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)
NCT ID: NCT03456063
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
453 participants
INTERVENTIONAL
2018-04-24
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm A: Atezolizumab + platinum-based chemotherapy
Neoadjuvant treatment will consist of 4 cycles; atezolizumab + platinum-based chemotherapy
Platinum-based chemotherapy may include:
* carboplatin + pemetrexed
* carboplatin + nab-paclitaxel
* cisplatin + pemetrexed
* cisplatin + gemcitabine
Post-operative adjuvant treatment will consist of 16-cycles of atezolizumab
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
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
Arm B: Placebo + platinum-based chemotherapy
Neoadjuvant treatment will consist of 4 cycles; placebo + platinum-based chemotherapy
Platinum-based chemotherapy may include:
* carboplatin + pemetrexed
* carboplatin + nab-paclitaxel
* cisplatin + pemetrexed
* cisplatin + gemcitabine
Participants will receive best supportive care and monitoring after surgery
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed, resectable Stage II, IIIA, or Select IIIB (T3N2 only) NSCLC of squamous or non-squamous histology. Staging should be based on the 8th edition of the AJCC/UICC staging system
* Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent
* Adequate pulmonary and cardiac function to undergo surgical resection
* Measurable disease as defined by RECIST v1.1
* Adequate hematologic and end organ function
* Negative HIV test at screening
* Negative for active HBV and HCV at screening
* Adequate tissue for PD-L1 IHC assessment
Exclusion Criteria
* Mixed NSCLC and small cell lung cancer histology
* Any prior therapy for lung cancer
* Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated expected curative outcome
* Non-squamous NSCLC histology with activating ALK and EGFR mutation
* Pregnant or lactating women
* History of autoimmune disease
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or evidence of active of active pneumonitis on screening chest Computed Tomography (CT) scan
* Prior treatment with cluster of differentiation 137 (CD137) agonist 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Uni of Maryland Cancer Center
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Brighton Center for Specialty Care
Brighton, 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 Winthrop Hospital
Mineola, 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
UT Health East Texas HOPE Cancer Center
Tyler, Texas, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 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
Padua, 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
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Hospital Universitario la Fe
Valencia, , Spain
Lungmedicinska kliniken, Centrum för kirurgi, ortopedi och cancervård, Universitetssjukhuset
Linköping, , Sweden
Uni Hospital in Lund
Lund, , Sweden
Karolinska Universitetssjukhuset, Solna
Solna, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
CHUV
Lausanne, , Switzerland
UniversitätsSpital Zürich
Zurich, , Switzerland
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Taichung Veterans General Hospital
Xitun Dist., , Taiwan
Chulalongkorn Hospital
Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, , Thailand
Chemotherapy SI Dnipropetrovsk MA of MOHU
Dnipropetrovsk, , Ukraine
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Barts and the London NHS Trust.
London, , United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Metropolitan Borough of Wirral, , United Kingdom
Countries
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References
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Romero Roman A, Campo-Canaveral de la Cruz JL, Macia I, Escobar Campuzano I, Figueroa Almanzar S, Delgado Roel M, Galvez Munoz C, Garcia Fontan EM, Muguruza Trueba I, Romero Vielva L, Cano Garcia JR, Martinez Tellez E, Partida Gonzalez C, Jimenez Lopez MF, Jimenez Maestre U, Mongil Poce R, Sanchez Lorente D, Alvarez Kindelan A, Provencio Pulla M. Outcomes of surgical resection after neoadjuvant chemoimmunotherapy in locally advanced stage IIIA non-small-cell lung cancer. Eur J Cardiothorac Surg. 2021 Jul 14;60(1):81-88. doi: 10.1093/ejcts/ezab007.
Other Identifiers
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2023-504209-35-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
GO40241
Identifier Type: -
Identifier Source: org_study_id
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