Clinical trial NCT03485326: A Multi-Centre, Prospective, Non-Interventional Study to Intensively Monitor the Safety of Osimertinib in Clinical Practice Among Chinese NSCLC Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Keywords: Osimertinib
Tagrisso
NSCLC
Non-small cell lung cancer
Safety
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2018-04-02
Enrollment: 1700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Eligibility 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

Primary outcomes:
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)
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
city: Chengde
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Dingzhou
country: China
facility: Research Site
city: Fuzhou
country: China
facility: Research Site
city: Ganzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Harbin
country: China
facility: Research Site
city: Huanghua
country: China
facility: Research Site
city: Jinan
country: China
facility: Research Site
city: Linhai
country: China
facility: Research Site
city: Nanchang
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shijiazhuang
country: China
facility: Research Site
city: Suzhou
country: China
facility: Research Site
city: Taiyuan
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
city: Weihai
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Zhuji
country: China
facility: Research Site
Study officials:
affiliation: Shanghai Chest Hospital
name: Baohui HAN, Doctor
role: PRINCIPAL_INVESTIGATOR
References: