n = number of participants analyzed within the specified group. Number of participants analyzed = overall number of participants who were evaluable for this outcome. | Posted | Median | 95% Confidence Interval | months | 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) |
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| Secondary | 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). | Efficacy evaluable population; n = number of participants analyzed within the specified group. Number of participants analyzed = overall number of participants who were evaluable for this outcome | Posted | Median | 95% Confidence Interval | months | 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) |
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| Secondary | 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. | Efficacy evaluable population; n = number of participants analyzed within the specified group. | Posted | Median | 95% Confidence Interval | months | 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) |
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| Secondary | 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. | Efficacy evaluable population; n = number of participants analyzed within the specified group. | Posted | Median | 95% Confidence Interval | months | 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) |
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| Secondary | 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. | Efficacy evaluable population; n = number of participants analyzed within the specified group. | Posted | Median | 95% Confidence Interval | months | 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) |
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| Secondary | Overall Survival : Percentage of Participants Without Event (Death) | Efficacy evaluable population; n = number of participants analyzed within the specified group. | Posted | Number | percentage of participants | 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) |
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| Secondary | 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. | Efficacy evaluable population; n = number of participants analyzed within the specified group. | Posted | Median | 95% Confidence Interval | months | 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) |
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| Secondary | Percentage of Participants Without an Event (Death) at 6 Months | Efficacy evaluable population; n = number of participants analyzed within the specified group. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 6 |
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| Secondary | Percentage of Participants Without an Event (Death) at 12 Months | Efficacy evaluable population; n = number of participants analyzed within the specified group. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 12 |
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| Secondary | 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. | Efficacy evaluable population; n = number of participants analyzed within the specified group. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 6 |
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| Secondary | 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. | Efficacy evaluable population; n = number of participants analyzed within the specified group. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 12 |
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| Secondary | 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. | Efficacy evaluable population | Posted | Median | 95% Confidence Interval | months | 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) |
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| Secondary | 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. | Efficacy evaluable population | Posted | Median | 95% Confidence Interval | months | 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) |
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| Secondary | 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. | Efficacy evaluable population | Posted | Median | 95% Confidence Interval | months | 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) |
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| Secondary | 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. | Pharmacokinetic evaluable population; n = number of participants analyzed for the specified time point. | Posted | Mean | Standard Deviation | micrograms per milliliter (μg/mL) | 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 |
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| Secondary | 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. | Efficacy evaluable population; n = number of participants analyzed at the specified time point. Number of participants analyzed = number participants who were evaluable for this outcome. | Posted | Number | percentage of participants | Baseline, post-baseline (up to 16 months) |
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| Secondary | 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. | Efficacy evaluable population; n = number of participants analyzed at the specified time point. | Posted | Number | percentage of participants | 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) |
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| Secondary | 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. | Efficacy evaluable population; n = number of participants analyzed at the specified time point. | Posted | Number | percentage of participants | 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) |
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| Secondary | 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). | Efficacy evaluable population; n = number of participants analyzed at the specified time point. | Posted | Number | percentage of participants | 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) |
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Adverse events were recorded from the date of Screening until 30 days after the final follow-up visit until data cut-off on 11 January 2019 (Up to 60 months)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: First Line Atezolizumab | Participants received 1200 milligrams (mg) atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by intravenous (IV) infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting. | 89 | 138 | 47 | 138 | 116 | 138 |
| EG001 | Cohort 2: Second Line Atezolizumab | Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in Eastern Cooperative Oncology Group (ECOG) performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting. | 193 | 269 | 117 | 269 | 229 | 269 |
| EG002 | Cohort 3: Third Line and Beyond Atezolizumab | Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting. | 198 | 252 | 113 | 252 | 229 | 252 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (22.0) | Non-systematic Assessment |
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| HAEMOLYSIS | Blood and lymphatic system disorders | MedDRA (22.0) | Non-systematic Assessment |
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| LYMPHADENITIS | Blood and lymphatic system disorders | MedDRA (22.0) | Non-systematic Assessment |
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| SPLENIC INFARCTION | Blood and lymphatic system disorders | MedDRA (22.0) | Non-systematic Assessment |
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| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA (22.0) | Non-systematic Assessment |
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| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA (22.0) | Non-systematic Assessment |
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| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (22.0) | Non-systematic Assessment |
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| ANGINA PECTORIS | Cardiac disorders | MedDRA (22.0) | Non-systematic Assessment |
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| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA (22.0) | Non-systematic Assessment |
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| ATRIAL FLUTTER | Cardiac disorders | MedDRA (22.0) | Non-systematic Assessment |
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| ATRIOVENTRICULAR BLOCK COMPLETE | Cardiac disorders | MedDRA (22.0) | Non-systematic Assessment |
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| ATRIOVENTRICULAR BLOCK SECOND DEGREE | Cardiac disorders | MedDRA (22.0) | Non-systematic Assessment |
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| CARDIAC ARREST | Cardiac disorders | MedDRA (22.0) | Non-systematic Assessment |
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| CARDIAC FAILURE | Cardiac disorders | MedDRA (22.0) | Non-systematic Assessment |
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| CARDIAC TAMPONADE | Cardiac disorders | MedDRA (22.0) | Non-systematic Assessment |
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| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA (22.0) | Non-systematic Assessment |
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| TACHYCARDIA | Cardiac disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| VENTRICULAR FIBRILLATION | Cardiac disorders | MedDRA (22.0) | Non-systematic Assessment |
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| ADRENAL INSUFFICIENCY | Endocrine disorders | MedDRA (22.0) | Non-systematic Assessment |
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| HYPOTHYROIDISM | Endocrine disorders | MedDRA (22.0) | Non-systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
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| ASCITES | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
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| COLITIS | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
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| DYSPHAGIA | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
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| GASTRIC PERFORATION | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
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| GASTRIC ULCER HAEMORRHAGE | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
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| GASTRITIS | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
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| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| HAEMATEMESIS | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
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| OESOPHAGEAL PERFORATION | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
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| OESOPHAGEAL STENOSIS | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
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| OESOPHAGEAL VARICES HAEMORRHAGE | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
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| PANCREATITIS | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
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| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
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| ASTHENIA | General disorders | MedDRA (22.0) | Non-systematic Assessment |
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| CHEST PAIN | General disorders | MedDRA (22.0) | Non-systematic Assessment |
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| CHILLS | General disorders | MedDRA (22.0) | Non-systematic Assessment |
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| DEATH | General disorders | MedDRA (22.0) | Non-systematic Assessment |
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| FATIGUE | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| HYPERTHERMIA | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| MALAISE | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PAIN | General disorders | MedDRA (22.0) | Non-systematic Assessment |
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| PYREXIA | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| SUDDEN DEATH | General disorders | MedDRA (22.0) | Non-systematic Assessment |
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| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| HEPATIC FAILURE | Hepatobiliary disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| HEPATIC HAEMORRHAGE | Hepatobiliary disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| HEPATOMEGALY | Hepatobiliary disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| BACTERAEMIA | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| CATHETER SITE INFECTION | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
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| CLOSTRIDIUM DIFFICILE COLITIS | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
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| DIVERTICULITIS | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
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| EMPYEMA | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
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| ENCEPHALITIS | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| ENTEROCOLITIS INFECTIOUS | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| ESCHERICHIA URINARY TRACT INFECTION | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| FEBRILE INFECTION | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| GASTROINTESTINAL INFECTION | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| INFECTION | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| INFECTIOUS PLEURAL EFFUSION | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| LARGE INTESTINE INFECTION | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| LUNG ABSCESS | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| LUNG INFECTION | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| MEDIASTINITIS | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| MYELITIS | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| OSTEOMYELITIS | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| PERITONITIS | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| PNEUMONIA BACTERIAL | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| PNEUMONIA PNEUMOCOCCAL | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| PNEUMONIA PSEUDOMONAL | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| SUBCUTANEOUS ABSCESS | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| VESTIBULAR NEURONITIS | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| ALLERGIC TRANSFUSION REACTION | Injury, poisoning and procedural complications | MedDRA (22.0) | Non-systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA (22.0) | Non-systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA (22.0) | Non-systematic Assessment |
| |
| INCISIONAL HERNIA | Injury, poisoning and procedural complications | MedDRA (22.0) | Non-systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA (22.0) | Non-systematic Assessment |
| |
| LOWER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA (22.0) | Non-systematic Assessment |
| |
| THORACIC VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA (22.0) | Non-systematic Assessment |
| |
| TRAUMATIC HAEMOTHORAX | Injury, poisoning and procedural complications | MedDRA (22.0) | Non-systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (22.0) | Non-systematic Assessment |
| |
| BLOOD LACTATE DEHYDROGENASE INCREASED | Investigations | MedDRA (22.0) | Non-systematic Assessment |
| |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA (22.0) | Non-systematic Assessment |
| |
| HEPATIC ENZYME INCREASED | Investigations | MedDRA (22.0) | Non-systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| FAILURE TO THRIVE | Metabolism and nutrition disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| TYPE 2 DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| GOUTY ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| INTERVERTEBRAL DISC COMPRESSION | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PATHOLOGICAL FRACTURE | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| SPINAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| ACUTE MYELOID LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
| |
| ADENOCARCINOMA OF COLON | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
| |
| BLADDER CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
| |
| COLON CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
| |
| GLIOBLASTOMA MULTIFORME | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
| |
| INVASIVE DUCTAL BREAST CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
| |
| LYMPHANGIOSIS CARCINOMATOSA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
| |
| MALIGNANT PLEURAL EFFUSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
| |
| METASTASES TO CENTRAL NERVOUS SYSTEM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
| |
| OESOPHAGEAL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
| |
| PERICARDIAL EFFUSION MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
| |
| PLEURAL MESOTHELIOMA MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
| |
| RECTAL ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
| |
| RENAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
| |
| RENAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
| |
| SMALL CELL LUNG CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
| |
| TRANSITIONAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
| |
| TUMOUR PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
| |
| APRAXIA | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| DYSARTHRIA | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| FACIAL PARALYSIS | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| HAEMORRHAGE INTRACRANIAL | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| MIGRAINE | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| MOTOR DYSFUNCTION | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| MYELOPATHY | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PARAPLEGIA | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PRESYNCOPE | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| SOMNOLENCE | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| SPINAL CORD COMPRESSION | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| VOCAL CORD PARALYSIS | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| DISORIENTATION | Psychiatric disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| CALCULUS URINARY | Renal and urinary disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| HAEMORRHAGE URINARY TRACT | Renal and urinary disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| RENAL INFARCT | Renal and urinary disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PELVIC PAIN | Reproductive system and breast disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| SCROTAL PAIN | Reproductive system and breast disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| ACQUIRED TRACHEO-OESOPHAGEAL FISTULA | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| BRONCHIAL HAEMORRHAGE | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| BRONCHIAL OBSTRUCTION | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| LARYNGEAL HAEMORRHAGE | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PULMONARY HAEMORRHAGE | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| TRACHEAL STENOSIS | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| DERMATOMYOSITIS | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| DRUG ERUPTION | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| ALCOHOL DETOXIFICATION | Surgical and medical procedures | MedDRA (22.0) | Non-systematic Assessment |
| |
| DRUG DETOXIFICATION | Surgical and medical procedures | MedDRA (22.0) | Non-systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| EMBOLISM | Vascular disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| HAEMATOMA | Vascular disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| INTERNAL HAEMORRHAGE | Vascular disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| JUGULAR VEIN THROMBOSIS | Vascular disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PERIPHERAL ARTERY OCCLUSION | Vascular disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PHLEBITIS | Vascular disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| SUPERIOR VENA CAVA SYNDROME | Vascular disorders | MedDRA (22.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| HYPOTHYROIDISM | Endocrine disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| CHILLS | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| MALAISE | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PAIN | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| LUNG INFECTION | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (22.0) | Non-systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA (22.0) | Non-systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA (22.0) | Non-systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 1-800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
Not provided
Not provided
Not provided
| Physician Decision |
|
| Unknown Reason |
|
| Withdrawal by Subject |
|
| On Survival Follow-Up |
|
| On Treatment |
|
| Lost to Follow-up |
|
| Male |
|
|
| TC3 or IC2/3 Responders |
|
|
| TC2/3 or IC2/3 Responders |
|
|
| OG002 | Cohort 3: Third Line and Beyond Atezolizumab | Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting. |
| OG003 | Cohorts 2 + 3 | This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group. |
|
|
Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
| OG002 | Cohort 3: Third Line and Beyond Atezolizumab | Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting. |
| OG003 | Cohorts 2 + 3 | This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group. |
|
|
| OG001 | Cohort 2: Second Line Atezolizumab | Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting. |
| OG002 | Cohort 3: Third Line and Beyond Atezolizumab | Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting. |
| OG003 | Cohorts 2 + 3 | This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group. |
|
|
| OG001 | Cohort 2: Second Line Atezolizumab | Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting. |
| OG002 | Cohort 3: Third Line and Beyond Atezolizumab | Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting. |
| OG003 | Cohorts 2 + 3 | This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group. |
|
|
| OG001 | Cohort 2: Second Line Atezolizumab | Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting. |
| OG002 | Cohort 3: Third Line and Beyond Atezolizumab | Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting. |
| OG003 | Cohorts 2 + 3 | This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group. |
|
|
| OG002 | Cohort 3: Third Line and Beyond Atezolizumab | Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting. |
| OG003 | Cohorts 2 + 3 | This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group. |
|
|
| OG002 | Cohort 3: Third Line and Beyond Atezolizumab | Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting. |
| OG003 | Cohorts 2 + 3 | This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group. |
|
|
| OG002 | Cohort 3: Third Line and Beyond Atezolizumab | Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting. |
| OG003 | Cohorts 2 + 3 | This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group. |
|
|
| OG002 | Cohort 3: Third Line and Beyond Atezolizumab | Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting. |
| OG003 | Cohorts 2 + 3 | This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group. |
|
|
| OG002 | Cohort 3: Third Line and Beyond Atezolizumab | Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting. |
| OG003 | Cohorts 2 + 3 | This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group. |
|
|
| Cohort 3: Third Line and Beyond Atezolizumab |
Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting. |
| OG003 | Cohorts 2 + 3 | This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group. |
|
|
| Cohort 3: Third Line and Beyond Atezolizumab |
Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting. |
| OG003 | Cohorts 2 + 3 | This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group. |
|
|
| OG002 | Cohort 3: Third Line and Beyond Atezolizumab | Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting. |
| OG003 | Cohorts 2 + 3 | This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group. |
|
|
| OG002 | Cohort 3: Third Line and Beyond Atezolizumab | Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting. |
| OG003 | Cohorts 2 + 3 | This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group. |
|
|
| OG002 | Cohort 3: Third Line and Beyond Atezolizumab | Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting. |
| OG003 | Cohorts 2 + 3 | This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group. |
|
|
| OG002 | Cohort 3: Third Line and Beyond Atezolizumab | Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting. |
| OG003 | Cohorts 2 + 3 | This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group. |
|
|
| OG002 | Cohort 3: Third Line and Beyond Atezolizumab | Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting. |
| OG003 | Cohorts 2 + 3 | This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group. |
|
|
|
| OG002 | Cohort 3: Third Line and Beyond Atezolizumab | Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting. |
| OG003 | Cohorts 2 + 3 | This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group. |
|
|
| OG002 | Cohort 3: Third Line and Beyond Atezolizumab | Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting. |
| OG003 | Cohorts 2 + 3 | This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group. |
|
|
| OG002 | Cohort 3: Third Line and Beyond Atezolizumab | Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting. |
| OG003 | Cohorts 2 + 3 | This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group. |
|
|
| OG002 | Cohort 3: Third Line and Beyond Atezolizumab | Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting. |
| OG003 | Cohorts 2 + 3 | This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group. |
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