A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC

Part of paid clinical trials in Chandler, Arizona.

Sponsor
AstraZeneca
Study ID
NCT05211895
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    Durvalumab IV (Intravenous infusion)
  • Domvanalimab — DRUG
    Domvanalimab IV (Intravenous infusion)
  • Placebo — OTHER
    Placebo IV (Intravenous infusion)

Study Details

This is a Phase III, randomised, double-blind, placebo-controlled, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) and domvanalimab (AB154) compared with durvalumab plus placebo in adults with locally advanced (Stage III), unresectable NSCLC whose disease has not progressed following definitive platinum-based cCRT.

Key Dates

Start date
Feb 18, 2022
Status verified
Jun 2026
Primary completion
Jul 12, 2028
Completion
Oct 1, 2030

Study Design

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

Arms

  • Experimental: Arm A: Durvalumab + Domvanalimab
    Durvalumab and domvanalimab as an IV infusion q4w, starting on Day 1 for up to a maximum of 12 months
  • Active Comparator: Arm B: Durvalumab + Placebo
    Durvalumab + placebo as an IV infusion q4w starting on Day 1 for up to a maximum of 12 months

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Up to 8 years after randomization ]

Central Contacts

Locations (43)

FacilityCityStateZIPSite coordinators
Research SiteChandlerArizona85224-
Research SitePhoenixArizona85054-
Research SiteFountain ValleyCalifornia92708-
Research SiteSanta RosaCalifornia95403-
Research SiteWashington D.C.District of Columbia20016-
Research SiteJacksonvilleFlorida32224-
Research SiteOrlandoFlorida32804-
Research SiteSaint AugustineFlorida32086-
Research SiteMaconGeorgia31217-
Research SiteElmhurstIllinois60126-
Research SiteMaywoodIllinois60153-
Research SiteNapervilleIllinois60540-
Research SiteLouisvilleKentucky40202-
Research SiteBaltimoreMaryland21224-
Research SiteSilver SpringMaryland20910-
Research SiteAnn ArborMichigan48106-0995-
Research SiteDetroitMichigan48202-
Research SiteMinneapolisMinnesota55407-
Research SiteRochesterMinnesota55905-
Research SiteRenoNevada89511-
Research SiteEast BrunswickNew Jersey08816-
Research SiteFlorham ParkNew Jersey07932-
Research SiteBuffaloNew York14221-
Research SiteJohnson CityNew York13790-
Research SiteAshevilleNorth Carolina28805-
Research SiteAshevilleNorth Carolina28806-
Research SiteCharlotteNorth Carolina28204-
Research SiteWinston-SalemNorth Carolina27157-
Research SiteColumbusOhio43214-
Research SiteColumbusOhio43219-
Research SiteMaumeeOhio43537-
Research SiteOklahoma CityOklahoma73102-
Research SitePittsburghPennsylvania15212-
Research SiteCharlestonSouth Carolina29401-
Research SiteChattanoogaTennessee37404-
Research SiteNashvilleTennessee37203-
Research SiteNashvilleTennessee37232-
Research SiteFort Sam HoustonTexas78234-
Research SiteKingwoodTexas77339-
Research SiteArlingtonVirginia22205-
Research SiteFort BelvoirVirginia22060-
Research SiteSpokane ValleyWashington99216-
Research SiteAppletonWisconsin54911-

Find similar trials in Chandler, AZ

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Research Site· Chandler, AZResearch Site· Phoenix, AZResearch Site· Fountain Valley, CAResearch Site· Santa Rosa, CAResearch Site· Washington D.C., DCResearch Site· Jacksonville, FL

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