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)

NCT03456063 | Completed Phase 3 DMC FDA Drug

• 2 other identifiers: GO402412023-504209-35-00
• Study Type: interventional
• Target: 453
• Locations: 22 countries
• Sites: 118

Brief 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.

Conditions

Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• Independent Review Facility (IRF)-Assessed Event Free Survival (EFS)

  IRF-assessed EFS is defined as the time from randomization to the first documented disease progression per RECIST v1.1 that precludes surgery, local or distant disease recurrence, or death from any cause, whichever occurs first.

  Up to approximately 96 months

Secondary Outcomes (19)

• Pathological Complete Response (pCR)

  At time of surgery

• Major Pathological Response (MPR)

  At time of surgery

• Objective Response (OR)

  Prior to surgery, up to approximately 84 days

• Overall Survival (OS)

  Up to approximately 96 months

• Investigator-Assessed EFS

  Up to approximately 96 months

Study Arms (2)

Arm A: Atezolizumab + platinum-based chemotherapy

EXPERIMENTAL

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

Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody; Drug: Nab-paclitaxel; Drug: Pemetrexed; Drug: Carboplatin; Drug: Cisplatin; Drug: Gemcitabine

Arm B: Placebo + platinum-based chemotherapy

PLACEBO COMPARATOR

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

Drug: Placebo Comparator; Drug: Nab-paclitaxel; Drug: Pemetrexed; Drug: Carboplatin; Drug: Cisplatin; Drug: Gemcitabine

Interventions

Cisplatin DRUG

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

Arm A: Atezolizumab + platinum-based chemotherapy; Arm B: Placebo + platinum-based chemotherapy

Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody DRUG

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

Also known as: Tecentriq

Arm A: Atezolizumab + platinum-based chemotherapy

Placebo Comparator DRUG

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

Arm B: Placebo + platinum-based chemotherapy

Nab-paclitaxel DRUG

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

Also known as: Abraxane

Arm A: Atezolizumab + platinum-based chemotherapy; Arm B: Placebo + platinum-based chemotherapy

Pemetrexed DRUG

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

Also known as: Alimta

Arm A: Atezolizumab + platinum-based chemotherapy; Arm B: Placebo + platinum-based chemotherapy

Carboplatin DRUG

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

Arm A: Atezolizumab + platinum-based chemotherapy; Arm B: Placebo + platinum-based chemotherapy

Gemcitabine DRUG

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

Also known as: Gemzar

Arm A: Atezolizumab + platinum-based chemotherapy; Arm B: Placebo + platinum-based chemotherapy

Eligibility Criteria

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

You may qualify if:

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• 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

You may not qualify if:

• NSCLC with histology of large cell neuroendocrine carcinoma or sarcomatoid carcinoma
• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (122)

Arizona Oncology

Tucson, Arizona, 85711, United States

Location

USC Norris Cancer Center

Los Angeles, California, 90033, United States

Location

The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange

Orange, California, 92868, United States

Location

UC Davis Cancer Center

Sacramento, California, 95817, United States

Location

Scripps Clinic

San Diego, California, 92037, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Washington Cancer Institute

Washington D.C., District of Columbia, 20010, United States

Location

Illinois Cancer Care

Peoria, Illinois, 61615, United States

Location

Uni of Maryland Cancer Center

Baltimore, Maryland, 21201, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Brighton Center for Specialty Care

Brighton, Michigan, 48116, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Minnesota Oncology Minneapolis

Minneapolis, Minnesota, 55404, United States

Location

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

Location

Mercy Clinic Cancer & Hematology

Springfield, Missouri, 65804, United States

Location

Nebraska Methodist Estabrook Cancer Center

Omaha, Nebraska, 68114, United States

Location

Northwell Health

Lake Success, New York, 11042, United States

Location

NYU Winthrop Hospital

Mineola, New York, 11501, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

Location

Sarah Cannon Research Institute / Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

Texas Oncology - South Austin

Austin, Texas, 78745, United States

Location

UT Health East Texas HOPE Cancer Center

Tyler, Texas, 75701, United States

Location

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031, United States

Location

Northwest Cancer Specialists - Vancouver

Vancouver, Washington, 98684, United States

Location

St George Hospital

Kogarah, New South Wales, 2217, Australia

Location

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

Peter MacCallum Cancer Center

Melbourne, Victoria, 3000, Australia

Location

Kepler Universitätskliniken GmbH - Med Campus III

Linz, 4020, Austria

Location

Ordensklinikum Linz Elisabethinen

Linz, 4020, Austria

Location

Klinik Penzing

Vienna, 1140, Austria

Location

Krankenhaus Nord - Klinik Floridsdorf

Vienna, 1210, Austria

Location

Cenantron - Centro Avancado de Tratamento Oncologico

Belo Horizonte, Minas Gerais, 30130-090, Brazil

Location

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, 01246-000, Brazil

Location

Shanghai Chest Hospital

Shanghai, 200030, China

Location

CHU Angers

Angers, 49933, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

Hopital d'Instruction des Armees de Begin

Saint-Mandé, 94160, France

Location

Centre Hospitalier Saint Quentin

Saint-Quentin, 02321, France

Location

CHU Strasbourg - Nouvel Hopital Civil

Strasbourg, 67091, France

Location

Hôpital d'Instruction des Armées de Sainte Anne

Toulon, 83000, France

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Asklepios-Fachkliniken Muenchen-Gauting

Gauting, 82131, Germany

Location

LungenClinic Großhansdorf GmbH

Großhansdorf, 22927, Germany

Location

Krankenhaus Martha-Maria Halle-Doelau gGmbH

Halle, 06120, Germany

Location

Pius-Hospital Oldenburg

Oldenburg, 26121, Germany

Location

Klinikum der Univer Regenburg

Regensburg, 93053, Germany

Location

Robert Bosch Krankenhaus

Stuttgart, 70376, Germany

Location

Missionsärztliche Klinik, Gemeinnützige Gesellschaft mbH

Würzburg, 97074, Germany

Location

Semmelweis Egyetem X

Budapest, 1083, Hungary

Location

Soroka Medical Center

Beersheba, 8410101, Israel

Location

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

Meir Medical Center

Kfar Saba, 4428164, Israel

Location

Sourasky / Ichilov Hospital

Tel Aviv, 6423906, Israel

Location

Policlinico Universitario Campus Biomedico

Rome, Lazio, 00128, Italy

Location

Irccs Istituto Nazionale Dei Tumori (Int)

Milan, Lombardy, 20133, Italy

Location

Irccs Istituto Europeo Di Oncologia (IEO)

Milan, Lombardy, 20141, Italy

Location

A.O. Universitaria Pisana-Ospedale Cisanello

Pisa, Tuscany, 56124, Italy

Location

IOV - Istituto Oncologico Veneto - IRCCS

Padua, Veneto, 35128, Italy

Location

Aichi Cancer Center Hospital

Aichi, 464-8681, Japan

Location

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395, Japan

Location

Hiroshima City Hiroshima Citizens Hospital

Hiroshima, 730-8518, Japan

Location

Hiroshima University Hospital

Hiroshima, 734-8551, Japan

Location

Kobe University Hospital

Hyōgo, 650-0017, Japan

Location

Hyogo Medical University Hospital

Hyōgo, 663-8501, Japan

Location

Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

Fukushima Medical University Hospital

Miyagi, 960-1295, Japan

Location

Sendai Kousei Hospital

Miyagi, 981-0914, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

Kurashiki Central Hospital

Okayama, 710-8602, Japan

Location

Osaka City General Hospital

Osaka, 534-0021, Japan

Location

Osaka International Cancer Institute

Osaka, 541-8567, Japan

Location

Juntendo University Hospital

Tokyo, 113-8431, Japan

Location

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

Tokyo, 113-8677, Japan

Location

The Cancer Institute Hospital of JFCR

Tokyo, 135-8550, Japan

Location

Tokyo Medical University Hospital

Tokyo, 160-0023, Japan

Location

Uniwersyteckie Centrum Kliniczne

Gda?sk, 80-214, Poland

Location

Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II

Krakow, 31-202, Poland

Location

Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad

Warsaw, 02-781, Poland

Location

Main Military Clinical Hospital named after N.N. Burdenko

Moscow, Moscow Oblast, 105229, Russia

Location

FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

Moscow, Moscow Oblast, 115478, Russia

Location

S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

Saint Petersburg, Sankt-Peterburg, 197758, Russia

Location

Scientific Research Oncology Institute named after N.N. Petrov

Saint Petersburg, Sankt-Peterburg, 197758, Russia

Location

University Hospital Medical Center Bezanijska kosa

Belgrade, 11080, Serbia

Location

University Clinic Golnik

Golnik, 4204, Slovenia

Location

Medical Oncology Centre of Rosebank

Johannesburg, 2196, South Africa

Location

Eugene Marais Hospital

Pretoria, South Africa

Location

Kosin University Gospel Hospital

Busan, 49267, South Korea

Location

St. Vincent's Hospital

Gyeonggi-do, 16247, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Hospital Son Llatzer

Palma de Mallorca, Balearic Islands, 07198, Spain

Location

Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona, 08208, Spain

Location

Clinica Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital de Basurto

Bilbao, Vizcaya, 48013, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Regional Universitario Carlos Haya

Málaga, 29010, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital Universitario la Fe

Valencia, 46026, Spain

Location

Lungmedicinska kliniken, Centrum för kirurgi, ortopedi och cancervård, Universitetssjukhuset

Linköping, 58185, Sweden

Location

Uni Hospital in Lund

Lund, 22185, Sweden

Location

Karolinska Universitetssjukhuset, Solna

Solna, 171 64, Sweden

Location

Uppsala University Hospital

Uppsala, SE-75185, Sweden

Location

CHUV

Lausanne, 1011, Switzerland

Location

UniversitätsSpital Zürich

Zurich, 8091, Switzerland

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 00833, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Taichung Veterans General Hospital

Xitun Dist., 40705, Taiwan

Location

Chulalongkorn Hospital

Bangkok, 10330, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, 50200, Thailand

Location

Chemotherapy SI Dnipropetrovsk MA of MOHU

Dnipropetrovsk, 49102, Ukraine

Location

Queen Elizabeth Hospital

Birmingham, B15 2TH, United Kingdom

Location

Barts and the London NHS Trust.

London, EC1A 7BE, United Kingdom

Location

The Clatterbridge Cancer Centre NHS Foundation Trust

Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 33661301 DERIVED

MeSH Terms

Interventions

atezolizumab; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Pemetrexed; Carboplatin; Cisplatin; Gemcitabine

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Coordination Complexes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 7, 2018
• Study Start: April 24, 2018
• Primary Completion: October 1, 2025
• Study Completion: December 31, 2025
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

FR (6); CH (2); RU (4); IL (4); ZA (2); JP (17); US (29); HU (1); AU (4); IT (5); TW (3); TH (2); SL (1); UA (1); SE (4); PL (3); KR (5); GB (3); BR (3); DE (8); ES (10); CN (1)