A Study in Participants Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study (IMbrella A)

NCT ID: NCT03148418

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

382 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-20

Study Completion Date

2030-03-06

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Atezolizumab Monotherapy

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.

Group Type EXPERIMENTAL

Atezolizumab

Intervention Type 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).

Combined Agents with Atezolizumab

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.

Group Type EXPERIMENTAL

Atezolizumab

Intervention Type 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).

Bevacizumab

Intervention Type DRUG

Bevacizumab will be administered as directed per the parent study.

Comparator Treatment

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.

Group Type ACTIVE_COMPARATOR

Bevacizumab

Intervention Type DRUG

Bevacizumab will be administered as directed per the parent study.

Interventions

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Atezolizumab

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).

Intervention Type DRUG

Bevacizumab

Bevacizumab will be administered as directed per the parent study.

Intervention Type DRUG

Other Intervention Names

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RO5541267 Tecentriq Avastin

Eligibility Criteria

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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):

* Eligible for continuing or crossing over to atezolizumab-based therapy at the time of the parent-study closure as per the parent study or eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study at the time of the parent-study closure as per the parent study, with no access to commercially available comparator agent
* First dose of study treatment in the extension study will be received within 7 days of the treatment interruption window allowed by the parent study
* Continue to benefit from atezolizumab-based study treatment or from the comparator at the time of parent-study closure as assessed by the investigator
* Negative serum pregnancy test within 7 days prior to start of study treatment in women of childbearing potential

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:

* Meet of any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in the extension study
* Study treatment is commercially marketed in the patient's country for the patient specific disease and is accessible to the patient
* Time between the last dose of treatment received in parent study and first dose in extension study is longer than the interruption period (± 7 days) allowed in the parent study
* Treatment with any anti-cancer treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in the extension study
* Permanent discontinuation of atezolizumab for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in the extension study (if applicable)
* Any unresolved or irreversible toxicities during the parent study that required permanent discontinuation of study treatment, in accordance to the parent study or local prescribing information
* Ongoing SAE(s) that has not resolved to baseline level or Grade less than or equal to (\<=) 1 from the parent study or during the time between last treatment in the parent study and the first dose of study treatment in the extension study
* Any serious uncontrolled concomitant disease that would contraindicate the use of study treatment at the time of the extension study or that would place the participant at high risk for treatment-related complications
* Concurrent participation in any therapeutic clinical trial (other than the parent 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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HonorHealth Research Institute ? Bisgrove

Scottsdale, Arizona, United States

Site Status

Angeles Clinic & Rsch Inst

Los Angeles, California, United States

Site Status

UCLA

Los Angeles, California, United States

Site Status

Kaiser Permanente - San Diego (Zion Ave)

San Marcos, California, United States

Site Status

University Of Colorado

Aurora, Colorado, United States

Site Status

Rocky Mountain Cancer Ctr - Denver (Williams)

Denver, Colorado, United States

Site Status

Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut, United States

Site Status

Georgetown University Medical Center Lombardi Cancer Center

Washington D.C., District of Columbia, United States

Site Status

Florida Cancer Specialists - Fort Myers (Broadway)

Fort Myers, Florida, United States

Site Status

Hematology Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, United States

Site Status

Florida Cancer Specialists.

St. Petersburg, Florida, United States

Site Status

H. Lee Moffitt Cancer Center and Research Inst.

Tampa, Florida, United States

Site Status

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

Marietta, Georgia, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

University Of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Ingalls Memorial Hospital

Harvey, Illinois, United States

Site Status

Illinois Cancer Care

Peoria, Illinois, United States

Site Status

New England Cancer Specialists

Westbrook, Maine, United States

Site Status

Johns Hopkins Univ Med Center

Baltimore, Maryland, United States

Site Status

Maryland Oncology Hematology, P.A.

Columbia, Maryland, United States

Site Status

Massachusetts General Hospital.

Boston, Massachusetts, United States

Site Status

Beth Israel Medical Center

Boston, Massachusetts, United States

Site Status

Dana Farber Cancer Inst.

Boston, Massachusetts, United States

Site Status

Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

US oncology research at Minnesota Oncology

Saint Louis Park, Minnesota, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Comprehensive Cancer Centers of Nevada - Eastern Avenue

Las Vegas, Nevada, United States

Site Status

Summit Medical Center

Florham Park, New Jersey, United States

Site Status

New York Oncology Hematology, P.C.

Albany, New York, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Carolina BioOncology Institute, PLCC

Huntersville, North Carolina, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Oncology Associates of Oregon, P.C

Eugene, Oregon, United States

Site Status

Northwest Cancer Specialists - Portland (N Broadway)

Portland, Oregon, United States

Site Status

Penn State Hershey Cancer Institute

Hershey, Pennsylvania, United States

Site Status

Allegheny Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status

Sarah Cannon Res Inst

Nashville, Tennessee, United States

Site Status

Texas Oncology - DFW

Dallas, Texas, United States

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Tyler Cancer Center

Tyler, Texas, United States

Site Status

Virginia Oncology Associates

Norfolk, Virginia, United States

Site Status

Blue Ridge Cancer Care

Roanoke, Virginia, United States

Site Status

University of Washington Seattle Cancer Care Alliance

Seattle, Washington, United States

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Northwest Medical Specialties

Tacoma, Washington, United States

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Fundación CENIT para la Investigación en Neurociencias

Buenos Aires, , Argentina

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Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

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Princess AleXandra Hospital

Woolloongabba, Queensland, Australia

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Klinik Penzing

Vienna, , Austria

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Krankenhaus Nord - Klinik Floridsdorf

Vienna, , Austria

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AZ Glorieux- vzw Werken Glorieux

Ronse, , Belgium

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ZAS Sint Augustinus Wilrijk

Wilrijk, , Belgium

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Hospital de Cancer de Barretos

Barretos, São Paulo, Brazil

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Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, Brazil

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Fundacao Antonio Prudente

São Paulo, São Paulo, Brazil

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Multiprofile Hospital for Active Treatment Serdika EOOD

Sofia, , Bulgaria

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Royal Victoria Hospital

Barrie, Ontario, Canada

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William Osler Health Centre

Brampton, Ontario, Canada

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Lakeridge Health Corporation-Oshawa

Oshawa, Ontario, Canada

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Sunnybrook Odette Cancer Centre

Toronto, Ontario, Canada

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Princess Margaret Cancer Center

Toronto, Ontario, Canada

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Cite de La Sante de Laval

Laval, Quebec, Canada

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Jewish General Hospital

Montreal, Quebec, Canada

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Bradford Hill Centro de Investigaciones Clinicas

Recoleta, , Chile

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Masarykuv onkologicky ustav

Brno, , Czechia

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Thomayerova nemocnice

Praha 4 - Krc, , Czechia

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Hopital Jean Minjoz

Besançon, , France

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Chu Grenoble - Hopital Albert Michallon

Grenoble, , France

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Centre Leon Berard

Lyon, , France

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Hopital Nord

Marseille, , France

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Centre René Gauducheau - cancer Nantes - Atlantique

Nantes, , France

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Centre Antoine Lacassagne, Centre de Lutte Contre le Cancer (CLCC) de Nice

Nice, , France

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Hopital Saint Louis

Paris, , France

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GH Paris Saint Joseph

Paris, , France

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Hopital Tenon

Paris, , France

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Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

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CH de Saint Quentin

Saint-Quentin, , France

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Centre Medico-Chirurgical Foch

Suresnes, , France

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CHU de Toulouse - Hôpital Larrey

Toulouse, , France

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Institut Gustave Roussy

Villejuif, , France

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Klinikum d.Universität München Campus Großhadern

München, , Germany

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Semmelweis Egyetem X

Budapest, , Hungary

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Református Pulmonológiai Centrum

Törökbálint, , Hungary

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Belinson Medical Center

Petah Tikva, , Israel

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Azienda Osp Uni Seconda Università Degli Studi Di Napoli

Napoli, Campania, Italy

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Azienda Ospedaliera A. Cardarelli

Napoli, Campania, Italy

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Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

Napoli, Campania, Italy

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A.O. Universitaria Policlinico Di Modena

Modena, Emilia-Romagna, Italy

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Università Cattolica Del S Cuore

Rome, Lazio, Italy

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IRCCS AOU San Martino - IST

Genoa, Liguria, Italy

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ASL 3 Genovese

Genoa, Liguria, Italy

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Irccs Istituto Nazionale Dei Tumori (Int)

Milan, Lombardy, Italy

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Irccs Istituto Europeo Di Oncologia (IEO)

Milan, Lombardy, Italy

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Asst Di Monza

Monza, Lombardy, Italy

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A.O.U. Maggiore della Carità

Novara, Piedmont, Italy

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Azienda Ospedaliero-Universitaria San Luigi Gonzaga

Orbassano, Piedmont, Italy

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Policlinico Vittorio Emanuele

Catania, Sicily, Italy

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Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato

Arezzo, Tuscany, Italy

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A.O. Universitaria Pisana-Ospedale Cisanello

Pisa, Tuscany, Italy

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Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica

Siena, Tuscany, Italy

Site Status

Ospedale Santa Maria Della

Perugia, Umbria, Italy

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IOV - Istituto Oncologico Veneto - IRCCS

Padua, Veneto, Italy

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Shikoku Cancer Center

Ehime, , Japan

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Sendai Kousei Hospital

Miyagi, , Japan

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Niigata Cancer Center Hospital

Niigata, , Japan

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Iwate Medical University Hospital

Numakunai, , Japan

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Okayama University Hospital

Okayama, , Japan

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Toranomon Hospital

Tokyo, , Japan

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The Cancer Institute Hospital of JFCR, Respiratory Medicine

Tokyo, , Japan

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Wakayama Medical University Hospital

Wakayama, , Japan

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NKI/AvL

Amsterdam, , Netherlands

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Auckland city hospital

Auckland, , New Zealand

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Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

Gdansk, , Poland

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Oddzia? Onkologii Klinicznej i Chemioterapii Szpitala ELBL?SKA

Warsaw, , Poland

Site Status

Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad

Warsaw, , Poland

Site Status

Hospital de Santa Maria

Lisbon, , Portugal

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Centro Hospitalar do Porto ? Hospital de Santo António

Porto, , Portugal

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Institut Oncologic Ion Chiricuta

Cluj-Napoca, , Romania

Site Status

ONCOMED - Medical Centre

Timișoara, , Romania

Site Status

Moscow City Oncology Hospital #62

Moscovskaya Oblast, Moscow Oblast, Russia

Site Status

Clinic for Pulmonology, Clinical Center of Serbia

Belgrade, , Serbia

Site Status

University Hospital Medical Center Bezanijska kosa

Belgrade, , Serbia

Site Status

Institute of Oncology Ljubljana

Ljubljana, , Slovenia

Site Status

National Cancer Center

Gyeonggi-do, , South Korea

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Seoul National University Bundang Hospital

Gyeonggi-do, , South Korea

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Chonnam National University Hwasun Hospital

Jeollanam-do, , South Korea

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Samsung Medical Center

Seoul, , South Korea

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Hospital Son Llatzer

Palma de Mallorca, Balearic Islands, Spain

Site Status

Hospital Universitario Reina Sofia

Córdoba, Cordoba, Spain

Site Status

Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología

A Coruña, LA Coruna, Spain

Site Status

Hospital Universitario Materno Infantil de Gran Canaria

Las Palmas de Gran Canaria, LAS Palmas, Spain

Site Status

Clinica Universitaria de Navarra

Pamplona, Navarre, Spain

Site Status

Hospital del Mar

Barcelona, , Spain

Site Status

Vall d'Hebron Institute of Oncology (VHIO), Barcelona

Barcelona, , Spain

Site Status

Hospital Clinic de Barcelona. Unidad de Nuevas Terapias

Barcelona, , Spain

Site Status

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Institut Catala d Oncologia Hospital Duran i Reynals

Barcelona, , Spain

Site Status

Hospital Universitari Germans Trias i Pujol

Barcelona, , Spain

Site Status

Hospital San Pedro De Alcantara

Cáceres, , Spain

Site Status

Complejo Hospitalario de Jaen

Jaén, , Spain

Site Status

Hospital Lucus Augusti

Lugo, , Spain

Site Status

Hospital General Universitario Gregorio Marañon

Madrid, , Spain

Site Status

Hospital Ramon y Cajal

Madrid, , Spain

Site Status

Hospital Universitario Clínico San Carlos

Madrid, , Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

Hospital de Madrid Norte Sanchinarro- Centro Integral Oncologico Clara Campal

Madrid, , Spain

Site Status

Hospital Regional Universitario Carlos Haya

Málaga, , Spain

Site Status

Hospital Universitario Virgen del Rocio

Seville, , Spain

Site Status

Hospital General Universitario de Valencia

Valencia, , Spain

Site Status

Hospital NisA 9 de Octubre

Valencia, , Spain

Site Status

CHUV

Lausanne, , Switzerland

Site Status

Changhua Christian Hospital

Changhua, , Taiwan

Site Status

China Medical University Hospital

Taichung, , Taiwan

Site Status

National Taiwan Uni Hospital

Taipei, , Taiwan

Site Status

Chulalongkorn Hospital

Bangkok, , Thailand

Site Status

Ramathibodi Hospital

Bangkok, , Thailand

Site Status

Faculty of Med. Siriraj Hosp.

Bangkok, , Thailand

Site Status

Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

Edirne, , Turkey (Türkiye)

Site Status

Istanbul Uni Cerrahpasa Medical Faculty Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Hacettepe Uni Medical Faculty Hospital

S?hhiye, Ankara, , Turkey (Türkiye)

Site Status

Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU

Dnipropetrovsk, , Ukraine

Site Status

Barts & London School of Med

London, , United Kingdom

Site Status

Royal Free Hospital

London, , United Kingdom

Site Status

St George's Hospital

London, , United Kingdom

Site Status

Royal Marsden Hospital - London

London, , United Kingdom

Site Status

Charing Cross Hospital

London, , United Kingdom

Site Status

Christie Hospital NHS Trust

Manchester, , United Kingdom

Site Status

The Clatterbridge Cancer Centre NHS Foundation Trust

Metropolitan Borough of Wirral, , United Kingdom

Site Status

Nottingham City Hospital

Nottingham, , United Kingdom

Site Status

Royal Marsden Hospital - Surrey

Surrey, , United Kingdom

Site Status

Countries

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United States Argentina Australia Austria Belgium Brazil Bulgaria Canada Chile Czechia France Germany Hungary Israel Italy Japan Netherlands New Zealand Poland Portugal Romania Russia Serbia Slovenia South Korea Spain Switzerland Taiwan Thailand Turkey (Türkiye) Ukraine United Kingdom

References

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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.

Reference Type DERIVED
PMID: 39306923 (View on PubMed)

Other Identifiers

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2016-005189-75

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BO39633

Identifier Type: -

Identifier Source: org_study_id

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