Back to resultsA 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"
Primary Purpose
Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Docetaxel
Atezolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Arizona Oncology Associates, PC - HOPE
- Genesis Cancer Center
- Loma Linda University Medical Center
- Kaiser Permanente - San Marcos
- Kaiser Permanente - Vallejo
- Innovative Clinical Research Institute
- Rocky Mountain Cancer Centers - Colorado Springs (Circle)
- Ocala Oncology Center
- Georgia Cancer Specialists
- Ingalls Memorial Hospital
- Illinois Cancer Care
- New England Cancer Specialists
- Karmanos Cancer Institute..
- Billings Clinic; Research Center
- Comprehensive Cancer Centers of Nevada - Eastern Avenue
- The Valley Hospital
- New York Oncology Hematology, P.C.
- Broome Oncology - Binghamton
- Willamette Valley Cancer Ctr - 520 Country Club
- Rhode Island Hospital
- Center for Biomedical Research LLC
- Texas Oncology - South Austin
- Texas Oncology, P.A. - Fort Worth
- Virginia Cancer Specialists, PC
- Virginia Oncology Associates
- Blue Ridge Cancer Care
- Northwest Cancer Specialists - Vancouver
- Providence St. Mary Regional Cancer Center
- Wenatchee Valley Hospital & Clinics
- UZ Leuven Gasthuisberg
- Chr de La Citadelle
- Cite de La Sante de Laval; Hemato-Oncologie
- McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
- Hopital Gabriel Montpied; Service de Pneumologie
- Hôpital Nord Michallon; Pneumologie
- Centre D'Oncologie de Gentilly; Oncology
- Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll; Pneumologie
- Hopital Larrey; Pneumologie
- Asklepios-Fachkliniken Muenchen-Gauting; Onkologie
- Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II
- Fachklinik für Lungenerkrankungen
- Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie
- Citta Ospedaliera; Divisione Oncologia Medica
- Irccs Ospedale San Raffaele;Oncologia Medica
- National Cancer Center; Medical Oncology
- Severance Hospital, Yonsei University Health System
- Samsung Medical Centre; Division of Hematology/Oncology
- Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
- Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii
- Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
- Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
- Hospital Ramon y Cajal; Servicio de Oncologia
- Hospital Universitario 12 de Octubre; Servicio de Oncologia
- Hospital La Paz
- Hospital Universitario Miguel Servet; Servicio Oncologia
- Universitetssjukhuset Linköping; Lungmedicinkliniken
- Chulalongkorn Hospital; Medical Oncology
- Rajavithi Hospital; Division of Medical Oncology
- Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
- Akdeniz University Medical Faculty; Medical Oncology Department
- Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
- Royal Free Hospital; Dept of Oncology
- Guys and St Thomas NHS Foundation Trust, Guys Hospital
- Charing Cross Hospital; Medical Oncology.
- Christie Hospital Nhs Trust; Medical Oncology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Docetaxel
Atezolizumab
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01903993
Brief Title
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"
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 6, 2013 (Actual)
Primary Completion Date
November 19, 2015 (Actual)
Study Completion Date
September 6, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
287 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Docetaxel
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Atezolizumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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.
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)
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
Baseline until date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)
Title
Progression-Free Survival (PFS)
Description
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.
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)
Title
Duration of Response (DOR)
Description
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.
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)
Title
ORR (Modified RECIST)
Description
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.
Time Frame
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)
Title
PFS (Modified RECIST)
Description
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.
Time Frame
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)
Title
DOR (Modified RECIST)
Description
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.
Time Frame
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Oncology Associates, PC - HOPE
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Genesis Cancer Center
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Kaiser Permanente - San Marcos
City
San Marcos
State/Province
California
ZIP/Postal Code
92069
Country
United States
Facility Name
Kaiser Permanente - Vallejo
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Innovative Clinical Research Institute
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Rocky Mountain Cancer Centers - Colorado Springs (Circle)
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Ocala Oncology Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Georgia Cancer Specialists
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Facility Name
Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Illinois Cancer Care
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
New England Cancer Specialists
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Karmanos Cancer Institute..
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Billings Clinic; Research Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada - Eastern Avenue
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
The Valley Hospital
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
Facility Name
New York Oncology Hematology, P.C.
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Broome Oncology - Binghamton
City
Binghamton
State/Province
New York
ZIP/Postal Code
13905
Country
United States
Facility Name
Willamette Valley Cancer Ctr - 520 Country Club
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401-8122
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Center for Biomedical Research LLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Texas Oncology - South Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Texas Oncology, P.A. - Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Virginia Cancer Specialists, PC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Blue Ridge Cancer Care
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Northwest Cancer Specialists - Vancouver
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Facility Name
Providence St. Mary Regional Cancer Center
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362
Country
United States
Facility Name
Wenatchee Valley Hospital & Clinics
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Chr de La Citadelle
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Cite de La Sante de Laval; Hemato-Oncologie
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7M 3L9
Country
Canada
Facility Name
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Hopital Gabriel Montpied; Service de Pneumologie
City
Clermont-ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Hôpital Nord Michallon; Pneumologie
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Centre D'Oncologie de Gentilly; Oncology
City
Nancy
ZIP/Postal Code
54100
Country
France
Facility Name
Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll; Pneumologie
City
St Brieuc
ZIP/Postal Code
22027
Country
France
Facility Name
Hopital Larrey; Pneumologie
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Asklepios-Fachkliniken Muenchen-Gauting; Onkologie
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Fachklinik für Lungenerkrankungen
City
Immenhausen
ZIP/Postal Code
34376
Country
Germany
Facility Name
Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Citta Ospedaliera; Divisione Oncologia Medica
City
Avellino
State/Province
Campania
ZIP/Postal Code
83100
Country
Italy
Facility Name
Irccs Ospedale San Raffaele;Oncologia Medica
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
National Cancer Center; Medical Oncology
City
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Samsung Medical Centre; Division of Hematology/Oncology
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Facility Name
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Hospital Ramon y Cajal; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Miguel Servet; Servicio Oncologia
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Universitetssjukhuset Linköping; Lungmedicinkliniken
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Chulalongkorn Hospital; Medical Oncology
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Rajavithi Hospital; Division of Medical Oncology
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Akdeniz University Medical Faculty; Medical Oncology Department
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
Facility Name
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
City
Istanbul
ZIP/Postal Code
34300
Country
Turkey
Facility Name
Royal Free Hospital; Dept of Oncology
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Guys and St Thomas NHS Foundation Trust, Guys Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Charing Cross Hospital; Medical Oncology.
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Christie Hospital Nhs Trust; Medical Oncology
City
Manchester
ZIP/Postal Code
M2O 4BX
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
33241650
Citation
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.
Results Reference
derived
PubMed Identifier
32115349
Citation
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.
Results Reference
derived
PubMed Identifier
31511069
Citation
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.
Results Reference
derived
PubMed Identifier
26970723
Citation
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.
Results Reference
derived
Learn more about this trial
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"
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