Phase III Study to Determine the Efficacy of Durvalumab in Combination With Chemotherapy in Completely Resected Stage II-III Non-small Cell Lung Cancer (NSCLC)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AstraZeneca
Study ID
NCT04385368
Phase
PHASE3
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

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

Interventions

Study Details

This is a Phase III, randomized, parallel-arm, placebo controlled, double blind, multicenter study assessing the efficacy and safety of durvalumab versus placebo following SoC chemotherapy in patients with completely resected stage II-III NSCLC who are MRD+ post surgery

Key Dates

Start date
Jul 17, 2020
Status verified
Aug 2024
Primary completion
Aug 31, 2023
Completion
Aug 31, 2023

Study Design

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

Arms

  • Experimental: Durvalumab + SoC chemotherapy
    Intravenous administration of Experimental and Standard of Care Therapy
  • Placebo Comparator: Placebo + SoC chemotherapy
    Intravenous administration of Placebo and Standard of Care Therapy

Primary Outcome Measure

Disease-free Survival (DFS) in FAS (Using Investigator Assessments According to Response Evaluation Criteria in Solid Tumors 1.1 [RECIST 1.1]) [ Time Frame: Every 12 weeks (q12w) ± 1 week until appearance of RECIST 1.1-defined disease recurrence or until primary DFS analysis, up to 33.28 months ]

Locations (15)

FacilityCityStateZIPSite coordinators
Research SiteBirminghamAlabama35294-
Research SiteLong BeachCalifornia90806-
Research SiteSanta RosaCalifornia95403-
Research SiteWest HollywoodCalifornia90048-
Research SiteMiamiFlorida33136-
Research SiteSilver SpringMaryland20910-
Research SiteMinneapolisMinnesota55407-
Research SiteLincolnNebraska68510-
Research SiteAlbuquerqueNew Mexico87131-
Research SiteNew YorkNew York10032-
Research SiteDurhamNorth Carolina27710-
Research SiteSpartanburgSouth Carolina29303-
Research SiteSioux FallsSouth Dakota57105-
Research SiteHoustonTexas77090-
Research SiteSeattleWashington98108-1532-

Find similar trials in Birmingham, AL

By research site
Research Site· Birmingham, ALResearch Site· Long Beach, CAResearch Site· Santa Rosa, CAResearch Site· West Hollywood, CAResearch Site· Miami, FLResearch Site· Silver Spring, MD

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