MedTrace Logo

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

NCT03735121 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 438

Last updated 2025-12-05

Study results available
· View outcomes & findings →

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

DRUG

Atezolizumab

Atezolizumab will be administered as per the schedule specified in arm or cohort.

DRUG

rHuPH20

rHuPH20 will be administered as per the scheduled specified in the cohort for Part 1.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-27
Primary Completion
2022-04-26
Completion
2024-11-11
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03735121 on ClinicalTrials.gov