Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy

Part of paid clinical trials in Tucson, Arizona.

Sponsor
AstraZeneca
Study ID
NCT03703297
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    Durvalumab IV (intravenous infusion)
  • Tremelimumab — DRUG
    Tremelimumab IV (intravenous infusion)
  • Placebo — OTHER
    Placebo IV (intravenous infusion)

Study Details

This is a Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with LS-SCLC Who Have Not Progressed Following Concurrent Chemoradiation Therapy

Key Dates

Start date
Sep 27, 2018
Status verified
Nov 2025
Primary completion
Jan 15, 2024
Completion
Oct 23, 2026

Study Design

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

Arms

  • Experimental: Durvalumab + Placebo
    Durvalumab monotherapy: Durvalumab (1500 mg intravenous \[IV\]) q4w in combination with placebo saline solution (IV) q4w for up to 4 doses/cycles each, followed by durvalumab 1500 mg q4w. The first durvalumab monotherapy 1500 mg dose q4w will be 4 weeks after the final dose of durvalumab in combination with placebo saline solution.
  • Experimental: Durvalumab + Tremelimumab
    Durvalumab in combination with tremelimumab: Durvalumab (1500 mg IV) q4w in combination with tremelimumab (75 mg IV) q4w for up to 4 doses/cycles each, followed by durvalumab 1500 mg q4w. The first durvalumab monotherapy 1500 mg dose q4w will be 4 weeks after the final dose of durvalumab in combination with tremelimumab.
  • Placebo Comparator: Placebo + Placebo
    Placebo: Placebo saline solution (IV) q4w in combination with a second placebo saline solution (IV) q4w for up to 4 doses/cycles each, followed by a single placebo saline solution q4w. The first placebo saline solution monotherapy dose q4w will be 4 weeks after the final dose of the 2 placebo saline solutions in combination.

Primary Outcome Measure

Durvalumab Versus Placebo: Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 [ Time Frame: Response evaluations performed every 8 weeks (q8w) ± 1 week up to 72 weeks, then every 12 weeks (q12w) ± 1 week up to 96 weeks, and then every 24 weeks (q24w) thereafter until PD, up to DCO date 15 January 2024 (a maximum of approximately 1936 days) ]

Locations (34)

FacilityCityStateZIPSite coordinators
Research SiteTucsonArizona85715-
Research SiteSanta RosaCalifornia95403-
Research SiteNew HavenConnecticut06510-
Research SiteFort MyersFlorida33901-
Research SiteOrange CityFlorida32763-
Research SiteSt. PetersburgFlorida33705-
Research SiteMariettaGeorgia30060-
Research SiteHinesIllinois60141-
Research SiteFort WayneIndiana46804-
Research SiteMuncieIndiana47303-
Research SiteLexingtonKentucky40536-
Research SiteAnnapolisMaryland21401-
Research SiteBaltimoreMaryland21287-
Research SiteTowsonMaryland21204-
Research SiteBostonMassachusetts02114-
Research SiteDetroitMichigan48201-
Research SiteGrand RapidsMichigan49503-
Research SiteMinneapolisMinnesota55407-
Research SiteSummitNew Jersey07902-
Research SiteNew Hyde ParkNew York11042-
Research SiteChapel HillNorth Carolina27599-
Research SitePortlandOregon97239-
Research SitePhiladelphiaPennsylvania19111-
Research SitePittsburghPennsylvania15212-
Research SiteSioux FallsSouth Dakota57104-
Research SiteChattanoogaTennessee37404-
Research SiteNashvilleTennessee37203-
Research SiteNashvilleTennessee37232-
Research SiteDallasTexas75390-
Research SiteKennewickWashington99336-
Research SiteTacomaWashington98405-
Research SiteCharlestonWest Virginia25304-
Research SiteHuntingtonWest Virginia25701-
Research SiteMilwaukeeWisconsin53226-

Find similar trials in Tucson, AZ

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Research Site· Tucson, AZResearch Site· Santa Rosa, CAResearch Site· New Haven, CTResearch Site· Fort Myers, FLResearch Site· Orange City, FLResearch Site· St. Petersburg, FL

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