A Phase 3 Study of Rilvegostomig Alone or With Dato-DXd Versus Standard Treatment for Stage 1 Lung Cancer With High-Risk Features

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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

ClinicalTrials.gov ID

NCT06564844