AzTrials
AzTrials

Non-Squamous Non-Small Cell Lung Cancer, Squamous Non-Small Cell Lung CancerPhase 3NCT02409342

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]

A Phase 3 study testing Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody, Carboplatin and Cisplatin in people with Non-Squamous Non-Small Cell Lung Cancer, Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 142 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody, Carboplatin and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
572 participants
Where
142 sitesin 19 countries
Study dates
20 Jul 2015to 8 Mar 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

142 sites in 19 countries.

142 sites in 19 countries

Japan16 sites

  • Aichi Cancer Center Hospital; Respiratory Medicine

    Aichi, 464-8681

  • Nagoya University Hospital; Respiratory Medicine

    Aichi, 466-8560

  • Kyushu University Hospital; Respiratory

    Fukuoka, 812-8582

  • Hokkaido University Hospital

    Hokkaido, 060-8648

  • Kobe City Medical Center General Hospital; Respiratory Medicine

    Hyōgo, 650-0047

  • Hyogo Cancer Center; Thoracic Oncology

    Hyōgo, 673-8558

  • Ibaraki Prefectural Central Hospital; Division of respiratory

    Ibaraki, 309-1793

  • Sendai Kousei Hospital; Pulmonary Medicine

    Miyagi, 980-0873

  • Okayama University Hospital; Respiratory and Allergy Medicine

    Okayama, 700-8558

  • Osaka International Cancer Institute; Thoracic Oncology

    Osaka, 541-8567

  • Kansai Medical university Hospital; Thoracic Oncology

    Osaka, 573-1191

  • Osaka Habikino Medical Center

    Osaka, 583-8588

  • National Hospital Organization Kinki-Chuo Chest Medical Center

    Sakaishi, 591-8555

  • Saitama Cancer Center; Thoracic Oncology

    Satima, 362-0806

  • National Cancer Center Hospital; Thoracic Medical Oncology

    Tokyo, 104-0045

  • Tokyo Medical University Hospital; Dept of Surgery

    Tokyo, 160-0023

Other trials in Japan

Spain15 sites

  • Hospital Universitario A Coruña

    A Coruña, LA Coruña, 15006

  • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

    Badalona, Barcelona, 08916

  • Hospital Universitario Cruces

    Barakaldo, Vizcaya, 48903

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 08035

  • Consorcio Hospitalario Provincial de Castellon

    Castellon de LA Plana/castello de LA Plana, Castellon, 12002

  • Complejo Hospitalario de Jaen

    Jaén, 23007

  • Hospital Clinico San Carlos; Servicio de Oncologia

    Madrid, 28040

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07010

  • Hospital Son Llatzer

    Palma de Mallorca, Balearic Islands, 07198

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

  • Hosp Clinico Univ Lozano Blesa; División De Oncología Médica

    Zaragoza, 50009

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Italy12 sites

  • Centro Di Riferimento Oncologico; Struttura Operativa Complessa Di Oncologia Medica B

    Aviano, Friuli Venezia Giulia, 33081

  • Asst Papa Giovanni XXIII

    Bergamo, Lombardy, 24100

  • Azienda Ospedaliero-Universitaria ?PoliclinicoVittorio Emanuele?- P.O. G. Rodolico; Oncologia Medica

    Catania, Sicily, 95123

  • Azienda Ospedaliera Istituti Ospitalieri

    Cremona, Lombardy, 26100

  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

    Meldola, Emilia-Romagna, 47014

  • Ospedale San Raffaele S.r.l.

    Milan, Lombardy, 20132

  • Istituto Europeo Di Oncologia

    Milan, Lombardy, 20141

  • Azienda Socio Sanitaria Territoriale ? ASST di Monza

    Monza, Lombardy, 20052

  • Istituto Nazionale dei Tumori

    Monza, Lombardy, 20052

  • Istituto Clinico Humanitas

    Rozzano (MI), Lombardy, 20089

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Turin, Piedmont, 10126

  • Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia

    Verona, Veneto, 37126

Other trials in Italy

Brazil11 sites

  • *X*Fundacao PIO XII

    Barretos, São Paulo, 14784-400

  • Centro de Pesquisas Clinicas em Oncologia - CPCO

    Cachoeiro de Itapemirim, Espírito Santo, 29308-014

  • Associacao Hospital de Caridade Ijui*X; Departamento De Oncologia

    Ijuí, Rio Grande do Sul, 98700-000

  • Instituto Joinvilense de Hematologia E Oncologia

    Joinville, Santa Catarina, 89201-260

  • Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia

    Passo Fundo, Rio Grande do Sul, 99010-260

  • Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Instituto Nacional de Cancer - INCa; Oncologia

    Rio de Janeiro, Rio de Janeiro, 20560-120

  • Oncovida*X

    Salvador, Estado de Bahia, 41820-021

  • Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira

    São Paulo, São Paulo, 01246 000

  • Hospital Santa Marcelina

    São Paulo, São Paulo, 08270-070

Other trials in Brazil

Greece11 sites

  • Sotiria Chest Hospital of Athens

    Athens, 11527

  • IASO General Hospital of Athens

    Athens, 155 62

  • Metropolitan Hospital

    Athens, 185 47

  • Attikon University General Hospital

    Chaïdári, 124 62

  • University General Hospital of Larissa

    Larissa, 412 21

  • University General Hospital of Patras

    Pátrai, 265 00

  • Thermi Clinic

    Thermi, Thessaloniki, 57001

  • Bioclinic Thessaloniki

    Thessaloniki, 546 22

  • EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department

    Thessaloniki, 54645

  • Papageorgiou General Hospital of Thessaloniki

    Thessaloniki, 564 29

  • Georgios Papanikolaou General Hosp. of Thessaloniki

    Thessaloniki, 57010

Other trials in Greece

Russia11 sites

  • Arkhangelsk Regional Clinical Oncology Dispensary

    Arkhangelsk, Arhangelsk, 163045

  • Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic

    Kazan', Tatarstan Republic, 420029

  • Moscow City Oncology Hospital #62

    Moscovskaya Oblast, Moscow Oblast, 143423

  • Principal Military Clinical Hospital n.a. N.N. Burdenko

    Moscow, Moscow Oblast, 105229

  • Federal State Institution Medical Radiology Research Center

    Obninsk, Kaluga Oblast, 249036

  • Regional Clinical Oncology Center

    Ryazan, 390046

  • Saint Petersburg Clinical Hospital of the Russian Academy of Sciences

    Saint Petersburg, Sankt-Peterburg, 194017

  • Leningrad Regional Clinical Hospital

    Saint Petersburg, 194291

  • St. Petersburg Med Univ; n.a. I.P. Pavlov; Pulmonology Research

    Saint Petersburg, 197089

  • Mordovia State University

    Saransk, 430032

  • Volgograd Regional Clinical Oncology Dispensary

    Volgograd, 400138

Other trials in Russia

France10 sites

  • CHU Angers

    Angers, 49933

  • Hospital d Instructions des Armees Percy

    Clamart, 92141

  • Hôpital Universitaire Dupuytren

    Limoges, 87042

  • Clinique Clémentville

    Montpellier, 34070

  • Centre D'oncologie de Gentilly

    Nancy, 54100

  • Hopital Tenon

    Paris, 75020

  • Centre Hospitalier Regional La Reunion Site Felix Guyon

    Saint-Denis, 97405

  • Hopital d'Instruction des Armees de Begin

    Saint-Mandé, 94160

  • Centre Hospitalier Regional Sud Reunion

    Saint-Pierre, 97448

  • Centre Paul Strauss

    Strasbourg, 67000

Other trials in France

United States9 sites

  • University of Maryland Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Lynn Cancer Institute - West

    Boca Raton, Florida, 33428

  • Hematology Oncology Associates of Fredericksburg, Inc.

    Fredericksburg, Virginia, 22408

  • Sarah Cannon Cancer Center

    Germantown, Tennessee, 38138

  • University of California San Diego

    La Jolla, California, 92093

  • Vanderbilt University Medical Center; Multiple Sclerosis Center

    Nashville, Tennessee, 37204

  • Yale Cancer Center

    New Haven, Connecticut, 06520

  • Oregon Health & Science Uni

    Portland, Oregon, 97239

  • VA Puget Sound Health Care Sys

    Seattle, Washington, 98108

Other trials in United States

Ukraine8 sites

  • Communal Non-profit Enterprise City Clinical Hospital #4 of Dnipro City Council - PPDS; Chemotherapy

    Dnipro, KIEV Governorate, 49102

  • Municipal Noncommercial Institution Regional Center of Oncology

    Kharkiv, Kharkiv Governorate, 61070

  • Private Enterprise Private Manufacturing Company Acinus

    Kirovograd, 25006

  • Kyiv Railway Clinical Hospital #3 of Branch Health Center of the PJSC Ukrainian Railway

    Kyiv, KIEV Governorate, 02096

  • The Municipal Enterprise Volyn Regional Medical Oncology Centre of the Volyn Regional Council

    Lutsk, Volhynian Governorate, 43018

  • Municipal Noncomercial Enterprise Odessa Regional Oncology Center ofthe Odessa StateAdministration

    Odesa, Kherson Governorate, 65055

  • Municipal non profit enterprise of Sumy Regional Council Sumy Regional Clinical Oncology Disp

    Sumy, Kholm Governorate, 40005

  • Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council

    Vinnytsia, KIEV Governorate, 21029

Other trials in Ukraine

Romania7 sites

  • Teo Health SA - Saint Constantin Hospital

    Brasov, 500091

  • Prof. Dr. I. Chiricuta Institute of Oncology

    Cluj-Napoca, 400015

  • Oncology Center Sf. Nectarie

    Craiova, 200347

  • Institutul Regional de Oncologie Iasi; Clinica de Hematologie

    Iași, 700483

  • Sibiu Emergency Clinical County Hospital

    Sibiu, 550245

  • Oncocenter Clinical Oncology

    Timi?oara, 300210

  • Oncomed SRL

    Timișoara, 300239

Other trials in Romania

Turkey (Türkiye)6 sites

  • Cukurova University Medical Faculty Balcali Hospital

    Adana, 1330

  • Hacettepe Universitesi Tip Fakultesi Hastanesi

    Ankara, 06100

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34000

  • Ege Universitesi Tip Fakultesi Hastanesi

    Izmir, 35100

  • Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi

    Izmir, 35110

  • Inonu University Faculty of Medicine Turgut Ozal Medical Center

    Malatya, 44280

Other trials in Turkey (Türkiye)

Poland5 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk

  • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii

    Olsztyn, 10-357

  • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

    Otwock, 05-400

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

    Poznan, 60-569

  • Med-Polonia Sp. z o.o.

    Poznan, 60-693

Other trials in Poland

Hungary4 sites

  • Uzsoki Utcai Korhaz

    Budapest, 1145

  • Szabolcs-Szatmar-Bereg Megyei; Korhazak es Egyetemi Oktatokorhaz

    Nyíregyháza, 4400

  • Pecsi Tudomanyegyetem

    Pécs, 7624

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet; Megyei Onkologiai Kozpont

    Szolnok, 5004

Other trials in Hungary

Serbia4 sites

  • Clinical Center of Serbia

    Belgrade, 11000

  • Institute for Oncology and Radiology of Serbia; Medical Oncology

    Belgrade, 11000

  • Institute of Lung Diseases Vojvodina

    Kamenitz, 21204

  • Clinical Center Kragujevac

    Kragujevac, 34000

Other trials in Serbia

Thailand4 sites

  • Prince of Songkla University; Department Of Internal Medicine, Faculty Of Medicine

    Hat Yai, 90110

  • Khon Kaen University

    Khon Kaen, 40002

  • Chiang Rai Prachanukroh Hospital

    Muang, 57000

  • Buddhachinnaraj Hospital

    Phitsanulok, 65000

Other trials in Thailand

South Korea3 sites

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Kangbuk Samsung Hospital

    Seoul, 03181

Other trials in South Korea

United Kingdom3 sites

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS

  • Colchester General Hospital

    Colchester, Essex, CO4 5JL

  • Christie Hospital

    Manchester, M20 3BG

Other trials in United Kingdom

Germany2 sites

  • Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie

    Gauting, 82131

  • Pius-Hospital Oldenburg

    Oldenburg, 26121

Other trials in Germany

China1 site

  • Harbin Medical University Tumor Hospital

    Harbin, 150081

Other trials in China

About this study

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

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.

Being tested
Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody, Carboplatin, Cisplatin, Gemcitabine, Pemetrexed

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibodyDrug

    Also called MPDL3280A, RO5541267

    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).

  • CarboplatinDrug

    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.

  • CisplatinDrug

    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.

  • GemcitabineDrug

    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.

  • PemetrexedDrug

    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).

Study groups in NCT02409342
Study groupRoleWhat they receive
(Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)Active comparatorParticipants 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).
Receives: Drug: Carboplatin; Drug: Cisplatin; Drug: Gemcitabine; Drug: Pemetrexed
AtezolizumabExperimentalParticipants 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).
Receives: Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS) in the TC3 or IC3-WT Populations

    OS is defined as the time from randomization to death from any cause.

    Measured: From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months)

  2. 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.

    Measured: From randomization to death from any cause until data cut-off on 4 February 2020 (up to approximately 54.5 months)

Secondary outcomes (21)

  1. 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.

    Measured: 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)

  2. 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.

    Measured: 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)

  3. 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.

    Measured: 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)

  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

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

    Measured: 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)

  5. 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.

    Measured: 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)

  6. 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.

    Measured: 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)

  7. Percentage of Participants Who Are Alive at 1 Year in the TC3 or IC3-WT Populations

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    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.

    Measured: Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)

  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

    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.

    Measured: Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)

  13. 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.

    Measured: Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)

  14. OS in Participants With PD-L1 Expression

    OS is defined as the time from randomization to death from any cause.

    Measured: From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months)

  15. 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)

    Measured: 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)

  16. OS in Participants With Blood Tumor Mutational Burden (bTMB)

    OS is defined as the time from randomization to death from any cause.

    Measured: From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months)

  17. Investigator-Assessed PFS in Participants With bTMB According to RECIST v1.1

    PFS according to RECIST v1.1 in the bTMB subpopulations.

    Measured: 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)

  18. Minimum Observed Serum Concentration (Cmin) of Atezolizumab

    Measured: 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

    Measured: 0 hour (predose) and 30 minutes after atezolizumab infusion on Day 1 (infusion duration = up to 1 hour)

  20. Percentage of Participants With at Least One Adverse Event

    Percentage of participants with at least one adverse event.

    Measured: Baseline up to until data cut-off on 8 March 2022 (up to approximately 79.5 months)

  21. Percentage of Participants With Anti-therapeutic Antibodies (ATAs)

    Measured: Baseline until data cut-off on 10 September 2018 (up to approximately 38 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2015 (estimated)
  2. Study start20 Jul 2015
  3. Primary completion4 Feb 2020
  4. Study completion8 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
572 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02409342
Sponsor's protocol ID
GO29431
Other IDs
2014-003083-21, 2014
Status last verified
Feb 2023
First submitted
1 Apr 2015
Last updated
15 Mar 2023

Publications

  • Li B, Rong D, Lin H. Atezolizumab monotherapy as first-line treatment for non-small cell lung cancer ineligible for treatment with a platinum-containing regimen (IPSOS): a cost-effectiveness analysis in the USA. BMJ Open. 2024 Nov 12;14(11):e083716. doi: 10.1136/bmjopen-2023-083716.

    PubMed 39532375

  • 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.

    PubMed 32997907

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody, Carboplatin and Cisplatin in people with Non-Squamous Non-Small Cell Lung Cancer, Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 142 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 142 sites in Japan, Spain, Italy, Brazil, Greece and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02409342, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.

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