A Study of 5 Years of Adjuvant Osimertinib in Completely Resected Epidermal Growth Factor Receptor Mutation (EGFRm) Non-small Cell Lung Carcinoma (NSCLC)

Conditions

• Stage II-IIIB Non-small Cell Lung Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 130 Years

Healthy Volunteers

Not accepted

Interventions

• Osimertinib 80 mg/40 mg — DRUG
  Participants will receive osimertinib (80 mg or 40 mg orally, once daily).

Study Details

To assess the efficacy and safety of osimertinib in participants with EGFRm positive stage II-IIIB NSCLC, following complete tumour resection with or without adjuvant chemotherapy.

Key Dates

Start date

Mar 6, 2023

Status verified

Jun 2026

Primary completion

Nov 22, 2029

Completion

Nov 22, 2029

Study Design

Enrollment

188 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Osimertinib
  Participants will receive osimertinib (AZD9291).

Primary Outcome Measure

Estimate the Efficacy of Osimertinib as Measured by Disease Free Survival (DFS) [Common EGFRm Cohort]. [ Time Frame: From date of first dose until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 5 years. Assessed at 5 years. ]

Locations (3)

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