First Line Osimertinib for EGFR Mutation-positive Non-Small Cell Lung Cancer in Real World Chinese Setting

NCT ID: NCT04391283

Last Updated: 2023-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-27
• Study Completion Date: 2024-12-31

Brief Summary

The results of phase III FLAURA study showed a significant PFS benefit for first-line Osimertinib versus standard EGFR-TKIs in patients with EGFR mutation-positive NSCLC, the median PFS was 18.9 months and 10.2 months, respectively. However, only 136 Chinese patients were enrolled in FLAURA study. The objectives of this study are to assess the efficacy and safety of Osimertinib in a real world setting in Chinese patients with locally advanced or metastatic, treatment naïve, epidermal growth factor receptor (EGFR) mutation-positive Non-Small Cell Lung Cancer (NSCLC).

Detailed Description

Total of ~30 study sites are selected for conducting this observational study. Eligible patients will be prospectively and consecutively included. Therefore, the clinical practice in the selected patients group can represent the "real-world" situation in China, and the patient's medical record will be well documented and archived in those hospitals. All data defined in the protocol will be collected during the study and entered in the Electric Data Capture (EDC), being consistent to the patients' medical records.

The most important bias of the study is that patients' characteristics will affect the treatment duration, efficacy and safety, such as, higher proportion of patients with WHO PS 2~3 enroll in the study will result in shorter TTD, poorer effectiveness and higher toxicities than expected. The ~30 sites are not randomly selected and potential selection bias exists. To minimize enrolment bias, the patients who are eligible and consent to participate in the current study will be enrolled consecutively as per protocol and without personal preference from investigators.

The self-selection bias may exit for the willingness and non-willingness participants. We'll try our best to discuss with the non-willingness participants to make sure the consistency/comparative between the willingness and non-willingness participants.

There could be a certain percentage of patients who would lost to follow up, it is unavoidable in clinical study, and is more common in real world study. We can minimize the bias by selecting the hospitals with normative and high-quality clinical practice, trying to collect the reason of lost to follow up and enhancing patient management during the follow up. The above bias is acceptable as this is a "real-world" study. Only descriptive analysis will be performed for the primary, secondary and exploratory objectives. No statistical comparisons between subgroups will be done.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Osimertinib

The recommended dose is 80 mg osimertinib once a day until disease progression or unacceptable toxicity according to the prescription information and clinical practice. It can be taken with or without food at the same time each day.

Intervention Type: DRUG

Other Intervention Names

TAGRISSO

Eligibility Criteria

Inclusion Criteria

• Ability to provide informed consent, complete all study assessments and have complete medical record;
• Histologically or cytologically documented locally advanced, metastatic NSCLC, which are not amenable to curative surgery or radiotherapy;
• With confirmation of the presence of the EGFR mutation.
• Patients must be treatment- naïve for locally advanced or metastatic NSCLC.
• Age ≥ 18 years
• Patients who plan to receive Osimertinib monotherapy as the initial first line treatment based on physician's medical judgement.

Exclusion Criteria

• Patients who will be or were involved in any other interventional anti-tumour clinical studies for locally advanced/metastatic NSCLC currently or previously
• Any concomitant condition evaluated by physicians which is not suitable for Osimertinib treatment.
• Patients who have received the first dose of Osimertinib before the signature of ICF won't be allowed to enroll in.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of College of Medicine Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

References

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Other Identifiers

Osimertinib-RWE-01

Identifier Type: -

Identifier Source: org_study_id