Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations

Part of paid clinical trials in Chandler, Arizona.

Sponsor
AstraZeneca
Study ID
NCT07291037
Phase
PHASE3
Status
Recruiting

Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

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

Interventions

  • Datopotamab deruxtecan (Dato-DXd) — DRUG
    Dato-DXd administered intravenously (IV)
  • Docetaxel — DRUG
    Docetaxel administered intravenously (IV)

Study Details

TROPION-Lung17 will measure the efficacy and safety of datopotamab deruxtecan (Dato-DXd) compared with docetaxel in patients with trophoblast cell surface protein 2 (TROP2) positive advanced or metastatic lung cancer without actionable genomic alterations (AGA).

Key Dates

Start date
Oct 31, 2025
Status verified
May 2026
Primary completion
Jan 29, 2029
Completion
Jan 29, 2029

Study Design

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

Arms

  • Experimental: Arm A: Datopotamab deruxtecan (Dato-DXd) monotherapy
    Participants in the Dato-DXd monotherapy group will receive Dato-DXd as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
  • Active Comparator: Arm B: Docetaxel monotherapy
    Participants in the docetaxel monotherapy group will receive docetaxel as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Approximately 2.5 years ]

Central Contacts

Locations (50)

FacilityCityStateZIPSite coordinators
Research SiteChandlerArizona85224-
Research SiteGilbertArizona85234-
Research SiteGoodyearArizona85338-
Research SiteDuarteCalifornia91010-
Research SiteIrvineCalifornia92618-
Research SiteLa JollaCalifornia92093-
Research SiteLoma LindaCalifornia92350-
Research SiteLos AngelesCalifornia90095-
Research SiteSan DiegoCalifornia92123-
Research SiteGrand JunctionColorado81501-
Research SiteWheat RidgeColorado80033-
Research SiteNewarkDelaware19713-
Research SiteWashington D.C.District of Columbia20037-
Research SiteFort MyersFlorida33901-
Research SiteJacksonvilleFlorida32224-
Research SiteSt. PetersburgFlorida33709-
Research SiteTampaFlorida33612-
Research SiteWest Palm BeachFlorida33401-
Research SiteMariettaGeorgia30060-
Research SiteNewnanGeorgia30265-
Research SiteChicagoIllinois60612-
Research SiteChicagoIllinois60637-
Research SiteNilesIllinois60714-
Research SiteZionIllinois60099-
Research SiteLouisvilleKentucky40207-
Research SiteSouth PortlandMaine04106-
Research SiteBaltimoreMaryland21201-
Research SiteBrandywineMaryland20613-
Research SiteBostonMassachusetts02215-
Research SiteDetroitMichigan48202-
Research SiteRochesterMinnesota55905-
Research SiteBridgetonMissouri63044-
Research SiteColumbiaMissouri65212-
Research SiteLincolnNebraska68516-
Research SiteAlbuquerqueNew Mexico87109-
Research SiteEast SyracuseNew York13057-
Research SitePortlandOregon97239-
Research SiteHersheyPennsylvania17033-
Research SitePhiladelphiaPennsylvania19104-
Research SiteGreenvilleSouth Carolina29607-
Research SiteMemphisTennessee38120-
Research SiteAustinTexas78745-
Research SiteDentonTexas76201-
Research SitePlanoTexas75075-
Research SiteCharlottesvilleVirginia22908-
Research SiteFairfaxVirginia22031-
Research SiteWilliamsburgVirginia23188-
Research SiteTacomaWashington98405-
Research SiteMorgantownWest Virginia26506-
Research SiteEau ClaireWisconsin54703-

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