NCT04501497

Prospective Multicenter Observational Study of Atezolizumab Combination Therapy in Lung Cancer (J-TAIL-2)

Prospective Multicenter Observational Study of Atezolizumab Combination Therapy in Patients With Unresectable, Advanced and Recurrent Non-small Cell Lung Cancer or Extensive Disease Small Cell Lung Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,221 (actual)
• Sponsor: Chugai Pharmaceutical · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: —

Summary

This is a multi-center observational study of atezolizumab combination therapy in patients with unresectable, advanced and recurrent non-small cell lung cancer(NSCLC) or extensive disease small cell lung cancer(ED-SCLC). 800 patients in NSCLC cohort and 400 patients in ED-SCLC cohort will be enrolled in this trial to assess the efficacy and safety of this combination.

Detailed description

Primary endpoint: 12 months OS, Secondary endpoints: Overall Survival(OS), 6 months survival rate(6mo OS), 12 months survival rate(12mo OS), Progression-Free Survival(PFS), Time to treatment failure (TTF), Objective Response Rate(ORR), Disease Control Rate(DCR), Duration of Response(DOR) ,Safety and Comprehensive geriatric assessment(G8)

Conditions

• Non-small Cell Lung Cancer
• Extensive Disease Small Cell Lung Cancer

Timeline

• Start date: 2020-08-21
• Primary completion: 2023-02-03
• Completion: 2023-02-03
• First posted: 2020-08-06
• Last updated: 2024-04-02

Locations

148 sites across 1 country: Japan