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

Completed

• Conditions: Non-small Cell Lung Cancer

• Registration Number: NCT03485326
• Lead Sponsor: AstraZeneca

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

Study Timeline

• Study First Submitted: 2018-03-27
• Study First Submitted QC: 2018-03-27
• Study First Posted: 2018-04-02
• Study Start: 2020-04-21
• Primary Completion: 2023-08-03
• Study Completion: 2023-08-03
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1700

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇨🇳 Zhuji, China