Clinical Trials Directory

Trials / Completed

CompletedNCT03735121

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

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

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
438 (actual)
Sponsor
Hoffmann-La Roche · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGAtezolizumabAtezolizumab will be administered as per the schedule specified in arm or cohort.
DRUGrHuPH20rHuPH20 will be administered as per the scheduled specified in the cohort for Part 1.

Timeline

Start date
2018-12-27
Primary completion
2022-04-26
Completion
2024-11-11
First posted
2018-11-08
Last updated
2025-12-05
Results posted
2023-06-13

Locations

74 sites across 23 countries: Argentina, Brazil, Chile, China, Costa Rica, France, Greece, Guatemala, Hungary, Italy, Latvia, Mexico, New Zealand, Peru, Poland, Russia, South Africa, South Korea, Spain, Thailand, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT03735121. Inclusion in this directory is not an endorsement.