A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features

Condition(s) studied

Investigational drug(s) / intervention(s)

Datopotamab Deruxtecan: Datopotamab Deruxtecan IV (intravenous)

Rilvegostomig: Rilvegostomig IV (intravenous)

Carboplatin: Carboplatin IV (intravenous), Active Comparator

Cisplatin: Cisplatin IV (intravenous), Active Comparator

Etoposide: Etoposide IV (intravenous), Active Comparator

Pemetrexed: Pemetrexed IV (intravenous), Active Comparator

Vinorelbine: Vinorelbine IV (intravenous), Active Comparator

UFT: UFT Oral route of administration, Active Comparator

Study summary

This is a Phase III, randomised, open-label, multicentre, global study assessing the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig compared with SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.

Eligibility

Primary outcome measure(s)

• Disease-Free Survival (DFS) using BICR in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive or having at least one high-risk pathological feature treated with adjuvant Dato-DXd in combination with rilvegostomig relative to SoC — From date of randomisation up to approximately 10 years.
  The analysis will include all randomised participants as randomised. All events will be included, regardless of whether the participant withdraws from randomised therapy or receives another anti-cancer therapy. The measure of interest is the HR of DFS. Descriptive analyses of Dato-DXd in combination with rilvegostomig versus rilvegostomig monotherapy and rilvegostomig monotherapy versus SoC will be performed to assess contribution of components.

Trial sites (90)

+ 50 more sites — see the full list on the official registry below.

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