A Phase III Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Non Small Cell Lung Cancer (NSCLC) Whose Disease Progressed On or After Prior Anti PD (L)1 Therapy And Platinum Based Chemotherapy

Part of paid clinical trials in Mobile, Alabama.

Sponsor
AstraZeneca
Study ID
NCT05450692
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Advanced or Metastatic Non-Small Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Ceralasertib — DRUG
    Participants will receive ceralasertib oral tablets.
  • Durvalumab — DRUG
    Participants will receive durvalumab as an intravenous infusion.
  • Docetaxel — DRUG
    Participants will received docetaxel as an intravenous infusion.

Study Details

This study will assess the efficacy and safety of the combination of ceralasertib and durvalumab versus standard of care docetaxel in patients with locally advanced and metastatic NSCLC after progression on prior anti-PD-(L)1 therapy and platinum-based chemotherapy.

Key Dates

Start date
Sep 15, 2022
Status verified
Apr 2026
Primary completion
Oct 6, 2025
Completion
Dec 31, 2027

Study Design

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

Arms

  • Experimental: Group A: Ceralasertib plus durvalumab combination therapy
    Participants will be administered ceralasertib orally followed by durvalumab administered intravenously.
  • Active Comparator: Group B: Docetaxel monotherapy
    Participants will be administered docetaxel (standard of care) administered intravenously.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Every 3 months (± 1 week) following objective progression of disease (PD) or treatment discontinuation (up to three years) ]

Locations (28)

FacilityCityStateZIPSite coordinators
Research SiteMobileAlabama36607-
Research SiteChandlerArizona85224-
Research SiteLos AlamitosCalifornia90720-
Research SiteLos AngelesCalifornia90017-
Research SiteWhittierCalifornia90603-
Research SiteJacksonvilleFlorida32256-
Research SiteOrlandoFlorida32804-
Research SiteTampaFlorida33612-
Research SiteAthensGeorgia30607-
Research SiteAtlantaGeorgia30318-
Research SiteFort WayneIndiana46804-
Research SiteBaltimoreMaryland21231-
Research SiteBethesdaMaryland20817-
Research SiteRockvilleMaryland20852-
Research SiteHattiesburgMississippi39401-
Research SiteSt LouisMissouri63110-
Research SiteOmahaNebraska68114-
Research SiteRenoNevada89511-
Research SiteCharlotteNorth Carolina28204-
Research SiteWinston-SalemNorth Carolina27103-
Research SiteCantonOhio44718-
Research SiteClevelandOhio44106-
Research SiteAllentownPennsylvania18103-
Research SiteYorkPennsylvania17403-
Research SiteHoustonTexas77090-
Research SiteHuntsvilleTexas77340-
Research SiteKingwoodTexas77339-
Research SiteAppletonWisconsin54911-

Find similar trials in Mobile, AL

By research site
Research Site· Mobile, ALResearch Site· Chandler, AZResearch Site· Los Alamitos, CAResearch Site· Los Angeles, CAResearch Site· Whittier, CAResearch Site· Jacksonville, FL

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