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]

NCT ID: NCT02409342

Last Updated: 2023-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 572 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-20
• Study Completion Date: 2022-03-08

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

(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).

Group Type: ACTIVE_COMPARATOR

Carboplatin

Intervention Type: DRUG

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.

Cisplatin

Intervention Type: DRUG

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.

Gemcitabine

Intervention Type: DRUG

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.

Pemetrexed

Intervention Type: DRUG

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).

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).

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

MPDL3280A, RO5541267

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

University of California San Diego

La Jolla, California, United States

Yale Cancer Center

New Haven, Connecticut, United States

Lynn Cancer Institute - West

Boca Raton, Florida, United States

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, United States

Oregon Health & Science Uni

Portland, Oregon, United States

Sarah Cannon Cancer Center

Germantown, Tennessee, United States

Vanderbilt University Medical Center; Multiple Sclerosis Center

Nashville, Tennessee, United States

Hematology Oncology Associates of Fredericksburg, Inc.

Fredericksburg, Virginia, United States

VA Puget Sound Health Care Sys

Seattle, Washington, United States

Centro de Pesquisas Clinicas em Oncologia - CPCO

Cachoeiro de Itapemirim, Espírito Santo, Brazil

Oncovida*X

Salvador, Estado de Bahia, Brazil

Instituto Nacional de Cancer - INCa; Oncologia

Rio de Janeiro, Rio de Janeiro, Brazil

Associacao Hospital de Caridade Ijui*X; Departamento De Oncologia

Ijuí, Rio Grande do Sul, Brazil

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

Passo Fundo, Rio Grande do Sul, Brazil

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Instituto Joinvilense de Hematologia E Oncologia

Joinville, Santa Catarina, Brazil

*X*Fundacao PIO XII

Barretos, São Paulo, Brazil

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

São Paulo, São Paulo, Brazil

Hospital Santa Marcelina

São Paulo, São Paulo, Brazil

Harbin Medical University Tumor Hospital

Harbin, , China

CHU Angers

Angers, , France

Hospital d Instructions des Armees Percy

Clamart, , France

Hôpital Universitaire Dupuytren

Limoges, , France

Clinique Clémentville

Montpellier, , France

Centre D'oncologie de Gentilly

Nancy, , France

Hopital Tenon

Paris, , France

Centre Hospitalier Regional La Reunion Site Felix Guyon

Saint-Denis, , France

Hopital d'Instruction des Armees de Begin

Saint-Mandé, , France

Centre Hospitalier Regional Sud Reunion

Saint-Pierre, , France

Centre Paul Strauss

Strasbourg, , France

Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie

Gauting, , Germany

Pius-Hospital Oldenburg

Oldenburg, , Germany

Sotiria Chest Hospital of Athens

Athens, , Greece

IASO General Hospital of Athens

Athens, , Greece

Metropolitan Hospital

Athens, , Greece

Attikon University General Hospital

Chaïdári, , Greece

University General Hospital of Larissa

Larissa, , Greece

University General Hospital of Patras

Pátrai, , Greece

Thermi Clinic

Thermi, Thessaloniki, , Greece

Bioclinic Thessaloniki

Thessaloniki, , Greece

EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department

Thessaloniki, , Greece

Papageorgiou General Hospital of Thessaloniki

Thessaloniki, , Greece

Georgios Papanikolaou General Hosp. of Thessaloniki

Thessaloniki, , Greece

Uzsoki Utcai Korhaz

Budapest, , Hungary

Szabolcs-Szatmar-Bereg Megyei; Korhazak es Egyetemi Oktatokorhaz

Nyíregyháza, , Hungary

Pecsi Tudomanyegyetem

Pécs, , Hungary

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

Szolnok, , Hungary

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

Meldola, Emilia-Romagna, Italy

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

Aviano, Friuli Venezia Giulia, Italy

Asst Papa Giovanni XXIII

Bergamo, Lombardy, Italy

Azienda Ospedaliera Istituti Ospitalieri

Cremona, Lombardy, Italy

Ospedale San Raffaele S.r.l.

Milan, Lombardy, Italy

Istituto Europeo Di Oncologia

Milan, Lombardy, Italy

Azienda Socio Sanitaria Territoriale ? ASST di Monza

Monza, Lombardy, Italy

Istituto Nazionale dei Tumori

Monza, Lombardy, Italy

Istituto Clinico Humanitas

Rozzano (MI), Lombardy, Italy

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Turin, Piedmont, Italy

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

Catania, Sicily, Italy

Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia

Verona, Veneto, Italy

Aichi Cancer Center Hospital; Respiratory Medicine

Aichi, , Japan

Nagoya University Hospital; Respiratory Medicine

Aichi, , Japan

Kyushu University Hospital; Respiratory

Fukuoka, , Japan

Hokkaido University Hospital

Hokkaido, , Japan

Kobe City Medical Center General Hospital; Respiratory Medicine

Hyōgo, , Japan

Hyogo Cancer Center; Thoracic Oncology

Hyōgo, , Japan

Ibaraki Prefectural Central Hospital; Division of respiratory

Ibaraki, , Japan

Sendai Kousei Hospital; Pulmonary Medicine

Miyagi, , Japan

Okayama University Hospital; Respiratory and Allergy Medicine

Okayama, , Japan

Osaka International Cancer Institute; Thoracic Oncology

Osaka, , Japan

Kansai Medical university Hospital; Thoracic Oncology

Osaka, , Japan

Osaka Habikino Medical Center

Osaka, , Japan

National Hospital Organization Kinki-Chuo Chest Medical Center

Sakaishi, , Japan

Saitama Cancer Center; Thoracic Oncology

Satima, , Japan

National Cancer Center Hospital; Thoracic Medical Oncology

Tokyo, , Japan

Tokyo Medical University Hospital; Dept of Surgery

Tokyo, , Japan

Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

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

Olsztyn, , Poland

Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

Otwock, , Poland

Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

Poznan, , Poland

Med-Polonia Sp. z o.o.

Poznan, , Poland

Teo Health SA - Saint Constantin Hospital

Brasov, , Romania

Prof. Dr. I. Chiricuta Institute of Oncology

Cluj-Napoca, , Romania

Oncology Center Sf. Nectarie

Craiova, , Romania

Institutul Regional de Oncologie Iasi; Clinica de Hematologie

Iași, , Romania

Sibiu Emergency Clinical County Hospital

Sibiu, , Romania

Oncocenter Clinical Oncology

Timi?oara, , Romania

Oncomed SRL

Timișoara, , Romania

Arkhangelsk Regional Clinical Oncology Dispensary

Arkhangelsk, Arhangelsk, Russia

Federal State Institution Medical Radiology Research Center

Obninsk, Kaluga Oblast, Russia

Moscow City Oncology Hospital #62

Moscovskaya Oblast, Moscow Oblast, Russia

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

Moscow, Moscow Oblast, Russia

Saint Petersburg Clinical Hospital of the Russian Academy of Sciences

Saint Petersburg, Sankt-Peterburg, Russia

Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic

Kazan', Tatarstan Republic, Russia

Regional Clinical Oncology Center

Ryazan, , Russia

Leningrad Regional Clinical Hospital

Saint Petersburg, , Russia

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

Saint Petersburg, , Russia

Mordovia State University

Saransk, , Russia

Volgograd Regional Clinical Oncology Dispensary

Volgograd, , Russia

Clinical Center of Serbia

Belgrade, , Serbia

Institute for Oncology and Radiology of Serbia; Medical Oncology

Belgrade, , Serbia

Institute of Lung Diseases Vojvodina

Kamenitz, , Serbia

Clinical Center Kragujevac

Kragujevac, , Serbia

Chonnam National University Hwasun Hospital

Jeollanam-do, , South Korea

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Kangbuk Samsung Hospital

Seoul, , South Korea

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, Spain

Hospital Son Llatzer

Palma de Mallorca, Balearic Islands, Spain

Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

Badalona, Barcelona, Spain

Consorcio Hospitalario Provincial de Castellon

Castellon de LA Plana/castello de LA Plana, Castellon, Spain

Hospital Universitario A Coruña

A Coruña, LA Coruña, Spain

Hospital Universitario Cruces

Barakaldo, Vizcaya, Spain

Hospital del Mar

Barcelona, , Spain

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, , Spain

Complejo Hospitalario de Jaen

Jaén, , Spain

Hospital Clinico San Carlos; Servicio de Oncologia

Madrid, , Spain

Hospital Universitario Virgen Macarena

Seville, , Spain

Hospital Clinico Universitario de Valencia

Valencia, , Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, , Spain

Hosp Clinico Univ Lozano Blesa; División De Oncología Médica

Zaragoza, , Spain

Hospital Universitario Miguel Servet

Zaragoza, , Spain

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

Hat Yai, , Thailand

Khon Kaen University

Khon Kaen, , Thailand

Chiang Rai Prachanukroh Hospital

Muang, , Thailand

Buddhachinnaraj Hospital

Phitsanulok, , Thailand

Cukurova University Medical Faculty Balcali Hospital

Adana, , Turkey (Türkiye)

Hacettepe Universitesi Tip Fakultesi Hastanesi

Ankara, , Turkey (Türkiye)

Istanbul University Cerrahpasa Medical Faculty

Istanbul, , Turkey (Türkiye)

Ege Universitesi Tip Fakultesi Hastanesi

Izmir, , Turkey (Türkiye)

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

Izmir, , Turkey (Türkiye)

Inonu University Faculty of Medicine Turgut Ozal Medical Center

Malatya, , Turkey (Türkiye)

Municipal Noncommercial Institution Regional Center of Oncology

Kharkiv, Kharkiv Governorate, Ukraine

Municipal Noncomercial Enterprise Odessa Regional Oncology Center ofthe Odessa StateAdministration

Odesa, Kherson Governorate, Ukraine

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

Sumy, Kholm Governorate, Ukraine

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

Dnipro, KIEV Governorate, Ukraine

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

Kyiv, KIEV Governorate, Ukraine

Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council

Vinnytsia, KIEV Governorate, Ukraine

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

Lutsk, Volhynian Governorate, Ukraine

Private Enterprise Private Manufacturing Company Acinus

Kirovograd, , Ukraine

Birmingham Heartlands Hospital

Birmingham, , United Kingdom

Colchester General Hospital

Colchester, Essex, , United Kingdom

Christie Hospital

Manchester, , United Kingdom

Countries

United States; Brazil; China; France; Germany; Greece; Hungary; Italy; Japan; Poland; Romania; Russia; Serbia; South Korea; Spain; Thailand; Turkey (Türkiye); Ukraine; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 39532375 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32997907 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2014-003083-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GO29431

Identifier Type: -

Identifier Source: org_study_id