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)

January 21, 2026 updated by: Hoffmann-La Roche

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
453

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • St George Hospital
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Melbourne, Victoria, Australia, 3000
        • Peter MacCallum Cancer Center
  • Austria
      • Linz, Austria, 4020
        • Ordensklinikum Linz Elisabethinen
      • Linz, Austria, 4020
        • Kepler Universitätskliniken GmbH - Med Campus III
      • Vienna, Austria, 1140
        • Klinik Penzing
      • Vienna, Austria, 1210
        • Krankenhaus Nord - Klinik Floridsdorf
  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130-090
        • Cenantron - Centro Avancado de Tratamento Oncologico
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
        • Hospital Nossa Senhora da Conceicao
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01246-000
        • Instituto do Cancer do Estado de Sao Paulo - ICESP
  • China
      • Shanghai, China, 200030
        • Shanghai Chest Hospital
  • France
      • Angers, France, 49933
        • CHU Angers
      • Lyon, France, 69008
        • Centre Leon Berard
      • Saint-Mandé, France, 94160
        • Hopital d'Instruction des Armees de Begin
      • Saint-Quentin, France, 02321
        • Centre Hospitalier Saint Quentin
      • Strasbourg, France, 67091
        • CHU Strasbourg - Nouvel Hopital Civil
      • Toulon, France, 83000
        • Hôpital d'Instruction des Armées de Sainte Anne
  • Germany
      • Freiburg im Breisgau, Germany, 79106
        • Universitätsklinikum Freiburg
      • Gauting, Germany, 82131
        • Asklepios-Fachkliniken Muenchen-Gauting
      • Großhansdorf, Germany, 22927
        • LungenClinic Grosshansdorf GmbH
      • Halle, Germany, 06120
        • Krankenhaus Martha-Maria Halle-Doelau gGmbH
      • Oldenburg, Germany, 26121
        • Pius-Hospital Oldenburg
      • Regensburg, Germany, 93053
        • Klinikum der Univer Regenburg
      • Stuttgart, Germany, 70376
        • Robert Bosch Krankenhaus
      • Würzburg, Germany, 97074
        • Missionsärztliche Klinik, Gemeinnützige Gesellschaft mbH
  • Hungary
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem X
  • Israel
      • Beersheba, Israel, 8410101
        • Soroka Medical Center
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center
      • Tel Aviv, Israel, 6423906
        • Sourasky / Ichilov Hospital
  • Italy
    • Lazio
      • Rome, Lazio, Italy, 00128
        • Policlinico Universitario Campus Biomedico
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Irccs Istituto Nazionale Dei Tumori (Int)
      • Milan, Lombardy, Italy, 20141
        • Irccs Istituto Europeo Di Oncologia (IEO)
    • Tuscany
      • Pisa, Tuscany, Italy, 56124
        • A.O. Universitaria Pisana-Ospedale Cisanello
    • Veneto
      • Padua, Veneto, Italy, 35128
        • IOV - Istituto Oncologico Veneto - IRCCS
  • Japan
      • Aichi, Japan, 464-8681
        • Aichi Cancer Center Hospital
      • Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center
      • Hiroshima, Japan, 730-8518
        • Hiroshima City Hiroshima Citizens Hospital
      • Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital
      • Hyōgo, Japan, 650-0017
        • Kobe University Hospital
      • Hyōgo, Japan, 663-8501
        • Hyogo Medical University Hospital
      • Kyoto, Japan, 606-8507
        • Kyoto University Hospital
      • Miyagi, Japan, 981-0914
        • Sendai Kousei Hospital
      • Miyagi, Japan, 960-1295
        • Fukushima Medical University 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
  • Poland
      • Gda?sk, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne
      • Krakow, Poland, 31-202
        • Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II
      • Warsaw, Poland, 02-781
        • Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad
  • Russia
    • Moscow Oblast
      • Moscow, Moscow Oblast, Russia, 115478
        • FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
      • Moscow, Moscow Oblast, Russia, 105229
        • Main Military Clinical Hospital named after N.N. Burdenko
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russia, 197758
        • S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
      • Saint Petersburg, Sankt-Peterburg, Russia, 197758
        • Scientific Research Oncology Institute named after N.N. Petrov
  • 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
      • Pretoria, South Africa
        • Eugene Marais Hospital
  • South Korea
      • Busan, South Korea, 49267
        • Kosin University Gospel Hospital
      • Gyeonggi-do, South Korea, 16247
        • St. Vincent's Hospital
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 06273
        • Gangnam Severance Hospital
      • Seoul, South Korea, 08308
        • Korea University Guro Hospital
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Málaga, Spain, 29010
        • Hospital Regional Universitario Carlos Haya
      • Seville, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
      • Valencia, Spain, 46026
        • Hospital Universitario la Fe
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Spain, 07198
        • Hospital Son Llatzer
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Corporacio Sanitaria Parc Tauli
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Clinica Universitaria de Navarra
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013
        • Hospital de Basurto
  • Sweden
      • Linköping, Sweden, 58185
        • Lungmedicinska kliniken, Centrum för kirurgi, ortopedi och cancervård, Universitetssjukhuset
      • Lund, Sweden, 22185
        • Uni Hospital in Lund
      • Solna, Sweden, 171 64
        • Karolinska Universitetssjukhuset, Solna
      • Uppsala, Sweden, SE-75185
        • Uppsala University Hospital
  • Switzerland
      • Lausanne, Switzerland, 1011
        • CHUV
      • Zurich, Switzerland, 8091
        • UniversitätsSpital Zürich
  • Taiwan
      • Kaohsiung City, Taiwan, 00833
        • Kaohsiung Chang Gung Memorial Hospital
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital
      • Xitun Dist., Taiwan, 40705
        • Taichung Veterans General Hospital
  • Thailand
      • Bangkok, Thailand, 10330
        • Chulalongkorn Hospital
      • Chiang Mai, Thailand, 50200
        • Maharaj Nakorn Chiang Mai Hospital
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49102
        • Chemotherapy SI Dnipropetrovsk MA of MOHU
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital
      • London, United Kingdom, EC1A 7BE
        • Barts and the London NHS Trust.
      • Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
        • The Clatterbridge Cancer Centre NHS Foundation Trust
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85711
        • Arizona Oncology
    • California
      • Los Angeles, California, United States, 90033
        • USC Norris Cancer Center
      • 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
      • San Diego, California, United States, 92037
        • Scripps Clinic
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Center
      • Denver, Colorado, United States, 80206
        • National Jewish Health
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Georgetown University
      • Washington D.C., District of Columbia, United States, 20010
        • Washington Cancer Institute
    • Illinois
      • Peoria, Illinois, United States, 61615
        • Illinois Cancer Care
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Uni of Maryland Cancer Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Brighton, Michigan, United States, 48116
        • Brighton Center for Specialty Care
      • Detroit, Michigan, United States, 48201
        • Barbara Ann Karmanos Cancer Institute
    • 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
      • 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
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Independent Review Facility (IRF)-Assessed Event Free Survival (EFS)
Time Frame: Up to approximately 96 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pathological Complete Response (pCR)
Time Frame: At time of surgery
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)
Time Frame: At time of surgery
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)
Time Frame: Prior to surgery, up to approximately 84 days
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)
Time Frame: Up to approximately 96 months
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
Time Frame: Up to approximately 96 months
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)
Time Frame: Up to approximately 96 months
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
Time Frame: Up to approximately 96 months
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
Time Frame: Up to approximately 96 months
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
Time Frame: Up to approximately 96 months
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
Time Frame: Up to approximately 96 months
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)
Time Frame: Up to approximately 96 months
Up to approximately 96 months
Number and Severity of Surgical Related Adverse Events
Time Frame: Up to approximately 96 months
Up to approximately 96 months
Number of Surgical Delays
Time Frame: Up to approximately 96 months
Number of surgical delays.
Up to approximately 96 months
Length of Surgical Delays
Time Frame: Up to approximately 96 months
Length of surgical delays.
Up to approximately 96 months
Number of Operative and Post-Operative Complications
Time Frame: Up to approximately 96 months
Number of operative and post-operative complications.
Up to approximately 96 months
Reasons for Surgical Cancellations
Time Frame: Up to approximately 96 months
Reasons for surgical cancellations.
Up to approximately 96 months
Minimum Observed Serum Atezolizumab Concentration (Cmin)
Time Frame: 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)
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)
Time Frame: 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)
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
Time Frame: 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)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 24, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GO40241
  • 2023-504209-35-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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