Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Safety
- description
- Safety
Primary outcomes (1)
- measure
- Incidence of all ADRs
- timeFrame
- 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)
- description
- Incidence of all Adverse drug reaction
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDZhong 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 41164890