Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Part of paid clinical trials in Anchorage, Alaska.

Sponsor
AstraZeneca
Study ID
NCT06357533
Phase
PHASE3
Status
Recruiting
Apply to this trial

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)
  • Pembrolizumab — DRUG
    Pembrolizumab IV (intravenous)

Study Details

The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.

Key Dates

Start date
Apr 11, 2024
Status verified
May 2026
Primary completion
Dec 28, 2029
Completion
Dec 28, 2029

Study Design

Enrollment
675 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Datopotamab Deruxtecan in Combination With Rilvegostomig
    Participants in the Datopotamab Deruxtecan (Dato-DXd) in combination with Rilvegostomig group will receive Dato-DXd plus rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
  • Experimental: Arm 2: Rilvegostomig Monotherapy
    Participants in the rilvegostomig monotherapy group will receive rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
  • Active Comparator: Arm 3: Pembrolizumab Monotherapy
    Participants in the pembrolizumab group will receive pembrolizumab as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.

Primary Outcome Measure

Progression-Free Survival (PFS) in TROP2 biomarker positive participants. [ Time Frame: Approximately 4 years ]

Central Contacts

Locations (63)

FacilityCityStateZIPSite coordinators
Research SiteAnchorageAlaska99508-
Research SiteTucsonArizona85719-
Research SiteLittle RockArkansas72205-
Research SiteSpringdaleArkansas72762-
Research SiteAnaheimCalifornia92801-
Research SiteBeverly HillsCalifornia90211-
Research SiteFountain ValleyCalifornia92708-
Research SiteNewport BeachCalifornia92663-
Research SiteClermontFlorida34711-
Research SiteGainesvilleFlorida32608-
Research SiteMiami BeachFlorida33140-
Research SiteOrange CityFlorida32763-
Research SiteOrlandoFlorida32806-
Research SiteOrlandoFlorida32827-
Research SiteWest Palm BeachFlorida33401-
Research SiteAtlantaGeorgia30303-
Research SiteAtlantaGeorgia30318-
Research SiteAtlantaGeorgia30322-
Research SiteAtlantaGeorgia30342-
Research SiteHinsdaleIllinois60521-
Research SiteNoblesvilleIndiana46062-
Research SitePaducahKentucky42003-
Research SiteAnnapolisMaryland21401-
Research SiteBostonMassachusetts02114-
Research SiteBostonMassachusetts02215-
Research SiteDearbornMichigan48126-
Research SiteFarmington HillsMichigan48334-
Research SiteGrand RapidsMichigan49503-
Research SiteTraverse CityMichigan49684-
Research SiteHattiesburgMississippi39401-
Research SiteKansas CityMissouri64132-
Research SiteBozemanMontana59715-
Research SiteGrand IslandNebraska68803-
Research SiteOmahaNebraska68130-
Research SiteLas VegasNevada89102-
Research SiteRenoNevada89502-
Research SiteVoorhees TownshipNew Jersey08043-
Research SiteStony BrookNew York11794-
Research SiteGreenvilleNorth Carolina27834-
Research SiteSalisburyNorth Carolina28144-
Research SiteCincinnatiOhio45219-
Research SiteColumbusOhio43210-
Research SiteMaumeeOhio43537-
Research SiteToledoOhio43623-
Research SitePortlandOregon97213-
Research SiteGreenvilleSouth Carolina29607-
Research SiteSioux FallsSouth Dakota57105-
Research SiteChattanoogaTennessee37404-
Research SiteKnoxvilleTennessee37920-
Research SiteFort WorthTexas76104-
Research SiteHoustonTexas77030-
Research SiteHoustonTexas77030-
Research SiteHoustonTexas77090-
Research SiteKingwoodTexas77339-
Research SiteOdessaTexas79761-
Research SiteFort BelvoirVirginia22060-
Research SiteLeesburgVirginia20176-
Research SiteMidlothianVirginia23114-
Research SiteRichmondVirginia23230-
Research SiteTacomaWashington98405-
Research SiteVancouverWashington98684-
Research SiteWenatcheeWashington98801-
Research SiteAppletonWisconsin54911-

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