Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
AstraZeneca
Study ID
NCT05687266
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Datopotamab deruxtecan — DRUG
    Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
  • Durvalumab — DRUG
    Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
  • Carboplatin — DRUG
    Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.
  • Pembrolizumab — DRUG
    Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle for a maximum of 35 cycles or 2 years (whichever occurs first).
  • Cisplatin — DRUG
    Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.
  • Pemetrexed — DRUG
    Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
  • Paclitaxel — DRUG
    Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.

Study Details

This is a Phase III, randomized, open-label, multicenter, global study to compare the efficacy and safety of Datopotamab Deruxtecan (Dato-DXd) in combination with durvalumab and carboplatin compared with pembrolizumab in combination with histology-specific platinum-based chemotherapy as first-line treatment of adults with stage IIIB, IIIC, or IV NSCLC without actionable genomic alterations (including sensitizing EGFR mutations, and ALK and ROS1 rearrangements).

Key Dates

Start date
Dec 29, 2022
Status verified
Apr 2026
Primary completion
Nov 1, 2027
Completion
Nov 1, 2027

Study Design

Enrollment
1,350 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dato-DXd + Durvalumab + Carboplatin
    Participants will be randomized to receive 6.0mg/kg Dato-DXd plus 1120 mg durvalumab plus carboplatin area under the curve \[AUC\] 5 mg/mL/minute.
  • Active Comparator: Histologic-specific therapy
    Non-squamous NSCLC participants will be randomized to receive 200 mg pembrolizumab plus 500 mg/m2 pemetrexed plus either AUC 5 mg/mL/minute carboplatin or 75 mg/m2 cisplatin. Squamous NSCLC participants will be randomized to receive 200 mg of pembrolizumab plus 200 mg/m2 paclitaxel plus AUC 5 or 6 mg/mL/minute carboplatin.

Primary Outcome Measure

Progression-Free Survival (PFS) by blinded independent central review (BICR) in the non-squamous TROP2 biomarker positive population [ Time Frame: Approximately 3 years ]

Locations (52)

FacilityCityStateZIPSite coordinators
Research SitePhoenixArizona85054-
Research SiteTucsonArizona85704-
Research SiteHot SpringsArkansas71913-
Research SiteLittle RockArkansas72205-
Research SiteSpringdaleArkansas72762-
Research SiteFountain ValleyCalifornia92708-
Research SiteLos AngelesCalifornia90017-
Research SiteOrangeCalifornia92868-
Research SiteBoulderColorado80303-
Research SiteFort MyersFlorida33901-
Research SiteJacksonvilleFlorida32224-
Research SiteSt. PetersburgFlorida33705-
Research SiteWest Palm BeachFlorida33401-
Research SiteHinsdaleIllinois60521-
Research SiteFort WayneIndiana46845-
Research SiteBettendorfIowa52722-
Research SiteIowa CityIowa52242-
Research SiteWaukeeIowa50263-
Research SiteBaton RougeLouisiana70808-
Research SiteCovingtonLouisiana70433-
Research SiteDuluthMinnesota55805-
Research SiteRochesterMinnesota55905-
Research SiteHannibalMissouri63401-
Research SiteLincolnNebraska68506-
Research SiteLincolnNebraska68516-
Research SiteClifton ParkNew York12065-
Research SiteAshevilleNorth Carolina28806-
Research SiteCantonOhio44710-
Research SiteColumbusOhio43219-
Research SiteMaumeeOhio43537-
Research SiteTulsaOklahoma74134-
Research SitePortlandOregon97239-
Research SiteSalemOregon97301-
Research SitePhiladelphiaPennsylvania19104-
Research SitePhiladelphiaPennsylvania19107-
Research SitePhiladelphiaPennsylvania19111-
Research SiteYorkPennsylvania17403-
Research SiteWatertownSouth Dakota57201-
Research SiteMemphisTennessee38120-
Research SiteDallasTexas75246-
Research SiteFort WorthTexas76104-
Research SiteHoustonTexas77030-
Research SiteHoustonTexas77090-
Research SiteIrvingTexas75063-
Research SiteFairfaxVirginia22031-
Research SiteHenricoVirginia23229-
Research SiteNorfolkVirginia23502-
Research SiteRentonWashington98055-
Research SiteSpokaneWashington99202-
Research SiteTacomaWashington98405-
Research SiteAppletonWisconsin54911-
Research SiteLa CrosseWisconsin54601-

Find similar trials in Phoenix, AZ

By condition
Lung cancer
By specialty
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By research site
Research Site· Phoenix, AZResearch Site· Tucson, AZResearch Site· Hot Springs, ARResearch Site· Little Rock, ARResearch Site· Springdale, ARResearch Site· Fountain Valley, CA

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