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]

NCT02409342 | Completed Phase 3 Results

• 2 other identifiers: GO294312014-003083-21
• Study Type: interventional
• Target: 572
• Locations: 19 countries
• Sites: 142

Brief 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.

Conditions

Non-Squamous Non-Small Cell Lung Cancer, Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Overall Survival (OS) in the TC3 or IC3-WT Populations

  OS is defined as the time from randomization to death from any cause.

  From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months)

• Overall Survival (OS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations

  OS is defined as the time from randomization to death from any cause.

  From randomization to death from any cause until data cut-off on 4 February 2020 (up to approximately 54.5 months)

Secondary Outcomes (21)

• Progression-free Survival (PFS) in the TC3 or IC3-WT Populations

  From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)

• Progression-free Survival (PFS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations

  From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 4 February 2020 (up to approximately 54.5 months)

• Percentage of Participants With Objective Response (ORR) in the TC3 or IC3-WT Populations

  Every 6 weeks for 48 weeks following Day 1, thereafter every 9 weeks after completion of Week 48 tumor assessment, regardless of treatment delays, until radiographic disease progression until data cut-off on 10 Sep 2018 (up to approximately 38 months)

• Percentage of Participants With Objective Response (ORR) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations

  Every 6 weeks for 48 weeks following Day 1, thereafter every 9 weeks after completion of Week 48 tumor assessment, regardless of treatment delays, until radiographic disease progression until data cut-off on 4 Feb 2020 (up to approximately 54.5 months)

• Duration of Response (DOR) in the TC3 or IC3-WT Populations

  From first occurrence of a complete response or partial response, whichever occurs first, until first date that progressive disease or death is documented, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)

Study Arms (2)

(Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)

ACTIVE COMPARATOR

Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).

Drug: Carboplatin; Drug: Cisplatin; Drug: Gemcitabine; Drug: Pemetrexed

Atezolizumab

EXPERIMENTAL

Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).

Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody

Interventions

Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody DRUG

Atezolizumab 1200 milligram (mg) will be administered as intravenous infusion every 21 days until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).

Also known as: MPDL3280A, RO5541267

Atezolizumab

Carboplatin DRUG

Carboplatin will be administered as intravenous infusion at a dose of area under the concentration-time curve (AUC) 6 when given in combination with pemetrexed or at a dose of AUC 5 when given in combination with gemcitabine, every 21 days for 4 or 6 cycles as per local standard of care.

(Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)

Cisplatin DRUG

Cisplatin will be administered as intravenous infusion at a dose of 75 mg per meter squared (mg/m\^2) every 21 days for 4 or 6 cycles as per local standard of care.

(Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)

Gemcitabine DRUG

Gemcitabine will be administered as intravenous infusion at a dose of 1250 mg/m\^2 (in combination with cisplatin) or 1000 mg/m\^2 (in combination with carboplatin), on Days 1 and 8 of each 21-day cycle for 4 or 6 cycles as per local standard of care.

(Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)

Pemetrexed DRUG

Pemetrexed will be administered as intravenous infusion at a dose of 500 mg/m\^2 on Day 1 of each 21-day cycle as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).

(Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (142)

University of California San Diego

La Jolla, California, 92093, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06520, United States

Location

Lynn Cancer Institute - West

Boca Raton, Florida, 33428, United States

Location

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

Oregon Health & Science Uni

Portland, Oregon, 97239, United States

Location

Sarah Cannon Cancer Center

Germantown, Tennessee, 38138, United States

Location

Vanderbilt University Medical Center; Multiple Sclerosis Center

Nashville, Tennessee, 37204, United States

Location

Hematology Oncology Associates of Fredericksburg, Inc.

Fredericksburg, Virginia, 22408, United States

Location

VA Puget Sound Health Care Sys

Seattle, Washington, 98108, United States

Location

Centro de Pesquisas Clinicas em Oncologia - CPCO

Cachoeiro de Itapemirim, Espírito Santo, 29308-014, Brazil

Location

Oncovida*X

Salvador, Estado de Bahia, 41820-021, Brazil

Location

Instituto Nacional de Cancer - INCa; Oncologia

Rio de Janeiro, Rio de Janeiro, 20560-120, Brazil

Location

Associacao Hospital de Caridade Ijui*X; Departamento De Oncologia

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia

Passo Fundo, Rio Grande do Sul, 99010-260, Brazil

Location

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Instituto Joinvilense de Hematologia E Oncologia

Joinville, Santa Catarina, 89201-260, Brazil

Location

*X*Fundacao PIO XII

Barretos, São Paulo, 14784-400, Brazil

Location

Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira

São Paulo, São Paulo, 01246 000, Brazil

Location

Hospital Santa Marcelina

São Paulo, São Paulo, 08270-070, Brazil

Location

Harbin Medical University Tumor Hospital

Harbin, 150081, China

Location

CHU Angers

Angers, 49933, France

Location

Hospital d Instructions des Armees Percy

Clamart, 92141, France

Location

Hôpital Universitaire Dupuytren

Limoges, 87042, France

Location

Clinique Clémentville

Montpellier, 34070, France

Location

Centre D'oncologie de Gentilly

Nancy, 54100, France

Location

Hopital Tenon

Paris, 75020, France

Location

Centre Hospitalier Regional La Reunion Site Felix Guyon

Saint-Denis, 97405, France

Location

Hopital d'Instruction des Armees de Begin

Saint-Mandé, 94160, France

Location

Centre Hospitalier Regional Sud Reunion

Saint-Pierre, 97448, France

Location

Centre Paul Strauss

Strasbourg, 67000, France

Location

Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie

Gauting, 82131, Germany

Location

Pius-Hospital Oldenburg

Oldenburg, 26121, Germany

Location

Sotiria Chest Hospital of Athens

Athens, 11527, Greece

Location

IASO General Hospital of Athens

Athens, 155 62, Greece

Location

Metropolitan Hospital

Athens, 185 47, Greece

Location

Attikon University General Hospital

Chaïdári, 124 62, Greece

Location

University General Hospital of Larissa

Larissa, 412 21, Greece

Location

University General Hospital of Patras

Pátrai, 265 00, Greece

Location

Thermi Clinic

Thermi, Thessaloniki, 57001, Greece

Location

Bioclinic Thessaloniki

Thessaloniki, 546 22, Greece

Location

EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department

Thessaloniki, 54645, Greece

Location

Papageorgiou General Hospital of Thessaloniki

Thessaloniki, 564 29, Greece

Location

Georgios Papanikolaou General Hosp. of Thessaloniki

Thessaloniki, 57010, Greece

Location

Uzsoki Utcai Korhaz

Budapest, 1145, Hungary

Location

Szabolcs-Szatmar-Bereg Megyei; Korhazak es Egyetemi Oktatokorhaz

Nyíregyháza, 4400, Hungary

Location

Pecsi Tudomanyegyetem

Pécs, 7624, Hungary

Location

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet; Megyei Onkologiai Kozpont

Szolnok, 5004, Hungary

Location

IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

Meldola, Emilia-Romagna, 47014, Italy

Location

Centro Di Riferimento Oncologico; Struttura Operativa Complessa Di Oncologia Medica B

Aviano, Friuli Venezia Giulia, 33081, Italy

Location

Asst Papa Giovanni XXIII

Bergamo, Lombardy, 24100, Italy

Location

Azienda Ospedaliera Istituti Ospitalieri

Cremona, Lombardy, 26100, Italy

Location

Ospedale San Raffaele S.r.l.

Milan, Lombardy, 20132, Italy

Location

Istituto Europeo Di Oncologia

Milan, Lombardy, 20141, Italy

Location

Azienda Socio Sanitaria Territoriale ? ASST di Monza

Monza, Lombardy, 20052, Italy

Location

Istituto Nazionale dei Tumori

Monza, Lombardy, 20052, Italy

Location

Istituto Clinico Humanitas

Rozzano (MI), Lombardy, 20089, Italy

Location

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Turin, Piedmont, 10126, Italy

Location

Azienda Ospedaliero-Universitaria ?PoliclinicoVittorio Emanuele?- P.O. G. Rodolico; Oncologia Medica

Catania, Sicily, 95123, Italy

Location

Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia

Verona, Veneto, 37126, Italy

Location

Aichi Cancer Center Hospital; Respiratory Medicine

Aichi, 464-8681, Japan

Location

Nagoya University Hospital; Respiratory Medicine

Aichi, 466-8560, Japan

Location

Kyushu University Hospital; Respiratory

Fukuoka, 812-8582, Japan

Location

Hokkaido University Hospital

Hokkaido, 060-8648, Japan

Location

Kobe City Medical Center General Hospital; Respiratory Medicine

Hyōgo, 650-0047, Japan

Location

Hyogo Cancer Center; Thoracic Oncology

Hyōgo, 673-8558, Japan

Location

Ibaraki Prefectural Central Hospital; Division of respiratory

Ibaraki, 309-1793, Japan

Location

Sendai Kousei Hospital; Pulmonary Medicine

Miyagi, 980-0873, Japan

Location

Okayama University Hospital; Respiratory and Allergy Medicine

Okayama, 700-8558, Japan

Location

Osaka International Cancer Institute; Thoracic Oncology

Osaka, 541-8567, Japan

Location

Kansai Medical university Hospital; Thoracic Oncology

Osaka, 573-1191, Japan

Location

Osaka Habikino Medical Center

Osaka, 583-8588, Japan

Location

National Hospital Organization Kinki-Chuo Chest Medical Center

Sakaishi, 591-8555, Japan

Location

Saitama Cancer Center; Thoracic Oncology

Satima, 362-0806, Japan

Location

National Cancer Center Hospital; Thoracic Medical Oncology

Tokyo, 104-0045, Japan

Location

Tokyo Medical University Hospital; Dept of Surgery

Tokyo, 160-0023, Japan

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Location

Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii

Olsztyn, 10-357, Poland

Location

Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

Otwock, 05-400, Poland

Location

Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

Poznan, 60-569, Poland

Location

Med-Polonia Sp. z o.o.

Poznan, 60-693, Poland

Location

Teo Health SA - Saint Constantin Hospital

Brasov, 500091, Romania

Location

Prof. Dr. I. Chiricuta Institute of Oncology

Cluj-Napoca, 400015, Romania

Location

Oncology Center Sf. Nectarie

Craiova, 200347, Romania

Location

Institutul Regional de Oncologie Iasi; Clinica de Hematologie

Iași, 700483, Romania

Location

Sibiu Emergency Clinical County Hospital

Sibiu, 550245, Romania

Location

Oncocenter Clinical Oncology

Timi?oara, 300210, Romania

Location

Oncomed SRL

Timișoara, 300239, Romania

Location

Arkhangelsk Regional Clinical Oncology Dispensary

Arkhangelsk, Arhangelsk, 163045, Russia

Location

Federal State Institution Medical Radiology Research Center

Obninsk, Kaluga Oblast, 249036, Russia

Location

Moscow City Oncology Hospital #62

Moscovskaya Oblast, Moscow Oblast, 143423, Russia

Location

Principal Military Clinical Hospital n.a. N.N. Burdenko

Moscow, Moscow Oblast, 105229, Russia

Location

Saint Petersburg Clinical Hospital of the Russian Academy of Sciences

Saint Petersburg, Sankt-Peterburg, 194017, Russia

Location

Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic

Kazan', Tatarstan Republic, 420029, Russia

Location

Regional Clinical Oncology Center

Ryazan, 390046, Russia

Location

Leningrad Regional Clinical Hospital

Saint Petersburg, 194291, Russia

Location

St. Petersburg Med Univ; n.a. I.P. Pavlov; Pulmonology Research

Saint Petersburg, 197089, Russia

Location

Mordovia State University

Saransk, 430032, Russia

Location

Volgograd Regional Clinical Oncology Dispensary

Volgograd, 400138, Russia

Location

Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

Institute for Oncology and Radiology of Serbia; Medical Oncology

Belgrade, 11000, Serbia

Location

Institute of Lung Diseases Vojvodina

Kamenitz, 21204, Serbia

Location

Clinical Center Kragujevac

Kragujevac, 34000, Serbia

Location

Chonnam National University Hwasun Hospital

Jeollanam-do, 58128, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, 07010, Spain

Location

Hospital Son Llatzer

Palma de Mallorca, Balearic Islands, 07198, Spain

Location

Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

Badalona, Barcelona, 08916, Spain

Location

Consorcio Hospitalario Provincial de Castellon

Castellon de LA Plana/castello de LA Plana, Castellon, 12002, Spain

Location

Hospital Universitario A Coruña

A Coruña, LA Coruña, 15006, Spain

Location

Hospital Universitario Cruces

Barakaldo, Vizcaya, 48903, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, 08035, Spain

Location

Complejo Hospitalario de Jaen

Jaén, 23007, Spain

Location

Hospital Clinico San Carlos; Servicio de Oncologia

Madrid, 28040, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, 46026, Spain

Location

Hosp Clinico Univ Lozano Blesa; División De Oncología Médica

Zaragoza, 50009, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Prince of Songkla University; Department Of Internal Medicine, Faculty Of Medicine

Hat Yai, 90110, Thailand

Location

Khon Kaen University

Khon Kaen, 40002, Thailand

Location

Chiang Rai Prachanukroh Hospital

Muang, 57000, Thailand

Location

Buddhachinnaraj Hospital

Phitsanulok, 65000, Thailand

Location

Cukurova University Medical Faculty Balcali Hospital

Adana, 1330, Turkey (Türkiye)

Location

Hacettepe Universitesi Tip Fakultesi Hastanesi

Ankara, 06100, Turkey (Türkiye)

Location

Istanbul University Cerrahpasa Medical Faculty

Istanbul, 34000, Turkey (Türkiye)

Location

Ege Universitesi Tip Fakultesi Hastanesi

Izmir, 35100, Turkey (Türkiye)

Location

Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi

Izmir, 35110, Turkey (Türkiye)

Location

Inonu University Faculty of Medicine Turgut Ozal Medical Center

Malatya, 44280, Turkey (Türkiye)

Location

Municipal Noncommercial Institution Regional Center of Oncology

Kharkiv, Kharkiv Governorate, 61070, Ukraine

Location

Municipal Noncomercial Enterprise Odessa Regional Oncology Center ofthe Odessa StateAdministration

Odesa, Kherson Governorate, 65055, Ukraine

Location

Municipal non profit enterprise of Sumy Regional Council Sumy Regional Clinical Oncology Disp

Sumy, Kholm Governorate, 40005, Ukraine

Location

Communal Non-profit Enterprise City Clinical Hospital #4 of Dnipro City Council - PPDS; Chemotherapy

Dnipro, KIEV Governorate, 49102, Ukraine

Location

Kyiv Railway Clinical Hospital #3 of Branch Health Center of the PJSC Ukrainian Railway

Kyiv, KIEV Governorate, 02096, Ukraine

Location

Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council

Vinnytsia, KIEV Governorate, 21029, Ukraine

Location

The Municipal Enterprise Volyn Regional Medical Oncology Centre of the Volyn Regional Council

Lutsk, Volhynian Governorate, 43018, Ukraine

Location

Private Enterprise Private Manufacturing Company Acinus

Kirovograd, 25006, Ukraine

Location

Birmingham Heartlands Hospital

Birmingham, B9 5SS, United Kingdom

Location

Colchester General Hospital

Colchester, Essex, CO4 5JL, United Kingdom

Location

Christie Hospital

Manchester, M20 3BG, United Kingdom

Location

Related Publications (2)

• Li B, Rong D, Lin H. Atezolizumab monotherapy as first-line treatment for non-small cell lung cancer ineligible for treatment with a platinum-containing regimen (IPSOS): a cost-effectiveness analysis in the USA. BMJ Open. 2024 Nov 12;14(11):e083716. doi: 10.1136/bmjopen-2023-083716.

  PMID: 39532375 DERIVED

• Herbst RS, Giaccone G, de Marinis F, Reinmuth N, Vergnenegre A, Barrios CH, Morise M, Felip E, Andric Z, Geater S, Ozguroglu M, Zou W, Sandler A, Enquist I, Komatsubara K, Deng Y, Kuriki H, Wen X, McCleland M, Mocci S, Jassem J, Spigel DR. Atezolizumab for First-Line Treatment of PD-L1-Selected Patients with NSCLC. N Engl J Med. 2020 Oct 1;383(14):1328-1339. doi: 10.1056/NEJMoa1917346.

  PMID: 32997907 DERIVED

MeSH Terms

Interventions

atezolizumab; Carboplatin; Cisplatin; Gemcitabine; Pemetrexed

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: April 6, 2015
• Study Start: July 20, 2015
• Primary Completion: February 4, 2020
• Study Completion: March 8, 2022
• Last Updated: March 15, 2023
• Results First Posted: February 18, 2021

Record last verified: 2023-02

Locations

CN (1); FR (10); HU (4); JP (16); RO (7); GR (11); IT (12); KR (3); SE (4); BR (11); RU (11); ES (15); TU (6); DE (2); GB (3); US (9); UA (8); TH (4); PL (5)