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)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Non-Small-Cell Lung
• Intervention / Treatment: Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody; Drug: Nab-paclitaxel; Drug: Pemetrexed; Drug: Carboplatin; Drug: Cisplatin; Drug: Gemcitabine; Drug: Placebo Comparator

• Study Type: Interventional
• Enrollment (Actual): 453
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • St George Hospital; Cancer Care Centre
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Box Hill Hospital; Oncology
    • North Melbourne, Victoria, Australia, 3051
      • Peter MacCallum Cancer Center
• Austria
  • Linz, Austria, 4020
    • Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Lungenkrankheiten
  • Linz, Austria, 4020
    • Ordensklinikum Linz Elisabethinen
  • Wien, Austria, 1210
    • Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie
  • Wien, Austria, 1140
    • Klinik Penzing; Abteilung für Atemwegs- und Lungenkrankheiten
• Brazil
  • MG
    • Belo Horizonte, MG, Brazil, 30130-090
      • Cenantron - Centro Avancado de Tratamento Oncologico
  • RS
    • Porto Alegre, RS, Brazil, 90040-373
      • Hospital Nossa Senhora da Conceicao
  • SP
    • Sao Paulo, SP, Brazil, 01246-000
      • Instituto do Cancer do Estado de Sao Paulo - ICESP
• China
  • Shanghai, China, 200000
    • Shanghai Chest Hospital
• France
  • Angers, France, 49933
    • CHU Angers
  • Lyon, France, 69008
    • Centre Leon Berard
  • Saint Quentin, France, 02321
    • Centre Hospitalier Saint Quentin
  • Saint-Mande, France, 94160
    • Hopital d'Instruction des Armees de Begin
  • Strasbourg, France, 67091
    • CHU Strasbourg - Nouvel Hopital Civil
  • Toulon, France, 83000
    • Hôpital d'Instruction des Armées de Sainte Anne; Service de Pneumologie
• Germany
  • Freiburg, Germany, 79106
    • Universitätsklinikum Freiburg; Klinik für Innere Medizin I; Hämatologie/Onkologie
  • Gauting, Germany, 82131
    • Asklepios-Fachkliniken Muenchen-Gauting; Onkologie
  • Gerlingen, Germany, 70839
    • Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie
  • Großhansdorf, Germany, 22927
    • LungenClinic Großhansdorf GmbH; Klinische Forschung
  • Halle, Germany, 06120
    • Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II
  • Oldenburg, Germany, 26121
    • Pius-Hospital Oldenburg
  • Regensburg, Germany, 93053
    • Klinikum der Univer Regenburg; Klinik und Poliklinik fuer Inn
  • Würzburg, Germany, 97074
    • Missionsärztliche Klinik, Gemeinnützige Gesellschaft mbH
• Hungary
  • Budapest, Hungary, 1083
    • Semmelweis Egyetem X; Pulmonologiai Klinika
• Israel
  • Beer Sheva, Israel, 8410101
    • Soroka Medical Center
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus; Oncology
  • Kfar-Saba, Israel, 4428164
    • Meir Medical Center; Oncology
  • Tel Aviv, Israel, 6423906
    • Sourasky / Ichilov Hospital; Dept. of Oncology
• Italy
  • Lazio
    • Roma, Lazio, Italy, 00128
      • Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica
  • Lombardia
    • Milano, Lombardia, Italy, 20133
      • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
    • Milano, Lombardia, Italy, 20141
      • Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica
  • Toscana
    • Pisa, Toscana, Italy, 56124
      • A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii
  • Veneto
    • Padova, Veneto, Italy, 35128
      • IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
• Japan
  • Aichi, Japan, 464-8681
    • Aichi Cancer Center Hospital
  • Fukuoka, Japan, 811-1395
    • National Hospital Organization Kyushu Cancer Center
  • Fukushima, Japan, 960-1295
    • Fukushima Medical University Hospital
  • Hiroshima, Japan, 730-8518
    • Hiroshima City Hiroshima Citizens Hospital
  • Hiroshima, Japan, 734-8551
    • Hiroshima University Hospital
  • Hyogo, Japan, 663-8501
    • Hyogo Medical University Hospital
  • Hyogo, Japan, 650-0017
    • Kobe University Hospital
  • Kyoto, Japan, 606-8507
    • Kyoto University Hospital
  • Miyagi, Japan, 981-0914
    • Sendai Kousei Hospital
  • Okayama, Japan, 700-8558
    • Okayama University Hospital
  • Okayama, Japan, 710-8602
    • Kurashiki Central Hospital
  • Osaka, Japan, 541-8567
    • Osaka International Cancer Institute
  • Osaka, Japan, 534-0021
    • Osaka City General Hospital
  • Tokyo, Japan, 160-0023
    • Tokyo Medical University Hospital
  • Tokyo, Japan, 135-8550
    • The Cancer Institute Hospital of JFCR
  • Tokyo, Japan, 113-8431
    • Juntendo University Hospital
  • Tokyo, Japan, 113-8677
    • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
• Korea, Republic of
  • Busan, Korea, Republic of, 49267
    • Kosin University Gospel Hospital
  • Gyeonggi-do, Korea, Republic of, 16247
    • St. Vincent's Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 08308
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of, 06273
    • Gangnam Severance Hospital
• Poland
  • Gdansk, Poland, 80-214
    • Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
  • Kraków, Poland, 31-202
    • Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II; Oddz. Klin. Chir. Klatki Piersiowej i Onkol.
  • Warszawa, Poland, 02-781
    • Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers
• Russian Federation
  • Moskovskaja Oblast
    • Moscow, Moskovskaja Oblast, Russian Federation, 105229
      • Main Military Clinical Hospital named after N.N. Burdenko
    • Moscow, Moskovskaja Oblast, Russian Federation, 115478
      • FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
  • Sankt Petersburg
    • Saint-Petersburg, Sankt Petersburg, Russian Federation, 197758
      • S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
    • St. Petersburg, Sankt Petersburg, Russian Federation, 197758
      • Scientific Research Oncology Institute named after N.N. Petrov; Oncology
• Serbia
  • Belgrade, Serbia, 11080
    • University Hospital Medical Center Bezanijska kosa
• Slovenia
  • Golnik, Slovenia, 4204
    • University Clinic Golnik
• South Africa
  • Johannesburg, South Africa, 2196
    • Medical Oncology Centre of Rosebank; Oncology
  • Pretoria, South Africa
    • Eugene Marais Hospital; Oncology
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron; Oncology
  • Madrid, Spain, 28027
    • Clinica Universidad de Navarra Madrid; Servicio de Oncología
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos; Servicio de Oncologia
  • Malaga, Spain, 29011
    • Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena; Servicio de Oncologia
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
  • Valencia, Spain, 46026
    • Hospital Universitario la Fe; Servicio de Oncologia
  • Barcelona
    • Sabadell, Barcelona, Spain, 8208
      • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
  • Islas Baleares
    • Palma de Mallorca, Islas Baleares, Spain, 07198
      • Hospital Son Llatzer; Servicio de Oncologia
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universitaria de Navarra; Servicio de Oncologia
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48013
      • Hospital de Basurto; Servicio de Oncologia
• Sweden
  • Linköping, Sweden, 58185
    • Lungmedicinska kliniken, Centrum för kirurgi, ortopedi och cancervård, Universitetssjukhuset
  • Lund, Sweden, 22185
    • Uni Hospital in Lund; Respiratory Medicine & Allergology
  • Stockholm, Sweden, 171 76
    • Karolinska Universitetssjukhuset, Solna; Kliniska prövningsenheten Z:4:01
  • Uppsala, Sweden, 751 85
    • Uppsala University Hospital; Department of Oncology
• Switzerland
  • Lausanne, Switzerland, 1011
    • CHUV; Departement d'Oncologie
  • Zürich, Switzerland, 8091
    • UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
• Taiwan
  • Kaohsiung, Taiwan, 83301
    • Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine
  • Taipei, Taiwan, 112
    • Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology
  • Xitun Dist., Taiwan, 40705
    • Taichung Veterans General Hospital
• Thailand
  • Bangkok, Thailand, 10330
    • Chulalongkorn Hospital; Medical Oncology
  • ChiangMai, Thailand, 50200
    • Maharaj Nakorn Chiang Mai Hospital; Department of Medicine
• Ukraine
  • Dnipropetrovsk, Ukraine, 49102
    • Chemotherapy SI Dnipropetrovsk MA of MOHU
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • Queen Elizabeth Hospital
  • Leeds, United Kingdom, LS9 7TF
    • Leeds Teaching Hosp NHS Trust;St James's Institute of Onc
  • Liverpool, United Kingdom, L7 8YA
    • The Clatterbridge Cancer Centre NHS Foundation Trust
  • London, United Kingdom, EC1A 7BE
    • Barts and the London NHS Trust.
• United States
  • Arizona
    • Tucson, Arizona, United States, 85711
      • Arizona Oncology
  • California
    • Los Angeles, California, United States, 90033
      • USC Norris Cancer Center
    • Newport Beach, California, United States, 92663
      • USC Norris Cancer Center; USC Oncology Hematology Newport Beach
    • Orange, California, United States, 92868
      • The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange
    • Sacramento, California, United States, 95817
      • UC Davis Cancer Center; Oncology
    • San Diego, California, United States, 92037
      • Scripps Clinic
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
    • Denver, Colorado, United States, 80218
      • Rocky Mountain Cancer Center
    • Denver, Colorado, United States, 80206
      • National Jewish Health
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University
    • Washington, District of Columbia, United States, 20010
      • Washington Cancer Institute; Washington Hospital Center
  • Illinois
    • Peoria, Illinois, United States, 61615
      • Illinois Cancer Care
  • Maine
    • Detroit, Maine, United States, 48201-2013
      • Barbara Ann Karmanos Cancer Institute
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Uni of Maryland Cancer Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-0934
      • University of Michigan
    • Brighton, Michigan, United States, 48116
      • Brighton Center for Specialty Care
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Minnesota Oncology Minneapolis
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic - Rochester
  • Missouri
    • Springfield, Missouri, United States, 65804
      • Mercy Clinic Cancer & Hematology
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Nebraska Methodist Estabrook Cancer Center
  • New York
    • Lake Success, New York, United States, 11042
      • Northwell Health; Monter Cancer Center
    • Mineola, New York, United States, 11501
      • NYU Winthrop Hospital
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10016
      • NYU Langone Medical Center; Laura and Isaac Perlmutter Cancer Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Levine Cancer Institute
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Health Network
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute / Tennessee Oncology
  • Texas
    • Austin, Texas, United States, 78745
      • Texas Oncology - South Austin
    • Tyler, Texas, United States, 75701
      • UT Health East Texas HOPE Cancer Center
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists, PC
  • Washington
    • Vancouver, Washington, United States, 98684
      • Northwest Cancer Specialists - Vancouver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• 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

Exclusion criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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; Other Names: Tecentriq; 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; Other Names: Abraxane; 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; Other Names: Alimta; 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; Other Names: Gemzar
Placebo Comparator: 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	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; Other Names: Abraxane; 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; Other Names: Alimta; 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; Other Names: Gemzar; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological Complete Response (pCR)	pCR is defined as the absence of any viable primary tumor cells at the time of surgical resection in the primary tumor and all sampled lymph nodes as assessed by central and local pathology laboratory.	At time of surgery
Major Pathological Response (MPR)	MPR is defined as ≤ 10% residual viable tumor cells at the time of surgical resection in the primary tumor, as assessed by central and local pathology laboratory.	At time of surgery
Objective Response (OR)	Objective response is defined as a complete response or partial response, as determined by the investigator according to RECIST v1.1	Prior to surgery, up to approximately 84 days
Overall Survival (OS)	OS is defined as the time from randomization to death from any cause during the course of the study.	Up to approximately 96 months
Investigator-Assessed EFS	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, as assessed by the investigator; or death from any cause, whichever occurs first.	Up to approximately 96 months
Disease-Free Survival (DFS)	DFS is defined as the time from the first date of no disease to local or distant recurrence (including occurrence of new primary NSCLC) or death due to any cause, whichever occurs first, as determined by the investigator during the adjuvant treatment and observation follow-up	Up to approximately 96 months
2-Year and 3-Year OS	The 2-year and 3-year OS rate is defined as the probability that a participant will be alive 2 years and 3 years after randomization, respectively.	Up to approximately 96 months
2-Year and 3-Year Independent Review Facility-Assessed EFS	EFS is defined as the probability that a participant will be event-free 2 years and 3 years after randomization, respectively, as assessed by the Independent Review Facility.	Up to approximately 96 months
2-Year and 3-Year Investigator-Assessed EFS	EFS is defined as the probability that a participant will be event-free 2 years and 3 years after randomization, respectively, as assessed by the Investigator.	Up to approximately 96 months
Change from baseline in HRQoL scores	Change from baseline in HRQoL scores as assessed through use of the two-item GHS/HRQoL subscale (Questions 29 and 30) of the EORTC QLQ-C30 at each assessment time point during the study through the completion of adjuvant treatment and observation follow-up assessments	Up to approximately 96 months
Percentage of Participants With Adverse Events (AEs)		Up to approximately 96 months
Number and Severity of Surgical Related Adverse Events		Up to approximately 96 months
Number of Surgical Delays	Number of surgical delays.	Up to approximately 96 months
Length of Surgical Delays	Length of surgical delays.	Up to approximately 96 months
Number of Operative and Post-Operative Complications	Number of operative and post-operative complications.	Up to approximately 96 months
Reasons for Surgical Cancellations	Reasons for surgical cancellations.	Up to approximately 96 months
Minimum Observed Serum Atezolizumab Concentration (Cmin)	Cmin is the minimum (or trough) concentration that a study drug achieves in the body.	Pre-dose on Day 1 of Cycles 1 and 3 (each cylce is 21 days) for Neoadjuvant Treatment; pre-dose on Day 1 of Cycles 5, 7, 9, 11 and 19 (each cycle is 21 days) for Arm A; at treatment or observation follow-up discontinuation (up to approximately 96 months)
Maximum Observed Serum Atezolizumab Concentration (Cmax)	Cmax is the maximum (or peak) concentration that a study drug achieves in the body.	Pre-dose on Day 1 of Cycles 1 and 3 for Neoadjuvant Treatment; Pre-dose on Day 1 of Cycles 5, 7, 9, 11 and 19 for Arm A. Each cycle is 21 days; at treatment or observation follow-up discontinuation (up to approximately 96 months)
Percentage of Participants With Anti-Drug Antibody (ADA) to Atezolizumab		Pre-dose on Day 1 of Cycles 1 and 3 for Neoadjuvant Treatment; Pre-dose on Day 1 of Cycles 5, 7, 9, 11 and 19 for Arm A. Each cycle is 21 days; at treatment or observation follow-up discontinuation (up to approximately 96 months)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2018
• Primary Completion (Estimated): January 19, 2025
• Study Completion (Estimated): January 19, 2025

Study Registration Dates

• First Submitted: March 5, 2018
• First Submitted That Met QC Criteria: March 5, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Estimated): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Folic Acid Antagonists; Carboplatin; Paclitaxel; Antibodies; Pemetrexed; Atezolizumab; Gemcitabine
• Other Study ID Numbers: GO40241

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No