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

Carcinoma, Non-Small-Cell Lung Clinical Trial

— KOREA-PLUS  

Official title:

Open Label, Multicenter, Real World Treatment Study of Single Agent Tagrisso; KOREA PLUS Study (Korea Osimertinib Real World Evidence Study to Assess Safety and Efficacy - PLUS).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03918304
• Other study ID #: D5161R00005
• Status: Recruiting
• Start date: June 11, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 852
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

• 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Locations

Country	Name	City	State
Korea, Republic of	Research Site	Busan
Korea, Republic of	Research Site	Busan
Korea, Republic of	Research Site	Daegu
Korea, Republic of	Research Site	Gyeonggi-do
Korea, Republic of	Research Site	Gyeonggi-do
Korea, Republic of	Research Site	Gyeonggi-do
Korea, Republic of	Research Site	Incheon
Korea, Republic of	Research Site	Jeollabuk-do
Korea, Republic of	Research Site	Jeollanam-do
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Severity of (S)AEs according to CTCAE		For about 1 year since the first dose of the study drug
Secondary	ORR (Objective response rate), if available		For about 1 year since the first dose of the study drug
Secondary	PFS (Progression free survival) , if available		For about 1 year since the first dose of the study drug
Secondary	DFS (Disease free survival), if available		For about 1 year since the first dose of the study drug