A Randomized Phase 2 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Therapy - "POPLAR"

September 10, 2019 updated by: Hoffmann-La Roche

A Phase II, Open-label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of MPDL3280A (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Platinum Failure

This multicenter, open-label, randomized study will evaluate the efficacy and safety of Atezolizumab compared with docetaxel in participants with advanced or metastatic non-small cell lung cancer after platinum failure. Participants will be randomized to receive either Atezolizumab 1200 milligram (mg) intravenously every 3 weeks or docetaxel 75 milligram per meter square (mg/m^2) intravenously every 3 weeks. Treatment with Atezolizumab may be continued as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.

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.
287

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 2

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

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven Gasthuisberg
      • Liège, Belgium, 4000
        • CHR de la Citadelle
  • Canada
    • Quebec
      • Laval, Quebec, Canada, H7M 3L9
        • Cite de La Sante de Laval; Hemato-Oncologie
      • Montreal, Quebec, Canada, H3T 1E2
        • McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
  • France
      • Clermont-ferrand, France, 63003
        • Hopital Gabriel Montpied; Service de Pneumologie
      • La Tronche, France, 38700
        • Hôpital Nord Michallon; Pneumologie
      • Nancy, France, 54100
        • Centre D'Oncologie de Gentilly; Oncology
      • St Brieuc, France, 22027
        • Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll; Pneumologie
      • Toulouse, France, 31059
        • Hopital Larrey; Pneumologie
  • Germany
      • Gauting, Germany, 82131
        • Asklepios-Fachkliniken Muenchen-Gauting; Onkologie
      • Halle, Germany, 06120
        • Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II
      • Immenhausen, Germany, 34376
        • Fachklinik für Lungenerkrankungen
      • Regensburg, Germany, 93053
        • Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie
  • Italy
    • Campania
      • Avellino, Campania, Italy, 83100
        • Citta Ospedaliera; Divisione Oncologia Medica
    • Lombardia
      • Milano, Lombardia, Italy, 20132
        • Irccs Ospedale San Raffaele;Oncologia Medica
  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of, 410-769
        • National Cancer Center; Medical Oncology
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Centre; Division of Hematology/Oncology
  • Poland
      • Gdansk, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
      • Lodz, Poland, 93-513
        • Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii
      • Otwock, Poland, 05-400
        • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
      • Warszawa, Poland, 02-781
        • Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
  • Spain
      • Madrid, Spain, 28046
        • Hospital La Paz
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal; Servicio de Oncologia
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre; Servicio de Oncologia
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet; Servicio Oncologia
  • Sweden
      • Linköping, Sweden, 581 85
        • Universitetssjukhuset Linköping; Lungmedicinkliniken
  • Thailand
      • Bangkok, Thailand, 10330
        • Chulalongkorn Hospital; Medical Oncology
      • Bangkok, Thailand, 10700
        • Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
      • Bangkok, Thailand, 10400
        • Rajavithi Hospital; Division of Medical Oncology
  • Turkey
      • Antalya, Turkey, 07070
        • Akdeniz University Medical Faculty; Medical Oncology Department
      • Istanbul, Turkey, 34300
        • Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Royal Free Hospital; Dept of Oncology
      • London, United Kingdom, SE1 9RT
        • Guys and St Thomas NHS Foundation Trust, Guys Hospital
      • London, United Kingdom, W6 8RF
        • Charing Cross Hospital; Medical Oncology.
      • Manchester, United Kingdom, M2O 4BX
        • Christie Hospital Nhs Trust; Medical Oncology
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Arizona Oncology Associates, PC - HOPE
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Genesis Cancer Center
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center
      • San Marcos, California, United States, 92069
        • Kaiser Permanente - San Marcos
      • Vallejo, California, United States, 94589
        • Kaiser Permanente - Vallejo
      • Whittier, California, United States, 90603
        • Innovative Clinical Research Institute
    • Colorado
      • Lone Tree, Colorado, United States, 80124
        • Rocky Mountain Cancer Centers - Colorado Springs (Circle)
    • Florida
      • Ocala, Florida, United States, 34471
        • Ocala Oncology Center
    • Georgia
      • Atlanta, Georgia, United States, 30341
        • Georgia Cancer Specialists
    • Illinois
      • Harvey, Illinois, United States, 60426
        • Ingalls Memorial Hospital
      • Peoria, Illinois, United States, 61615
        • Illinois Cancer Care
    • Maine
      • Scarborough, Maine, United States, 04074
        • New England Cancer Specialists
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute..
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic; Research Center
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada - Eastern Avenue
    • New Jersey
      • Paramus, New Jersey, United States, 07652
        • The Valley Hospital
    • New York
      • Albany, New York, United States, 12206
        • New York Oncology Hematology, P.C.
      • Binghamton, New York, United States, 13905
        • Broome Oncology - Binghamton
    • Oregon
      • Eugene, Oregon, United States, 97401-8122
        • Willamette Valley Cancer Ctr - 520 Country Club
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Center for Biomedical Research LLC
    • Texas
      • Austin, Texas, United States, 78745
        • Texas Oncology - South Austin
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology, P.A. - Fort Worth
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists, PC
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
      • Roanoke, Virginia, United States, 24014
        • Blue Ridge Cancer Care
    • Washington
      • Vancouver, Washington, United States, 98684
        • Northwest Cancer Specialists - Vancouver
      • Walla Walla, Washington, United States, 99362
        • Providence St. Mary Regional Cancer Center
      • Wenatchee, Washington, United States, 98801
        • Wenatchee Valley Hospital & Clinics

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult participants, >/= 18 years of age
  • Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) non-small cell lung cancer (NSCLC)
  • Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens
  • Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen
  • Measurable disease, as defined by RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

  • Known active or untreated central nervous system (CNS) metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments
  • Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
  • History of autoimmune disease
  • History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
  • Active hepatitis B or hepatitis C
  • Prior treatment with docetaxel
  • Prior treatment with CD137 agonists, anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents

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: None (Open Label)

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.
Active Comparator: Docetaxel
Participants received docetaxel 75 milligram per meter square (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
Drug: Docetaxel
Participants received starting dose of 75 mg/m^2 every three week (q3w) until disease progression, unacceptable toxicity or death. Dose modifications were according to the locally approved label. Participants randomized to receive docetaxel had to be premedicated with corticosteroids according to local practice.
Experimental: Atezolizumab
Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
Drug: Atezolizumab
Participants received atezolizumab of 1200 mg (equivalent to an average body weight-based dose of 15 milligram per kilogram [mg/kg]) which was administered by IV infusion q3w on Day 1 of each 21 day cycle. Participants were allowed to continue treatment beyond progression per response evaluation criteria in solid tumors (RECIST) v1.1 if they were experiencing clinical benefit per investigator, did not have a decline in performance status, did not have signs or symptoms of unequivocal progression, did not have tumor progression at critical sites, and signed an informed consent signature page acknowledging deferment any standard treatment options that may exist in favor of continuing atezolizumab.

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
Overall Survival (OS)
Time Frame: From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)
Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as dead at the time of analysis was censored at the date when they were last known to be alive.
From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 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
Objective Response Rate (ORR)
Time Frame: Baseline until date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)
ORR was defined as the percentage of participants with confirmed objective tumor response, complete response (CR) or partial response (PR), as determined by investigator using RECIST v1.1 criteria. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Baseline until date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)
Progression-Free Survival (PFS)
Time Frame: From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)
PFS was defined as the time (in months) between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1. Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions including baseline In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)
Duration of Response (DOR)
Time Frame: From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)
DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurs first.
From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)
ORR (Modified RECIST)
Time Frame: From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months)
ORR was defined as the percentage of participants with confirmed objective tumor response, CR or PR, as determined by investigator using modified RECIST criteria. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to l< 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months)
PFS (Modified RECIST)
Time Frame: From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months)
PFS was defined as the time (in months) between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using modified RECIST criteria. PD: at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months)
DOR (Modified RECIST)
Time Frame: From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months)
DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurs first.
From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 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

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.
August 6, 2013

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.
November 19, 2015

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.
September 6, 2018

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).
July 17, 2013

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.
July 17, 2013

First Posted (Estimate)

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.
July 19, 2013

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.
October 2, 2019

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.
September 10, 2019

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.
September 1, 2019

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.
  • GO28753
  • 2013-001142-34 (EudraCT Number)

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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