Purpose of this Study
We are doing this study to find the most effective, safe dose of an experimental drug called rilvegostomig (the study drug). We want to know how well the study drug works on its own and when it is used in combination with another anti-cancer drug called datopotamab deruxtecan (also called Dato-DXd). We will compare how well both of these regimens work versus the standard treatment for non-small cell lung cancer (NSCLC) that is ctDNA-positive.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with NSCLC
- Have not received any treatment yet for their cancer
- Are scheduled or planning to have surgery to remove the tumor
- Have a positive blood test for ctDNA
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
If you choose to join this study, we will schedule you to come to our clinic for some screening visits to make sure you are eligible. If you are eligible, you will get a random assignment (like picking numbers from a hat) to 1 of 3 different study groups. Each study group will have a different regimen to follow after surgery.
After you have surgery to remove your tumor, your study group assignment after surgery will be one of the following:
- Group 1: If you are in this group, you will take the study drug in combination with Dato-DXd. You will take the drugs in combination with each other every 3 weeks for 4 cycles, and then you will take only the study drug every 3 weeks for a year.
- Group 2: If you are in this group, you will take the study drug on its own every 3 weeks for a year.
- Group 3: If you are in this group, you will get treatment with the standard therapy. This will involve either chemotherapy or no drug treatment at all, whichever the study doctor believes is the best option for you.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase III, Randomised, Open-label, Global Study of Adjuvant Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma Non-small Cell Lung Cancer who are ctDNA-positive or Have High-risk Pathological Features (TROPION-Lung12)
Principal Investigator
Cameron
Oswalt
Protocol Number
PRO00117229
NCT ID
NCT06564844
Phase
III
Enrollment Status
Pending Open to Enrollment