CancerPhase 3NCT03148418
A Study in Participants Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study (IMbrella A)
A Phase 3 study testing Atezolizumab and Bevacizumab in people with Cancer, run by Hoffmann-La Roche at 170 sites in 32 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- What is being tested?
- Atezolizumab and Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 170 sitesin 32 countries
- Study dates
- 20 Sep 2017to 30 Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
170 sites in 32 countries.
170 sites in 32 countries
United States44 sites
New York Oncology Hematology, P.C.
Albany, New York, 12206
University Of Colorado
Aurora, Colorado, 80045
Johns Hopkins Univ Med Center
Baltimore, Maryland, 21231
Massachusetts General Hospital.
Boston, Massachusetts, 02114
Beth Israel Medical Center
Boston, Massachusetts, 02215
Dana Farber Cancer Inst.
Boston, Massachusetts, 02215
Northwestern University
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612-3244
University Of Chicago Medical Center
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 44195
Maryland Oncology Hematology, P.A.
Columbia, Maryland, 21044
Texas Oncology - DFW
Dallas, Texas, 75246
Rocky Mountain Cancer Ctr - Denver (Williams)
Denver, Colorado, 80218
Karmanos Cancer Institute
Detroit, Michigan, 48201
Oncology Associates of Oregon, P.C
Eugene, Oregon, 97401
Summit Medical Center
Florham Park, New Jersey, 07932
Florida Cancer Specialists - Fort Myers (Broadway)
Fort Myers, Florida, 33901
Ingalls Memorial Hospital
Harvey, Illinois, 60426
Penn State Hershey Cancer Institute
Hershey, Pennsylvania, 17033
Carolina BioOncology Institute, PLCC
Huntersville, North Carolina, 28078
Comprehensive Cancer Centers of Nevada - Eastern Avenue
Las Vegas, Nevada, 89169
Angeles Clinic & Rsch Inst
Los Angeles, California, 90025
UCLA
Los Angeles, California, 90095
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, 30060
Sarah Cannon Res Inst
Nashville, Tennessee, 37203
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, 06510
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Virginia Oncology Associates
Norfolk, Virginia, 23502
Illinois Cancer Care
Peoria, Illinois, 61615
Allegheny Cancer Center
Pittsburgh, Pennsylvania, 15212
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952
Northwest Cancer Specialists - Portland (N Broadway)
Portland, Oregon, 97227
Blue Ridge Cancer Care
Roanoke, Virginia, 24014
US oncology research at Minnesota Oncology
Saint Louis Park, Minnesota, 55416
Kaiser Permanente - San Diego (Zion Ave)
San Marcos, California, 92078
HonorHealth Research Institute ? Bisgrove
Scottsdale, Arizona, 85258
University of Washington Seattle Cancer Care Alliance
Seattle, Washington, 98109
Washington University School of Medicine
St Louis, Missouri, 63110
Florida Cancer Specialists.
St. Petersburg, Florida, 33705
Northwest Medical Specialties
Tacoma, Washington, 98405
H. Lee Moffitt Cancer Center and Research Inst.
Tampa, Florida, 33612
Tyler Cancer Center
Tyler, Texas, 75702
Georgetown University Medical Center Lombardi Cancer Center
Washington D.C., District of Columbia, 20057
New England Cancer Specialists
Westbrook, Maine, 04092
Spain24 sites
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
A Coruña, LA Coruna, 15006
Hospital del Mar
Barcelona, 08003
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035
Hospital Clinic de Barcelona. Unidad de Nuevas Terapias
Barcelona, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Institut Catala d Oncologia Hospital Duran i Reynals
Barcelona, 08908
Hospital Universitari Germans Trias i Pujol
Barcelona, 08916
Hospital San Pedro De Alcantara
Cáceres, 10003
Hospital Universitario Reina Sofia
Córdoba, Cordoba, 14004
Complejo Hospitalario de Jaen
Jaén, 23007
Hospital Universitario Materno Infantil de Gran Canaria
Las Palmas de Gran Canaria, LAS Palmas, 35016
Hospital Lucus Augusti
Lugo, 27003
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Hospital Ramon y Cajal
Madrid, 28034
Hospital Universitario Clínico San Carlos
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
Hospital de Madrid Norte Sanchinarro- Centro Integral Oncologico Clara Campal
Madrid, 28050
Hospital Regional Universitario Carlos Haya
Málaga, 29010
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, 07198
Clinica Universitaria de Navarra
Pamplona, Navarre, 31008
Hospital Universitario Virgen del Rocio
Seville, 41013
Hospital General Universitario de Valencia
Valencia, 46014
Hospital NisA 9 de Octubre
Valencia, 46015
Italy18 sites
Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato
Arezzo, Tuscany, 52100
Policlinico Vittorio Emanuele
Catania, Sicily, 95123
IRCCS AOU San Martino - IST
Genoa, Liguria, 16132
ASL 3 Genovese
Genoa, Liguria, 16149
Irccs Istituto Nazionale Dei Tumori (Int)
Milan, Lombardy, 20133
Irccs Istituto Europeo Di Oncologia (IEO)
Milan, Lombardy, 20141
A.O. Universitaria Policlinico Di Modena
Modena, Emilia-Romagna, 41100
Asst Di Monza
Monza, Lombardy, 20900
Azienda Osp Uni Seconda Università Degli Studi Di Napoli
Naples, Campania, 80131
Azienda Ospedaliera A. Cardarelli
Naples, Campania, 80131
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
Naples, Campania, 80131
A.O.U. Maggiore della Carità
Novara, Piedmont, 28100
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano, Piedmont, 10043
IOV - Istituto Oncologico Veneto - IRCCS
Padova, Veneto, 35128
Ospedale Santa Maria Della
Perugia, Umbria, 06129
A.O. Universitaria Pisana-Ospedale Cisanello
Pisa, Tuscany, 56124
Università Cattolica Del S Cuore
Rome, Lazio, 00168
Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica
Siena, Tuscany, 53100
France14 sites
Hopital Jean Minjoz
Besançon, 25030
Chu Grenoble - Hopital Albert Michallon
Grenoble, 38043
Centre Leon Berard
Lyon, 69373
Hopital Nord
Marseille, 13915
Centre René Gauducheau - cancer Nantes - Atlantique
Nantes, 44805
Centre Antoine Lacassagne, Centre de Lutte Contre le Cancer (CLCC) de Nice
Nice, 06189
Hopital Saint Louis
Paris, 75475
GH Paris Saint Joseph
Paris, 75674
Hopital Tenon
Paris, 75970
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
CH de Saint Quentin
Saint-Quentin, 2100
Centre Medico-Chirurgical Foch
Suresnes, 92151
CHU de Toulouse - Hôpital Larrey
Toulouse, 31059
Institut Gustave Roussy
Villejuif, 94805
United Kingdom9 sites
Barts & London School of Med
London, EC1A 7BE
Royal Free Hospital
London, NW3 2QG
St George's Hospital
London, SW17 0QT
Royal Marsden Hospital - London
London, SW3 6JJ
Charing Cross Hospital
London, W6 8RF
Christie Hospital NHS Trust
Manchester, M20 4BX
The Clatterbridge Cancer Centre NHS Foundation Trust
Metropolitan Borough of Wirral, L63 4JY
Nottingham City Hospital
Nottingham, NG5 1PB
Royal Marsden Hospital - Surrey
Surrey, SM2 5PT
Japan8 sites
Shikoku Cancer Center
Ehime, 791-0280
Sendai Kousei Hospital
Miyagi, 981-0914
Niigata Cancer Center Hospital
Niigata, 951-8566
Iwate Medical University Hospital
Numakunai, 028-3695
Okayama University Hospital
Okayama, 700-8558
Toranomon Hospital
Tokyo, 105-8470
The Cancer Institute Hospital of JFCR, Respiratory Medicine
Tokyo, 135-8550
Wakayama Medical University Hospital
Wakayama, 641-8510
Canada7 sites
Royal Victoria Hospital
Barrie, Ontario, L4M 6M2
William Osler Health Centre
Brampton, Ontario, L6R 3J7
Cite de La Sante de Laval
Laval, Quebec, H7M 3L9
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Lakeridge Health Corporation-Oshawa
Oshawa, Ontario, L1G 2B9
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N 3M5
Princess Margaret Cancer Center
Toronto, Ontario, M5G 1Z5
South Korea4 sites
National Cancer Center
Gyeonggi-do, 10408
Seoul National University Bundang Hospital
Gyeonggi-do, 13620
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128
Samsung Medical Center
Seoul, 06351
Brazil3 sites
Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, 01246-000
Fundacao Antonio Prudente
São Paulo, São Paulo, 01509-900
Poland3 sites
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Gdansk, 80-952
Oddzia? Onkologii Klinicznej i Chemioterapii Szpitala ELBL?SKA
Warsaw, 01-748
Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad
Warsaw, 02-781
Taiwan3 sites
Changhua Christian Hospital
Changhua, 500
China Medical University Hospital
Taichung, 40447
National Taiwan Uni Hospital
Taipei, 100
Thailand3 sites
Chulalongkorn Hospital
Bangkok, 10330
Ramathibodi Hospital
Bangkok, 10400
Faculty of Med. Siriraj Hosp.
Bangkok, 10700
Turkey (Türkiye)3 sites
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
Edirne, 22030
Istanbul Uni Cerrahpasa Medical Faculty Hospital
Istanbul, 34300
Hacettepe Uni Medical Faculty Hospital
S?hhiye, Ankara, 06100
Australia2 sites
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
Princess AleXandra Hospital
Woolloongabba, Queensland, 4102
Austria2 sites
Klinik Penzing
Vienna, 1140
Krankenhaus Nord - Klinik Floridsdorf
Vienna, 1210
Belgium2 sites
AZ Glorieux- vzw Werken Glorieux
Ronse, 9600
ZAS Sint Augustinus Wilrijk
Wilrijk, 2610
Czechia2 sites
Masarykuv onkologicky ustav
Brno, 656 53
Thomayerova nemocnice
Praha 4 - Krc, 140 59
Hungary2 sites
Semmelweis Egyetem X
Budapest, 1083
Református Pulmonológiai Centrum
Törökbálint, 2045
Portugal2 sites
Hospital de Santa Maria
Lisbon, 1649-035
Centro Hospitalar do Porto ? Hospital de Santo António
Porto, 4099-001
Romania2 sites
Institut Oncologic Ion Chiricuta
Cluj-Napoca, 400015
ONCOMED - Medical Centre
Timișoara, 300239
Serbia2 sites
Clinic for Pulmonology, Clinical Center of Serbia
Belgrade, 11000
University Hospital Medical Center Bezanijska kosa
Belgrade, 11080
Argentina1 site
Fundación CENIT para la Investigación en Neurociencias
Buenos Aires, C1125ABD
Bulgaria1 site
Multiprofile Hospital for Active Treatment Serdika EOOD
Sofia, 1303
Ukraine1 site
Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU
Dnipropetrovsk, 49102
About this study
Official title: An Open-Label, Multicenter Extension and Long-Term Observational Study in Patients Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study
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.
- Conditions
- Cancer
- Being tested
- Atezolizumab, Bevacizumab
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabDrug
Also called RO5541267, Tecentriq
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).
BevacizumabDrug
Also called Avastin
Bevacizumab will be administered as directed per the parent study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Atezolizumab |
| 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. Receives: Drug: Atezolizumab; Drug: Bevacizumab |
| 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. Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Continued Access to Atezolizumab-Based Therapy and/or Comparator Agent(s)
Measured: Day 1 up to maximum 10 years
Secondary outcomes (3)
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
Measured: 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)
Percentage of Participants With Adverse Events of Special Interest by Severity Determined According to NCI CTCAE Version 4.0
Measured: 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
Measured: Day 1 (as indicated in parent study protocol) until death due to any cause (up to maximum 10 years or until the sponsor stop)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start20 Sep 2017
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148418
- Sponsor's protocol ID
- BO39633
- Other IDs
- 2016-005189-75, 2016
- Status last verified
- Oct 2026
- First submitted
- 9 May 2017
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 39306923
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter Extension and Long-Term Observational Study in Patients Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study
- ClinicalTrials.gov ID
- NCT03148418
- Acronym / sponsor ID
- BO39633
- Conditions
- Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 382 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 11 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atezolizumab Monotherapy | Experimental | Drug: AtezolizumabParticipants 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 | Drug: Atezolizumab, Drug: BevacizumabParticipants 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 | Drug: BevacizumabParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtezolizumabAlso: RO5541267, TecentriqAtezolizumab 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). | Drug | Atezolizumab Monotherapy, Combined Agents with Atezolizumab |
| BevacizumabAlso: AvastinBevacizumab will be administered as directed per the parent study. | Drug | Combined Agents with Atezolizumab, Comparator Treatment |
Primary outcome
Number of Participants With Continued Access to Atezolizumab-Based Therapy and/or Comparator Agent(s)
Time frame: Day 1 up to maximum 10 years
3 secondary outcomes
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
Time frame: 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)
Percentage of Participants With Adverse Events of Special Interest by Severity Determined According to NCI CTCAE Version 4.0
Time frame: 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
Time frame: Day 1 (as indicated in parent study protocol) until death due to any cause (up to maximum 10 years or until the sponsor stop)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Derived from this study: PubMed 39306923Reck 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.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
170 sites in 32 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atezolizumab and Bevacizumab in people with Cancer, run by Hoffmann-La Roche at 170 sites in 32 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 170 sites in United States, Spain, Italy, France, United Kingdom and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Continued Access to Atezolizumab-Based Therapy and/or Comparator Agent(s) (time frame: Day 1 up to maximum 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03148418, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.