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A Study of Atezolizumab (Tecentriq) to Investigate Long-term Safety and Efficacy in Previously-treated Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

NCT03285763 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 619

Last updated 2025-01-23

Study results available
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Summary

This is a Phase III/IV, single-arm, multicenter study of the long-term safety and efficacy of atezolizumab treatment in participants with Stage IIIb or Stage IV NSCLC who have progressed after standard systemic chemotherapy (including if given in combination with anti-programmed cell death protein 1 \[anti-PD-1\] therapy, after anti-PD-1 as monotherapy, or after tyrosine kinase inhibitor \[TKI\] therapy). The study will consist of a Screening Period, a Treatment Period, a Treatment Discontinuation Visit, and a Follow-Up Period.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Atezolizumab

Participants will receive 1200 milligrams (mg) of atezolizumab administered by intravenous infusion on Day 1 of every 3-week cycle until Investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first).

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-25
Primary Completion
2022-04-07
Completion
2022-04-07

Countries

  • Argentina
  • Brazil
  • China
  • Colombia
  • Costa Rica
  • Denmark
  • Greece
  • Guatemala
  • Italy
  • Latvia
  • Lebanon
  • Malaysia
  • Mexico
  • Morocco
  • Netherlands
  • Panama
  • Peru
  • Philippines
  • Poland
  • Slovenia
  • Spain
  • Sweden
  • United Arab Emirates
  • United Kingdom

Study Locations

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Entities

Drugs
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 NCT03285763 on ClinicalTrials.gov