At a glance
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A Randomized, Multicenter, Phase Ib/III Study to Investigate the Pharmacokinetics, Efficacy, and Safety of Atezolizumab Subcutaneous Compared With Atezolizumab Intravenous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
In Brief
A Phase 3 clinical trial evaluating Atezolizumab and rHuPH20 for Non-Small Cell Lung Cancer. Completed, enrolled 438 participants across 74 sites in 23 countries.
Detailed Summary
This study will evaluate the pharmacokinetics, safety, and efficacy of atezolizumab subcutaneous (SC) compared with atezolizumab intravenous (IV) in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) who have not been exposed to cancer immunotherapy (CIT) and for whom prior platinum-based therapy has failed. The study is comprised of two parts, as follows: A dose-finding part (Part 1, Phase Ib) will aim to identify the dose of atezolizumab SC to be tested in Part 2. A dose-confirmation part (Part 2, Phase III, randomized) will aim to confirm that the dose moved forward from Part 1 yields drug exposure that is comparable to that of atezolizumab IV.
Study Details
Timeline
Interventions
Atezolizumab will be administered as per the schedule specified in arm or cohort.
rHuPH20 will be administered as per the scheduled specified in the cohort for Part 1.