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

Official Title

A Randomized, Multicentre, 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

Summary:

This is a Phase II, randomized, multi-centre, 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).

Trial Description

Primary Outcome:

  • Proportion of Participants Who Preferred Atezolizumab SC to Atezolizumab IV
Secondary Outcome:
  • Participant-Reported Satisfaction With Atezolizumab SC and Atezolizumab IV
  • Proportion of Participants Who Select Atezolizumab SC
  • HCP Perception of Time/Resource Use With Atezolizumab SC Compared to Atezolizumab IV
  • HCP Perception of Convenience for Administration With Atezolizumab SC Compared to Atezolizumab IV
  • Change in Symptoms, as Assessed by EORTC QLQ-C30 Scores
  • Change in Function, as Assessed by EORTC QLQ-C30 Scores
  • Changes in Score in HRQoL
  • Percentage of Participants With Continuing Clinical Benefit
  • Percentage of Participants With Adverse Events
  • Percentage of Participants With Adverse Events During Treatment Cross-over Period

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society