A Multi-Centre, Prospective, Non-Interventional Study to Intensively Monitor the Safety of Osimertinib in Clinical Practice Among Chinese NSCLC Patients
1 other identifier
observational
1,700
1 country
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
Typical duration for all trials
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2018
CompletedFirst Posted
Study publicly available on registry
April 2, 2018
CompletedStudy Start
First participant enrolled
April 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 3, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 3, 2023
CompletedJuly 23, 2024
July 1, 2024
3.3 years
March 27, 2018
July 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of all ADRs
Incidence of all Adverse drug reaction
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)
Study Arms (1)
Safety
Safety
Eligibility Criteria
The study will recruit about 1700 Chinese patients histologically or cytologically diagnosed as NSCLC and received at least one dose of osimertinib treatment in China mainland.
You may qualify if:
- 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
You may not qualify if:
- Enrollment in other on-going studies, which prohibit any participation in this non-interventional study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (29)
Research Site
Beijing, 100142, China
Research Site
Chengde, China
Research Site
Chengdu, 610041, China
Research Site
Dingzhou, China
Research Site
Fuzhou, China
Research Site
Ganzhou, China
Research Site
Guangzhou, 510010, China
Research Site
Guangzhou, 510080, China
Research Site
Guangzhou, 510120, China
Research Site
Guangzhou, China
Research Site
Hangzhou, 310003, China
Research Site
Hangzhou, 310014, China
Research Site
Hangzhou, 310052, China
Research Site
Hangzhou, 321000, China
Research Site
Hangzhou, China
Research Site
Harbin, 150081, China
Research Site
Huanghua, China
Research Site
Jinan, 2501117, China
Research Site
Linhai, 317000, China
Research Site
Nanchang, China
Research Site
Shanghai, 200052, China
Research Site
Shijiazhuang, 050035, China
Research Site
Suzhou, 215004, China
Research Site
Taiyuan, 030000, China
Research Site
Tianjin, 300052, China
Research Site
Weihai, China
Research Site
Wuhan, 430030, China
Research Site
Wuhan, 430079, China
Research Site
Zhuji, China
Related Publications (1)
Zhong H, Jiang S, Yao W, Song X, Lv D, Zhu D, Guo Y, Ding C, Xue Y, Bai X, Xiao L, Chen P, Wang Y, Tian P, Lin G, Li W, Chen J, Hu Y, Xia B, Wang Z, Long H, Yao W, Zhang H, Zhao Q, Wang Y, Lu L, Duan W, Xing L, Yang F, Chen Y, Wei Y, Han B, He J. Safety of osimertinib in Chinese patients with non-small cell lung cancer: a multi-center, prospective, observational study. Future Oncol. 2025 Dec;21(28):3639-3648. doi: 10.1080/14796694.2025.2579208. Epub 2025 Oct 30.
PMID: 41164890DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Baohui HAN, Doctor
Shanghai Chest Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2018
First Posted
April 2, 2018
Study Start
April 21, 2020
Primary Completion
August 3, 2023
Study Completion
August 3, 2023
Last Updated
July 23, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.