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 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
2 other identifiers
interventional
287
13 countries
65
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 nonsmall-cell-lung-cancer
Started Aug 2013
Typical duration for phase_2 nonsmall-cell-lung-cancer
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2013
CompletedFirst Posted
Study publicly available on registry
July 19, 2013
CompletedStudy Start
First participant enrolled
August 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 19, 2015
CompletedResults Posted
Study results publicly available
May 23, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 6, 2018
CompletedOctober 2, 2019
September 1, 2019
2.3 years
July 17, 2013
November 16, 2016
September 10, 2019
Conditions
Outcome Measures
Primary Outcomes (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.
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)
Objective Response Rate (ORR)
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)
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)
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)
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)
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)
- +1 more secondary outcomes
Study Arms (2)
Docetaxel
ACTIVE 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.
Atezolizumab
EXPERIMENTALParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (65)
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, 85704, United States
Genesis Cancer Center
Hot Springs, Arkansas, 71913, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Kaiser Permanente - San Marcos
San Marcos, California, 92069, United States
Kaiser Permanente - Vallejo
Vallejo, California, 94589, United States
Innovative Clinical Research Institute
Whittier, California, 90603, United States
Rocky Mountain Cancer Centers - Colorado Springs (Circle)
Lone Tree, Colorado, 80124, United States
Ocala Oncology Center
Ocala, Florida, 34471, United States
Georgia Cancer Specialists
Atlanta, Georgia, 30341, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Illinois Cancer Care
Peoria, Illinois, 61615, United States
New England Cancer Specialists
Scarborough, Maine, 04074, United States
Karmanos Cancer Institute..
Detroit, Michigan, 48201, United States
Billings Clinic; Research Center
Billings, Montana, 59101, United States
Comprehensive Cancer Centers of Nevada - Eastern Avenue
Las Vegas, Nevada, 89169, United States
The Valley Hospital
Paramus, New Jersey, 07652, United States
New York Oncology Hematology, P.C.
Albany, New York, 12206, United States
Broome Oncology - Binghamton
Binghamton, New York, 13905, United States
Willamette Valley Cancer Ctr - 520 Country Club
Eugene, Oregon, 97401-8122, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Center for Biomedical Research LLC
Knoxville, Tennessee, 37909, United States
Texas Oncology - South Austin
Austin, Texas, 78745, United States
Texas Oncology, P.A. - Fort Worth
Fort Worth, Texas, 76104, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Blue Ridge Cancer Care
Roanoke, Virginia, 24014, United States
Northwest Cancer Specialists - Vancouver
Vancouver, Washington, 98684, United States
Providence St. Mary Regional Cancer Center
Walla Walla, Washington, 99362, United States
Wenatchee Valley Hospital & Clinics
Wenatchee, Washington, 98801, United States
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
Chr de La Citadelle
Liège, 4000, Belgium
Cite de La Sante de Laval; Hemato-Oncologie
Laval, Quebec, H7M 3L9, Canada
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal, Quebec, H3T 1E2, Canada
Hopital Gabriel Montpied; Service de Pneumologie
Clermont-Ferrand, 63003, France
Hôpital Nord Michallon; Pneumologie
La Tronche, 38700, France
Centre D'Oncologie de Gentilly; Oncology
Nancy, 54100, France
Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll; Pneumologie
Saint-Brieuc, 22027, France
Hopital Larrey; Pneumologie
Toulouse, 31059, France
Asklepios-Fachkliniken Muenchen-Gauting; Onkologie
Gauting, 82131, Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II
Halle, 06120, Germany
Fachklinik für Lungenerkrankungen
Immenhausen, 34376, Germany
Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie
Regensburg, 93053, Germany
Citta Ospedaliera; Divisione Oncologia Medica
Avellino, Campania, 83100, Italy
Irccs Ospedale San Raffaele;Oncologia Medica
Milan, Lombardy, 20132, Italy
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Gdansk, 80-214, Poland
Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii
Lodz, 93-513, Poland
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
Otwock, 05-400, Poland
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
Warsaw, 02-781, Poland
National Cancer Center; Medical Oncology
Gyeonggi-do, 410-769, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Samsung Medical Centre; Division of Hematology/Oncology
Seoul, 135-710, South Korea
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, 28041, Spain
Hospital La Paz
Madrid, 28046, Spain
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza, 50009, Spain
Universitetssjukhuset Linköping; Lungmedicinkliniken
Linköping, 581 85, Sweden
Chulalongkorn Hospital; Medical Oncology
Bangkok, 10330, Thailand
Rajavithi Hospital; Division of Medical Oncology
Bangkok, 10400, Thailand
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
Bangkok, 10700, Thailand
Akdeniz University Medical Faculty; Medical Oncology Department
Antalya, 07070, Turkey (Türkiye)
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
Istanbul, 34300, Turkey (Türkiye)
Royal Free Hospital; Dept of Oncology
London, NW3 2QG, United Kingdom
Guys and St Thomas NHS Foundation Trust, Guys Hospital
London, SE1 9RT, United Kingdom
Charing Cross Hospital; Medical Oncology.
London, W6 8RF, United Kingdom
Christie Hospital Nhs Trust; Medical Oncology
Manchester, M2O 4BX, United Kingdom
Related Publications (5)
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.
PMID: 36428744DERIVEDShemesh 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.
PMID: 33241650DERIVEDChalabi 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.
PMID: 32115349DERIVEDFehlings 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.
PMID: 31511069DERIVEDFehrenbacher 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.
PMID: 26970723DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2013
First Posted
July 19, 2013
Study Start
August 6, 2013
Primary Completion
November 19, 2015
Study Completion
September 6, 2018
Last Updated
October 2, 2019
Results First Posted
May 23, 2017
Record last verified: 2019-09