Lung Cancer Clinical Trial

A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110]

Summary

This randomized, open-label study will evaluate the efficacy and safety of atezolizumab compared with chemotherapy consisting of a platinum agent (cisplatin or carboplatin per investigator discretion) combined with either pemetrexed (non-squamous disease) or gemcitabine (squamous disease) in programmed death-ligand 1 (PD-L1)-selected, chemotherapy-naive participants with Stage IV Non-Squamous or Squamous NSCLC.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically confirmed, Stage IV non-squamous or squamous NSCLC
No prior treatment for Stage IV non-squamous or squamous NSCLC. Participant known to have a sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene are excluded from the study
Tumor PD-L1 expression as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Adequate hematologic and end-organ function

Exclusion Criteria:

Known sensitizing mutation in the EGFR gene or ALK fusion oncogene
Active or untreated central nervous system (CNS) metastases as determined by Computed Tomography (CT) or magnetic resonance imaging (MRI) evaluation
Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
Pregnant or lactating women
History of autoimmune disease
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
Positive test for Human Immunodeficiency Virus (HIV)
Active hepatitis B or hepatitis C
Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti PD1, and anti-PD-L1 therapeutic antibody
Severe infection within 4 weeks prior to randomization
Significant history of cardiovascular disease

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

572

Study ID:

NCT02409342

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 136 Locations for this study

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University of California San Diego
La Jolla California, 92093, United States
Yale Cancer Center
New Haven Connecticut, 06520, United States
Lynn Cancer Institute - West
Boca Raton Florida, 33428, United States
University of Maryland Greenebaum Cancer Center
Baltimore Maryland, 21201, United States
Oregon Health & Science Uni
Portland Oregon, 97239, United States
Sarah Cannon Cancer Center
Germantown Tennessee, 38138, United States
Vanderbilt University Medical Center; Multiple Sclerosis Center
Nashville Tennessee, 37204, United States
Hematology Oncology Associates of Fredericksburg, Inc.
Fredericksburg Virginia, 22408, United States
VA Puget Sound Health Care Sys
Seattle Washington, 98108, United States
Oncovida*X
Salvador BA, 41820, Brazil
Centro de Pesquisas Clinicas em Oncologia - CPCO
Cachoeiro de Itapemirim ES, 29308, Brazil
Instituto Nacional de Cancer - INCa; Oncologia
Rio de Janeiro RJ, 20560, Brazil
Associacao Hospital de Caridade Ijui*X; Departamento De Oncologia
Ijui RS, 98700, Brazil
Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia
Passo Fundo RS, 99010, Brazil
Santa Casa de Misericordia de Porto Alegre
Porto Alegre RS, 90020, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre RS, 90610, Brazil
Instituto Joinvilense de Hematologia E Oncologia
Joinville SC, 89201, Brazil
*X*Fundacao PIO XII
Barretos SP, 14784, Brazil
Hospital Santa Marcelina
Sao Paulo SP, 08270, Brazil
Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira
São Paulo SP, 01246, Brazil
Harbin Medical University Tumor Hospital
Harbin City , 15008, China
CHU Angers
Angers , 49933, France
Hospital d Instructions des Armees Percy
Clamart , 92141, France
Hôpital Universitaire Dupuytren
Limoges , 87042, France
Clinique Clémentville
Montpellier , 34070, France
Centre D'oncologie de Gentilly
Nancy , 54100, France
Hopital Tenon
Paris , 75020, France
Centre Hospitalier Regional La Reunion Site Felix Guyon
Saint Denis Cedex , 97405, France
Hopital d'Instruction des Armees de Begin
Saint-Mande , 94160, France
Centre Hospitalier Regional Sud Reunion
Saint-pierre , 97448, France
Centre Paul Strauss
Strasbourg , 67000, France
Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie
Gauting , 82131, Germany
Pius-Hospital Oldenburg
Oldenburg , 26121, Germany
Sotiria Chest Hospital of Athens
Athens , 11527, Greece
IASO General Hospital of Athens
Athens , 155 6, Greece
Metropolitan Hospital
Athens , 185 4, Greece
Attikon University General Hospital
Chaidari , 124 6, Greece
University General Hospital of Larissa
Larissa , 412 2, Greece
University General Hospital of Patras
Patras , 265 0, Greece
Thermi Clinic
Thermi, Thessaloniki , 57001, Greece
Bioclinic Thessaloniki
Thessaloniki , 546 2, Greece
EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department
Thessaloniki , 54645, Greece
Papageorgiou General Hospital of Thessaloniki
Thessaloniki , 564 2, Greece
Georgios Papanikolaou General Hosp. of Thessaloniki
Thessaloniki , 57010, Greece
Uzsoki Utcai Korhaz
Budapest , 1145, Hungary
Szabolcs-Szatmar-Bereg Megyei; Korhazak es Egyetemi Oktatokorhaz
Nyiregyhaza , 4400, Hungary
Pecsi Tudomanyegyetem
Pecs , 7624, Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet; Megyei Onkologiai Kozpont
Szolnok , 5004, Hungary
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola Emilia-Romagna, 47014, Italy
Centro Di Riferimento Oncologico; Struttura Operativa Complessa Di Oncologia Medica B
Aviano Friuli-Venezia Giulia, 33081, Italy
Asst Papa Giovanni XXIII
Bergamo Lombardia, 24100, Italy
Azienda Ospedaliera Istituti Ospitalieri
Cremona Lombardia, 26100, Italy
Ospedale San Raffaele S.r.l.
Milano Lombardia, 20132, Italy
Istituto Europeo Di Oncologia
Milano Lombardia, 20141, Italy
Azienda Socio Sanitaria Territoriale ? ASST di Monza
Monza Lombardia, 20052, Italy
Istituto Nazionale dei Tumori
Monza Lombardia, 20052, Italy
Istituto Clinico Humanitas
Rozzano (MI) Lombardia, 20089, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino Piemonte, 10126, Italy
Azienda Ospedaliero-Universitaria ?PoliclinicoVittorio Emanuele?- P.O. G. Rodolico; Oncologia Medica
Catania Sicilia, 95123, Italy
Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia
Verona Veneto, 37126, Italy
Aichi Cancer Center Hospital; Respiratory Medicine
Aichi , 464-8, Japan
Nagoya University Hospital; Respiratory Medicine
Aichi , 466-8, Japan
Kyushu University Hospital; Respiratory
Fukuoka , 812-8, Japan
Hokkaido University Hospital
Hokkaido , 060-8, Japan
Kobe City Medical Center General Hospital; Respiratory Medicine
Hyogo , 650-0, Japan
Hyogo Cancer Center; Thoracic Oncology
Hyogo , 673-8, Japan
Ibaraki Prefectural Central Hospital; Division of respiratory
Ibaraki , 309-1, Japan
Sendai Kousei Hospital; Pulmonary Medicine
Miyagi , 980-0, Japan
Okayama University Hospital; Respiratory and Allergy Medicine
Okayama , 700-8, Japan
Osaka International Cancer Institute; Thoracic Oncology
Osaka , 541-8, Japan
Kansai Medical university Hospital; Thoracic Oncology
Osaka , 573-1, Japan
Osaka Habikino Medical Center
Osaka , 583-8, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai-shi , 591-8, Japan
Saitama Cancer Center; Thoracic Oncology
Satima , 362-0, Japan
National Cancer Center Hospital; Thoracic Medical Oncology
Tokyo , 104-0, Japan
Tokyo Medical University Hospital; Dept of Surgery
Tokyo , 160-0, Japan
Chonnam National University Hwasun Hospital
Jeollanam-do , 58128, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si , 13620, Korea, Republic of
Kangbuk Samsung Hospital
Seoul , 03181, Korea, Republic of
Uniwersyteckie Centrum Kliniczne
Gdansk , , Poland
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii
Olsztyn , 10-35, Poland
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
Otwock , 05-40, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
Poznan , 60-56, Poland
Med-Polonia Sp. z o.o.
Poznan , 60-69, Poland
Teo Health SA - Saint Constantin Hospital
Brasov , 50009, Romania
Prof. Dr. I. Chiricuta Institute of Oncology
Cluj Napoca , 40001, Romania
Oncology Center Sf. Nectarie
Craiova , 20034, Romania
Institutul Regional de Oncologie Iasi; Clinica de Hematologie
Iasi , 70048, Romania
Sibiu Emergency Clinical County Hospital
Sibiu , 55024, Romania
Oncocenter Clinical Oncology
Timi?oara , 30021, Romania
Oncomed SRL
Timisoara , 30023, Romania
Arkhangelsk Regional Clinical Oncology Dispensary
Arkhangelsk Arhangelsk, 16304, Russian Federation
Federal State Institution Medical Radiology Research Center
Obninsk Kaluga, 24903, Russian Federation
Moscow City Oncology Hospital #62
Moscovskaya Oblast Moskovskaja Oblast, 14342, Russian Federation
Principal Military Clinical Hospital n.a. N.N. Burdenko
Moscow Moskovskaja Oblast, 10522, Russian Federation
Saint Petersburg Clinical Hospital of the Russian Academy of Sciences
St. Petersburg Sankt Petersburg, 19401, Russian Federation
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
Kazan Tatarstan, 42002, Russian Federation
Regional Clinical Oncology Center
Ryazan , 39004, Russian Federation
Mordovia State University
Saransk , 43003, Russian Federation
Leningrad Regional Clinical Hospital
St Petersburg , 19429, Russian Federation
St. Petersburg Med Univ; n.a. I.P. Pavlov; Pulmonology Research
St Petersburg , 19708, Russian Federation
Volgograd Regional Clinical Oncology Dispensary
Volgograd , 40013, Russian Federation
Clinical Center of Serbia
Belgrade , 11000, Serbia
Institute for Oncology and Radiology of Serbia; Medical Oncology
Belgrade , 11000, Serbia
Clinical Center Kragujevac
Kragujevac , 34000, Serbia
Institute of Lung Diseases Vojvodina
Sremska Kamenica , 21204, Serbia
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Badalona Barcelona, 08916, Spain
Consorcio Hospitalario Provincial de Castellon
Castellon DE LA Plana/castello DE LA Plana Castellon, 12002, Spain
Hospital Universitario Son Espases
Palma de Mallorca Islas Baleares, 07010, Spain
Hospital Son Llatzer
Palma de Mallorca Islas Baleares, 07198, Spain
Hospital Universitario A Coruña
Coruna LA Coruña, 15006, Spain
Hospital Universitario Cruces
Barakaldo Vizcaya, 48903, Spain
Hospital del Mar
Barcelona , 08003, Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona , 08035, Spain
Complejo Hospitalario de Jaen
Jaen , 23007, Spain
Hospital Clinico San Carlos; Servicio de Oncologia
Madrid , 28040, Spain
Hospital Universitario Virgen Macarena
Sevilla , 41009, Spain
Hospital Clinico Universitario de Valencia
Valencia , 46010, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia , 46026, Spain
Hosp Clinico Univ Lozano Blesa; División De Oncología Médica
Zaragoza , 50009, Spain
Hospital Universitario Miguel Servet
Zaragoza , 50009, Spain
Prince of Songkla University; Department Of Internal Medicine, Faculty Of Medicine
Hat Yai , 90110, Thailand
Khon Kaen University
Khon Kaen , 40002, Thailand
Chiang Rai Prachanukroh Hospital
Muang , 57000, Thailand
Buddhachinnaraj Hospital
Phitsanulok , 65000, Thailand
Cukurova University Medical Faculty Balcali Hospital
Adana , 1330, Turkey
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara , 06100, Turkey
Istanbul University Cerrahpasa Medical Faculty
Istanbul , 34000, Turkey
Ege Universitesi Tip Fakultesi Hastanesi
Izmir , 35100, Turkey
Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
Izmir , 35110, Turkey
Inonu University Faculty of Medicine Turgut Ozal Medical Center
Malatya , 44280, Turkey
Municipal Noncommercial Institution Regional Center of Oncology
Kharkiv Kharkiv Governorate, 61070, Ukraine
Municipal Noncomercial Enterprise Odessa Regional Oncology Center ofthe Odessa StateAdministration
Odesa Kherson Governorate, 65055, Ukraine
Municipal non profit enterprise of Sumy Regional Council Sumy Regional Clinical Oncology Disp
Sumy Kholm Governorate, 40005, Ukraine
Communal Non-profit Enterprise City Clinical Hospital #4 of Dnipro City Council - PPDS; Chemotherapy
Dnipro KIEV Governorate, 49102, Ukraine
Kyiv Railway Clinical Hospital #3 of Branch Health Center of the PJSC Ukrainian Railway
Kyiv KIEV Governorate, 02096, Ukraine
Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council
Vinnytsia KIEV Governorate, 21029, Ukraine
The Municipal Enterprise Volyn Regional Medical Oncology Centre of the Volyn Regional Council
Lutsk Volhynian Governorate, 43018, Ukraine
Private Enterprise Private Manufacturing Company Acinus
Kirovograd , 25006, Ukraine
Birmingham Heartlands Hospital
Birmingham , B9 5S, United Kingdom
Colchester General Hospital
Colchester, Essex , CO4 5, United Kingdom
Christie Hospital
Manchester , M20 3, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

572

Study ID:

NCT02409342

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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