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

Study 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 II, IIIA, and selected IIIB (T3-N2) 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).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAtezolizumab

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · PD-L1 · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 11, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?36 U.S. locations

Locations may change over time.

Who runs it?Hoffmann-La Roche

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Hoffmann-La Roche
Interventions being studied: Drug: Atezolizumab

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Early-stage or resectable→Metastatic or stage IV→Recurrent or relapsed→

Biomarkers

PD-L1→

Treatment approach

Immunotherapy→Chemotherapy→

Study topics

After surgery (adjuvant)→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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 II, IIIA, and selected 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. For participants in the adjuvant setting, neoadjuvant chemotherapy or chemoradiotherapy is acceptable provided that participants also received adjuvant chemotherapy as per protocol's requirement. 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.

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

New Jersey Hematology Oncology Associates LLCBrick, New Jersey
Tri County HematologyoncologyMassillon, Ohio
Asante Rogue Regional Medical CenterMedford, Oregon
UPMC - Hillman Cancer CenterPittsburgh, Pennsylvania
Fundación CENIT para la Investigación en NeurocienciasBuenos Aires
CEMICBuenos Aires
Centro Oncologico KorbenCiudad Autonoma Buenos Aires
Oncosite - Centro de Pesquisa Clinica Em Oncologia LtdaIjuí, Rio Grande do Sul
Hospital das Clinicas - UFRGSPorto Alegre, Rio Grande do Sul
Hospital Nossa Senhora da ConceicaoPorto Alegre, Rio Grande do Sul
Instituto do Cancer do Estado de Sao Paulo - ICESPSão Paulo, São Paulo
Royal Victoria Regional Health CentreBarrie, Ontario

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 11, 2025. Always confirm current availability with the study team.

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