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AzTrials

Non-Small Cell Lung CancerPhase 2NCT01903993

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"

A Phase 2 study testing Docetaxel and Atezolizumab in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 65 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Docetaxel and Atezolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
287 participants
Where
65 sitesin 13 countries
Study dates
6 Aug 2013to 6 Sep 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

65 sites in 13 countries.

65 sites in 13 countries

United States29 sites

  • New York Oncology Hematology, P.C.

    Albany, New York, 12206

  • Georgia Cancer Specialists

    Atlanta, Georgia, 30341

  • Texas Oncology - South Austin

    Austin, Texas, 78745

  • Billings Clinic; Research Center

    Billings, Montana, 59101

  • Broome Oncology - Binghamton

    Binghamton, New York, 13905

  • Karmanos Cancer Institute..

    Detroit, Michigan, 48201

  • Willamette Valley Cancer Ctr - 520 Country Club

    Eugene, Oregon, 97401-8122

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Texas Oncology, P.A. - Fort Worth

    Fort Worth, Texas, 76104

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Genesis Cancer Center

    Hot Springs, Arkansas, 71913

  • Center for Biomedical Research LLC

    Knoxville, Tennessee, 37909

  • Comprehensive Cancer Centers of Nevada - Eastern Avenue

    Las Vegas, Nevada, 89169

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Rocky Mountain Cancer Centers - Colorado Springs (Circle)

    Lone Tree, Colorado, 80124

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Ocala Oncology Center

    Ocala, Florida, 34471

  • The Valley Hospital

    Paramus, New Jersey, 07652

  • Illinois Cancer Care

    Peoria, Illinois, 61615

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Blue Ridge Cancer Care

    Roanoke, Virginia, 24014

  • Kaiser Permanente - San Marcos

    San Marcos, California, 92069

  • New England Cancer Specialists

    Scarborough, Maine, 04074

  • Arizona Oncology Associates, PC - HOPE

    Tucson, Arizona, 85704

  • Kaiser Permanente - Vallejo

    Vallejo, California, 94589

  • Northwest Cancer Specialists - Vancouver

    Vancouver, Washington, 98684

  • Providence St. Mary Regional Cancer Center

    Walla Walla, Washington, 99362

  • Wenatchee Valley Hospital & Clinics

    Wenatchee, Washington, 98801

  • Innovative Clinical Research Institute

    Whittier, California, 90603

Other trials in United States

France5 sites

  • Hopital Gabriel Montpied; Service de Pneumologie

    Clermont-Ferrand, 63003

  • Hôpital Nord Michallon; Pneumologie

    La Tronche, 38700

  • Centre D'Oncologie de Gentilly; Oncology

    Nancy, 54100

  • Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll; Pneumologie

    Saint-Brieuc, 22027

  • Hopital Larrey; Pneumologie

    Toulouse, 31059

Other trials in France

Germany4 sites

  • Asklepios-Fachkliniken Muenchen-Gauting; Onkologie

    Gauting, 82131

  • Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II

    Halle, 06120

  • Fachklinik für Lungenerkrankungen

    Immenhausen, 34376

  • Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie

    Regensburg, 93053

Other trials in Germany

Poland4 sites

  • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

    Gdansk, 80-214

  • Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii

    Lodz, 93-513

  • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii

    Otwock, 05-400

  • Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii

    Warsaw, 02-781

Other trials in Poland

Spain4 sites

  • Hospital Ramon y Cajal; Servicio de Oncologia

    Madrid, 28034

  • Hospital Universitario 12 de Octubre; Servicio de Oncologia

    Madrid, 28041

  • Hospital La Paz

    Madrid, 28046

  • Hospital Universitario Miguel Servet; Servicio Oncologia

    Zaragoza, 50009

Other trials in Spain

United Kingdom4 sites

  • Royal Free Hospital; Dept of Oncology

    London, NW3 2QG

  • Guys and St Thomas NHS Foundation Trust, Guys Hospital

    London, SE1 9RT

  • Charing Cross Hospital; Medical Oncology.

    London, W6 8RF

  • Christie Hospital Nhs Trust; Medical Oncology

    Manchester, M2O 4BX

Other trials in United Kingdom

South Korea3 sites

  • National Cancer Center; Medical Oncology

    Gyeonggi-do, 410-769

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Samsung Medical Centre; Division of Hematology/Oncology

    Seoul, 135-710

Other trials in South Korea

Thailand3 sites

  • Chulalongkorn Hospital; Medical Oncology

    Bangkok, 10330

  • Rajavithi Hospital; Division of Medical Oncology

    Bangkok, 10400

  • Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

    Bangkok, 10700

Other trials in Thailand

Belgium2 sites

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • Chr de La Citadelle

    Liège, 4000

Other trials in Belgium

Canada2 sites

  • Cite de La Sante de Laval; Hemato-Oncologie

    Laval, Quebec, H7M 3L9

  • McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

    Montreal, Quebec, H3T 1E2

Other trials in Canada

Italy2 sites

  • Citta Ospedaliera; Divisione Oncologia Medica

    Avellino, Campania, 83100

  • Irccs Ospedale San Raffaele;Oncologia Medica

    Milan, Lombardy, 20132

Other trials in Italy

Turkey (Türkiye)2 sites

  • Akdeniz University Medical Faculty; Medical Oncology Department

    Antalya, 07070

  • Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

    Istanbul, 34300

Other trials in Turkey (Türkiye)

Sweden1 site

  • Universitetssjukhuset Linköping; Lungmedicinkliniken

    Linköping, 581 85

Other trials in Sweden

About this study

Official title: 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.

Being tested
Docetaxel, Atezolizumab
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DocetaxelDrug

    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.

  • AtezolizumabDrug

    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.

Study groups in NCT01903993
Study groupRoleWhat they receive
DocetaxelActive comparatorParticipants 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.
Receives: Drug: Docetaxel
AtezolizumabExperimentalParticipants 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.
Receives: Drug: Atezolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    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.

    Measured: 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 outcomes (6)

  1. Objective Response Rate (ORR)

    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.

    Measured: Baseline until date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)

  2. Progression-Free Survival (PFS)

    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.

    Measured: 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)

  3. Duration of Response (DOR)

    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.

    Measured: 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)

  4. ORR (Modified RECIST)

    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.

    Measured: 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)

  5. PFS (Modified RECIST)

    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.

    Measured: 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)

  6. DOR (Modified RECIST)

    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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2013 (estimated)
  2. Study start6 Aug 2013
  3. Primary completion19 Nov 2015
  4. Study completion6 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
287 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01903993
Sponsor's protocol ID
GO28753
Other IDs
2013-001142-34
Status last verified
Sep 2019
First submitted
17 Jul 2013
Last updated
2 Oct 2019

Publications

  • Liu J, Chu C, Yi B, Chen MH. A Max 0-1 Weighted Log-Rank Test for Time-to-Event Data With Random Delayed Treatment Effect. Stat Med. 2026 Oct;45(23-24):e70773. doi: 10.1002/sim.70773.

    PubMed 42888494

  • Dong Y, Zhu Y, Zhuo M, Chen X, Xie Y, Duan J, Bai H, Hao S, Yu Z, Yi Y, Guan Y, Yuan J, Xia X, Yi X, Wang J, Wang Z. Maximum Somatic Allele Frequency-Adjusted Blood-Based Tumor Mutational Burden Predicts the Efficacy of Immune Checkpoint Inhibitors in Advanced Non-Small Cell Lung Cancer. Cancers (Basel). 2022 Nov 17;14(22):5649. doi: 10.3390/cancers14225649.

    PubMed 36428744

  • Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685.

    PubMed 33241650

  • Chalabi M, Cardona A, Nagarkar DR, Dhawahir Scala A, Gandara DR, Rittmeyer A, Albert ML, Powles T, Kok M, Herrera FG; imCORE working group of early career investigators. Efficacy of chemotherapy and atezolizumab in patients with non-small-cell lung cancer receiving antibiotics and proton pump inhibitors: pooled post hoc analyses of the OAK and POPLAR trials. Ann Oncol. 2020 Apr;31(4):525-531. doi: 10.1016/j.annonc.2020.01.006. Epub 2020 Jan 16.

    PubMed 32115349

  • Fehlings M, Jhunjhunwala S, Kowanetz M, O'Gorman WE, Hegde PS, Sumatoh H, Lee BH, Nardin A, Becht E, Flynn S, Ballinger M, Newell EW, Yadav M. Late-differentiated effector neoantigen-specific CD8+ T cells are enriched in peripheral blood of non-small cell lung carcinoma patients responding to atezolizumab treatment. J Immunother Cancer. 2019 Sep 12;7(1):249. doi: 10.1186/s40425-019-0695-9.

    PubMed 31511069

  • Fehrenbacher L, Spira A, Ballinger M, Kowanetz M, Vansteenkiste J, Mazieres J, Park K, Smith D, Artal-Cortes A, Lewanski C, Braiteh F, Waterkamp D, He P, Zou W, Chen DS, Yi J, Sandler A, Rittmeyer A; POPLAR Study Group. Atezolizumab versus docetaxel for patients with previously treated non-small-cell lung cancer (POPLAR): a multicentre, open-label, phase 2 randomised controlled trial. Lancet. 2016 Apr 30;387(10030):1837-46. doi: 10.1016/S0140-6736(16)00587-0. Epub 2016 Mar 10.

    PubMed 26970723

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel and Atezolizumab in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 65 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States, France, Germany, Poland, Spain and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01903993, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2019.

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