A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer

Part of paid clinical trials in San Diego, California.

Sponsor
AstraZeneca
Study ID
NCT05221840
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    Durvalumab IV (intravenous infusion)
  • Oleclumab — DRUG
    Oleclumab IV (intravenous infusion)
  • Monalizumab — DRUG
    Monalizumab IV (intravenous infusion)
  • Placebo — OTHER
    Placebo IV (intravenous infusion)

Study Details

This is a Phase III, randomised, double-blind, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) or durvalumab (MEDI4736) with monalizumab (IPH2201) in adults with locally advanced (Stage III), unresectable NSCLC, who have not progressed following platinum-based cCRT.

Key Dates

Start date
Feb 7, 2022
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
Jul 2, 2030

Study Design

Enrollment
1,051 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Durvalumab and Oleclumab
    Durvalumab on Day 1 of each 28-day cycle + Oleclumab on Days 1 and 15 of cycles 1 and 2, then on Day 1 of each subsequent 28-day cycle for up to 12 months
  • Experimental: Arm B: Durvalumab and Monalizumab
    Durvalumab + Monalizumab on Day 1 of each 28-day cycle for up to 12 months. Placebo infusion will be administered on Day 15 of cycles 1 and 2 only
  • Active Comparator: Arm C: Durvalumab and Placebo
    Durvalumab on Day 1 of each 28-day cycle + Placebo on Days 1 and 15 of cycles 1 and 2, then on Day 1 of each subsequent 28-day cycle for up to 12 months

Primary Outcome Measure

Progression Free Surival (PFS) [ Time Frame: Up to 5 years after first patient randomized. ]

Locations (33)

FacilityCityStateZIPSite coordinators
Research SiteSan DiegoCalifornia92123-
Research SiteNew HavenConnecticut06510-
Research SiteStuartFlorida34994-
Research SiteUrbanaIllinois61801-
Research SiteNew AlbanyIndiana47150-
Research SiteLexingtonKentucky40503-
Research SiteLouisvilleKentucky40241-
Research SiteAnnapolisMaryland21401-
Research SiteBaltimoreMaryland21201-
Research SiteBaltimoreMaryland21229-
Research SiteBethesdaMaryland20817-
Research SiteGrand RapidsMichigan49503-
Research SiteDuluthMinnesota55805-
Research SiteBillingsMontana59101-
Research SiteRidgewoodNew Jersey07450-
Research SiteIthacaNew York14850-
Research SiteGreensboroNorth Carolina27403-
Research SiteClevelandOhio44124-
Research SiteClevelandOhio44195-
Research SiteMaumeeOhio43537-
Research SitePortlandOregon97239-
Research SitePhiladelphiaPennsylvania19104-
Research SiteYorkPennsylvania17403-
Research SiteSioux FallsSouth Dakota57105-
Research SiteHoustonTexas77030-
Research SiteCharlottesvilleVirginia22908-
Research SiteFairfaxVirginia22031-
Research SiteFredericksburgVirginia22408-
Research SiteRichmondVirginia23235-
Research SiteRichlandWashington99352-
Research SiteSpokaneWashington99204-
Research SiteTacomaWashington98405-
Research SiteMilwaukeeWisconsin53226-

Find similar trials in San Diego, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Research Site· San Diego, CAResearch Site· New Haven, CTResearch Site· Stuart, FLResearch Site· Urbana, ILResearch Site· New Albany, INResearch Site· Lexington, KY

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