Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around
Principal Investigator
by James Urbanic, MD (ucsd)

Description

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.

Official Title

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

Details

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

Keywords

NSCLC, Non-Small-Cell Lung Carcinoma, Atezolizumab, Tiragolumab, Atezolizumab and Tiragolumab

Eligibility

Locations

  • University of California San Diego Moores Cancer Center accepting new patients
    La Jolla California 92037 United States
  • Kaiser Permanente San Francisco Medical Center accepting new patients
    San Francisco California 94115 United States
  • Kaiser Permanente Oakland Medical Center accepting new patients
    Oakland California 94611 United States
  • Kaiser Permanente Vallejo Medical Center accepting new patients
    Vallejo California 94589 United States

Lead Scientist at University of California Health

  • James Urbanic, MD (ucsd)
    Professor Of Clinical, Radiation Medicine and Applied Science, Vc-health Sciences-schools. Authored (or co-authored) 74 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alliance Foundation Trials, LLC.
ID
NCT05798663
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 178 study participants
Last Updated