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

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ClinicalTrials.gov Identifier: NCT03485326
Recruitment Status : Recruiting
First Posted : April 2, 2018
Last Update Posted : February 18, 2022
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.


Condition or disease
Non-small Cell Lung Cancer

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
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Study Type : Observational
Estimated Enrollment : 1700 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : April 21, 2020
Estimated Primary Completion Date : June 22, 2023
Estimated Study Completion Date : June 22, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety
Drug Information available for: Osimertinib

Groups and Cohorts
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Group/Cohort
Safety
Safety


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03485326


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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China
Research Site Recruiting
Beijing, China, 100032
Research Site Recruiting
Beijing, China, 100142
Research Site Recruiting
Changchun, China, 130021
Research Site Recruiting
Chengdu, China, 610041
Research Site Recruiting
Guangzhou, China, 510010
Research Site Recruiting
Guangzhou, China, 510080
Research Site Recruiting
Guangzhou, China, 510120
Research Site Recruiting
Hangzhou, China, 310003
Research Site Recruiting
Hangzhou, China, 310014
Research Site Recruiting
Hangzhou, China, 310052
Research Site Recruiting
Harbin, China, 150081
Research Site Recruiting
Jinan, China, 2501117
Research Site Recruiting
Jinhua, China, 321000
Research Site Recruiting
Linhai, China, 317000
Research Site Recruiting
Linyi, China, 276000
Research Site Recruiting
Shanghai, China, 200052
Research Site Recruiting
Shijiazhuang, China, 050035
Research Site Recruiting
Suzhou, China, 215004
Research Site Recruiting
Taiyuan, China, 030000
Research Site Recruiting
Tianjin, China, 300052
Research Site Recruiting
Weihai, China
Research Site Recruiting
Wuhan, China, 430030
Research Site Recruiting
Wuhan, China, 430079
Research Site Recruiting
Xuzhou, China, 221006
Research Site Not yet recruiting
Zhengzhou, China, 450008
Research Site Recruiting
Zhuji, China
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Baohui HAN, Doctor Shanghai Chest Hospital
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03485326    
Other Study ID Numbers: D5160R00026
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: February 18, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by AstraZeneca:
Osimertinib
Tagrisso
NSCLC
Non-small cell lung cancer
Safety
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms