Purpose of this Study
Participants will either be monitored with regular scans or receive the study drug atezolizumab, given by IV infusion or injection every 21 days for up to 1 year. Treatment will continue unless the cancer returns or side effects become too severe. Researchers will compare whether the study drug helps prevent the cancer from coming back compared with monitoring alone.
Who Can Participate?
Eligibility
Participants may be able to join if they are adults with stage IA3 or IB non-small cell lung cancer who have had the tumor completely removed with surgery. They must have had testing of nearby lymph nodes and cannot have certain genetic changes, such as EGFR or ALK alterations. Participants cannot have received previous drug treatment for their current lung cancer and cannot have serious uncontrolled illnesses or infections.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is comparing the usual approach of monitoring patients after lung cancer surgery with treatment using atezolizumab. Researchers want to learn if giving atezolizumab after surgery can better prevent the cancer from returning compared with observation alone.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
Protocol A082302, Evaluating Adjuvant Atezolizumab or Atezolizumab and Hyaluronidase-tqjs to Prevent Recurrence in Stage I Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase III Trial (AASI-NSCLC)
Principal Investigator
Eziafa
Oduah
Protocol Number
PRO00121052
NCT ID
NCT07388524
Phase
III
Enrollment Status
Pending Open to Enrollment