Phase
Condition
Small Cell Lung Cancer
Treatment
Durvalumab
Atezolizumab
Etoposide
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant has provided informed consent prior to initiation of any study specificactivities/procedures.
Age greater than or equal to 18 years old at the same time of signing the informedconsent.
Histologically or cytologically confirmed Extensive Stage Small Cell Lung Cancer (ES-SCLC) and no prior systemic treatment for ES-SCLC.
Participants with prior treatment for limited-stage SCLC (LS-SCLC) are permitted.
Eastern Cooperative Oncology Group (ECOG) 0 to 1.
Participants with treated asymptomatic brain metastases are eligible provided theymeet defined criteria.
Adequate organ function as defined in protocol.
Exclusion
Exclusion Criteria:
History of other malignancy within the past 2 years with exceptions.
Major surgery within 28 days of study day 1.
Untreated or symptomatic brain metastases and leptomeningeal disease.
Participants who experienced recurrent grade 2 pneumonitis or severe orlife-threatening immune-mediated adverse events or infusion-related reactionsincluding those that lead to permanent discontinuation while on treatment withimmuno-oncology agents.
History of immune-related colitis.
History or evidence of interstitial lung disease or active, non-infectiouspneumonitis.
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or anyother form of immunosuppressive therapy within 7 days prior to the first dose ofstudy treatment.
Participants with symptoms and/or clinical signs and/or radiographic signs thatindicate an acute and/or uncontrolled active systemic infection within 7 days priorto the first dose of study treatment
Participant has known active infection requiring parenteral antibiotic treatment.Upon completion of parenteral antibiotics and resolution of symptoms, theparticipant may be considered eligible for the study from an infection standpoint
NOTE: Simple urinary tract infections and uncomplicated bacterial pharyngitis arepermitted if responding to an active treatment and after consultation with MedicalMonitor. Participants requiring oral antibiotics who have been afebrile for >24hours, have no leukocytosis, nor clinical signs of infection are eligible. Screeningfor chronic infectious conditions is not required.
History of hypophysitis or pituitary dysfunction.
History of solid organ transplantation or allogeneic hematopoietic stem celltransplantation.
Active autoimmune disease that has required systemic treatment (except replacementtherapy) within the past 2 years or any other diseases requiring immunosuppressivetherapy while on study. Participants with Type I diabetes, vitiligo, psoriasis,hypo- or hyper-thyroid disease not requiring immunosuppressive treatment arepermitted.
Study Design
Connect with a study center
Chris OBrien Lifehouse
Camperdown, New South Wales 2050
AustraliaSite Not Available
Chris OBrien Lifehouse
Camperdown 2172563, New South Wales 2155400 2050
AustraliaSite Not Available
Universitair Ziekenhuis Antwerpen
Edegem, 2650
BelgiumSite Not Available
Universitair Ziekenhuis Antwerpen
Edegem 2799007, 2650
BelgiumSite Not Available
Algemeen Ziekenhuis Maria Middelares
Gent, 9000
BelgiumSite Not Available
Algemeen Ziekenhuis Maria Middelares
Ghent 2797656, 9000
BelgiumSite Not Available
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, 3500
BelgiumSite Not Available
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt 2796491, 3500
BelgiumSite Not Available
AZ Delta Campus Rumbeke
Roeselare, 8800
BelgiumSite Not Available
AZ Delta Campus Rumbeke
Roeselare 2787889, 8800
BelgiumSite Not Available
Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9
CanadaSite Not Available
Princess Margaret Cancer Centre
Toronto 6167865, Ontario 6093943 M5G 2M9
CanadaSite Not Available
CHU de Quebec Hopital de l Enfant Jesus
Québec 6325494, Quebec 6115047 G1R 2J6
CanadaSite Not Available
CHU de Quebec Hopital de l Enfant Jesus
Quebec, G1R 2J6
CanadaSite Not Available
Rigshospitalet
Copenhagen 2618425, 2100
DenmarkSite Not Available
Rigshospitalet
Kobenhavn, 2100
DenmarkSite Not Available
Centre Leon Berard
Lyon 2996944, 69373
FranceSite Not Available
Centre Leon Berard
Lyon cedex 8, 69373
FranceSite Not Available
Centre Hospitalier Universitaire de Nantes, Hôpital Nord Laënnec
Saint Herblain, 44800
FranceSite Not Available
Centre Hospitalier Universitaire de Nantes, Hôpital Nord Laënnec
Saint-Herblain 2979590, 44800
FranceSite Not Available
Gustave Roussy
Villejuif, 94805
FranceSite Not Available
Gustave Roussy
Villejuif 2968705, 94805
FranceSite Not Available
Universitaetsklinikum Carl Gustav Carus
Dresden, 01307
GermanyActive - Recruiting
Universitaetsklinikum Dresden
Dresden, 01307
GermanySite Not Available
Universitaetsklinikum Dresden
Dresden 2935022, 01307
GermanySite Not Available
Universitaetsklinikum Essen
Essen, 45147
GermanySite Not Available
Universitätsklinikum Essen
Essen, 45147
GermanyActive - Recruiting
Universitaetsklinikum Essen
Essen 2928810, 45147
GermanySite Not Available
Universitaetsklinikum Freiburg
Freiburg, 79106
GermanySite Not Available
Universitätsklinikum Freiburg
Freiburg, 79106
GermanyActive - Recruiting
Universitaetsklinikum Freiburg
Freiburg im Breisgau 2925177, 79106
GermanySite Not Available
Rambam Medical Center
Haifa, 3109601
IsraelSite Not Available
Rambam Medical Center
Haifa 294801, 3109601
IsraelSite Not Available
Hadassah Ein-Kerem Medical Center
Jerusalem, 9112001
IsraelSite Not Available
Hadassah Ein-Kerem Medical Center
Jerusalem 281184, 9112001
IsraelSite Not Available
Rabin Medical Center
Petah Tikva, 4941492
IsraelSite Not Available
Rabin Medical Center
Petah Tikva 293918, 4941492
IsraelSite Not Available
Sheba Medical Center
Ramat Gan, 5265601
IsraelSite Not Available
Sheba Medical Center
Ramat Gan 293788, 5265601
IsraelSite Not Available
Azienda Ospedaliera Universitaria Renato Dulbecco
Catanzaro, 88100
ItalySite Not Available
Azienda Ospedaliero Universitaria Mater Domini
Catanzaro, 88100
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Renato Dulbecco
Catanzaro 2525059, 88100
ItalySite Not Available
Fondazione IRCCS San Gerardo dei Tintori
Monza (MB), 20900
ItalySite Not Available
Fondazione IRCCS San Gerardo dei Tintori
Monza (MB) 3172629, 20900
ItalySite Not Available
IRCCS Istituti Fisioterapici Ospitalieri Istituto Nazionale Tumori Regina Elena
Rome, 00144
ItalyActive - Recruiting
Istituti Fisioterapici Ospitalieri Regina Elena San Gallicano
Rome, 00144
ItalyActive - Recruiting
Istituto Nazionale Tumori Regina Elena
Rome, 00144
ItalySite Not Available
Istituto Nazionale Tumori Regina Elena
Rome 3169070, 00144
ItalySite Not Available
National Cancer Center Hospital East
Kashiwa-shi, Chiba 2113014 277-8577
JapanSite Not Available
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo 1850144 135-8550
JapanSite Not Available
Asan Medical Center
Seoul, 05505
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 06351
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
NetherlandsSite Not Available
Universitair Medisch Centrum Groningen
Groningen 2755251, 9713 GZ
NetherlandsSite Not Available
Asan Medical Center
Seoul 1835848, 05505
South KoreaSite Not Available
Samsung Medical Center
Seoul 1835848, 06351
South KoreaSite Not Available
Seoul National University Hospital
Seoul 1835848, 03080
South KoreaSite Not Available
Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol
Badalona 3129028, Catalonia 3336901 08916
SpainSite Not Available
Hospital Universitari Vall d Hebron
Barcelona 3128760, Catalonia 3336901 08035
SpainSite Not Available
Institut Catala d Oncologia Badalona
Badalona, Cataluña 08916
SpainActive - Recruiting
Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol
Badalona, Cataluña 08916
SpainSite Not Available
Hospital Universitari Vall d Hebron
Barcelona, Cataluña 08035
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid 3117735, 28041
SpainSite Not Available
Universitaetsspital Basel
Basel, 4031
SwitzerlandSite Not Available
Universitaetsspital Basel
Basel 2661604, 4031
SwitzerlandSite Not Available
Inselspital Bern
Bern, 3010
SwitzerlandSite Not Available
Inselspital Bern
Bern 2661552, 3010
SwitzerlandSite Not Available
National Cheng Kung University Hospital
Tainan, 70403
TaiwanSite Not Available
National Cheng Kung University Hospital
Tainan 1668355, 70403
TaiwanSite Not Available
National Taiwan University Hospital
Taipei, 10002
TaiwanSite Not Available
Taipei Veterans General Hospital
Taipei, 11217
TaiwanSite Not Available
National Taiwan University Hospital
Taipei 1668341, 10002
TaiwanSite Not Available
Taipei Veterans General Hospital
Taipei 1668341, 11217
TaiwanSite Not Available
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California 90033
United StatesSite Not Available
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles 5368361, California 5332921 90033
United StatesSite Not Available
Christiana Care Health Services
Newark, Delaware 19713
United StatesSite Not Available
Christiana Care Health Services
Newark 4143861, Delaware 4142224 19713
United StatesSite Not Available
Henry Ford Health System
Detroit, Michigan 48202
United StatesSite Not Available
Henry Ford Health System
Detroit 4990729, Michigan 5001836 48202
United StatesSite Not Available
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901
United StatesSite Not Available
Rutgers Cancer Institute of New Jersey
New Brunswick 5101717, New Jersey 5101760 08901
United StatesSite Not Available
New York University Grossman School of Medicine and New York University Langone Hospitals
New York, New York 10016
United StatesSite Not Available
New York University Langone Medical Center
New York, New York 10016
United StatesActive - Recruiting
New York University Grossman School of Medicine and New York University Langone Hospitals
New York 5128581, New York 5128638 10016
United StatesSite Not Available
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
United StatesSite Not Available
The University of North Carolina at Chapel Hill
Chapel Hill 4460162, North Carolina 4482348 27599
United StatesSite Not Available
Avera Cancer Institute
Sioux Falls, South Dakota 57105
United StatesSite Not Available
Avera Cancer Institute
Sioux Falls 5231851, South Dakota 5769223 57105
United StatesSite Not Available
Swedish Cancer Institute Medical Oncology
Seattle, Washington 98104
United StatesSite Not Available
Swedish Cancer Institute Medical Oncology
Seattle 5809844, Washington 5815135 98104
United StatesSite Not Available
West Virginia University Health Sciences Center
Morgantown, West Virginia 26506
United StatesSite Not Available
West Virginia University Health Sciences Center
Morgantown 4815352, West Virginia 4826850 26506
United StatesSite Not Available

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