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

NSCLC Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05798663
Study type Interventional
Source Alliance Foundation Trials, LLC.
Contact Quality Management and Compliance
Phone 617-732-8727
Email ClinicalTrials.Queries@alliancefoundationtrials.org
Status Recruiting
Phase Phase 2
Start date December 7, 2023
Completion date October 2027
View Details
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