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)

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02409355
• Other study ID #: GO29432
• Secondary ID: 2014-003106-33
• Status: Terminated
• Phase: Phase 3
• Start date: May 7, 2015
• Est. completion date: December 7, 2017

Study information

• Verified date: February 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 Therefore the planned objectives of this study are no longer applicable and formal analyses of efficacy or safety have not been performed.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 7, 2017
• Est. primary completion date: December 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Atezolizumab
Atezolizumab will be administered at a dose of 1200 milligrams (mg) by IV infusion on Day 1 of each 21-day cycle until loss of clinical benefit.
• Carboplatin
Carboplatin will be administered at area under the concentration-time curve (AUC) 5 IV infusion once on Day 1 of each 21-day cycle for 4 or 6 cycles.
• Cisplatin
Cisplatin will be administered at 75 milligrams per square meter (mg/m^2) IV infusion once on Day 1 of each 21-day cycle for 4 or 6 cycles.
• Gemcitabine
Gemcitabine will be administered at 1000 mg/m^2 (when coadministered with carboplatin) or 1250 mg/m^2 (when coadministered with cisplatin) IV infusion on Days 1 and 8 of each 21-day cycle for 4 or 6 cycles.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Czechia,  France,  Germany,  Greece,  Hungary,  Italy,  Korea, Republic of,  Poland,  Romania,  Russian Federation,  Serbia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)		Baseline up to death or disease progression, whichever occurs first (up to approximately 2.5 years)