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NCT Number: NCT03918304

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

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.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Busan, South Korea

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria:
  • 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:
  • History of hypersensitivity to the active substance or to any of the excipients of this drug
  • Pregnancy and/or breast feeding
  • Current participation in any interventional trial

Treatment and study plan

Primary outcomes

  1. Proportion (%) of patients with at least one event of adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI)

    Time frame: For about 1 year since the first dose of the study drug

  2. Severity of (S)AEs according to CTCAE

    Time frame: For about 1 year since the first dose of the study drug

Secondary outcomes

  1. ORR (Objective response rate), if available

    Time frame: For about 1 year since the first dose of the study drug

  2. PFS (Progression free survival) , if available

    Time frame: For about 1 year since the first dose of the study drug

  3. DFS (Disease free survival), if available

    Time frame: For about 1 year since the first dose of the study drug

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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).

Acronym: KOREA-PLUS

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Apr 17, 2019
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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