A Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower131]
A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel or Atezolizumab in Combination With Carboplatin+Nab-Paclitaxel Versus Carboplatin+Nab-Paclitaxel in Chemotherapy-Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer
2 other identifiers
interventional
1,021
25 countries
232
Brief Summary
This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV squamous NSCLC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2015
Longer than P75 for phase_3
232 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2015
CompletedFirst Posted
Study publicly available on registry
February 20, 2015
CompletedStudy Start
First participant enrolled
June 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 3, 2018
CompletedResults Posted
Study results publicly available
November 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 17, 2021
CompletedMarch 21, 2022
March 1, 2022
3.3 years
February 13, 2015
September 25, 2019
March 17, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Progression Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Intent-to-Treat (ITT) Population
PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the ITT population.
Up to approximately 30 months after first participant enrolled
Overall Survival (OS) in the ITT Population
OS is defined as the time between the date of randomization and date of death from any cause in the ITT population.
Up to approximately 39 months after first participant enrolled
Secondary Outcomes (21)
OS in the in the Teff Population
Up to approximately 39 months after first participant enrolled
PFS as Determined by the Investigator Using RECIST v1.1 in the Teff Population
Up to approximately 30 months after first participant enrolled
PFS as Determined by the Investigator Using RECIST v1.1 in the Tumor Cell (TC) 2/3 or Tumor-Infiltrating Immune Cell (IC) 2/3 Population
Up to approximately 30 months after first participant enrolled
PFS as Determined by the Investigator Using RECIST v1.1 in the TC1/2/3 or IC1/2/3 Population
Up to approximately 30 months after first participant enrolled
OS in the TC2/3 or IC2/3 Population
Up to approximately 39 months after first participant enrolled
- +16 more secondary outcomes
Study Arms (3)
Arm A: Atezolizumab + Paclitaxel + Carboplatin
EXPERIMENTALThe induction phase of the study will consist of four or six cycles; atezolizumab, paclitaxel, and carboplatin will be administered on Day 1 of each 21-day cycle. The Day 1 order of drug administration is as follows: atezolizumab, then paclitaxel, then carboplatin. Participants who experience no further clinical benefit at any time during the induction phase will discontinue all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants will begin maintenance therapy with atezolizumab. Atezolizumab will be continued as long as there is a clinical benefit to the participant.
Arm B: Atezolizumab + Nab-Paclitaxel + Carboplatin
EXPERIMENTALThe induction phase of the study will consist of four or six cycles; atezolizumab and carboplatin will be administered on Day 1 of each 21-day cycle. Nab-Paclitaxel will be administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration is as follows: atezolizumab, then nab-paclitaxel, then carboplatin. Participants who experience no further clinical benefit at any time during the induction phase will discontinue all study treatments. In the absence of the above criteria, after the 4- or 6-cycle induction phase, participants will begin maintenance therapy with atezolizumab. Atezolizumab will be continued as long as there is a clinical benefit to the participant.
Arm C: Nab-Paclitaxel + Carboplatin
ACTIVE COMPARATORThe induction phase of the study will consist of four or six cycles; carboplatin will be administered on Day 1 of each 21-day cycle, nab-paclitaxel will be administered on Days 1, 8, and 15 of each 21-day cycle. The Day 1 order of drug administration is as follows: nab-paclitaxel, then carboplatin. Participants who experience disease progression at any time during the induction phase will discontinue all study treatment. In the maintenance phase, participants will receive best supportive care.
Interventions
Atezolizumab 1200 milligrams (mg) intravenous infusion (IV) on day 1 of each 21-day cycle.
Carboplatin area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles.
Nab-paclitaxel 100 milligrams per meter squared (mg/m\^2) IV on Day 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles.
Paclitaxel 200 mg/m\^2 IV on Day 1 of each 21-day cycle for 4 or 6 cycles. Participants of Asian race/ethnicity will be administered paclitaxel 175 mg/m\^2 IV.
Eligibility Criteria
You may qualify if:
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Histologically or cytologically confirmed, treatment-naïve Stage IV squamous NSCLC
- Previously obtained archival tumor tissue or tissue obtained from biopsy at screening
- Measurable disease as defined by RECIST v1.1
- Adequate hematologic and end organ function
You may not qualify if:
- Active or untreated central nervous system (CNS) metastasis
- 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 Computed Tomography (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 137 (CD137) agonists or immune checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibody
- Severe infection within 4 weeks prior to randomization
- Significant history of cardiovascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (242)
Ironwood Cancer & Research Centers
Chandler, Arizona, 85224, United States
Highlands Oncology Group
Springdale, Arkansas, 72762, United States
Southern CA Permanente Med Grp
Bellflower, California, United States
Kaiser Permanente Oakland Medical Center
Oakland, California, 94611, United States
Kaiser Permanente - Sacramento Medical Center and Medical Offices
Sacramento, California, 95825, United States
Kaiser Permanente - San Leandro Medical Center
San Leandro, California, 94577, United States
Kaiser Permanente - Santa Clara
Santa Clara, California, 95051, United States
Kaiser Permanente; Oncology Clinical Trials
Vallejo, California, 94589, United States
Kaiser Permanente - Walnut Creek
Walnut Creek, California, 94596, United States
Rocky Mountain Cancer Center
Denver, Colorado, 80218, United States
Danbury Hospital
Danbury, Connecticut, 06810, United States
Holy Cross Hospital Inc
Fort Lauderdale, Florida, 33308, United States
SCRI Florida Cancer Specialists South
Fort Myers, Florida, 33916, United States
Florida Cancer Specialists
Palm Beach Gardens, Florida, 33410, United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952, United States
Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)
St. Petersburg, Florida, 33705, United States
University Cancer & Blood Center, LLC; Research
Athens, Georgia, 30607, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Carrollton, Georgia, 30117, United States
Central Georgia Cancer Care PC
Macon, Georgia, 31201, United States
Southeastern Regional Medical Center, Inc.
Newnan, Georgia, 30265, United States
University of Chicago
Chicago, Illinois, 60637, United States
Joliet Oncology-Hematology; Associates, Ltd.
Joliet, Illinois, 60435, United States
Quincy Medical Group
Quincy, Illinois, 62301, United States
Fort Wayne Med Oncology & Hematology Inc
Fort Wayne, Indiana, 46845, United States
Hematology-Oncology; Associates of the Quad Cities
Bettendorf, Iowa, 52722, United States
Siouxland Hematology/Oncology
Sioux City, Iowa, 51101, United States
Lahey Clinic Med Ctr
Lexington, Kentucky, 02421, United States
Norton Cancer Institute
Louisville, Kentucky, 40202, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
New England Cancer Specialists
Scarborough, Maine, 04074, United States
Southcoast Health System; Southcoast Centers For Cancer Care
Fairhaven, Massachusetts, 02719, United States
St. Joseph Mercy Health System
Ann Arbor, Michigan, 48106, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
St. Luke's Regional Cancer Center
Duluth, Minnesota, 55805, United States
Hematology and Oncology Associates at Bridgepoint
Tupelo, Mississippi, 38801, United States
Billings Clinic
Billings, Montana, 59102, United States
Valley Hospital; Oncology Research
Paramus, New Jersey, 07652, United States
Regional Cancer Care Associates LLC
Sewell, New Jersey, 08080, United States
Clinical Research Alliance
Westbury, New York, 11590, United States
W.G. Bill Hefner VA Medical Center
Salisbury, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, 45203-0542, United States
Mark H. Zangmeister Center
Columbus, Ohio, 43219, United States
Oncology Hematology Care, Inc.
Hamilton, Ohio, 45103, United States
Oregon Health & Science Uni
Portland, Oregon, 97239, United States
St. Luke's Cancer Care Associates
Bethlehem, Pennsylvania, 18015, United States
Maryland Oncology Hematology (Lanham) - USOR
Gettysburg, Pennsylvania, 17325, United States
Allegheny Cancer Center
Pittsburgh, Pennsylvania, 15212, United States
Univ of Pittsburgh Medical Ctr
Pittsburgh, Pennsylvania, 15232, United States
SCRI Tennessee Oncology Chattanooga
Chattanooga, Tennessee, 37404, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, 37920, United States
SCRI The Center For Cancer and Blood Disorders
Denton, Texas, 76210, United States
Longview Cancer Center
Longview, Texas, 75601, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Blue Ridge Cancer Care
Roanoke, Virginia, 24014, United States
Providence Regional Cancer Partnership
Everett, Washington, 98201, United States
Medical Oncology Associates
Spokane, Washington, 99208, United States
Fundación CENIT para la Investigación en Neurociencias
Buenos Aires, C1125ABD, Argentina
Sanatorio Allende
Córdoba, X5000JHQ, Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja, F5300COE, Argentina
Clínica Pergamino
Pergamino, B2700CPM, Argentina
Fundacion Koriza
Santa Rosa, L6304BOC, Argentina
Centro de Investigacion; Clinica - Clinica Viedma S.A.
Viedma, R8500ACE, Argentina
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050, Australia
Calvary Mater Newcastle; Medical Oncology
Waratah, New South Wales, 2298, Australia
Prince Charles Hospital
Chermside, Queensland, 4032, Australia
Townsville Hospital
Townsville, Queensland, 4810, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
Cabrini Hospital Malvern
Malvern, Victoria, 3144, Australia
Sunshine Hospital
St Albans, Victoria, 3021, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
Paracelsus Medizinische Privatuniversität
Salzburg, 5020, Austria
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
CHU Sart-Tilman
Liège, 4000, Belgium
Clinique Ste-Elisabeth
Namur, 5000, Belgium
Werken Glorieux VZW
Ronse, 9600, Belgium
GasthuisZusters Antwerpen
Wilrijk, 2610, Belgium
Cenantron - Centro Avancado de Tratamento Oncologico
Belo Horizonte, Minas Gerais, 30130-090, Brazil
Instituto Do Cancer Delondrina_X; Unidade De Pesquisa Clinica
Londrina, Paraná, 86 015 520, Brazil
Liga Norte Riograndense Contra O Câncer
Natal, Rio Grande do Norte, 59040150, Brazil
IPCEM; Instituto de Pesquisa de Estudos Multicêntricos
Caxias do Sul, Rio Grande do Sul, 95070-560, Brazil
Hospital Bruno Born
Lajeado, Rio Grande do Sul, 95900-000, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Hospital Mae de Deus
Porto Alegre, Rio Grande do Sul, 90470-340, Brazil
*X*Fundação Pio XII Hospital de Câncer de Barretos
Barretos, São Paulo, 14784-400, Brazil
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090-000, Brazil
Hospital Do Cancer A C Camargo
São Paulo, São Paulo, 01525-001, Brazil
Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
Plovdiv, 4000, Bulgaria
Multiprofile Hospital for Active Treatment Serdika EOOD
Sofia, 1303, Bulgaria
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2, Canada
William Osler Health Centre
Etobicoke, Ontario, M9V 1R8, Canada
Lakeridge Health Center
Oshawa, Ontario, L1J 2J2, Canada
Cite de La Sante de Laval; Hemato-Oncologie
Laval, Quebec, H7M 3L9, Canada
Hôpital du Sacré-Coeur de Montreal
Montreal, Quebec, H4J 1C5, Canada
St. Jerome Medical Research
Saint-Jérôme, Quebec, J7Z 5T3, Canada
Health & Care SPA
Santiago, 7500006, Chile
Sociedad de Investigaciones Medicas Ltda (SIM)
Temuco, 4810469, Chile
CHU de Grenoble
Grenoble, 38043, France
Ctr Jean Bernard Clin V. Hugo; Service d'Oncologie Méd
Le Mans, 72000, France
Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
Lyon, 69008, France
Clinique Clémentville
Montpellier, 34070, France
Hopital de La Source
Orléans, 45067, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Hopital de Pontchaillou; Service de Pneumologie
Rennes, 35033, France
Centre Hospitalier Regional Sud Reunion; Service de Pneumologie
Saint-Pierre, 97448, France
CH de Saint Quentin
Saint-Quentin, 2100, France
Hôpital d'Instruction des Armées de Sainte Anne; Service Pharmacie Essais Cliniques
Toulon, 83800, France
Charite - Universitätsmedizin Berlin
Berlin, 12203, Germany
Ev.Krankenhaus Bielefeld gGmbH; Klinik für Innere Medizin und Geriatrie
Bielefeld, 33611, Germany
Augusta Kranken-Anstalt gGmbH
Bochum, 44791, Germany
Kliniken der Stadt Koln gGmbH
Cologne, 51109, Germany
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
Dresden, 01307, Germany
St. Elisabethen Krankenhaus
Frankfurt am Main, 60487, Germany
Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie
Gerlingen, 70839, Germany
LungenClinic Großhansdorf GmbH
Großhansdorf, 22927, Germany
Krankenhaus Martha-Maria; Halle-Dolau gGmbH
Halle, 06120, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
Asklepios Klinik Harburg
Hamburg, 21075, Germany
Lungenklinik Hemer
Hemer, 58675, Germany
Universität Des Saarlandes; Klinik für Innere Medizin V
Homburg, 66421, Germany
Fachklinik für Lungenerkrankungen
Immenhausen, 34376, Germany
Johannes Wesling Klinikum Minden; Hämatologie, Onkologie, Hämostaseologie und Palliativmedizin
Minden, 32429, Germany
Klinikum Bogenhausen; Klinik für Pneumologie und Pneumologische Onkologie
München, 81925, Germany
Krankenhaus Barmherzige Bruder Regensburg
Regensburg, 93049, Germany
Klinikum der Universität Regensburg
Regensburg, 93053, Germany
Stiftung Mathias-Spital Rheine
Rheine, 48431, Germany
Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie
Villingen-Schwenningen, 78052, Germany
Soroka Medical Center
Beersheba, 8410101, Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, 9112001, Israel
Meir Medical Center; Oncology
Kfar Saba, 4428164, Israel
Rabin Medical Center
Petach Tiqwa, 4941492, Israel
Chaim Sheba Medical Center; Oncology Dept
Ramat Gan, 5262100, Israel
Rambam Health Corporation; Oncology Institute
Rambam, 3525408, Israel
Tel Aviv Sourasky Medical Ctr; Oncology
Tel Aviv, 6423906, Israel
IRCCS Giovanni Paolo II Istituto Oncologico
Bari, Apulia, 70124, Italy
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati
Avellino, Campania, 83100, Italy
AORN A Cardarelli
Napoli, Campania, 80131, Italy
Azienda Ospedaliero Universitaria Seconda Università degli Studi di Napoli; Farmacia Centralizzata
Napoli, Campania, 80131, Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
Napoli, Campania, 80131, Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, Lazio, 00152, Italy
ASL 3 Genovese; DSM
Genoa, Liguria, 16147, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, 27100, Italy
Policlinico Vittorio Emanuele
Catania, Sicily, 95123, Italy
Ospedale Civile - Livorno
Livorno, Tuscany, 57124, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, 56100, Italy
Ospedale Silvestrini
Perugia, Umbria, 06122, Italy
Aichi Cancer Center Hospital; Respiratory Medicine
Aichi, 464-8681, Japan
Nagoya University Hospital; Respiratory Medicine
Aichi, 466-8560, Japan
National Cancer Center Hospital East; Thoracic Oncology
Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center; Internal Medicine
Ehime, 791-0280, Japan
National Hospital Organization Kyushu Medical Center; Respiratory Internal Medicine
Fukuoka, 810-8563, Japan
Kyushu University Hospital; Respiratory
Fukuoka, 812-8582, Japan
Kobe City Medical Center General Hospital; Respiratory Medicine
Hyōgo, 650-0047, Japan
National Hospital Organization Himeji Medical Center
Hyōgo, 670-8520, Japan
Hyogo Cancer Center; Thoracic Oncology
Hyōgo, 673-8558, Japan
Ibaraki Prefectural Central Hospital; Division of respiratory
Ibaraki, 309-1793, Japan
Kanagawa Cancer Center;Thoracic Oncology
Kanagawa, 241-8515, Japan
Kyoto University Hospital, Respiratory Medicine
Kyoto, 606-8507, Japan
Sendai Kousei Hospital; Pulmonary Medicine
Miyagi, 980-0873, Japan
Niigata University Medical & Dental Hospital; Respiratory Medicine and Infectious Disease
Niigata, 951-8520, Japan
Okayama University Hospital; Respiratory and Allergy Medicine
Okayama, 700-8558, Japan
Osaka International Cancer Institute; Thoracic Oncology
Osaka, 541-8567, Japan
Osaka City Uni Hospital; Respiratory Medicine
Osaka, 545-8586, Japan
Kansai Medical university Hospital; Thoracic Oncology
Osaka, 573-1191, Japan
Osaka Habikino Medical Center
Osaka, 583-8588, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakaishi, 591-8555, Japan
Saitama Cancer Center; Thoracic Oncology
Satima, 362-0806, Japan
Shizuoka Cancer Center; Thoracic Oncology
Shizuoka, 411-8777, Japan
National Cancer Center Hospital; Thoracic Medical Oncology
Tokyo, 104-0045, Japan
Tokyo Medical University Hospital; Dept of Surgery
Tokyo, 160-0023, Japan
Pauls Stradins Clinical University Hospital
Riga, LV-1002, Latvia
Riga East Clinical University Hospital Latvian Oncology Centre
Riga, LV-1079, Latvia
National Cancer Institute
Vilnius, 08660, Lithuania
Centro Universitario Contra El Cancer
Monterrey, 64020, Mexico
Cancerología
Querétaro, 76090, Mexico
VU Medisch Centrum; VU University Medical Center
Amsterdam, 1007 MB, Netherlands
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, 1066 CX, Netherlands
Ziekenhuis Gelderse Vallei
Ede, 6716 RP, Netherlands
Catharina Hospital; Afdeling Longgeneeskunde en Tuberculose
Eindhoven, 5623 EJ, Netherlands
St. Antonius Ziekenhuis; R&D Long
Nieuwegein, 3435 CM, Netherlands
Centro Medico Monte Carmelo
Arequipa, 04001, Peru
Hospital Nacional Guillermo Almenara Irigoyen ESSALUD
Lima, Lima 13, Peru
Instituto Regional de Enfermedades Neoplásicas Del Norte
Trujillo, 12345, Peru
IPO de Lisboa; Servico de Pneumologia
Lisbon, 1099-023, Portugal
Hospital Pulido Valente; Servico de Pneumologia
Lisbon, 1796-001, Portugal
Centro Hospitalar do Porto - Hospital de Santo António
Porto, 4099-001, Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe
Porto, 4200-072, Portugal
Hospital de Sao Joao; Servico de Pneumologia
Porto, 4200, Portugal
Moscow City Oncology Hospital #62
Moscovskaya Oblast, Moscow Oblast, 143423, Russia
Russian Oncology Research Center n.a. N.N. Blokhin
Moscow, 115478, Russia
Clinical Oncology Dispensary
Omsk, 644013, Russia
City Clinical Oncology Dispensary
Saint Petersburg, 197022, Russia
Volgograd Regional Clinical Oncology Dispensary
Volgograd, 400138, Russia
National University Hospital
Singapore, 119074, Singapore
National Cancer Centre
Singapore, 169610, Singapore
Univerzitna nemocnica Bratislava
Bratislava, 813 69, Slovakia
Narodny onkologicky ustav
Bratislava, 833 10, Slovakia
POKO Poprad s.r.o.
Poprad, 058 01, Slovakia
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07014, Spain
Instituto Catalan de Oncologia de Hospitalet (ICO); Servicio de Farmacia
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell, Barcelona, 8208, Spain
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
Santander, Cantabria, 39008, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, LA Coruña, 15006, Spain
Complejo Hospitalario Universitario Insular-Materno Infantil
Las Palmas de Gran Canaria, LAS Palmas, 35016, Spain
Hospital Nuestra Senora de Valme
Seville, Sevilla, 41014, Spain
Hospital Universitario de Canarias
S. Cristobal de La Laguna, Tenerife, 38320, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona, 08041, Spain
Hospital Universitario Reina Sofia
Córdoba, 14008, Spain
Hospital Lucus Augusti; Servicio de Oncologia
Lugo, 27003, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, 28007, Spain
Hospital Universitario La Paz
Madrid, 280146, Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, 28034, Spain
Fundación Jimenez Díaz
Madrid, 28040, Spain
Hospital Clinico San Carlos; Servicio de Oncologia
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
Madrid, 28050, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Hospital General Universitario de Valencia
Valencia, 46014, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Changhua Christian Hospital; Hematology-Oncology
Changhua, 500, Taiwan
Kaohsiung Medical University Hospital; Department of Urology
Kaohsiung City, 807, Taiwan
Chi Mei Medical Center Liou Ying Campus
Liuying Township, 736, Taiwan
Chang Gung Memorial Hospital Chiayi
Putzu, 613, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
National Taiwan Uni Hospital
Taipei, 10041, Taiwan
Mackay Memorial Hospital
Taipei, 104, Taiwan
Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS; Dept of Chemotherapy
Dnipropetrovsk, Katerynoslav Governorate, 49102, Ukraine
Uzhgorod Central City Clinical Hospital
Uzhhorod, Katerynoslav Governorate, 88000, Ukraine
MNPE Zaporizhzhia Regional Antitumor Center ZRC
Zaporizhzhia, Katerynoslav Governorate, 69040, Ukraine
Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs
Kharkiv, Kharkiv Governorate, 61070, Ukraine
Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council
Vinnytsia, KIEV Governorate, 21029, Ukraine
MI of the Lviv Regional Council Lviv Oncology Regional Treatment and Diagnostic Centre; Chemotherapy
Lviv, Volhynian Governorate, 79031, Ukraine
Municipal Institution Chernivtsi Regional Clinical Oncology Dispensary; Surgery Department #1
Chernivtsi, 58013, Ukraine
SI Institute of Medical Radiology n.a. S.P. Hryhoriev of NAMS of Ukraine
Kharkiv, 61024, Ukraine
ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department
Kryvyi Rih, 50048, Ukraine
Poltava Regional Clinical Oncology Dispensary of Poltava Regional Council; Thoracic department
Poltava, 36011, Ukraine
Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary
Sumy, 40005, Ukraine
Related Publications (1)
Ton TGN, Pal N, Trinh H, Mahrus S, Bretscher MT, Machado RJM, Sadetsky N, Chaudhary N, Lu MW, Riely GJ. Replication of Overall Survival, Progression-Free Survival, and Overall Response in Chemotherapy Arms of Non-Small Cell Lung Cancer Trials Using Real-World Data. Clin Cancer Res. 2022 Jul 1;28(13):2844-2853. doi: 10.1158/1078-0432.CCR-22-0471.
PMID: 35511917DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
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
February 13, 2015
First Posted
February 20, 2015
Study Start
June 11, 2015
Primary Completion
October 3, 2018
Study Completion
February 17, 2021
Last Updated
March 21, 2022
Results First Posted
November 12, 2019
Record last verified: 2022-03