A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection

Part of paid clinical trials in Anchorage, Alaska.

Sponsor
AstraZeneca
Study ID
NCT05120349
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Osimertinib — DRUG
    The initial dose of Osimertinib 80mg once daily can be reduced to 40mg once daily. Treatment can continue until disease recurrence, unacceptable toxicity or other discontinuation criteria are met.
  • Placebo — DRUG
    Matching placebo. Initial dose of 80mg once daily can be reduced to 40mg once daily.

Study Details

This is a global study to assess the effects of osimertinib in participants with EGFRm stage IA2-IA3 non-small cell lung cancer following complete tumour resection.

Key Dates

Start date
Feb 21, 2022
Status verified
Apr 2026
Primary completion
Aug 2, 2027
Completion
Nov 1, 2032

Study Design

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

Arms

  • Experimental: Osimertinib
    Osimertinib 80mg, orally, once daily (Dose may be reduced to 40 mg once daily if required at the discretion of the investigator)
  • Placebo Comparator: Placebo
    Matching placebo for osimertinib, orally, once daily

Primary Outcome Measure

Disease-Free Survival (DFS) in high-risk stratum [ Time Frame: From date of randomisation up to approximately 10 years ]

Locations (15)

FacilityCityStateZIPSite coordinators
Research SiteAnchorageAlaska99508-
Research SiteLos AngelesCalifornia90024-
Research SiteOrangeCalifornia92868-
Research SiteGrand JunctionColorado81501-
Research SiteNewarkDelaware19713-
Research SiteAtlantaGeorgia30322-
Research SiteChicagoIllinois60612-
Research SiteFrederickMaryland21702-
Research SiteMorristownNew Jersey07960-
Research SiteFlushingNew York11355-
Research SiteNew YorkNew York10032-
Research SiteNew YorkNew York10065-
Research SiteWhite PlainsNew York10601-
Research SiteHoustonTexas77030-
Research SiteFort BelvoirVirginia22060-

Find similar trials in Anchorage, AK

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Research Site· Anchorage, AKResearch Site· Los Angeles, CAResearch Site· Orange, CAResearch Site· Grand Junction, COResearch Site· Newark, DEResearch Site· Atlanta, GA

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