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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

NCT06564844 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-05-22

No results posted yet for this 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.

Conditions

Interventions

DRUG

Datopotamab Deruxtecan

Datopotamab Deruxtecan IV (intravenous)

DRUG

Rilvegostomig

Rilvegostomig IV (intravenous)

DRUG

Carboplatin

Carboplatin IV (intravenous), Active Comparator

DRUG

Cisplatin

Cisplatin IV (intravenous), Active Comparator

DRUG

Etoposide

Etoposide IV (intravenous), Active Comparator

DRUG

Pemetrexed

Pemetrexed IV (intravenous), Active Comparator

DRUG

Vinorelbine

Vinorelbine IV (intravenous), Active Comparator

DRUG

UFT

UFT Oral route of administration, Active Comparator

Sponsors & Collaborators

Principal Investigators

  • David Jones, MD · Memorial Sloan Kettering Cancer Center, New York, United States of America

  • Enriqueta Felip, MD · Vall d'Hebron Hospital, Barcelona, Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-15
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Canada
  • Hong Kong
  • Japan
  • Malaysia
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06564844 on ClinicalTrials.gov