Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC

Part of paid clinical trials in Anaheim, California.

Sponsor
MedImmune LLC
Study ID
NCT03822351
Phase
PHASE2
Status
Completed

Conditions

  • Stage III Non-small Cell Lung Cancer
  • Unresectable

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to compare the clinical activity of durvalumab alone vs durvalumab in combination with novel agents. The overall study goal is early identification of novel durvalumab combinations that are more active than durvalumab alone in the treatment of patients with unresectable, Stage III NSCLC who have not progressed after cCRT.

Key Dates

Start date
Dec 19, 2018
Status verified
Oct 2024
Primary completion
Jul 18, 2023
Completion
Jul 18, 2023

Study Design

Enrollment
189 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Control Arm (Durvalumab monotherapy)
    durvalumab IV
  • Experimental: Arm A (durvalumab + oleclumab):
    durvalumab IV and oleclumab IV
  • Experimental: Arm B (durvalumab + monalizumab)
    durvalumab IV and monalizumab IV

Primary Outcome Measure

Objective Response (OR) Rate as a Measure of Antitumor Activity of Durvalumab Alone vs Durvalumab in Combination With Novel Agents [ Time Frame: ORR at 16 weeks after randomization is the timing for radiologic assessment of the primary endpoint ]

Locations (28)

FacilityCityStateZIPSite coordinators
Research SiteAnaheimCalifornia92801-
Research SiteDuarteCalifornia91010-
Research SiteSacramentoCalifornia95825-
Research SiteNew HavenConnecticut06510-
Research SiteWest HavenConnecticut06516-
Research SiteWashington D.C.District of Columbia20007-
Research SiteOrlandoFlorida32804-
Research SiteWinter HavenFlorida33881-
Research SiteWichitaKansas67214-
Research SiteLexingtonKentucky40503-
Research SiteLouisvilleKentucky40202-
Research SiteBaton RougeLouisiana70809-
Research SiteCovingtonLouisiana70433-
Research SiteRosedaleMaryland21237-
Research SiteLincolnNebraska68510-
Research SiteNew YorkNew York10029-
Research SiteNew YorkNew York10065-
Research SitePortlandOregon97227-1191-
Research SiteGettysburgPennsylvania17325-
Research SiteLancasterPennsylvania17601-
Research SitePhiladelphiaPennsylvania19104-
Research SiteSioux FallsSouth Dakota57105-
Research SiteGermantownTennessee38138-
Research SiteMemphisTennessee38120-
Research SiteTylerTexas75701-
Research SiteSalt Lake CityUtah84112-
Research SiteRichmondVirginia23230-
Research SiteTacomaWashington98405-

Find similar trials in Anaheim, CA

By research site
Research Site· Anaheim, CAResearch Site· Duarte, CAResearch Site· Sacramento, CAResearch Site· New Haven, CTResearch Site· West Haven, CTResearch Site· Washington D.C., DC

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