Clinical trialNCT06564844Active, not recruitingPhase 3Interventional

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

SponsorAstraZenecaEnrollment25Non-small Cell Lung Cancer

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

David Jones, MD
Memorial Sloan Kettering Cancer Center, New York, United States of America
Principal Investigator
clinicaltrials.gov ↗
Enriqueta Felip, MD
Vall d'Hebron Hospital, Barcelona, Spain
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

90 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Brazil

Research Site
Barretos, Brazil
Research Site
Brasília, Brazil
Research Site
Florianópolis, Brazil
Research Site
São Paulo, Brazil
Research Site
Teresina, Brazil

Canada

Research Site
Halifax, Nova Scotia, Canada
Research Site
Oshawa, Ontario, Canada
Research Site
Montreal, Quebec, Canada

Hong Kong

Research Site
Hong Kong, Hong Kong

Japan

Research Site
Bunkyō City, Japan
Research Site
Chiba, Japan
Research Site
Chūōku, Japan
Research Site
Fukuoka, Japan
Research Site
Hidaka-shi, Japan
Research Site
Hiroshima, Japan
Research Site
Hiroshima, Japan
Research Site
Iwakuni-shi, Japan
Research Site
Kashiwa, Japan
Research Site
Kitaadachi-gun, Japan
Research Site
Kobe, Japan
Research Site
Kumamoto, Japan
Research Site
Kōtoku, Japan
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Nagoya, Japan
Research Site
Niigata, Japan
Research Site
Osakasayama-shi, Japan
Research Site
Sapporo, Japan
Research Site
Sendai, Japan
Research Site
Sendai, Japan
Research Site
Wakayama, Japan
Research Site
Yokohama, Japan

Malaysia

Research Site
Kuala Lumpur, Malaysia
Research Site
Kuala Lumpur, Malaysia
Research Site
Kuching, Malaysia

Taiwan

Research Site
Kaohsiung City, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taoyuan, Taiwan

Thailand

Research Site
Bangkok, Thailand
Research Site
Bangkoknoi, Thailand

50 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Carboplatin →Cisplatin →Datopotamab deruxtecan →Etoposide →Pemetrexed →RilvegostomigTegafur / uracilVinorelbine →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 15 Oct 2024
Primary completion: 30 Jun 2027
Completion: 30 Jun 2027
Last update posted: 18 Aug 2026
Registered enrollment: 25
Registry id: NCT06564844

Cross-registrations

EU-CTR / CTIS (EudraCT)2024-512195-35-00

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.