A Multi-Centre, Prospective, Non-Interventional Study to Intensively Monitor the Safety of Osimertinib in Clinical Practice Among Chinese NSCLC Patients

A Multi-Centre, Prospective, Non-Interventional Study to Intensively Monitor the Safety of Osimertinib in Clinical Practice Among Chinese NSCLC Patients An Observational Study Conducted Among Chinese NSCLC Patients to Evaluate Osimertinib Safety Profile in a Real World Setting

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03485326

Enrollment

1700

Registered

2018-04-02

Start date

2020-04-21

Completion date

2023-08-03

Last updated

2024-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

Osimertinib, Tagrisso, NSCLC, Non-small cell lung cancer, Safety

Brief summary

This is a multi-center, prospective, non-interventional study. The study will enroll about 1700 Chinese patients diagnosed as NSCLC and treated with osimertinib at least one dose. The objective of this non-interventional study is to monitor the safety profile of osimertinib in Chinese NSCLC patients in real world clinical practice.

Detailed description

This is a multi-center, prospective, non-interventional study. The study will enroll about 1700 Chinese patients diagnosed as NSCLC and treated with osimertinib at least one dose. The investigator in an observational study cannot intervene in the treatment. The prescribing doctor is in charge of prescribing or discontinuation of osimertinib. It is planned that all eligible patients who received at least one dose of osimertinib at the participating sites will be enrolled until 1700 patients has been recruited. The recruited patients will be followed up according to standard clinical practice. They will be tracked up to 30 days after discontinuation of osimertinib treatment, or 12 months after study enrolment, whichever comes earlier. For patients who accrued SAE, the SAE will be followed up until the outcome is defined, or the study is terminated, whichever comes earlier. The study would be terminated 12 months after the last patient is enrolled. The objective of this non-interventional study is to monitor the safety profile of osimertinib in Chinese NSCLC patients in real world clinical practice. The primary endpoint of this study is the incidence of all adverse drug reactions (ADRs). The second endpoints include the severity for AEs, the incidence of all AEs, AESIs, SAEs, the incidence of AEs for elderly population (age ≥ 65 years old), and AEs leading to osimertinib-associated interruption, dose reduction, discontinuation, and death

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Provision of signed and dated written informed consent by the patient or legally acceptable representative prior to any study-specific procedures * Patients histologically or cytologically diagnosed as NSCLC * Eligible for osimertinib treatment per the judgement of the treating physician in clinical practice * Received at least one dose of osimertinib

Exclusion criteria

• Enrollment in other on-going studies, which prohibit any participation in this non-interventional study

Design outcomes

Primary

Measure	Time frame	Description
Incidence of all ADRs	From time of patients enrolled in the study until end of study follow-up (30 days after discontinuation of osimertinib treatment, or 12 months after study enrolment, whichever comes earlier)	Incidence of all Adverse drug reaction

Countries

China

Outcome results