Study to Assess the Efficacy and Safety of Adjuvant Osimertinib in NSCLC With Uncommon EGFRm

Sponsor
AstraZeneca
Study ID
NCT05546866
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Osimertinib — DRUG
    Subjects successfully enrolled into the study will receive 80mg osimertinib QD p.o. until completion of planned treatment duration, recurrence of disease, or other treatment discontinuation criteria is met. The maximum treatment duration period is 3 years.

Study Details

This is an open-label, multi-centre, single-arm study assessing the efficacy and safety of osimertinib as adjuvant treatment in stage IB-IIIB (8th AJCC) NSCLC with uncommon EGFRm after receiving complete surgical resection with or without adjuvant chemotherapy.

Key Dates

Start date
Feb 9, 2023
Status verified
May 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
51 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Osimertinib
    Subjects successfully enrolled into the study will receive 80mg osimertinib QD p.o. until completion of planned treatment duration, recurrence of disease, or other treatment discontinuation criteria is met. The maximum treatment duration period is 3 years.

Primary Outcome Measure

3-year disease-free survival (DFS) rate by investigator assessment [ Time Frame: Up to 3 years for each subject from the first dosing of study treatment. ]

Related Studies