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)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

453

Participants

Timeline

Start Date

April 24, 2018

Primary Completion Date

October 1, 2025

Study Completion Date

December 31, 2025

Conditions
Non-Small-Cell Lung
Interventions
DRUG

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"

DRUG

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

DRUG

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

DRUG

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

DRUG

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

DRUG

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

DRUG

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

Trial Locations (117)

112

Taipei Veterans General Hospital, Taipei

1011

CHUV, Lausanne

1083

Semmelweis Egyetem X, Budapest

1140

Klinik Penzing, Vienna

1210

Krankenhaus Nord - Klinik Floridsdorf, Vienna

2196

Medical Oncology Centre of Rosebank, Johannesburg

2217

St George Hospital, Kogarah

3000

Peter MacCallum Cancer Center, Melbourne

3128

Box Hill Hospital, Box Hill

4020

Kepler Universitätskliniken GmbH - Med Campus III, Linz

Ordensklinikum Linz Elisabethinen, Linz

4204

University Clinic Golnik, Golnik

8091

UniversitätsSpital Zürich, Zurich

10016

NYU Langone Medical Center, New York

10032

Columbia University Medical Center, New York

10330

Chulalongkorn Hospital, Bangkok

11042

Northwell Health, Lake Success

11080

University Hospital Medical Center Bezanijska kosa, Belgrade

11501

NYU Winthrop Hospital, Mineola

16247

St. Vincent's Hospital, Gyeonggi-do

18103

Lehigh Valley Health Network, Allentown

20007

Georgetown University, Washington D.C.

20010

Washington Cancer Institute, Washington D.C.

20133

Irccs Istituto Nazionale Dei Tumori (Int), Milan

20141

Irccs Istituto Europeo Di Oncologia (IEO), Milan

21201

Uni of Maryland Cancer Center, Baltimore

22031

Virginia Cancer Specialists, PC, Fairfax

22185

Uni Hospital in Lund, Lund

26121

Pius-Hospital Oldenburg, Oldenburg

28040

Hospital Clinico San Carlos, Madrid

28204

Levine Cancer Institute, Charlotte

29010

Hospital Regional Universitario Carlos Haya, Málaga

31008

Clinica Universitaria de Navarra, Pamplona

35128

IOV - Istituto Oncologico Veneto - IRCCS, Padua

37203

Sarah Cannon Research Institute / Tennessee Oncology, Nashville

40705

Taichung Veterans General Hospital, Xitun Dist.

41009

Hospital Universitario Virgen Macarena, Seville

46010

Hospital Clinico Universitario de Valencia, Valencia

46026

Hospital Universitario la Fe, Valencia

48013

Hospital de Basurto, Bilbao

48109

University of Michigan, Ann Arbor

48116

Brighton Center for Specialty Care, Brighton

48201

Barbara Ann Karmanos Cancer Institute, Detroit

49102

Chemotherapy SI Dnipropetrovsk MA of MOHU, Dnipropetrovsk

49267

Kosin University Gospel Hospital, Busan

49933

CHU Angers, Angers

50200

Maharaj Nakorn Chiang Mai Hospital, Chiang Mai

55404

Minnesota Oncology Minneapolis, Minneapolis

55905

Mayo Clinic - Rochester, Rochester

56124

A.O. Universitaria Pisana-Ospedale Cisanello, Pisa

58185

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

61615

Illinois Cancer Care, Peoria

65804

Mercy Clinic Cancer & Hematology, Springfield

67091

CHU Strasbourg - Nouvel Hopital Civil, Strasbourg

68114

Nebraska Methodist Estabrook Cancer Center, Omaha

69008

Centre Léon Bérard, Lyon

70376

Robert Bosch Krankenhaus, Stuttgart

78745

Texas Oncology - South Austin, Austin

79106

Universitätsklinikum Freiburg, Freiburg im Breisgau

80206

National Jewish Health, Denver

80218

Rocky Mountain Cancer Center, Denver

82131

Asklepios-Fachkliniken Muenchen-Gauting, Gauting

83000

Hôpital d'Instruction des Armées de Sainte Anne, Toulon

85711

Arizona Oncology, Tucson

90033

USC Norris Cancer Center, Los Angeles

92037

Scripps Clinic, San Diego

92868

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

93053

Klinikum der Univer Regenburg, Regensburg

94160

Hopital d'Instruction des Armees de Begin, Saint-Mandé

95817

UC Davis Cancer Center, Sacramento

97074

Missionsärztliche Klinik, Gemeinnützige Gesellschaft mbH, Würzburg

98684

Northwest Cancer Specialists - Vancouver, Vancouver

105229

Main Military Clinical Hospital named after N.N. Burdenko, Moscow

115478

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

197758

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

Scientific Research Oncology Institute named after N.N. Petrov, Saint Petersburg

200030

Shanghai Chest Hospital, Shanghai

3109601

Rambam Health Care Campus, Haifa

4428164

Meir Medical Center, Kfar Saba

6423906

Sourasky / Ichilov Hospital, Tel Aviv

8410101

Soroka Medical Center, Beersheba

30130-090

Cenantron - Centro Avancado de Tratamento Oncologico, Belo Horizonte

91350-200

Hospital Nossa Senhora da Conceicao, Porto Alegre

01246-000

Instituto do Cancer do Estado de Sao Paulo - ICESP, São Paulo

02321

Centre Hospitalier Saint Quentin, Saint-Quentin

06120

Krankenhaus Martha-Maria Halle-Doelau gGmbH, Halle

00128

Policlinico Universitario Campus Biomedico, Rome

811-1395

National Hospital Organization Kyushu Cancer Center, Fukuoka

730-8518

Hiroshima City Hiroshima Citizens Hospital, Hiroshima

734-8551

Hiroshima University Hospital, Hiroshima

650-0017

Kobe University Hospital, Hyōgo

663-8501

Hyogo Medical University Hospital, Hyōgo

606-8507

Kyoto University Hospital, Kyoto

960-1295

Fukushima Medical University Hospital, Miyagi

981-0914

Sendai Kousei Hospital, Miyagi

700-8558

Okayama University Hospital, Okayama

710-8602

Kurashiki Central Hospital, Okayama

534-0021

Osaka City General Hospital, Osaka

541-8567

Osaka International Cancer Institute, Osaka

113-8677

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital, Tokyo

135-8550

The Cancer Institute Hospital of JFCR, Tokyo

160-0023

Tokyo Medical University Hospital, Tokyo

80-214

Uniwersyteckie Centrum Kliniczne, Gda?sk

31-202

Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II, Krakow

02-781

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

Unknown

Eugene Marais Hospital, Pretoria

03080

Seoul National University Hospital, Seoul

06273

Gangnam Severance Hospital, Seoul

08308

Korea University Guro Hospital, Seoul

07198

Hospital Son Llatzer, Palma de Mallorca

08208

Corporacio Sanitaria Parc Tauli, Sabadell

08035

Hospital Universitari Vall d'Hebron, Barcelona

171 64

Karolinska Universitetssjukhuset, Solna, Solna

SE-75185

Uppsala University Hospital, Uppsala

B15 2TH

Queen Elizabeth Hospital, Birmingham

EC1A 7BE

Barts and the London NHS Trust., London

CH63 4JY

The Clatterbridge Cancer Centre NHS Foundation Trust, Metropolitan Borough of Wirral

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY