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A Study of Neoadjuvant Atezolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer (IMpower030)
Sponsor: Hoffmann-La Roche
Summary
This is a randomized, double-blinded study designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of neoadjuvant treatment with atezolizumab (MPDL3280A) or placebo in combination with platinum-based chemotherapy in participants with resectable Stage II, IIIA, or select IIIB non-small cell lung cancer (NSCLC) followed by open-label adjuvant/postoperative atezolizumab or best supportive care and monitoring.
Official title: A Phase III, Double-Blinded, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Neoadjuvant Treatment With Atezolizumab or Placebo in Combination With Platinum-Based Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
453
Start Date
2018-04-24
Completion Date
2025-12-31
Last Updated
2026-10-09
Healthy Volunteers
No
Conditions
Interventions
Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Atezolizumab will be administered as intravenous (IV) infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle (every 3 weeks) for 4 cycles during the neoadjuvant treatment phase Atezolizumab will be administered as IV infusion at a dose of 1200 milligrams (mg) every 3 weeks for 16 cycles during the post-operative adjuvant phase
Placebo Comparator
Placebo will be administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase
Nab-paclitaxel
Nab-paclitaxel 100 mg/m\^2 will be administered intravenously on Days 1, 8, and 15 of each 21 day cycle for 4 cycles during the neoadjuvant treatment phase
Pemetrexed
Pemetrexed 500 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase
Carboplatin
Carboplatin initial target AUC of 6 mg/mL/min will be administered intravenously on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase
Cisplatin
Cisplatin 75 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase
Gemcitabine
Gemcitabine 1250 mg/m\^2 will be administered intravenously on Day 1 and 8 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase
Locations (117)
Arizona Oncology
Tucson, Arizona, United States
USC Norris Cancer Center
Los Angeles, California, United States
The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange
Orange, California, United States
UC Davis Cancer Center
Sacramento, California, United States
Scripps Clinic
San Diego, California, United States
National Jewish Health
Denver, Colorado, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
Georgetown University
Washington D.C., District of Columbia, United States
Washington Cancer Institute
Washington D.C., District of Columbia, United States
Illinois Cancer Care
Peoria, Illinois, United States
University of Michigan
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Minnesota Oncology Minneapolis
Minneapolis, Minnesota, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Mercy Clinic Cancer & Hematology
Springfield, Missouri, United States
Nebraska Methodist Estabrook Cancer Center
Omaha, Nebraska, United States
Northwell Health
Lake Success, New York, United States
NYU Langone Medical Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
Sarah Cannon Research Institute / Tennessee Oncology
Nashville, Tennessee, United States
Texas Oncology - South Austin
Austin, Texas, United States
Northwest Cancer Specialists - Vancouver
Vancouver, Washington, United States
St George Hospital
Kogarah, New South Wales, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Peter MacCallum Cancer Center
Melbourne, Victoria, Australia
Kepler Universitätskliniken GmbH - Med Campus III
Linz, Austria
Ordensklinikum Linz Elisabethinen
Linz, Austria
Klinik Penzing
Vienna, Austria
Krankenhaus Nord - Klinik Floridsdorf
Vienna, Austria
Cenantron - Centro Avancado de Tratamento Oncologico
Belo Horizonte, Minas Gerais, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, Brazil
Shanghai Chest Hospital
Shanghai, China
CHU Angers
Angers, France
Centre Léon Bérard
Lyon, France
Hopital d'Instruction des Armees de Begin
Saint-Mandé, France
Centre Hospitalier Saint Quentin
Saint-Quentin, France
CHU Strasbourg - Nouvel Hopital Civil
Strasbourg, France
Hôpital d'Instruction des Armées de Sainte Anne
Toulon, France
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
Asklepios-Fachkliniken Muenchen-Gauting
Gauting, Germany
LungenClinic Großhansdorf GmbH
Großhansdorf, Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH
Halle, Germany
Pius-Hospital Oldenburg
Oldenburg, Germany
Klinikum der Univer Regenburg
Regensburg, Germany
Robert Bosch Krankenhaus
Stuttgart, Germany
Missionsärztliche Klinik, Gemeinnützige Gesellschaft mbH
Würzburg, Germany
Semmelweis Egyetem X
Budapest, Hungary
Soroka Medical Center
Beersheba, Israel
Rambam Health Care Campus
Haifa, Israel
Meir Medical Center
Kfar Saba, Israel
Sourasky / Ichilov Hospital
Tel Aviv, Israel
Policlinico Universitario Campus Biomedico
Rome, Lazio, Italy
Irccs Istituto Nazionale Dei Tumori (Int)
Milan, Lombardy, Italy
Irccs Istituto Europeo Di Oncologia (IEO)
Milan, Lombardy, Italy
A.O. Universitaria Pisana-Ospedale Cisanello
Pisa, Tuscany, Italy
IOV - Istituto Oncologico Veneto - IRCCS
Padova, Veneto, Italy
Aichi Cancer Center Hospital
Aichi, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Japan
Hiroshima University Hospital
Hiroshima, Japan
Kobe University Hospital
Hyōgo, Japan
Hyogo Medical University Hospital
Hyōgo, Japan
Kyoto University Hospital
Kyoto, Japan
Fukushima Medical University Hospital
Miyagi, Japan
Sendai Kousei Hospital
Miyagi, Japan
Okayama University Hospital
Okayama, Japan
Kurashiki Central Hospital
Okayama, Japan
Osaka City General Hospital
Osaka, Japan
Osaka International Cancer Institute
Osaka, Japan
Juntendo University Hospital
Tokyo, Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Tokyo, Japan
The Cancer Institute Hospital of JFCR
Tokyo, Japan
Tokyo Medical University Hospital
Tokyo, Japan
Uniwersyteckie Centrum Kliniczne
Gda?sk, Poland
Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II
Krakow, Poland
Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad
Warsaw, Poland
Main Military Clinical Hospital named after N.N. Burdenko
Moscow, Moscow Oblast, Russia
FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
Moscow, Moscow Oblast, Russia
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
Saint Petersburg, Sankt-Peterburg, Russia
Scientific Research Oncology Institute named after N.N. Petrov
Saint Petersburg, Sankt-Peterburg, Russia
University Hospital Medical Center Bezanijska kosa
Belgrade, Serbia
University Clinic Golnik
Golnik, Slovenia
Medical Oncology Centre of Rosebank
Johannesburg, South Africa
Eugene Marais Hospital
Pretoria, South Africa
Kosin University Gospel Hospital
Busan, South Korea
St. Vincent's Hospital
Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, Spain
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, Spain
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain
Hospital de Basurto
Bilbao, Vizcaya, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Regional Universitario Carlos Haya
Málaga, Spain
Hospital Universitario Virgen Macarena
Seville, Spain