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) (WCG)Purpose
Researchers are comparing three different treatment regimens given after surgery for people with stage 1 lung adenocarcinoma. The people in this study have lung cancer that has a high risk of coming back after treatment. This risk may be determined by the presence of circulating tumor DNA (ctDNA) in the bloodstream or other tests.
If you take part in this study, you will be randomly assigned to get one of these therapies:
- Datopotamab deruxtecan (Dato-DXd) plus rilvegostomig
- Rilvegostomig alone
- Standard lung cancer chemotherapy chosen by your doctor. Examples include carboplatin, cisplatin, etoposide, pemetrexed, and vinorelbine.
Who Can Join
To join this study, there are a few conditions. You must:
- Have stage 1 adenocarcinoma of the lung that has not yet been treated with medication.
- Have lung cancer that was surgically removed 4-12 weeks before starting the study.
- Have ctDNA or other test results showing your cancer is high risk.
- Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
- Be age 18 or older.
Contact
For more information or to see if you can join this study, please call Dr. David Jones’ office at 212-639-6428.
Protocol
25-096
Phase
Phase III (phase 3)
Disease Status
Newly Diagnosed
Investigator
Co-Investigators
Diseases
ClinicalTrials.gov ID
NCT06564844