NCT02777567

Brief Summary

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 in adult patients with advanced or metastatic, epidermal growth factor receptor (EGFR) T790M mutation-positive Non-Small Cell Lung Cancer (NSCLC), Who Have Progressed on or after EGFR tyrosine kinase receptor (TKI) therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 19, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

September 29, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2020

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

3.5 years

First QC Date

May 13, 2016

Last Update Submit

September 8, 2020

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • Proportion (%) of patients with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI)

    Proportion (%) of patients with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI)

    up to one year

  • Severity of (S)AEs

    Severity of (S)AEs

    up to one year

Secondary Outcomes (2)

  • ORR (Objective response rate), if available

    up to one year

  • PFS (Progression free survival), if available

    up to one year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with locally advanced or metastatic, EGFR T790M mutation-positive NSCLC, who have progressed on or after EGFR tyrosine kinase receptor (TKI) therapy

You may qualify if:

  • \. Eligible for, or on active study drug treatment according to the approved label; patients with locally advanced or metastatic, EGFR T790M mutation-positive NSCLC, who have progressed on or after EGFR tyrosine kinase receptor (TKI) therapy
  • \. Provision of signed and dated written informed consent by the patient or legally acceptable representative

You may not qualify if:

  • \. History of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug
  • \. Pregnancy and/or breast feeding
  • \. Current participation in any interventional trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

South Korea, South Korea, South Korea

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2016

First Posted

May 19, 2016

Study Start

September 29, 2016

Primary Completion

March 19, 2020

Study Completion

March 19, 2020

Last Updated

September 10, 2020

Record last verified: 2020-09

Locations

KR(1)