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"
- Registration Number
- NCT01903993
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 287
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Atezolizumab 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. Docetaxel 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.
- Primary Outcome Measures
Name Time Method Overall Survival (OS) 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.
- Secondary Outcome Measures
Name Time Method 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) 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.
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) 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.
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) 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.
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) 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.
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) 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.
DOR (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) 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.
Trial Locations
- Locations (65)
Kaiser Permanente - Vallejo
🇺🇸Vallejo, California, United States
New York Oncology Hematology, P.C.
🇺🇸Albany, New York, United States
Wenatchee Valley Hospital & Clinics
🇺🇸Wenatchee, Washington, United States
Rocky Mountain Cancer Centers - Colorado Springs (Circle)
🇺🇸Lone Tree, Colorado, United States
Blue Ridge Cancer Care
🇺🇸Roanoke, Virginia, United States
Hopital Gabriel Montpied; Service de Pneumologie
🇫🇷Clermont-ferrand, France
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Texas Oncology - South Austin
🇺🇸Austin, Texas, United States
The Valley Hospital
🇺🇸Paramus, New Jersey, United States
Chr de La Citadelle
🇧🇪Liège, Belgium
Ocala Oncology Center
🇺🇸Ocala, Florida, United States
Willamette Valley Cancer Ctr - 520 Country Club
🇺🇸Eugene, Oregon, United States
Arizona Oncology Associates, PC - HOPE
🇺🇸Tucson, Arizona, United States
Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
🇨🇦Montreal, Quebec, Canada
UZ Leuven Gasthuisberg
🇧🇪Leuven, Belgium
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Samsung Medical Centre; Division of Hematology/Oncology
🇰🇷Seoul, Korea, Republic of
Universitetssjukhuset Linköping; Lungmedicinkliniken
🇸🇪Linköping, Sweden
Christie Hospital Nhs Trust; Medical Oncology
🇬🇧Manchester, United Kingdom
Hôpital Nord Michallon; Pneumologie
🇫🇷La Tronche, France
Genesis Cancer Center
🇺🇸Hot Springs, Arkansas, United States
Kaiser Permanente - San Marcos
🇺🇸San Marcos, California, United States
Innovative Clinical Research Institute
🇺🇸Whittier, California, United States
Georgia Cancer Specialists
🇺🇸Atlanta, Georgia, United States
Illinois Cancer Care
🇺🇸Peoria, Illinois, United States
New England Cancer Specialists
🇺🇸Scarborough, Maine, United States
Center for Biomedical Research LLC
🇺🇸Knoxville, Tennessee, United States
Broome Oncology - Binghamton
🇺🇸Binghamton, New York, United States
Cite de La Sante de Laval; Hemato-Oncologie
🇨🇦Laval, Quebec, Canada
Asklepios-Fachkliniken Muenchen-Gauting; Onkologie
🇩🇪Gauting, Germany
Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll; Pneumologie
🇫🇷St Brieuc, France
Hopital Larrey; Pneumologie
🇫🇷Toulouse, France
Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II
🇩🇪Halle, Germany
Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie
🇩🇪Regensburg, Germany
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
🇵🇱Gdansk, Poland
Irccs Ospedale San Raffaele;Oncologia Medica
🇮🇹Milano, Lombardia, Italy
National Cancer Center; Medical Oncology
🇰🇷Gyeonggi-do, Korea, Republic of
Citta Ospedaliera; Divisione Oncologia Medica
🇮🇹Avellino, Campania, Italy
Hospital Universitario 12 de Octubre; Servicio de Oncologia
🇪🇸Madrid, Spain
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
🇵🇱Otwock, Poland
Hospital Ramon y Cajal; Servicio de Oncologia
🇪🇸Madrid, Spain
Hospital La Paz
🇪🇸Madrid, Spain
Hospital Universitario Miguel Servet; Servicio Oncologia
🇪🇸Zaragoza, Spain
Rajavithi Hospital; Division of Medical Oncology
🇹🇭Bangkok, Thailand
Chulalongkorn Hospital; Medical Oncology
🇹🇭Bangkok, Thailand
Akdeniz University Medical Faculty; Medical Oncology Department
🇹🇷Antalya, Turkey
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
🇹🇭Bangkok, Thailand
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
🇹🇷Istanbul, Turkey
Guys and St Thomas NHS Foundation Trust, Guys Hospital
🇬🇧London, United Kingdom
Royal Free Hospital; Dept of Oncology
🇬🇧London, United Kingdom
Charing Cross Hospital; Medical Oncology.
🇬🇧London, United Kingdom
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Fachklinik für Lungenerkrankungen
🇩🇪Immenhausen, Germany
Virginia Cancer Specialists, PC
🇺🇸Fairfax, Virginia, United States
Northwest Cancer Specialists - Vancouver
🇺🇸Vancouver, Washington, United States
Texas Oncology, P.A. - Fort Worth
🇺🇸Fort Worth, Texas, United States
Providence St. Mary Regional Cancer Center
🇺🇸Walla Walla, Washington, United States
Centre D'Oncologie de Gentilly; Oncology
🇫🇷Nancy, France
Karmanos Cancer Institute..
🇺🇸Detroit, Michigan, United States
Comprehensive Cancer Centers of Nevada - Eastern Avenue
🇺🇸Las Vegas, Nevada, United States
Billings Clinic; Research Center
🇺🇸Billings, Montana, United States
Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii
🇵🇱Lodz, Poland
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
🇵🇱Warszawa, Poland
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States