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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
AstraZeneca
Study ID
NCT06564844
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Datopotamab Deruxtecan — DRUG
    Datopotamab Deruxtecan IV (intravenous)
  • Rilvegostomig — DRUG
    Rilvegostomig IV (intravenous)
  • Carboplatin — DRUG
    Carboplatin IV (intravenous), Active Comparator
  • Cisplatin — DRUG
    Cisplatin IV (intravenous), Active Comparator
  • Etoposide — DRUG
    Etoposide IV (intravenous), Active Comparator
  • Pemetrexed — DRUG
    Pemetrexed IV (intravenous), Active Comparator
  • Vinorelbine — DRUG
    Vinorelbine IV (intravenous), Active Comparator
  • UFT — DRUG
    UFT Oral route of administration, Active Comparator

Study Details

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.

Key Dates

Start date
Oct 15, 2024
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
25 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dato-DXd + rilvegostomig
    Participants in the Dato-DXd in combination with rilvegostomig group will receive Dato-DXd and rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W).
  • Experimental: Rilvegostomig
    Participants in the rilvegostomig monotherapy group will receive rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W).
  • Active Comparator: Standard of Care (SoC)
    Patients in SoC group will undergo observation or will receive Investigator's Choice of Chemotherapy (ICC).

Primary Outcome Measure

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 [ Time Frame: From date of randomisation up to approximately 10 years. ]

Locations (37)

FacilityCityStateZIPSite coordinators
Research SiteTucsonArizona85724-
Research SiteDuarteCalifornia91010-
Research SiteGlendaleCalifornia91204-
Research SiteLos AngelesCalifornia90089-
Research SiteLone TreeColorado80124-
Research SiteWashington D.C.District of Columbia20007-
Research SiteJacksonvilleFlorida32224-
Research SiteSt. PetersburgFlorida33709-
Research SiteChicagoIllinois60637-
Research SiteEvanstonIllinois60201-
Research SiteZionIllinois60099-
Research SiteKansas CityKansas66160-
Research SiteLexingtonKentucky40503-
Research SiteBaltimoreMaryland21237-
Research SiteFarmington HillsMichigan48334-
Research SiteGrand RapidsMichigan49503-
Research SiteMinneapolisMinnesota55407-
Research SiteBillingsMontana59102-
Research SiteOmahaNebraska68130-
Research SiteEast SyracuseNew York13057-
Research SiteMineolaNew York11501-
Research SiteNew YorkNew York10016-
Research SiteNew YorkNew York10065-
Research SitePortlandOregon97239-
Research SiteBethlehemPennsylvania18015-
Research SitePhiladelphiaPennsylvania19107-
Research SitePittsburghPennsylvania15212-
Research SiteKnoxvilleTennessee37920-
Research SiteMemphisTennessee38120-
Research SiteNashvilleTennessee37203-
Research SiteAustinTexas78745-
Research SiteDallasTexas75231-
Research SiteHoustonTexas77030-
Research SiteSan AntonioTexas78217-
Research SiteFairfaxVirginia22031-
Research SiteSeattleWashington98104-
Research SiteMadisonWisconsin53792-

Find similar trials in Tucson, AZ

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Research Site· Tucson, AZResearch Site· Duarte, CAResearch Site· Glendale, CAResearch Site· Los Angeles, CAResearch Site· Lone Tree, COResearch Site· Washington D.C., DC

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