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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-005189-75 | EudraCT Number |
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This is an open-label, multicenter, non-randomized extension and long-term observational study. Participants receiving atezolizumab monotherapy or atezolizumab combined with other agent(s) or comparator agent(s) in a Genentech or Roche-sponsored study (the parent study) and who continue to receive study treatment at the time of the parent-study closure and do not have access to the study treatment locally are eligible for continued treatment in the extension study. Dosing regimen for a given participant and indication will be the same or equivalent to the respective parent study protocol. Study treatment in the extension study can continue until disease progression or beyond if the patient continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; patient non-compliance; or study termination by the Sponsor, whichever occurs first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab Monotherapy | Experimental | Participants will continue to receive atezolizumab monotherapy in a Genentech or Roche-sponsored study (the parent study) in accordance with local prescribing information till the participant continues to derive clinical benefit or until death, withdrawal of study consent, unacceptable toxicity, pregnancy, participant non-compliance, or study termination by the Sponsor, whichever occurs first. |
|
| Combined Agents with Atezolizumab | Experimental | Participants will receive treatment of atezolizumab with combined agent(s) as directed per the parent study. Participants will receive agent(s) in combination with atezolizumab at the same dose and schedule, and with the same administration guidelines that were in effect at the time of participant discontinuation from the parent study. |
|
| Comparator Treatment | Active Comparator | Participants will receive comparator treatment administration as directed per the parent study. Participants will receive comparator treatment at the same dose and schedule, and with the same administration guidelines that were in effect at the time of participant discontinuation from the parent study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab will be administered as a monotherapy or atezolizumab with other agent(s) as per parent protocol. Dosing regimen will continue in accordance with the parent study or at equivalent dose (if applicable) and at the same schedule as the parent study, or switch to a fixed atezolizumab dose of 1200 mg every 3 weeks (Q3W). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Continued Access to Atezolizumab-Based Therapy and/or Comparator Agent(s) | Day 1 up to maximum 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Serious Adverse Events (SAEs) by Severity Determined According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Day 1 up to 90 days after last dose of study treatment (last dose=till clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years) |
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Inclusion Criteria:
Specific criteria for patients who continue treatment as well as safety and survival follow-up in the extension study (and survival follow up for pattients who roll over from IMpower133):
Specific criteria for patients from the IMpower133 parent study only who do not continue treatment in the extension study and/or receive commercially available atezolizumab (Tecentriq) outside this extension study and continue safety and survival follow-up only in the extension study:
- Discontinuation of atezolizumab-based therapy in the IMpower133 parent study and in survival follow- up at the time of IMpower133 parent study closure, or eligible for continuing or crossing over to atezolizumab-based therapy as per the IMpower133 parent protocol and have access to commercially available atezolizumab (Tecentriq) outside this extension study at the time of the IMpower133 parent-study closure
Exclusion Criteria:
Specific criteria for patients who continue treatment as well as safety and survival follow-up in the extension study:
Specific criteria for patients who do not continue treatment in the extension study and/or receive commercially available atezolizumab (Tecentriq) outside this extension study and continue safety and survival follow-up only in the extension study:
- Discontinuation of comparator in parent study and in survival follow-up at the time of parent study closure
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute ? Bisgrove | Scottsdale | Arizona | 85258 | United States | ||
| Angeles Clinic & Rsch Inst |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39306923 | Derived | Reck M, Dziadziuszko R, Sugawara S, Kao S, Hochmair M, Huemer F, de Castro G Jr, Havel L, Bernabe Caro R, Losonczy G, Lee JS, Kowalski DM, Andric Z, Califano R, Veatch A, Gerstner G, Batus M, Morris S, Kaul M, Cuchelkar V, Li H, Danner BJ, Nabet BY, Liu SV. Five-year survival in patients with extensive-stage small cell lung cancer treated with atezolizumab in the Phase III IMpower133 study and the Phase III IMbrella A extension study. Lung Cancer. 2024 Oct;196:107924. doi: 10.1016/j.lungcan.2024.107924. Epub 2024 Aug 10. |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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|
|
| Bevacizumab | Drug | Bevacizumab will be administered as directed per the parent study. |
|
|
| Percentage of Participants With Adverse Events of Special Interest by Severity Determined According to NCI CTCAE Version 4.0 | Day 1 up to 90 days after last dose of study treatment (last dose=till clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years) |
| Time from Randomization or Treatment Initiation to Death due to any Cause for IMpower133 Participants Only | Day 1 (as indicated in parent study protocol) until death due to any cause (up to maximum 10 years or until the sponsor stop) |
| Los Angeles |
| California |
| 90025 |
| United States |
| UCLA | Los Angeles | California | 90095 | United States |
| Kaiser Permanente - San Diego (Zion Ave) | San Marcos | California | 92078 | United States |
| University Of Colorado | Aurora | Colorado | 80045 | United States |
| Rocky Mountain Cancer Ctr - Denver (Williams) | Denver | Colorado | 80218 | United States |
| Smilow Cancer Hospital at Yale New Haven | New Haven | Connecticut | 06510 | United States |
| Georgetown University Medical Center Lombardi Cancer Center | Washington D.C. | District of Columbia | 20057 | United States |
| Florida Cancer Specialists - Fort Myers (Broadway) | Fort Myers | Florida | 33901 | 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 |
| H. Lee Moffitt Cancer Center and Research Inst. | Tampa | Florida | 33612 | United States |
| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital | Marietta | Georgia | 30060 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612-3244 | United States |
| University Of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Ingalls Memorial Hospital | Harvey | Illinois | 60426 | United States |
| Illinois Cancer Care | Peoria | Illinois | 61615 | United States |
| New England Cancer Specialists | Westbrook | Maine | 04092 | United States |
| Johns Hopkins Univ Med Center | Baltimore | Maryland | 21231 | United States |
| Maryland Oncology Hematology, P.A. | Columbia | Maryland | 21044 | United States |
| Massachusetts General Hospital. | Boston | Massachusetts | 02114 | United States |
| Beth Israel Medical Center | Boston | Massachusetts | 02215 | United States |
| Dana Farber Cancer Inst. | Boston | Massachusetts | 02215 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| US oncology research at Minnesota Oncology | Saint Louis Park | Minnesota | 55416 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Comprehensive Cancer Centers of Nevada - Eastern Avenue | Las Vegas | Nevada | 89169 | United States |
| Summit Medical Center | Florham Park | New Jersey | 07932 | United States |
| New York Oncology Hematology, P.C. | Albany | New York | 12206 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Carolina BioOncology Institute, PLCC | Huntersville | North Carolina | 28078 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Oncology Associates of Oregon, P.C | Eugene | Oregon | 97401 | United States |
| Northwest Cancer Specialists - Portland (N Broadway) | Portland | Oregon | 97227 | United States |
| Penn State Hershey Cancer Institute | Hershey | Pennsylvania | 17033 | United States |
| Allegheny Cancer Center | Pittsburgh | Pennsylvania | 15212 | United States |
| Sarah Cannon Res Inst | Nashville | Tennessee | 37203 | United States |
| Texas Oncology - DFW | Dallas | Texas | 75246 | United States |
| Tyler Cancer Center | Tyler | Texas | 75702 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| Blue Ridge Cancer Care | Roanoke | Virginia | 24014 | United States |
| University of Washington Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | United States |
| Fundación CENIT para la Investigación en Neurociencias | Buenos Aires | C1125ABD | Argentina |
| Chris O'Brien Lifehouse | Camperdown | New South Wales | 2050 | Australia |
| Princess AleXandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Klinik Penzing | Vienna | 1140 | Austria |
| Krankenhaus Nord - Klinik Floridsdorf | Vienna | 1210 | Austria |
| AZ Glorieux- vzw Werken Glorieux | Ronse | 9600 | Belgium |
| ZAS Sint Augustinus Wilrijk | Wilrijk | 2610 | Belgium |
| Hospital de Cancer de Barretos | Barretos | São Paulo | 14784-400 | Brazil |
| Instituto do Cancer do Estado de Sao Paulo - ICESP | São Paulo | São Paulo | 01246-000 | Brazil |
| Fundacao Antonio Prudente | São Paulo | São Paulo | 01509-900 | Brazil |
| Multiprofile Hospital for Active Treatment Serdika EOOD | Sofia | 1303 | Bulgaria |
| Royal Victoria Hospital | Barrie | Ontario | L4M 6M2 | Canada |
| William Osler Health Centre | Brampton | Ontario | L6R 3J7 | Canada |
| Lakeridge Health Corporation-Oshawa | Oshawa | Ontario | L1G 2B9 | Canada |
| Sunnybrook Odette Cancer Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Princess Margaret Cancer Center | Toronto | Ontario | M5G 1Z5 | Canada |
| Cite de La Sante de Laval | Laval | Quebec | H7M 3L9 | Canada |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| Bradford Hill Centro de Investigaciones Clinicas | Recoleta | 8420383 | Chile |
| Masarykuv onkologicky ustav | Brno | 656 53 | Czechia |
| Thomayerova nemocnice | Praha 4 - Krc | 140 59 | Czechia |
| Hopital Jean Minjoz | Besançon | 25030 | France |
| Chu Grenoble - Hopital Albert Michallon | Grenoble | 38043 | France |
| Centre Leon Berard | Lyon | 69373 | France |
| Hopital Nord | Marseille | 13915 | France |
| Centre René Gauducheau - cancer Nantes - Atlantique | Nantes | 44805 | France |
| Centre Antoine Lacassagne, Centre de Lutte Contre le Cancer (CLCC) de Nice | Nice | 06189 | France |
| Hopital Saint Louis | Paris | 75475 | France |
| GH Paris Saint Joseph | Paris | 75674 | France |
| Hopital Tenon | Paris | 75970 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| CH de Saint Quentin | Saint-Quentin | 2100 | France |
| Centre Medico-Chirurgical Foch | Suresnes | 92151 | France |
| CHU de Toulouse - Hôpital Larrey | Toulouse | 31059 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Klinikum d.Universität München Campus Großhadern | München | 81377 | Germany |
| Semmelweis Egyetem X | Budapest | 1083 | Hungary |
| Református Pulmonológiai Centrum | Törökbálint | 2045 | Hungary |
| Belinson Medical Center | Petah Tikva | 4922297 | Israel |
| Azienda Osp Uni Seconda Università Degli Studi Di Napoli | Naples | Campania | 80131 | Italy |
| Azienda Ospedaliera A. Cardarelli | Naples | Campania | 80131 | Italy |
| Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale | Naples | Campania | 80131 | Italy |
| A.O. Universitaria Policlinico Di Modena | Modena | Emilia-Romagna | 41100 | Italy |
| Università Cattolica Del S Cuore | Rome | Lazio | 00168 | Italy |
| IRCCS AOU San Martino - IST | Genoa | Liguria | 16132 | Italy |
| ASL 3 Genovese | Genoa | Liguria | 16149 | Italy |
| Irccs Istituto Nazionale Dei Tumori (Int) | Milan | Lombardy | 20133 | Italy |
| Irccs Istituto Europeo Di Oncologia (IEO) | Milan | Lombardy | 20141 | Italy |
| Asst Di Monza | Monza | Lombardy | 20900 | Italy |
| A.O.U. Maggiore della Carità | Novara | Piedmont | 28100 | Italy |
| Azienda Ospedaliero-Universitaria San Luigi Gonzaga | Orbassano | Piedmont | 10043 | Italy |
| Policlinico Vittorio Emanuele | Catania | Sicily | 95123 | Italy |
| Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato | Arezzo | Tuscany | 52100 | Italy |
| A.O. Universitaria Pisana-Ospedale Cisanello | Pisa | Tuscany | 56124 | Italy |
| Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica | Siena | Tuscany | 53100 | Italy |
| Ospedale Santa Maria Della | Perugia | Umbria | 06129 | Italy |
| IOV - Istituto Oncologico Veneto - IRCCS | Padova | Veneto | 35128 | Italy |
| Shikoku Cancer Center | Ehime | 791-0280 | Japan |
| Sendai Kousei Hospital | Miyagi | 981-0914 | Japan |
| Niigata Cancer Center Hospital | Niigata | 951-8566 | Japan |
| Iwate Medical University Hospital | Numakunai | 028-3695 | Japan |
| Okayama University Hospital | Okayama | 700-8558 | Japan |
| Toranomon Hospital | Tokyo | 105-8470 | Japan |
| The Cancer Institute Hospital of JFCR, Respiratory Medicine | Tokyo | 135-8550 | Japan |
| Wakayama Medical University Hospital | Wakayama | 641-8510 | Japan |
| NKI/AvL | Amsterdam | 1066 CX | Netherlands |
| Auckland city hospital | Auckland | 1023 | New Zealand |
| Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii | Gdansk | 80-952 | Poland |
| Oddzia? Onkologii Klinicznej i Chemioterapii Szpitala ELBL?SKA | Warsaw | 01-748 | Poland |
| Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad | Warsaw | 02-781 | Poland |
| Hospital de Santa Maria | Lisbon | 1649-035 | Portugal |
| Centro Hospitalar do Porto ? Hospital de Santo António | Porto | 4099-001 | Portugal |
| Institut Oncologic Ion Chiricuta | Cluj-Napoca | 400015 | Romania |
| ONCOMED - Medical Centre | Timișoara | 300239 | Romania |
| Moscow City Oncology Hospital #62 | Moscovskaya Oblast | Moscow Oblast | 143423 | Russia |
| Clinic for Pulmonology, Clinical Center of Serbia | Belgrade | 11000 | Serbia |
| University Hospital Medical Center Bezanijska kosa | Belgrade | 11080 | Serbia |
| Institute of Oncology Ljubljana | Ljubljana | 1000 | Slovenia |
| National Cancer Center | Gyeonggi-do | 10408 | South Korea |
| Seoul National University Bundang Hospital | Gyeonggi-do | 13620 | South Korea |
| Chonnam National University Hwasun Hospital | Jeollanam-do | 58128 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Hospital Son Llatzer | Palma de Mallorca | Balearic Islands | 07198 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | Cordoba | 14004 | Spain |
| Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología | A Coruña | LA Coruna | 15006 | Spain |
| Hospital Universitario Materno Infantil de Gran Canaria | Las Palmas de Gran Canaria | LAS Palmas | 35016 | Spain |
| Clinica Universitaria de Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Vall d'Hebron Institute of Oncology (VHIO), Barcelona | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona. Unidad de Nuevas Terapias | Barcelona | 08036 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
| Institut Catala d Oncologia Hospital Duran i Reynals | Barcelona | 08908 | Spain |
| Hospital Universitari Germans Trias i Pujol | Barcelona | 08916 | Spain |
| Hospital San Pedro De Alcantara | Cáceres | 10003 | Spain |
| Complejo Hospitalario de Jaen | Jaén | 23007 | Spain |
| Hospital Lucus Augusti | Lugo | 27003 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28007 | Spain |
| Hospital Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario Clínico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital de Madrid Norte Sanchinarro- Centro Integral Oncologico Clara Campal | Madrid | 28050 | Spain |
| Hospital Regional Universitario Carlos Haya | Málaga | 29010 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| Hospital NisA 9 de Octubre | Valencia | 46015 | Spain |
| CHUV | Lausanne | 1011 | Switzerland |
| Changhua Christian Hospital | Changhua | 500 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| National Taiwan Uni Hospital | Taipei | 100 | Taiwan |
| Chulalongkorn Hospital | Bangkok | 10330 | Thailand |
| Ramathibodi Hospital | Bangkok | 10400 | Thailand |
| Faculty of Med. Siriraj Hosp. | Bangkok | 10700 | Thailand |
| Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi | Edirne | 22030 | Turkey (Türkiye) |
| Istanbul Uni Cerrahpasa Medical Faculty Hospital | Istanbul | 34300 | Turkey (Türkiye) |
| Hacettepe Uni Medical Faculty Hospital | S?hhiye, Ankara | 06100 | Turkey (Türkiye) |
| Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU | Dnipropetrovsk | 49102 | Ukraine |
| Barts & London School of Med | London | EC1A 7BE | United Kingdom |
| Royal Free Hospital | London | NW3 2QG | United Kingdom |
| St George's Hospital | London | SW17 0QT | United Kingdom |
| Royal Marsden Hospital - London | London | SW3 6JJ | United Kingdom |
| Charing Cross Hospital | London | W6 8RF | United Kingdom |
| Christie Hospital NHS Trust | Manchester | M20 4BX | United Kingdom |
| The Clatterbridge Cancer Centre NHS Foundation Trust | Metropolitan Borough of Wirral | L63 4JY | United Kingdom |
| Nottingham City Hospital | Nottingham | NG5 1PB | United Kingdom |
| Royal Marsden Hospital - Surrey | Surrey | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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