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A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110]

Primary Purpose

Non-Squamous Non-Small Cell Lung Cancer, Squamous Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody
Carboplatin
Cisplatin
Gemcitabine
Pemetrexed
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Squamous Non-Small Cell Lung Cancer, Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically or cytologically confirmed, Stage IV non-squamous or squamous NSCLC
  • No prior treatment for Stage IV non-squamous or squamous NSCLC. Participant known to have a sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene are excluded from the study
  • Tumor PD-L1 expression as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
  • Adequate hematologic and end-organ function

Exclusion Criteria:

  • Known sensitizing mutation in the EGFR gene or ALK fusion oncogene
  • Active or untreated central nervous system (CNS) metastases as determined by Computed Tomography (CT) or magnetic resonance imaging (MRI) evaluation
  • Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
  • Pregnant or lactating women
  • History of autoimmune disease
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
  • Positive test for Human Immunodeficiency Virus (HIV)
  • Active hepatitis B or hepatitis C
  • Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti PD1, and anti-PD-L1 therapeutic antibody
  • Severe infection within 4 weeks prior to randomization
  • Significant history of cardiovascular disease

Sites / Locations

  • University of California San Diego
  • Yale Cancer Center
  • Lynn Cancer Institute - West
  • University of Maryland Greenebaum Cancer Center
  • Oregon Health & Science Uni
  • Sarah Cannon Cancer Center
  • Vanderbilt University Medical Center; Multiple Sclerosis Center
  • Hematology Oncology Associates of Fredericksburg, Inc.
  • VA Puget Sound Health Care Sys
  • Oncovida*X
  • Centro de Pesquisas Clinicas em Oncologia - CPCO
  • Instituto Nacional de Cancer - INCa; Oncologia
  • Associacao Hospital de Caridade Ijui*X; Departamento De Oncologia
  • Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia
  • Santa Casa de Misericordia de Porto Alegre
  • Hospital Sao Lucas - PUCRS
  • Instituto Joinvilense de Hematologia E Oncologia
  • *X*Fundacao PIO XII
  • Hospital Santa Marcelina
  • Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira
  • Harbin Medical University Tumor Hospital
  • CHU Angers
  • Hospital d Instructions des Armees Percy
  • Hôpital Universitaire Dupuytren
  • Clinique Clémentville
  • Centre D'oncologie de Gentilly
  • Hopital Tenon
  • Centre Hospitalier Regional La Reunion Site Felix Guyon
  • Hopital d'Instruction des Armees de Begin
  • Centre Hospitalier Regional Sud Reunion
  • Centre Paul Strauss
  • Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie
  • Pius-Hospital Oldenburg
  • Sotiria Chest Hospital of Athens
  • IASO General Hospital of Athens
  • Metropolitan Hospital
  • Attikon University General Hospital
  • University General Hospital of Larissa
  • University General Hospital of Patras
  • Thermi Clinic
  • Bioclinic Thessaloniki
  • EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department
  • Papageorgiou General Hospital of Thessaloniki
  • Georgios Papanikolaou General Hosp. of Thessaloniki
  • Uzsoki Utcai Korhaz
  • Szabolcs-Szatmar-Bereg Megyei; Korhazak es Egyetemi Oktatokorhaz
  • Pecsi Tudomanyegyetem
  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet; Megyei Onkologiai Kozpont
  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
  • Centro Di Riferimento Oncologico; Struttura Operativa Complessa Di Oncologia Medica B
  • Asst Papa Giovanni XXIII
  • Azienda Ospedaliera Istituti Ospitalieri
  • Ospedale San Raffaele S.r.l.
  • Istituto Europeo Di Oncologia
  • Azienda Socio Sanitaria Territoriale ? ASST di Monza
  • Istituto Nazionale dei Tumori
  • Istituto Clinico Humanitas
  • Azienda Ospedaliera Città della Salute e della Scienza di Torino
  • Azienda Ospedaliero-Universitaria ?PoliclinicoVittorio Emanuele?- P.O. G. Rodolico; Oncologia Medica
  • Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia
  • Aichi Cancer Center Hospital; Respiratory Medicine
  • Nagoya University Hospital; Respiratory Medicine
  • Kyushu University Hospital; Respiratory
  • Hokkaido University Hospital
  • Kobe City Medical Center General Hospital; Respiratory Medicine
  • Hyogo Cancer Center; Thoracic Oncology
  • Ibaraki Prefectural Central Hospital; Division of respiratory
  • Sendai Kousei Hospital; Pulmonary Medicine
  • Okayama University Hospital; Respiratory and Allergy Medicine
  • Osaka International Cancer Institute; Thoracic Oncology
  • Kansai Medical university Hospital; Thoracic Oncology
  • Osaka Habikino Medical Center
  • National Hospital Organization Kinki-Chuo Chest Medical Center
  • Saitama Cancer Center; Thoracic Oncology
  • National Cancer Center Hospital; Thoracic Medical Oncology
  • Tokyo Medical University Hospital; Dept of Surgery
  • Chonnam National University Hwasun Hospital
  • Seoul National University Bundang Hospital
  • Kangbuk Samsung Hospital
  • Uniwersyteckie Centrum Kliniczne
  • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii
  • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
  • Med-Polonia Sp. z o.o.
  • Teo Health SA - Saint Constantin Hospital
  • Prof. Dr. I. Chiricuta Institute of Oncology
  • Oncology Center Sf. Nectarie
  • Institutul Regional de Oncologie Iasi; Clinica de Hematologie
  • Sibiu Emergency Clinical County Hospital
  • Oncocenter Clinical Oncology
  • Oncomed SRL
  • Arkhangelsk Regional Clinical Oncology Dispensary
  • Federal State Institution Medical Radiology Research Center
  • Moscow City Oncology Hospital #62
  • Principal Military Clinical Hospital n.a. N.N. Burdenko
  • Saint Petersburg Clinical Hospital of the Russian Academy of Sciences
  • Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
  • Regional Clinical Oncology Center
  • Mordovia State University
  • Leningrad Regional Clinical Hospital
  • St. Petersburg Med Univ; n.a. I.P. Pavlov; Pulmonology Research
  • Volgograd Regional Clinical Oncology Dispensary
  • Clinical Center of Serbia
  • Institute for Oncology and Radiology of Serbia; Medical Oncology
  • Clinical Center Kragujevac
  • Institute of Lung Diseases Vojvodina
  • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
  • Consorcio Hospitalario Provincial de Castellon
  • Hospital Universitario Son Espases
  • Hospital Son Llatzer
  • Hospital Universitario A Coruña
  • Hospital Universitario Cruces
  • Hospital del Mar
  • Hospital Universitario Vall d'Hebron - PPDS
  • Complejo Hospitalario de Jaen
  • Hospital Clinico San Carlos; Servicio de Oncologia
  • Hospital Universitario Virgen Macarena
  • Hospital Clinico Universitario de Valencia
  • Hospital Universitari i Politecnic La Fe de Valencia
  • Hosp Clinico Univ Lozano Blesa; División De Oncología Médica
  • Hospital Universitario Miguel Servet
  • Prince of Songkla University; Department Of Internal Medicine, Faculty Of Medicine
  • Khon Kaen University
  • Chiang Rai Prachanukroh Hospital
  • Buddhachinnaraj Hospital
  • Cukurova University Medical Faculty Balcali Hospital
  • Hacettepe Universitesi Tip Fakultesi Hastanesi
  • Istanbul University Cerrahpasa Medical Faculty
  • Ege Universitesi Tip Fakultesi Hastanesi
  • Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
  • Inonu University Faculty of Medicine Turgut Ozal Medical Center
  • Municipal Noncommercial Institution Regional Center of Oncology
  • Municipal Noncomercial Enterprise Odessa Regional Oncology Center ofthe Odessa StateAdministration
  • Municipal non profit enterprise of Sumy Regional Council Sumy Regional Clinical Oncology Disp
  • Communal Non-profit Enterprise City Clinical Hospital #4 of Dnipro City Council - PPDS; Chemotherapy
  • Kyiv Railway Clinical Hospital #3 of Branch Health Center of the PJSC Ukrainian Railway
  • Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council
  • The Municipal Enterprise Volyn Regional Medical Oncology Centre of the Volyn Regional Council
  • Private Enterprise Private Manufacturing Company Acinus
  • Birmingham Heartlands Hospital
  • Colchester General Hospital
  • Christie Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

(Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)

Atezolizumab

Arm Description

Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).

Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).

Outcomes

Primary Outcome Measures

Overall Survival (OS) in the TC3 or IC3-WT Populations
OS is defined as the time from randomization to death from any cause.
Overall Survival (OS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
OS is defined as the time from randomization to death from any cause.

Secondary Outcome Measures

Progression-free Survival (PFS) in the TC3 or IC3-WT Populations
PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first. PFS could not be formally tested.
Progression-free Survival (PFS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first. PFS could not be formally tested.
Percentage of Participants With Objective Response (ORR) in the TC3 or IC3-WT Populations
Objective response (partial response plus complete response) as determined by the investigator according to RECIST v1.1.
Percentage of Participants With Objective Response (ORR) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
Objective response (partial response plus complete response) as determined by the investigator according to RECIST v1.1.
Duration of Response (DOR) in the TC3 or IC3-WT Populations
DOR is defined as the time from the first occurrence of a documented objective response to the time of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first.
Duration of Response (DOR) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
DOR is defined as the time from the first occurrence of a documented objective response to the time of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first.
Percentage of Participants Who Are Alive at 1 Year in the TC3 or IC3-WT Populations
Percentage of Participants Who Are Alive at 2 Years in the TC3 or IC3-WT Populations
Percentage of Participants Who Are Alive at 1 Year in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
Percentage of Participants Who Are Alive at 2 Years in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Score as Assessed by the Symptoms in Lung Cancer (SILC) Scale Symptom Score in the TC3 or IC3-WT Populations
TTD in each of the patient-reported lung cancer symptoms with use of the SILC scale. The SILC scale is a nine-item content valid self-report measure of lung cancer symptoms. It measures severity of cough, dyspnea, and chest pain with a total symptom severity score. Each SILC symptom scale (dyspnea, cough, chest pain) score was calculated as the average of the component items (range 0 to 4). An increase in score suggested worsening in symptomatology. A symptom score change of 0.3 points for the dyspnea and cough scores was considered to be clinically significant; whereas a symptom score change of 0.5 points for the chest pain score was considered to be clinically significant.
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Change from baseline in each of the patient-reported lung cancer symptoms with use of the SILC scale. The SILC scale is a nine-item content valid self-report measure of lung cancer symptoms. It measures severity of cough, dyspnea, and chest pain with a total symptom severity score. Each SILC symptom scale (dyspnea, cough, chest pain) score was calculated as the average of the component items (range 0 to 4). An increase in score suggested worsening in symptomatology. A symptom score change of 0.3 points for the dyspnea and cough scores was considered to be clinically significant; whereas a symptom score change of 0.5 points for the chest pain score was considered to be clinically significant.
TTD as Assessed Using EORTC QLQ Supplementary Lung Cancer Module (EORTC QLQ-LC13) in the TC3 or IC3-WT Populations
TTD in patient-reported lung cancer symptoms, defined as time from randomization to deterioration (10-point change) in any of the following symptom subscales (cough, dyspnea [multi-item scale], and chest pain), whichever occurs first, as measured by the EORTC QLQ-LC13. EORTC QLQ-LC13 module incorporates one multi-item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis.
OS in Participants With PD-L1 Expression
OS is defined as the time from randomization to death from any cause.
Investigator-Assessed PFS in Participants With PD-L1 Expression According to RECIST v1.1
Investigator-assessed PFS according to RECIST v1.1 in the PD-L1 (defined with SP263 IHC assay)
OS in Participants With Blood Tumor Mutational Burden (bTMB)
OS is defined as the time from randomization to death from any cause.
Investigator-Assessed PFS in Participants With bTMB According to RECIST v1.1
PFS according to RECIST v1.1 in the bTMB subpopulations.
Minimum Observed Serum Concentration (Cmin) of Atezolizumab
Maximum Observed Serum Concentration (Cmax) of Atezolizumab
Percentage of Participants With at Least One Adverse Event
Percentage of participants with at least one adverse event.
Percentage of Participants With Anti-therapeutic Antibodies (ATAs)

Full Information

First Posted
April 1, 2015
Last Updated
February 17, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02409342
Brief Title
A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110]
Official Title
A Phase III, Open Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With a Platinum Agent (Cisplatin or Carboplatin) in Combination With Either Pemetrexed or Gemcitabine for PD-L1-Selected, Chemotherapy-Naive Patients With Stage IV Non-Squamous Or Squamous Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 20, 2015 (Actual)
Primary Completion Date
February 4, 2020 (Actual)
Study Completion Date
March 8, 2022 (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 randomized, open-label study will evaluate the efficacy and safety of atezolizumab compared with chemotherapy consisting of a platinum agent (cisplatin or carboplatin per investigator discretion) combined with either pemetrexed (non-squamous disease) or gemcitabine (squamous disease) in programmed death-ligand 1 (PD-L1)-selected, chemotherapy-naive participants with Stage IV Non-Squamous or Squamous NSCLC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Squamous Non-Small Cell Lung Cancer, Squamous Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
572 (Actual)

8. Arms, Groups, and Interventions

Arm Title
(Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
Arm Type
Active Comparator
Arm Description
Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
Arm Title
Atezolizumab
Arm Type
Experimental
Arm Description
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
Intervention Type
Drug
Intervention Name(s)
Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody
Other Intervention Name(s)
MPDL3280A, RO5541267
Intervention Description
Atezolizumab 1200 milligram (mg) will be administered as intravenous infusion every 21 days until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin will be administered as intravenous infusion at a dose of area under the concentration-time curve (AUC) 6 when given in combination with pemetrexed or at a dose of AUC 5 when given in combination with gemcitabine, every 21 days for 4 or 6 cycles as per local standard of care.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin will be administered as intravenous infusion at a dose of 75 mg per meter squared (mg/m^2) every 21 days for 4 or 6 cycles as per local standard of care.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine will be administered as intravenous infusion at a dose of 1250 mg/m^2 (in combination with cisplatin) or 1000 mg/m^2 (in combination with carboplatin), on Days 1 and 8 of each 21-day cycle for 4 or 6 cycles as per local standard of care.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Pemetrexed will be administered as intravenous infusion at a dose of 500 mg/m^2 on Day 1 of each 21-day cycle as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).
Primary Outcome Measure Information:
Title
Overall Survival (OS) in the TC3 or IC3-WT Populations
Description
OS is defined as the time from randomization to death from any cause.
Time Frame
From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months)
Title
Overall Survival (OS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
Description
OS is defined as the time from randomization to death from any cause.
Time Frame
From randomization to death from any cause until data cut-off on 4 February 2020 (up to approximately 54.5 months)
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS) in the TC3 or IC3-WT Populations
Description
PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first. PFS could not be formally tested.
Time Frame
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)
Title
Progression-free Survival (PFS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
Description
PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first. PFS could not be formally tested.
Time Frame
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 4 February 2020 (up to approximately 54.5 months)
Title
Percentage of Participants With Objective Response (ORR) in the TC3 or IC3-WT Populations
Description
Objective response (partial response plus complete response) as determined by the investigator according to RECIST v1.1.
Time Frame
Every 6 weeks for 48 weeks following Day 1, thereafter every 9 weeks after completion of Week 48 tumor assessment, regardless of treatment delays, until radiographic disease progression until data cut-off on 10 Sep 2018 (up to approximately 38 months)
Title
Percentage of Participants With Objective Response (ORR) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
Description
Objective response (partial response plus complete response) as determined by the investigator according to RECIST v1.1.
Time Frame
Every 6 weeks for 48 weeks following Day 1, thereafter every 9 weeks after completion of Week 48 tumor assessment, regardless of treatment delays, until radiographic disease progression until data cut-off on 4 Feb 2020 (up to approximately 54.5 months)
Title
Duration of Response (DOR) in the TC3 or IC3-WT Populations
Description
DOR is defined as the time from the first occurrence of a documented objective response to the time of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first.
Time Frame
From first occurrence of a complete response or partial response, whichever occurs first, until first date that progressive disease or death is documented, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)
Title
Duration of Response (DOR) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
Description
DOR is defined as the time from the first occurrence of a documented objective response to the time of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first.
Time Frame
From first occurrence of a complete response or partial response, whichever occurs first, until first date that progressive disease or death is documented, whichever occurs first until data cut-off on 4 February 2020 (up to approximately 54.5 months)
Title
Percentage of Participants Who Are Alive at 1 Year in the TC3 or IC3-WT Populations
Time Frame
Baseline to 1 year or death, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)
Title
Percentage of Participants Who Are Alive at 2 Years in the TC3 or IC3-WT Populations
Time Frame
Baseline to 2 years or death, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)
Title
Percentage of Participants Who Are Alive at 1 Year in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
Time Frame
Baseline to 1 year or death, whichever occurs first until clinical cut-off date on 4 February 2020 (up to approximately 54.5 months)
Title
Percentage of Participants Who Are Alive at 2 Years in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations
Time Frame
Baseline to 2 years or death, whichever occurs first until clinical cut-off date on 4 February 2020 (up to approximately 54.5 months)
Title
Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Score as Assessed by the Symptoms in Lung Cancer (SILC) Scale Symptom Score in the TC3 or IC3-WT Populations
Description
TTD in each of the patient-reported lung cancer symptoms with use of the SILC scale. The SILC scale is a nine-item content valid self-report measure of lung cancer symptoms. It measures severity of cough, dyspnea, and chest pain with a total symptom severity score. Each SILC symptom scale (dyspnea, cough, chest pain) score was calculated as the average of the component items (range 0 to 4). An increase in score suggested worsening in symptomatology. A symptom score change of 0.3 points for the dyspnea and cough scores was considered to be clinically significant; whereas a symptom score change of 0.5 points for the chest pain score was considered to be clinically significant.
Time Frame
Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)
Title
Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations
Description
Change from baseline in each of the patient-reported lung cancer symptoms with use of the SILC scale. The SILC scale is a nine-item content valid self-report measure of lung cancer symptoms. It measures severity of cough, dyspnea, and chest pain with a total symptom severity score. Each SILC symptom scale (dyspnea, cough, chest pain) score was calculated as the average of the component items (range 0 to 4). An increase in score suggested worsening in symptomatology. A symptom score change of 0.3 points for the dyspnea and cough scores was considered to be clinically significant; whereas a symptom score change of 0.5 points for the chest pain score was considered to be clinically significant.
Time Frame
Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)
Title
TTD as Assessed Using EORTC QLQ Supplementary Lung Cancer Module (EORTC QLQ-LC13) in the TC3 or IC3-WT Populations
Description
TTD in patient-reported lung cancer symptoms, defined as time from randomization to deterioration (10-point change) in any of the following symptom subscales (cough, dyspnea [multi-item scale], and chest pain), whichever occurs first, as measured by the EORTC QLQ-LC13. EORTC QLQ-LC13 module incorporates one multi-item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis.
Time Frame
Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)
Title
OS in Participants With PD-L1 Expression
Description
OS is defined as the time from randomization to death from any cause.
Time Frame
From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months)
Title
Investigator-Assessed PFS in Participants With PD-L1 Expression According to RECIST v1.1
Description
Investigator-assessed PFS according to RECIST v1.1 in the PD-L1 (defined with SP263 IHC assay)
Time Frame
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)
Title
OS in Participants With Blood Tumor Mutational Burden (bTMB)
Description
OS is defined as the time from randomization to death from any cause.
Time Frame
From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months)
Title
Investigator-Assessed PFS in Participants With bTMB According to RECIST v1.1
Description
PFS according to RECIST v1.1 in the bTMB subpopulations.
Time Frame
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)
Title
Minimum Observed Serum Concentration (Cmin) of Atezolizumab
Time Frame
Prior to infusion (0 hour) on Day 1 of Cycles 2, 3, 4, 8, 16, and every eighth cycle thereafter, and at treatment discontinuation until data cut-off on 10 September 2018 (up to approximately 38 months) (cycle duration = 21 days)
Title
Maximum Observed Serum Concentration (Cmax) of Atezolizumab
Time Frame
0 hour (predose) and 30 minutes after atezolizumab infusion on Day 1 (infusion duration = up to 1 hour)
Title
Percentage of Participants With at Least One Adverse Event
Description
Percentage of participants with at least one adverse event.
Time Frame
Baseline up to until data cut-off on 8 March 2022 (up to approximately 79.5 months)
Title
Percentage of Participants With Anti-therapeutic Antibodies (ATAs)
Time Frame
Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed, Stage IV non-squamous or squamous NSCLC No prior treatment for Stage IV non-squamous or squamous NSCLC. Participant known to have a sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene are excluded from the study Tumor PD-L1 expression as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Adequate hematologic and end-organ function Exclusion Criteria: Known sensitizing mutation in the EGFR gene or ALK fusion oncogene Active or untreated central nervous system (CNS) metastases as determined by Computed Tomography (CT) or magnetic resonance imaging (MRI) evaluation Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome Pregnant or lactating women History of autoimmune disease History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted Positive test for Human Immunodeficiency Virus (HIV) Active hepatitis B or hepatitis C Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti PD1, and anti-PD-L1 therapeutic antibody Severe infection within 4 weeks prior to randomization Significant history of cardiovascular disease
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
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Lynn Cancer Institute - West
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428
Country
United States
Facility Name
University of Maryland Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Oregon Health & Science Uni
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Sarah Cannon Cancer Center
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Vanderbilt University Medical Center; Multiple Sclerosis Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Facility Name
Hematology Oncology Associates of Fredericksburg, Inc.
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22408
Country
United States
Facility Name
VA Puget Sound Health Care Sys
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
Oncovida*X
City
Salvador
State/Province
BA
ZIP/Postal Code
41820-021
Country
Brazil
Facility Name
Centro de Pesquisas Clinicas em Oncologia - CPCO
City
Cachoeiro de Itapemirim
State/Province
ES
ZIP/Postal Code
29308-014
Country
Brazil
Facility Name
Instituto Nacional de Cancer - INCa; Oncologia
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20560-120
Country
Brazil
Facility Name
Associacao Hospital de Caridade Ijui*X; Departamento De Oncologia
City
Ijui
State/Province
RS
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia
City
Passo Fundo
State/Province
RS
ZIP/Postal Code
99010-260
Country
Brazil
Facility Name
Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90020-090
Country
Brazil
Facility Name
Hospital Sao Lucas - PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Instituto Joinvilense de Hematologia E Oncologia
City
Joinville
State/Province
SC
ZIP/Postal Code
89201-260
Country
Brazil
Facility Name
*X*Fundacao PIO XII
City
Barretos
State/Province
SP
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Hospital Santa Marcelina
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
08270-070
Country
Brazil
Facility Name
Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira
City
São Paulo
State/Province
SP
ZIP/Postal Code
01246 000
Country
Brazil
Facility Name
Harbin Medical University Tumor Hospital
City
Harbin City
ZIP/Postal Code
150081
Country
China
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Hospital d Instructions des Armees Percy
City
Clamart
ZIP/Postal Code
92141
Country
France
Facility Name
Hôpital Universitaire Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Clinique Clémentville
City
Montpellier
ZIP/Postal Code
34070
Country
France
Facility Name
Centre D'oncologie de Gentilly
City
Nancy
ZIP/Postal Code
54100
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Centre Hospitalier Regional La Reunion Site Felix Guyon
City
Saint Denis Cedex
ZIP/Postal Code
97405
Country
France
Facility Name
Hopital d'Instruction des Armees de Begin
City
Saint-Mande
ZIP/Postal Code
94160
Country
France
Facility Name
Centre Hospitalier Regional Sud Reunion
City
Saint-pierre
ZIP/Postal Code
97448
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Pius-Hospital Oldenburg
City
Oldenburg
ZIP/Postal Code
26121
Country
Germany
Facility Name
Sotiria Chest Hospital of Athens
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
IASO General Hospital of Athens
City
Athens
ZIP/Postal Code
155 62
Country
Greece
Facility Name
Metropolitan Hospital
City
Athens
ZIP/Postal Code
185 47
Country
Greece
Facility Name
Attikon University General Hospital
City
Chaidari
ZIP/Postal Code
124 62
Country
Greece
Facility Name
University General Hospital of Larissa
City
Larissa
ZIP/Postal Code
412 21
Country
Greece
Facility Name
University General Hospital of Patras
City
Patras
ZIP/Postal Code
265 00
Country
Greece
Facility Name
Thermi Clinic
City
Thermi, Thessaloniki
ZIP/Postal Code
57001
Country
Greece
Facility Name
Bioclinic Thessaloniki
City
Thessaloniki
ZIP/Postal Code
546 22
Country
Greece
Facility Name
EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department
City
Thessaloniki
ZIP/Postal Code
54645
Country
Greece
Facility Name
Papageorgiou General Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
564 29
Country
Greece
Facility Name
Georgios Papanikolaou General Hosp. of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Uzsoki Utcai Korhaz
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Szabolcs-Szatmar-Bereg Megyei; Korhazak es Egyetemi Oktatokorhaz
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet; Megyei Onkologiai Kozpont
City
Szolnok
ZIP/Postal Code
5004
Country
Hungary
Facility Name
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
City
Meldola
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Facility Name
Centro Di Riferimento Oncologico; Struttura Operativa Complessa Di Oncologia Medica B
City
Aviano
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33081
Country
Italy
Facility Name
Asst Papa Giovanni XXIII
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24100
Country
Italy
Facility Name
Azienda Ospedaliera Istituti Ospitalieri
City
Cremona
State/Province
Lombardia
ZIP/Postal Code
26100
Country
Italy
Facility Name
Ospedale San Raffaele S.r.l.
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
Istituto Europeo Di Oncologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale ? ASST di Monza
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20052
Country
Italy
Facility Name
Istituto Nazionale dei Tumori
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20052
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano (MI)
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Facility Name
Azienda Ospedaliera Città della Salute e della Scienza di Torino
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria ?PoliclinicoVittorio Emanuele?- P.O. G. Rodolico; Oncologia Medica
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95123
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia
City
Verona
State/Province
Veneto
ZIP/Postal Code
37126
Country
Italy
Facility Name
Aichi Cancer Center Hospital; Respiratory Medicine
City
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Nagoya University Hospital; Respiratory Medicine
City
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Kyushu University Hospital; Respiratory
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Hokkaido University Hospital
City
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Kobe City Medical Center General Hospital; Respiratory Medicine
City
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Hyogo Cancer Center; Thoracic Oncology
City
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Facility Name
Ibaraki Prefectural Central Hospital; Division of respiratory
City
Ibaraki
ZIP/Postal Code
309-1793
Country
Japan
Facility Name
Sendai Kousei Hospital; Pulmonary Medicine
City
Miyagi
ZIP/Postal Code
980-0873
Country
Japan
Facility Name
Okayama University Hospital; Respiratory and Allergy Medicine
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Osaka International Cancer Institute; Thoracic Oncology
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
Kansai Medical university Hospital; Thoracic Oncology
City
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
Osaka Habikino Medical Center
City
Osaka
ZIP/Postal Code
583-8588
Country
Japan
Facility Name
National Hospital Organization Kinki-Chuo Chest Medical Center
City
Sakai-shi
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
Saitama Cancer Center; Thoracic Oncology
City
Satima
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
National Cancer Center Hospital; Thoracic Medical Oncology
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Tokyo Medical University Hospital; Dept of Surgery
City
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Chonnam National University Hwasun Hospital
City
Jeollanam-do
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
Country
Poland
Facility Name
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii
City
Olsztyn
ZIP/Postal Code
10-357
Country
Poland
Facility Name
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Med-Polonia Sp. z o.o.
City
Poznan
ZIP/Postal Code
60-693
Country
Poland
Facility Name
Teo Health SA - Saint Constantin Hospital
City
Brasov
ZIP/Postal Code
500091
Country
Romania
Facility Name
Prof. Dr. I. Chiricuta Institute of Oncology
City
Cluj Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Oncology Center Sf. Nectarie
City
Craiova
ZIP/Postal Code
200347
Country
Romania
Facility Name
Institutul Regional de Oncologie Iasi; Clinica de Hematologie
City
Iasi
ZIP/Postal Code
700483
Country
Romania
Facility Name
Sibiu Emergency Clinical County Hospital
City
Sibiu
ZIP/Postal Code
550245
Country
Romania
Facility Name
Oncocenter Clinical Oncology
City
Timi?oara
ZIP/Postal Code
300210
Country
Romania
Facility Name
Oncomed SRL
City
Timisoara
ZIP/Postal Code
300239
Country
Romania
Facility Name
Arkhangelsk Regional Clinical Oncology Dispensary
City
Arkhangelsk
State/Province
Arhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Federal State Institution Medical Radiology Research Center
City
Obninsk
State/Province
Kaluga
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
Moscow City Oncology Hospital #62
City
Moscovskaya Oblast
State/Province
Moskovskaja Oblast
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
Principal Military Clinical Hospital n.a. N.N. Burdenko
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Saint Petersburg Clinical Hospital of the Russian Academy of Sciences
City
St. Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
194017
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
City
Kazan
State/Province
Tatarstan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Regional Clinical Oncology Center
City
Ryazan
ZIP/Postal Code
390046
Country
Russian Federation
Facility Name
Mordovia State University
City
Saransk
ZIP/Postal Code
430032
Country
Russian Federation
Facility Name
Leningrad Regional Clinical Hospital
City
St Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
St. Petersburg Med Univ; n.a. I.P. Pavlov; Pulmonology Research
City
St Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
Facility Name
Volgograd Regional Clinical Oncology Dispensary
City
Volgograd
ZIP/Postal Code
400138
Country
Russian Federation
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute for Oncology and Radiology of Serbia; Medical Oncology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Institute of Lung Diseases Vojvodina
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Consorcio Hospitalario Provincial de Castellon
City
Castellon DE LA Plana/castello DE LA Plana
State/Province
Castellon
ZIP/Postal Code
12002
Country
Spain
Facility Name
Hospital Universitario Son Espases
City
Palma de Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07010
Country
Spain
Facility Name
Hospital Son Llatzer
City
Palma de Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07198
Country
Spain
Facility Name
Hospital Universitario A Coruña
City
Coruna
State/Province
LA Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitario Cruces
City
Barakaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron - PPDS
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Complejo Hospitalario de Jaen
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Facility Name
Hospital Clinico San Carlos; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hosp Clinico Univ Lozano Blesa; División De Oncología Médica
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Prince of Songkla University; Department Of Internal Medicine, Faculty Of Medicine
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Chiang Rai Prachanukroh Hospital
City
Muang
ZIP/Postal Code
57000
Country
Thailand
Facility Name
Buddhachinnaraj Hospital
City
Phitsanulok
ZIP/Postal Code
65000
Country
Thailand
Facility Name
Cukurova University Medical Faculty Balcali Hospital
City
Adana
ZIP/Postal Code
1330
Country
Turkey
Facility Name
Hacettepe Universitesi Tip Fakultesi Hastanesi
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Istanbul University Cerrahpasa Medical Faculty
City
Istanbul
ZIP/Postal Code
34000
Country
Turkey
Facility Name
Ege Universitesi Tip Fakultesi Hastanesi
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
City
Izmir
ZIP/Postal Code
35110
Country
Turkey
Facility Name
Inonu University Faculty of Medicine Turgut Ozal Medical Center
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Facility Name
Municipal Noncommercial Institution Regional Center of Oncology
City
Kharkiv
State/Province
Kharkiv Governorate
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Municipal Noncomercial Enterprise Odessa Regional Oncology Center ofthe Odessa StateAdministration
City
Odesa
State/Province
Kherson Governorate
ZIP/Postal Code
65055
Country
Ukraine
Facility Name
Municipal non profit enterprise of Sumy Regional Council Sumy Regional Clinical Oncology Disp
City
Sumy
State/Province
Kholm Governorate
ZIP/Postal Code
40005
Country
Ukraine
Facility Name
Communal Non-profit Enterprise City Clinical Hospital #4 of Dnipro City Council - PPDS; Chemotherapy
City
Dnipro
State/Province
KIEV Governorate
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Kyiv Railway Clinical Hospital #3 of Branch Health Center of the PJSC Ukrainian Railway
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
02096
Country
Ukraine
Facility Name
Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council
City
Vinnytsia
State/Province
KIEV Governorate
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
The Municipal Enterprise Volyn Regional Medical Oncology Centre of the Volyn Regional Council
City
Lutsk
State/Province
Volhynian Governorate
ZIP/Postal Code
43018
Country
Ukraine
Facility Name
Private Enterprise Private Manufacturing Company Acinus
City
Kirovograd
ZIP/Postal Code
25006
Country
Ukraine
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Colchester General Hospital
City
Colchester, Essex
ZIP/Postal Code
CO4 5JL
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
ZIP/Postal Code
M20 3BG
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32997907
Citation
Herbst RS, Giaccone G, de Marinis F, Reinmuth N, Vergnenegre A, Barrios CH, Morise M, Felip E, Andric Z, Geater S, Ozguroglu M, Zou W, Sandler A, Enquist I, Komatsubara K, Deng Y, Kuriki H, Wen X, McCleland M, Mocci S, Jassem J, Spigel DR. Atezolizumab for First-Line Treatment of PD-L1-Selected Patients with NSCLC. N Engl J Med. 2020 Oct 1;383(14):1328-1339. doi: 10.1056/NEJMoa1917346.
Results Reference
derived

Learn more about this trial

A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110]

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