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"
NCT ID: NCT01903993
Last Updated: 2019-10-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
287 participants
INTERVENTIONAL
2013-08-06
2018-09-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States
Genesis Cancer Center
Hot Springs, Arkansas, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Kaiser Permanente - San Marcos
San Marcos, California, United States
Kaiser Permanente - Vallejo
Vallejo, California, United States
Innovative Clinical Research Institute
Whittier, California, United States
Rocky Mountain Cancer Centers - Colorado Springs (Circle)
Lone Tree, Colorado, United States
Ocala Oncology Center
Ocala, Florida, United States
Georgia Cancer Specialists
Atlanta, Georgia, United States
Ingalls Memorial Hospital
Harvey, Illinois, United States
Illinois Cancer Care
Peoria, Illinois, United States
New England Cancer Specialists
Scarborough, Maine, United States
Karmanos Cancer Institute..
Detroit, Michigan, United States
Billings Clinic; Research Center
Billings, Montana, United States
Comprehensive Cancer Centers of Nevada - Eastern Avenue
Las Vegas, Nevada, United States
The Valley Hospital
Paramus, New Jersey, United States
New York Oncology Hematology, P.C.
Albany, New York, United States
Broome Oncology - Binghamton
Binghamton, New York, United States
Willamette Valley Cancer Ctr - 520 Country Club
Eugene, Oregon, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Center for Biomedical Research LLC
Knoxville, Tennessee, United States
Texas Oncology - South Austin
Austin, Texas, United States
Texas Oncology, P.A. - Fort Worth
Fort Worth, Texas, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Blue Ridge Cancer Care
Roanoke, Virginia, United States
Northwest Cancer Specialists - Vancouver
Vancouver, Washington, United States
Providence St. Mary Regional Cancer Center
Walla Walla, Washington, United States
Wenatchee Valley Hospital & Clinics
Wenatchee, Washington, United States
UZ Leuven Gasthuisberg
Leuven, , Belgium
Chr de La Citadelle
Liège, , Belgium
Cite de La Sante de Laval; Hemato-Oncologie
Laval, Quebec, Canada
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal, Quebec, Canada
Hopital Gabriel Montpied; Service de Pneumologie
Clermont-Ferrand, , France
Hôpital Nord Michallon; Pneumologie
La Tronche, , France
Centre D'Oncologie de Gentilly; Oncology
Nancy, , France
Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll; Pneumologie
Saint-Brieuc, , France
Hopital Larrey; Pneumologie
Toulouse, , France
Asklepios-Fachkliniken Muenchen-Gauting; Onkologie
Gauting, , Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II
Halle, , Germany
Fachklinik für Lungenerkrankungen
Immenhausen, , Germany
Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie
Regensburg, , Germany
Citta Ospedaliera; Divisione Oncologia Medica
Avellino, Campania, Italy
Irccs Ospedale San Raffaele;Oncologia Medica
Milan, Lombardy, Italy
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Gdansk, , Poland
Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii
Lodz, , Poland
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
Otwock, , Poland
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
Warsaw, , Poland
National Cancer Center; Medical Oncology
Gyeonggi-do, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Samsung Medical Centre; Division of Hematology/Oncology
Seoul, , South Korea
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, , Spain
Hospital La Paz
Madrid, , Spain
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza, , Spain
Universitetssjukhuset Linköping; Lungmedicinkliniken
Linköping, , Sweden
Chulalongkorn Hospital; Medical Oncology
Bangkok, , Thailand
Rajavithi Hospital; Division of Medical Oncology
Bangkok, , Thailand
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
Bangkok, , Thailand
Akdeniz University Medical Faculty; Medical Oncology Department
Antalya, , Turkey (Türkiye)
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
Istanbul, , Turkey (Türkiye)
Royal Free Hospital; Dept of Oncology
London, , United Kingdom
Guys and St Thomas NHS Foundation Trust, Guys Hospital
London, , United Kingdom
Charing Cross Hospital; Medical Oncology.
London, , United Kingdom
Christie Hospital Nhs Trust; Medical Oncology
Manchester, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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2013-001142-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GO28753
Identifier Type: -
Identifier Source: org_study_id
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