CompletedPhase 2NCT05171777

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

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).

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

StatusCompleted
PhasePhase 2
U.S. locations36
SponsorHoffmann-La Roche
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Hoffmann-La Roche
Interventions being studied
Drug: Atezolizumab
02
Explore related studies

How this study is categorized

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

03
Public criteria

Who may be able to participate

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 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. 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

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

04
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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