NCT05798663

Atezolizumab Immunotherapy With or Without Tiragolumab for Patients With Unresectable Stage III NSCLC

Randomized Phase II Trial of Neoadjuvant and Adjuvant Atezolizumab With or Without Tiragolumab in Conjunction With Chemoradiotherapy for Unresectable Stage III NSCLC

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 178 (estimated)
• Sponsor: Alliance Foundation Trials, LLC. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II trial of neoadjuvant and adjuvant atezolizumab with or without tiragolumab in conjunction with chemoradiotherapy for unresectable stage III NSCLC.

Detailed description

This randomized phase II design provides a fairly rapid way to determine which of two potential neoadjuvant immunotherapy regimens holds the most promise for evaluation in a subsequent phase III trial against standard of care adjuvant immunotherapy. The AFT-16 trial of neoadjuvant atezolizumab in this setting provided proof of concept for safety of the neoadjuvant approach and for outcomes that compare favorably with standard of care therapy. The field of lung cancer immunotherapy is evolving rapidly and since the start of AFT-16 not only has adjuvant immunotherapy with durvalumab become standard of care, but combination immunotherapy with tiragolumab and atezolizumab for NSCLC has received breakthrough therapy designation. Safety of combination immunotherapy and radiation has been established in several trials, but the safety and efficacy of dual immunotherapy is not yet known. In a group of patients who can be but often are not cured with current therapies, establishment of a strategy that could increase cure rate is urgent. This randomized phase II trial can be advocated to determine the best of the two arms for further study with slightly inflated type I error rate

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Atezolizumab	Atezolizumab will be given to participants either intravenously at a dosage of 1200mg or subcutaneously at a dosage of 1875 mg on Day 1 of each 21-day cycle for Arms A, B, and C, and on days 1 and 22 of concurrent chemoradiotherapy for Arm C only.
DRUG	Tiragolumab	Tiragolumab will be given to participants intravenously at a dosage of 600 mg on day 1 of each 21-day cycle (Arms B and C), and on days 1 and 22 of concurrent chemoradiotherapy (Arm C only).

Timeline

• Start date: 2023-12-07
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2023-04-04
• Last updated: 2026-04-07

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study