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]

February 17, 2023 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
572

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • MPDL3280A, RO5541267

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months)
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.
From randomization to death from any cause until data cut-off on 4 February 2020 (up to approximately 54.5 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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)
Baseline to 1 year or death, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)
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)
Baseline to 2 years or death, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months)
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)
Baseline to 1 year or death, whichever occurs first until clinical cut-off date on 4 February 2020 (up to approximately 54.5 months)
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)
Baseline to 2 years or death, whichever occurs first until clinical cut-off date on 4 February 2020 (up to approximately 54.5 months)
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.
Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)
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.
Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)
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.
Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)
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)
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 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.
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)
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)
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)
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)
0 hour (predose) and 30 minutes after atezolizumab infusion on Day 1 (infusion duration = up to 1 hour)
Percentage of Participants With Anti-therapeutic Antibodies (ATAs)
Time Frame: Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)
Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)
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 is defined as the time from randomization to death from any cause.
From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months)
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 is defined as the time from randomization to death from any cause.
From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months)
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)
Percentage of participants with at least one adverse event.
Baseline up to until data cut-off on 8 March 2022 (up to approximately 79.5 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 4, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 8, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GO29431
  • 2014-003083-21 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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