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).
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
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There are 49 Locations for this study
Los Angeles California, 90017, United States
Grand Junction Colorado, 81501, United States
Marietta Georgia, 30060, United States
Fairhaven Massachusetts, 02719, United States
Springfield Missouri, 65807, United States
Brick New Jersey, 08724, United States
Canton Ohio, 44718, United States
Medford Oregon, 97504, United States
Gettysburg Pennsylvania, 17325, United States
Pittsburgh Pennsylvania, 15232, United States
Saint George Utah, 84790, United States
Spokane Washington, 99218, United States
Buenos Aires , C1125, Argentina
Buenos Aires , C1431, Argentina
Ciudad Autonoma Buenos Aires , C1426, Argentina
Ijui RS, 98700, Brazil
Porto Alegre RS, 90035, Brazil
Porto Alegre RS, 91350, Brazil
Sao Paulo SP, 01246, Brazil
Barrie Ontario, L4M 6, Canada
Ottawa Ontario, K1H 8, Canada
Sault Ste. Marie Ontario, P6B 0, Canada
Providencia , 75009, Chile
Santiago , 75007, Chile
Temuco , 48008, Chile
San José , 10103, Costa Rica
San José , 10108, Costa Rica
Oulu , 90220, Finland
Tampere , 33521, Finland
Turku , 20521, Finland
Vaasa , 65130, Finland
Siena Abruzzo, 53100, Italy
Roma Lazio, 00144, Italy
Milano Lombardia, 20141, Italy
Novara Piemonte, 28100, Italy
Cheongju-si , 28644, Korea, Republic of
Seoul , 05505, Korea, Republic of
R?ga , LV-10, Latvia
Riga , LV-10, Latvia
Olsztyn , 10-35, Poland
Otwock , 05-40, Poland
Moskva Moskovskaja Oblast, 11112, Russian Federation
UFA , 45005, Russian Federation
A Coruña LA Coruña, 15006, Spain
La Laguna Tenerife, 38320, Spain
Barcelona , 08035, Spain
Barcelona , 08041, Spain
Madrid , 28007, Spain
Madrid , 28041, Spain
Zaragoza , 50009, Spain
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