Lung Cancer Clinical Trial

A Study to Evaluate Participant and Healthcare Professional Reported Preference for Subcutaneous Atezolizumab Compared With Intravenous Atezolizumab Formulation in Participants With Non-Small Cell Lung Cancer

Summary

This is a Phase II, randomized, multi-center, multinational, open-label, cross-over study in adult participants with PD-L1-positive NSCLC. Two populations will be included: participants with resected Stage IIB-IIIB (early-stage) NSCLC who have completed adjuvant platinum-based chemotherapy without evidence of disease relapse/recurrence, and chemotherapy-naïve participants with Stage IV NSCLC. The study will evaluate participant- and healthcare professionals (HCP)-reported preference for atezolizumab subcutaneous (SC) compared with atezolizumab intravenous (IV).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria for All Participants:

ECOG performance status of 0 or 1

Inclusion Criteria for Participants with Early-stage NSCLC:

Participants must have a complete resection of a histologically or cytologically confirmed Stage IIB-IIIB (T3-N2) NSCLC
PD-L1 expression TC ≥ 1% or TPS ≥ 1%
Participants must have completed adjuvant chemotherapy at least 4 weeks and up to 12 weeks prior to randomization and must be adequately recovered from chemotherapy therapy

Inclusion Criteria for Participants with Stage IV NSCLC:

Histologically or cytologically confirmed, Stage IV non-squamous or squamous NSCLC
Life expectancy ≥ 18 weeks in the opinion of the investigator
PD-L1 expression TC ≥ 50% or TPS ≥ 50% or TC3 or IC3
No prior systemic treatment for Stage IV non-squamous or squamous NSCLC
Participants who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from randomization since the last chemotherapy, radiotherapy, or chemoradiotherapy cycle.

Exclusion Criteria for All Participants:

History of malignancy within 5 years prior to initiation of study treatment, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death
Uncontrolled tumor-related pain
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
Participants known to have a sensitizing mutation in the EGFR gene or an ALK fusion oncogene
History of leptomeningeal disease
Uncontrolled or symptomatic hypercalcemia
Active or history of autoimmune disease or immune deficiency
History of idiopathic pulmonary fibrosis, organizing pneumonia), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina

Exclusion Criteria for Participants with Stage IV NSCLC:

Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

140

Study ID:

NCT05171777

Recruitment Status:

Recruiting

Sponsor:

Hoffmann-La Roche

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There are 47 Locations for this study

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Los Angeles Cancer Network
Los Angeles California, 90017, United States
St Mary's Hospital and Medical Center
Grand Junction Colorado, 81502, United States
Northwest Georgia Oncology Centers PC - Marietta
Marietta Georgia, 30060, United States
Southcoast Health System
Fairhaven Massachusetts, 02719, United States
Cox Health Systems
Springfield Missouri, 65807, United States
New Jersey Hematology Oncology Associates LLC
Brick New Jersey, 08724, United States
Tri County Hematologyoncology
Canton Ohio, 44718, United States
Asante Rogue Regional Medical Center
Medford Oregon, 97504, United States
Pennsylvania Cancer Specialists and Research Institute
Gettysburg Pennsylvania, 17325, United States
UPMC - Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States
Intermountain Cancer Center
Saint George Utah, 84790, United States
MultiCare Institute for Research and Innovation
Spokane Washington, 99218, United States
Fundación CENIT para la Investigación en Neurociencias
Buenos Aires , C1125, Argentina
Cemic; Oncologia Clinica
Buenos Aires , C1431, Argentina
Centro Oncologico Korben; Oncology
Ciudad Autonoma Buenos Aires , C1426, Argentina
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
Ijui RS, 98700, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre RS, 90035, Brazil
Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials
Barrie Ontario, L4M 6, Canada
Ottawa Hospital
Ottawa Ontario, K1H 8, Canada
Sault Area Hospital
Sault Ste. Marie Ontario, P6B 0, Canada
Fundacion Arturo Lopez Perez; Quimioterapia
Providencia , 75009, Chile
OrlandiOncología
Santiago , 75007, Chile
James Lind Centro de Investigación Del Cáncer
Temuco , 48008, Chile
Clinica CIMCA
San José , 10103, Costa Rica
ICIMED Instituto de Investigación en Ciencias Médicas
San José , 10108, Costa Rica
Oulun yliopistollinen sairaala (OYS); Syöpätautien poliklinikka B
Oulu , 90220, Finland
Tampereen yliopistollinen sairaala (TAYS); Syöpätautien poliklinikka
Tampere , 33521, Finland
Turun yliopistollinen keskussairaala (TYKS); Syöpäklinikka
Turku , 20521, Finland
VAASAN KESKUSSAIRAALA; Onkologian poliklinikka
Vaasa , 65130, Finland
Azienda Ospedaliera Universitaria Senese
Siena Abruzzo, 53100, Italy
IRCCS Istituto Regina Elena (IFO); Oncologia Medica B
Roma Lazio, 00144, Italy
Instituto Europeo di Oncologia
Milano Lombardia, 20141, Italy
A.O.U. Maggiore della Carità
Novara Piemonte, 28100, Italy
Chungbuk National University Hospital
Cheongju-si , 28644, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Riga East Clinical University Hospital Latvian Oncology Centre
Riga , LV-10, Latvia
Pauls Stradins Clinical University Hospital
Rīga , LV-10, Latvia
Warminsko-Mazurskie Centrum Chorób Płuc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii
Olsztyn , 10-35, Poland
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy; Oddzial III Chorob Pluc
Otwock , 05-40, Poland
SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"
Moskva Moskovskaja Oblast, 11112, Russian Federation
Bashkirian Republican Clinical Oncology Dispensary
UFA , 45005, Russian Federation
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
A Coruña LA Coruña, 15006, Spain
Hospital Universitario de Canarias;servicio de Oncologia
La Laguna Tenerife, 38320, Spain
Hospital Universitari Vall d'Hebron; Oncology
Barcelona , 08035, Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
Barcelona , 08041, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid , 28007, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid , 28041, Spain
Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia
Zaragoza , 50009, Spain

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

140

Study ID:

NCT05171777

Recruitment Status:

Recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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