"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"

PHASE2CompletedINTERVENTIONAL
Enrollment

287

Participants

Timeline

Start Date

August 6, 2013

Primary Completion Date

November 19, 2015

Study Completion Date

September 6, 2018

Conditions
Non-Small Cell Lung Cancer
Interventions
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.

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.

Trial Locations (65)

3000

UZ Leuven Gasthuisberg, Leuven

4000

Chr de La Citadelle, Liège

10330

Chulalongkorn Hospital; Medical Oncology, Bangkok

10400

Rajavithi Hospital; Division of Medical Oncology, Bangkok

10700

Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology, Bangkok

12206

New York Oncology Hematology, P.C., Albany

13905

Broome Oncology - Binghamton, Binghamton

20132

Irccs Ospedale San Raffaele;Oncologia Medica, Milan

22027

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

22031

Virginia Cancer Specialists, PC, Fairfax

23502

Virginia Oncology Associates, Norfolk

24014

Blue Ridge Cancer Care, Roanoke

28034

Hospital Ramon y Cajal; Servicio de Oncologia, Madrid

28041

Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid

28046

Hospital La Paz, Madrid

30341

Georgia Cancer Specialists, Atlanta

31059

Hopital Larrey; Pneumologie, Toulouse

34300

Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology, Istanbul

34376

Fachklinik für Lungenerkrankungen, Immenhausen

34471

Ocala Oncology Center, Ocala

37909

Center for Biomedical Research LLC, Knoxville

38700

Hôpital Nord Michallon; Pneumologie, La Tronche

48201

Karmanos Cancer Institute.., Detroit

50009

Hospital Universitario Miguel Servet; Servicio Oncologia, Zaragoza

54100

Centre D'Oncologie de Gentilly; Oncology, Nancy

59101

Billings Clinic; Research Center, Billings

60426

Ingalls Memorial Hospital, Harvey

61615

Illinois Cancer Care, Peoria

63003

Hopital Gabriel Montpied; Service de Pneumologie, Clermont-Ferrand

71913

Genesis Cancer Center, Hot Springs

76104

Texas Oncology, P.A. - Fort Worth, Fort Worth

78745

Texas Oncology - South Austin, Austin

80124

Rocky Mountain Cancer Centers - Colorado Springs (Circle), Lone Tree

82131

Asklepios-Fachkliniken Muenchen-Gauting; Onkologie, Gauting

83100

Citta Ospedaliera; Divisione Oncologia Medica, Avellino

85704

Arizona Oncology Associates, PC - HOPE, Tucson

89169

Comprehensive Cancer Centers of Nevada - Eastern Avenue, Las Vegas

90603

Innovative Clinical Research Institute, Whittier

92069

Kaiser Permanente - San Marcos, San Marcos

92354

Loma Linda University Medical Center, Loma Linda

93053

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

94589

Kaiser Permanente - Vallejo, Vallejo

98684

Northwest Cancer Specialists - Vancouver, Vancouver

98801

Wenatchee Valley Hospital & Clinics, Wenatchee

99362

Providence St. Mary Regional Cancer Center, Walla Walla

04074

New England Cancer Specialists, Scarborough

07652

The Valley Hospital, Paramus

97401-8122

Willamette Valley Cancer Ctr - 520 Country Club, Eugene

02903

Rhode Island Hospital, Providence

H7M 3L9

Cite de La Sante de Laval; Hemato-Oncologie, Laval

H3T 1E2

McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology, Montreal

06120

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

80-214

Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii, Gdansk

93-513

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

05-400

Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii, Otwock

02-781

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

410-769

National Cancer Center; Medical Oncology, Gyeonggi-do

03722

Severance Hospital, Yonsei University Health System, Seoul

135-710

Samsung Medical Centre; Division of Hematology/Oncology, Seoul

581 85

Universitetssjukhuset Linköping; Lungmedicinkliniken, Linköping

07070

Akdeniz University Medical Faculty; Medical Oncology Department, Antalya

NW3 2QG

Royal Free Hospital; Dept of Oncology, London

SE1 9RT

Guys and St Thomas NHS Foundation Trust, Guys Hospital, London

W6 8RF

Charing Cross Hospital; Medical Oncology., London

M2O 4BX

Christie Hospital Nhs Trust; Medical Oncology, Manchester

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT01903993 - "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" | Biotech Hunter | Biotech Hunter