Non-small Cell Lung CancerNCT03485326
A Multi-Centre, Prospective, Non-Interventional Study to Intensively Monitor the Safety of Osimertinib in Clinical Practice Among Chinese NSCLC Patients
An observational study of Non-small Cell Lung Cancer, run by AstraZeneca at 29 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-small Cell Lung Cancer
- How many people
- 1,700 participants
- Where
- 29 sitesChina
- Study dates
- 21 Apr 2020to 3 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Enrollment in other on-going studies, which prohibit any participation in this non-interventional study
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
China29 sites
Research Site
Beijing, 100142
Research Site
Chengde
Research Site
Chengdu, 610041
Research Site
Dingzhou
Research Site
Fuzhou
Research Site
Ganzhou
Research Site
Guangzhou, 510010
Research Site
Guangzhou, 510080
Research Site
Guangzhou, 510120
Research Site
Guangzhou
Research Site
Hangzhou, 310003
Research Site
Hangzhou, 310014
Research Site
Hangzhou, 310052
Research Site
Hangzhou, 321000
Research Site
Hangzhou
Research Site
Harbin, 150081
Research Site
Huanghua
Research Site
Jinan, 2501117
Research Site
Linhai, 317000
Research Site
Nanchang
Research Site
Shanghai, 200052
Research Site
Shijiazhuang, 050035
Research Site
Suzhou, 215004
Research Site
Taiyuan, 030000
Research Site
Tianjin, 300052
Research Site
Weihai
Research Site
Wuhan, 430030
Research Site
Wuhan, 430079
Research Site
Zhuji
About this study
Official title: 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
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.
Read the 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
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Osimertinib, Tagrisso, NSCLC, Non-small cell lung cancer, Safety
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Safety | Safety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of all ADRs
Incidence of all Adverse drug reaction
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start21 Apr 2020
- Primary completion3 Aug 2023
- Study completion3 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,700 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Baohui HAN, Doctor, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485326
- Sponsor's protocol ID
- D5160R00026
- Status last verified
- Jul 2024
- First submitted
- 27 Mar 2018
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41164890
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03485326
- Acronym / sponsor ID
- D5160R00026
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Osimertinib, Tagrisso, NSCLC, Non-small cell lung cancer, Safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,700 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2020 (actual)
- Primary completion
- 3 Aug 2023 (actual)
- Study completion
- 3 Aug 2023 (actual)
- First posted
- 2 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Safety | – | –Safety |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Enrollment in other on-going studies, which prohibit any participation in this non-interventional study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of all ADRs
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Derived from this study: PubMed 41164890Zhong 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.
- Redacted CSR synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baohui HAN, Doctor principal investigator
Shanghai Chest Hospital
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by AstraZeneca at 29 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of all ADRs (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03485326, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.