OncRef

Clinical Trial: NCT03735121

A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Hoffmann-La Roche
Information Provided By:Hoffmann-La Roche
Last Update Posted:2025-12-05

Study Overview

Brief 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.

Official Title

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

Conditions

Non-Small Cell Lung Cancer

Intervention / Treatment

  • Drug: Atezolizumab
  • Drug: rHuPH20

Other Study ID Numbers

  • BP40657
  • 2018-002328-18
  • 2018

Start Date (Actual)

2018-12-27

Primary Completion Date (Actual)

2022-04-26

Study Completion Date (Actual)

2024-11-11

Enrollment (Actual)

438

Study Type

Interventional

Phase

Phase 3