Clinical trial NCT03918304: Korea Osimertinib Real World Evidence Study to Assess Safety and Efficacy - 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).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2019-04-17
Enrollment: 923
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: On active study drug treatment according to the approved label

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.

Eligibility criteria: * 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

Primary outcomes:
measure: Proportion (%) of patients with at least one event of adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI)
timeFrame: For about 1 year since the first dose of the study drug
measure: Severity of (S)AEs according to CTCAE
timeFrame: For about 1 year since the first dose of the study drug
Secondary outcomes:
measure: ORR (Objective response rate), if available
timeFrame: For about 1 year since the first dose of the study drug
measure: PFS (Progression free survival) , if available
timeFrame: For about 1 year since the first dose of the study drug
measure: DFS (Disease free survival), if available
timeFrame: For about 1 year since the first dose of the study drug
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Research Site
city: Chungcheongbuk-do
country: Korea, Republic of
facility: Research Site
city: Daegu
country: Korea, Republic of
facility: Research Site
city: Daejeon
country: Korea, Republic of
facility: Research Site
city: Gangwon State
country: Korea, Republic of
facility: Research Site
city: Gyeonggi-do
country: Korea, Republic of
facility: Research Site
city: Incheon
country: Korea, Republic of
facility: Research Site
city: Jeollabuk-do
country: Korea, Republic of
facility: Research Site
city: Jeollanam-do
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
Study officials:
References: