Clinical trial NCT02409355: A Study of Atezolizumab Compared With Gemcitabine Plus (+) Cisplatin or Carboplatin for PD-L1-Selected Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower111)
Official title: A Phase III, Open-Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With Gemcitabine+Cisplatin or Carboplatin for PD-L1-Selected, Chemotherapy Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-04-06
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, open-label study was designed to evaluate and compare the safety and efficacy of atezolizumab with gemcitabine + cisplatin or carboplatin in PD-L1 selected participants with chemotherapy-naive, Stage IV squamous NSCLC. The study was closed due to low patient enrollment and the Sponsor's decision to include patients with squamous NSCLC into the GO29431 study, NCT02409342. Therefore the planned objectives of this study are no longer applicable and formal analyses of efficacy or safety have not been performed.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed Stage IV squamous NSCLC
* Tumor programmed death-ligand 1 (PD-L1) expression, as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening
* No prior treatment for Stage IV squamous NSCLC
* Measurable disease as defined by RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate hematologic and end-organ function

Exclusion Criteria:

* Active or untreated central nervous system (CNS) metastases
* Untreated or inadequately treated spinal cord compression
* Leptomeningeal disease
* Uncontrolled pleural effusion, pericardial effusion, or ascites
* Uncontrolled tumor-related pain
* Uncontrolled hypercalcemia
* Any other malignancies within 5 years except those with negligible risk of metastasis or death
* Pregnant or lactating women
* Known hypersensitivity to any component of atezolizumab formulation or other study medication
* History of autoimmune disease except controlled, treated hypothyroidism or type I diabetes
* Prior allogeneic bone marrow or solid organ transplantation
* Positive human immunodeficiency virus (HIV) test
* Active hepatitis B or C
* Active tuberculosis
* Significant cardiovascular disease
* Severe infection or major surgery within 4 weeks prior to randomization
* Use of any approved anti-cancer therapy within 3 weeks prior to treatment
* Use of an investigational agent or participation in another clinical trial within 4 weeks prior to randomization
* Exposure to oral or IV antibiotics within 2 weeks or live attenuated vaccines within 4 weeks prior to randomization
* Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies
* Treatment with immunostimulatory agents within 4 weeks or immunosuppressive agents within 2 weeks prior to randomization

Primary outcomes:
measure: Progression-Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
timeFrame: Baseline up to death or disease progression, whichever occurs first (up to approximately 2.5 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: California Cancer Associates for Research & Excellence, Inc.
state: California
city: Greenbrae
country: United States
facility: Marin Cancer Care Inc
state: California
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center; UC Irvine Medical Center
state: California
city: Norwich
country: United States
facility: Eastern Connecticut Hematology and Oncology Associates; (ECHO)
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Honolulu
country: United States
facility: Straub Clinic & Hospital; Oncology
state: Hawaii
city: Harvey
country: United States
facility: Ingalls Memorial Hospital
state: Illinois
city: Louisville
country: United States
facility: Consultants in Blood Disorders & Cancer
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Easton
country: United States
facility: Bay Hematology Oncology
state: Maryland
city: Missoula
country: United States
facility: Montana Cancer Specialists
state: Montana
city: Summit
country: United States
facility: Atlantic Health Cancer Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: Charlotte
country: United States
facility: Presbyterian Hospital
state: North Carolina
city: Hickory
country: United States
facility: Carolina Oncology Specialists, PA - Hickory
state: North Carolina
city: Pinehurst
country: United States
facility: First Health of the Carolinas
state: North Carolina
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
city: Bristol
country: United States
facility: Wellmont Cancer Institute
state: Tennessee
city: Chattanooga
country: United States
facility: University Oncology Associates
state: Tennessee
city: Germantown
country: United States
facility: Sarah Cannon Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Medical Center
state: Tennessee
city: Auburn
country: United States
facility: MultiCare Regional Cancer Center - Auburn
state: Washington
city: Morgantown
country: United States
facility: West Virginia University Hospital
state: West Virginia
city: Pardubice
country: Czechia
facility: Multiscan s.r.o.
city: Limoges
country: France
facility: Hôpital du Cluzeau
city: Paris
country: France
facility: Hopital Tenon; Oncologie Radiotherapie
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Hannover
country: Germany
facility: KRH Klinikum Siloah-Oststadt-Heidehaus
city: Paderborn
country: Germany
facility: Brüderkrankenhaus St. Josef Paderborn
city: Athens
country: Greece
facility: Sotiria Chest Hospital of Athens
city: Athens
country: Greece
facility: Attikon University General Hospital
city: Thessaloniki
country: Greece
facility: Bioclinic Thessaloniki
city: Thessaloniki
country: Greece
facility: Georgios Papanikolaou General Hosp. of Thessaloniki
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Uzsoki Utcai Korhaz
city: Matrahaza
country: Hungary
facility: Matrai Gyogyintezet
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Megyei; Korhazak es Egyetemi Oktatokorhaz
city: Pecs
country: Hungary
facility: University of Pecs, I st Dept of Internal Medicine
city: Szolnok
country: Hungary
facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
city: Meldola
country: Italy
facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
state: Emilia-Romagna
city: Rimini
country: Italy
facility: Ospedale Infermi di Rimini
state: Emilia-Romagna
city: Aviano
country: Italy
facility: Irccs Centro Di Riferimento Oncologico (CRO)
state: Friuli-Venezia Giulia
city: Bergamo
country: Italy
facility: Asst Papa Giovanni XXIII
state: Lombardia
city: Cremona
country: Italy
facility: Azienda Ospedaliera Istituti Ospitalieri
state: Lombardia
city: Milano
country: Italy
facility: Ospedale San Raffaele S.r.l.
state: Lombardia
city: Milano
country: Italy
facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
state: Lombardia
city: Milano
country: Italy
facility: Istituto Europeo Di Oncologia
state: Lombardia
city: Monza
country: Italy
facility: Asst Di Monza
state: Lombardia
city: Rozzano (MI)
country: Italy
facility: Istituto Clinico Humanitas
state: Lombardia
city: Torino
country: Italy
facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino
state: Piemonte
city: Verona
country: Italy
facility: A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.
state: Veneto
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Jeollanam-do
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Suwon-si,
country: Korea, Republic of
facility: The Catholic University of Korea St. Vincent's Hospital
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Alba Iulia
country: Romania
facility: County Hospital Alba; Oncology
city: Baia Mare
country: Romania
facility: Dr Constantin Opris Emergency County Hospital Baia Mare
city: Brasov
country: Romania
facility: Teo Health SA - Saint Constantin Hospital
city: Craiova
country: Romania
facility: Oncology Center Sf. Nectarie
city: Iasi
country: Romania
facility: Institutul Regional de Oncologie Iasi; Clinica de Hematologie
city: Sibiu
country: Romania
facility: Sibiu Emergency Clinical County Hospital
city: Timisoara
country: Romania
facility: Oncomed SRL
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Regional Clinical Oncology Dispensary
city: Kursk
country: Russian Federation
facility: Kursk Regional Clinical Oncology Dispensary
city: Nizhny Novgorod
country: Russian Federation
facility: Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod
city: Saransk
country: Russian Federation
facility: Mordovia State University
city: St Petersburg
country: Russian Federation
facility: Leningrad Regional Clinical Hospital
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Bezanijska kosa; Clinic for Oncology
city: Kragujevac
country: Serbia
facility: Clin Hospital Center - Kragujevac; Pulmonary Diseases
city: Sremska Kamenica
country: Serbia
facility: Institute of Lung Diseases Vojvodina
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
state: Barcelona
city: Valencia
country: Spain
facility: Fundacion Investigacion Hospital La Fe de Valencia
city: Zaragoza
country: Spain
facility: Hosp Clinico Univ Lozano Blesa
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Grimsby
country: United Kingdom
facility: Diana Princess of Wales Hosp.
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Trust
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: