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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]

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02409342
Recruitment Status : Active, not recruiting
First Posted : April 6, 2015
Results First Posted : February 18, 2021
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Non-Squamous Non-Small Cell Lung Cancer, Squamous Non-Small Cell Lung Cancer Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody Drug: Carboplatin Drug: Cisplatin Drug: Gemcitabine Drug: Pemetrexed Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 572 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 20, 2015
Actual Primary Completion Date : February 4, 2020
Estimated Study Completion Date : May 25, 2021


Arm Intervention/treatment
Active Comparator: (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
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).
Drug: Carboplatin
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.

Drug: Cisplatin
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.

Drug: Gemcitabine
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.

Drug: Pemetrexed
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).

Experimental: Atezolizumab
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).
Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody
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).
Other Name: MPDL3280A, RO5541267




Primary Outcome Measures :
  1. Overall Survival (OS) in the TC3 or IC3-WT Populations [ Time Frame: From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months) ]
    OS is defined as the time from randomization to death from any cause.

  2. Overall Survival (OS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations [ Time Frame: From randomization to death from any cause until data cut-off on 4 February 2020 (up to approximately 54.5 months) ]
    OS is defined as the time from randomization to death from any cause.


Secondary Outcome Measures :
  1. Progression-free Survival (PFS) in the TC3 or IC3-WT Populations [ 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) ]
    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.

  2. Progression-free Survival (PFS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations [ 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) ]
    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.

  3. Percentage of Participants With Objective Response (ORR) in the TC3 or IC3-WT Populations [ 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) ]
    Objective response (partial response plus complete response) as determined by the investigator according to RECIST v1.1.

  4. 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 [ 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) ]
    Objective response (partial response plus complete response) as determined by the investigator according to RECIST v1.1.

  5. Duration of Response (DOR) in the TC3 or IC3-WT Populations [ 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) ]
    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.

  6. Duration of Response (DOR) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations [ 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) ]
    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.

  7. 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) ]
  8. 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) ]
  9. 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) ]
  10. 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) ]
  11. 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 [ Time Frame: Baseline until data cut-off on 10 September 2018 (up to approximately 38 months) ]
    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.

  12. 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 [ Time Frame: Baseline until data cut-off on 10 September 2018 (up to approximately 38 months) ]
    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.

  13. TTD as Assessed Using EORTC QLQ Supplementary Lung Cancer Module (EORTC QLQ-LC13) in the TC3 or IC3-WT Populations [ Time Frame: Baseline until data cut-off on 10 September 2018 (up to approximately 38 months) ]
    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.

  14. OS in Participants With PD-L1 Expression [ Time Frame: From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months) ]
    OS according to RECIST v1.1 in the PD-L1 (defined with SP263 IHC assay)

  15. Investigator-Assessed PFS in Participants With PD-L1 Expression According to RECIST v1.1 [ 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) ]
    Investigator-assessed PFS according to RECIST v1.1 in the PD-L1 (defined with SP263 IHC assay)

  16. OS in Participants With Blood Tumor Mutational Burden (bTMB) [ Time Frame: From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months) ]
    OS according to RECIST v1.1 in the bTMB subpopulations.

  17. Investigator-Assessed PFS in Participants With bTMB According to RECIST v1.1 [ 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) ]
    PFS according to RECIST v1.1 in the bTMB subpopulations.

  18. 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) ]
  19. 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) ]
  20. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to approximately 70 months ]
  21. Percentage of Participants With Anti-therapeutic Antibodies (ATAs) [ Time Frame: Baseline until data cut-off on 10 September 2018 (up to approximately 38 months) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02409342


Locations
Hide Hide 143 study locations
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United States, California
University of California San Diego
La Jolla, California, United States, 92093
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06520
United States, Florida
Lynn Cancer Institute - West
Boca Raton, Florida, United States, 33428
United States, Maryland
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
United States, Oregon
Oregon Health & Science Uni
Portland, Oregon, United States, 97239
United States, Tennessee
Sarah Cannon Cancer Center
Germantown, Tennessee, United States, 38138
Vanderbilt University Medical Center; Multiple Sclerosis Center
Nashville, Tennessee, United States, 37204
United States, Virginia
Hematology Oncology Associates of Fredericksburg, Inc.
Fredericksburg, Virginia, United States, 22408
United States, Washington
VA Puget Sound Health Care Sys
Seattle, Washington, United States, 98108
Brazil
Oncovida*X
Salvador, BA, Brazil, 41820-021
Centro de Pesquisas Clinicas em Oncologia - CPCO
Cachoeiro de Itapemirim, ES, Brazil, 29308-014
Instituto Nacional de Cancer - INCa; Oncologia
Rio de Janeiro, RJ, Brazil, 20560-120
Associacao Hospital de Caridade Ijui*X; Departamento De Oncologia
Ijui, RS, Brazil, 98700-000
Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia
Passo Fundo, RS, Brazil, 99010-260
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, RS, Brazil, 90050-170
Hospital Sao Lucas - PUCRS
Porto Alegre, RS, Brazil, 90610-000
Instituto Joinvilense de Hematologia E Oncologia
Joinville, SC, Brazil, 89201-260
*X*Fundacao PIO XII
Barretos, SP, Brazil, 14784-400
Hospital Santa Marcelina
Sao Paulo, SP, Brazil, 08270-070
Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira
São Paulo, SP, Brazil, 01246 000
China
Harbin Medical University Tumor Hospital
Harbin City, China, 150081
France
CHU Angers
Angers, France, 49933
Hospital d Instructions des Armees Percy
Clamart, France, 92141
Hôpital Universitaire Dupuytren
Limoges, France, 87042
Clinique Clémentville
Montpellier, France, 34070
Centre D'oncologie de Gentilly
Nancy, France, 54100
Hopital Tenon
Paris, France, 75020
Centre Hospitalier Regional La Reunion Site Felix Guyon
Saint Denis Cedex, France, 97405
Hopital d'Instruction des Armees de Begin
Saint-Mande, France, 94160
Centre Hospitalier Regional Sud Reunion
Saint-pierre, France, 97448
Centre Paul Strauss
Strasbourg, France, 67085
Germany
Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie
Gauting, Germany, 82131
Pius-Hospital Oldenburg
Oldenburg, Germany, 26121
Greece
Sotiria Chest Hospital of Athens
Athens, Greece, 11527
Attikon University General Hospital
Athens, Greece, 124 64
IASO General Hospital of Athens
Athens, Greece, 155 62
Metropolitan Hospital
Athens, Greece, 185 47
University General Hospital of Larissa
Larissa, Greece, 412 21
University General Hospital of Patras
Patras, Greece, 265 00
Thermi Clinic
Thermi, Thessaloniki, Greece, 57001
Bioclinic Thessaloniki
Thessaloniki, Greece, 546 22
EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department
Thessaloniki, Greece, 54645
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, Greece, 564 29
Georgios Papanikolaou General Hosp. of Thessaloniki
Thessaloniki, Greece, 57010
Hungary
Uzsoki Utcai Korhaz
Budapest, Hungary, 1145
Szabolcs-Szatmar-Bereg Megyei; Korhazak es Egyetemi Oktatokorhaz
Nyiregyhaza, Hungary, 4400
Pecsi Tudomanyegyetem
Pecs, Hungary, 7624
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet; Megyei Onkologiai Kozpont
Szolnok, Hungary, 5004
Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola, Emilia-Romagna, Italy, 47014
Centro Di Riferimento Oncologico; Struttura Operativa Complessa Di Oncologia Medica B
Aviano, Friuli-Venezia Giulia, Italy, 33081
Asst Papa Giovanni XXIII
Bergamo, Lombardia, Italy, 24100
Azienda Ospedaliera Istituti Ospitalieri
Cremona, Lombardia, Italy, 26100
Ospedale San Raffaele S.r.l.
Milano, Lombardia, Italy, 20132
Istituto Europeo Di Oncologia
Milano, Lombardia, Italy, 20141
Azienda Socio Sanitaria Territoriale - ASST di Monza
Monza, Lombardia, Italy, 20052
Istituto Nazionale dei Tumori
Monza, Lombardia, Italy, 20052
Istituto Clinico Humanitas
Rozzano (MI), Lombardia, Italy, 20089
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, Piemonte, Italy, 10126
Azienda Ospedaliero-Universitaria "PoliclinicoVittorio Emanuele"- P.O. G. Rodolico; Oncologia Medica
Catania, Sicilia, Italy, 95123
Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia
Verona, Veneto, Italy, 37126
Japan
Aichi Cancer Center Hospital; Respiratory Medicine
Aichi, Japan, 464-8681
Nagoya University Hospital; Respiratory Medicine
Aichi, Japan, 466-8560
Kyushu University Hospital; Respiratory
Fukuoka, Japan, 812-8582
Hokkaido University Hospital
Hokkaido, Japan, 060-8648
Kobe City Medical Center General Hospital; Respiratory Medicine
Hyogo, Japan, 650-0047
Hyogo Cancer Center; Thoracic Oncology
Hyogo, Japan, 673-8558
Ibaraki Prefectural Central Hospital; Division of respiratory
Ibaraki, Japan, 309-1793
Sendai Kousei Hospital; Pulmonary Medicine
Miyagi, Japan, 980-0873
Okayama University Hospital; Respiratory and Allergy Medicine
Okayama, Japan, 700-8558
Osaka International Cancer Institute; Thoracic Oncology
Osaka, Japan, 541-8567
Kansai Medical university Hospital; Thoracic Oncology
Osaka, Japan, 573-1191
Osaka Habikino Medical Center
Osaka, Japan, 583-8588
Saitama Cancer Center; Thoracic Oncology
Saitama, Japan, 362-0806
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai-shi, Japan, 591-8555
National Cancer Center Hospital; Thoracic Medical Oncology
Tokyo, Japan, 104-0045
Tokyo Medical University Hospital; Dept of Surgery
Tokyo, Japan, 160-0023
Korea, Republic of
Chonnam National University Hwasun Hospital
Jeollanam-do, Korea, Republic of, 58128
Seoul National University Bundang Hospital
Seongnam-si, Korea, Republic of, 13605
Kangbuk Samsung Hospital
Seoul, Korea, Republic of, 03181
Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-214
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie
Olsztyn, Poland, 10-357
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
Otwock, Poland, 05-400
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
Poznan, Poland, 60-569
Med-Polonia Sp. z o.o.
Poznan, Poland, 60-693
Romania
Teo Health SA - Saint Constantin Hospital
Brasov, Romania, 500091
Prof. Dr. I. Chiricuta Institute of Oncology
Cluj Napoca, Romania, 400015
Oncology Center Sf. Nectarie
Craiova, Romania, 200347
Institutul Regional de Oncologie Iasi; Clinica de Hematologie
Iasi, Romania, 700483
Sibiu Emergency Clinical County Hospital
Sibiu, Romania, 550245
Oncomed SRL
Timisoara, Romania, 300239
Oncocenter Clinical Oncology
Timişoara, Romania, 300210
Russian Federation
Federal State Institution Medical Radiology Research Center
Obninsk, Kaluga, Russian Federation, 249036
Moscow City Oncology Hospital #62
Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation, 143423
Principal Military Clinical Hospital n.a. N.N. Burdenko
Moscow, Moskovskaja Oblast, Russian Federation, 105229
Saint Petersburg Clinical Hospital of the Russian Academy of Sciences
St. Petersburg, Sankt Petersburg, Russian Federation, 194017
Arkhangelsk Regional Clinical Oncology Dispensary
Arkhangelsk, Russian Federation, 163045
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic
Kazan, Russian Federation, 420029
Regional Clinical Oncology Center
Ryazan, Russian Federation, 390046
Mordovia State University
Saransk, Russian Federation, 430032
Leningrad Regional Clinical Hospital
St Petersburg, Russian Federation, 194291
St. Petersburg Med Univ; n.a. I.P. Pavlov; Pulmonology Research
St Petersburg, Russian Federation, 197089
Volgograd Regional Clinical Oncology Dispensary
Volgograd, Russian Federation, 400138
Serbia
Clinical Center of Serbia
Belgrade, Serbia, 11000
Clinical Hospital Center Bezanijska kosa; Clinic for Oncology
Belgrade, Serbia, 11000
Institute for Oncology and Radiology of Serbia; Medical Oncology
Belgrade, Serbia, 11000
Clinical Center Kragujevac
Kragujevac, Serbia, 34000
Institute of Lung Diseases Vojvodina
Sremska Kamenica, Serbia, 21204
Spain
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Badalona, Barcelona, Spain, 08916
Consorcio Hospitalario Provincial de Castellon
Castellon DE LA Plana/castello DE LA Plana, Castellon, Spain, 12002
Hospital Universitario Son Espases
Palma de Mallorca, Islas Baleares, Spain, 07010
Hospital Son Llatzer
Palma de Mallorca, Islas Baleares, Spain, 07198
Hospital Universitario A Coruña
Coruna, LA Coruña, Spain, 15006
Hospital Universitario Cruces
Barakaldo, Vizcaya, Spain, 48903
Hospital del Mar
Barcelona, Spain, 08003
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, Spain, 08035
Complejo Hospitalario de Jaen
Jaen, Spain, 23007
Hospital Clinico San Carlos; Servicio de Oncologia
Madrid, Spain, 28040
Hospital Universitario Virgen Macarena
Sevilla, Spain, 41009
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Spain, 46026
Hosp Clinico Univ Lozano Blesa; División De Oncología Médica
Zaragoza, Spain, 50009
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Thailand
Prince of Songkla University; Department Of Internal Medicine, Faculty Of Medicine
Hat Yai, Thailand, 90110
Khon Kaen University
Khon Kaen, Thailand, 40002
Chiang Rai Prachanukroh Hospital
Muang, Thailand, 57000
Buddhachinnaraj Hospital
Phitsanulok, Thailand, 65000
Turkey
Cukurova University Medical Faculty Balcali Hospital
Adana, Turkey, 1330
Hacettepe Universitesi Tip Fakultesi Hastanesi; Ic Hastaliklari Anabiim Dali
Ankara, Turkey, 06100
Istanbul University Cerrahpasa Medical Faculty
Istanbul, Turkey, 34000
Ege Universitesi Tip Fakultesi Hastanesi
Izmir, Turkey, 35100
Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi
Izmir, Turkey, 35110
Inonu University Faculty of Medicine Turgut Ozal Medical Center
Malatya, Turkey, 44280
Ukraine
Municipal Noncommercial Institution Regional Center of Oncology
Kharkiv, Kharkiv Governorate, Ukraine, 61070
Municipal Noncomercial Enterprise Odessa Regional Oncology Center ofthe Odessa StateAdministration
Odesa, Kherson Governorate, Ukraine, 65055
Municipal non profit enterprise of Sumy Regional Council Sumy Regional Clinical Oncology Disp
Sumy, Kholm Governorate, Ukraine, 40005
Communal Non-profit Enterprise City Clinical Hospital #4 of Dnipro City Council - PPDS; Chemotherapy
Dnipro, KIEV Governorate, Ukraine, 49102
Kyiv Railway Clinical Hospital #3 of Branch Health Center of the PJSC Ukrainian Railway
Kyiv, KIEV Governorate, Ukraine, 02096
Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council
Vinnytsia, KIEV Governorate, Ukraine, 21029
The Municipal Enterprise Volyn Regional Medical Oncology Centre of the Volyn Regional Council
Lutsk, Volhynian Governorate, Ukraine, 43018
Private Enterprise Private Manufacturing Company Acinus
Kirovograd, Ukraine, 25006
United Kingdom
Birmingham Heartlands Hospital
Birmingham, United Kingdom, B9 5SS
Colchester General Hospital
Colchester, Essex, United Kingdom, CO4 5JL
Christie Hospital
Manchester, United Kingdom, M20 3BG
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
  Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:
Study Protocol  [PDF] February 8, 2020
Statistical Analysis Plan  [PDF] April 2, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02409342    
Other Study ID Numbers: GO29431
2014-003083-21 ( EudraCT Number )
First Posted: April 6, 2015    Key Record Dates
Results First Posted: February 18, 2021
Last Update Posted: February 24, 2021
Last Verified: February 2021
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Carboplatin
Pemetrexed
Atezolizumab
Antibodies
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors