Korea Osimertinib Real World Evidence Study to Assess Safety and Efficacy - PLUS

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung

• Registration Number: NCT03918304
• Lead Sponsor: AstraZeneca

Brief Summary

This is a local, prospective, non-interventional, regulatory postmarketing surveillance study. The objectives of this study are to assess the safety and efficacy of single agent Tagrisso (Osimertinib, hereinafter "the study drug") in a real world setting according to the approved label in Korea.

Detailed Description

* Primary objective: To assess safety of the Tagrisso for patients with NSCLC treated with Tagrisso under the approved indication in Korea

* Secondary objective: To assess efficacy of the Tagrisso for patients with NSCLC treated with Tagrisso under the approved indication in Korea.

Study Timeline

• Study First Submitted: 2019-04-15
• Study First Submitted QC: 2019-04-15
• Study First Posted: 2019-04-17
• Study Start: 2019-06-11
• Primary Completion: 2024-10-27
• Study Completion: 2024-10-27
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 923

Inclusion Criteria

1. Eligible for, or on active study drug treatment according to the approved prescribing information;

• The first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations
• Treatment of patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC who have been previously treated with EGFR TKI therapy
• The adjuvant treatment after complete tumour resection in patients with non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations 2. Provision of signed and dated written informed consent by the patient or legally acceptable representative

Exclusion Criteria

1. History of hypersensitivity to the active substance or to any of the excipients of this drug
2. Pregnancy and/or breast feeding
3. Current participation in any interventional trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion (%) of patients with at least one event of adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI)	For about 1 year since the first dose of the study drug
Severity of (S)AEs according to CTCAE	For about 1 year since the first dose of the study drug

Secondary Outcome Measures

Name	Time	Method
ORR (Objective response rate), if available	For about 1 year since the first dose of the study drug
PFS (Progression free survival) , if available	For about 1 year since the first dose of the study drug
DFS (Disease free survival), if available	For about 1 year since the first dose of the study drug

Trial Locations

Locations (1)

Research Site; 🇰🇷 Seoul, Korea, Republic of