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
Recruiting
- Argentina
- Brazil
- Canada
- Chile
- Costa Rica
- Finland
- Italy
- Latvia
- Poland
- Russia
- South Korea
- Spain
- United States
NCT05171777 MO43576
Trial 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).
A Randomized, Multicenter, Open-Label Cross-Over 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
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
For the latest version of this information please go to www.forpatients.roche.com