A study of 5 years of adjuvant osimertinib in completely resected epidermal growth factor receptor mutation (EGFRm) non-small cell lung carcinoma (NSCLC) - TARGET

Study identifier:D5162C00048

ClinicalTrials.gov identifier:NCT05526755

EudraCT identifier:2021-003024-33

CTIS identifier:N/A

Recruiting

Official Title

An open-label, single-arm, Phase II, multinational, multicentre study to assess the efficacy and safety of 5 years of osimertinib in participants with EGFRm-positive Stage II-IIIB NSCLC, following complete tumour resection with or without adjuvant chemotherapy

Medical condition

Stage II-IIIB Non-small Cell Lung Carcinoma

Phase

Phase 2

Healthy volunteers

No

Study drug

Osimertinib 80 mg/40 mg

Sex

All

Estimated Enrollment

180

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 06 Mar 2023
Estimated Primary Completion Date: 05 Apr 2029
Estimated Study Completion Date: 05 Apr 2029

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria