NCT03285763

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)

A Phase III/IV, Single Arm, Multicenter Study of Atezolizumab (Tecentriq) to Investigate Long-term Safety and Efficacy in Previously-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (TAIL)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 619 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2017-10-25
• Primary completion: 2022-04-07
• Completion: 2022-04-07
• First posted: 2017-09-18
• Last updated: 2025-01-23
• Results posted: 2025-01-23

Locations

111 sites across 24 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