An observational study in Carcinoma, Non-Small-Cell Lung, sponsored by First Affiliated Hospital of Zhejiang University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-17.
Sponsored by First Affiliated Hospital of Zhejiang University · Observational
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).
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 500 is above the median of 161 across 949 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →First Affiliated Hospital of Zhejiang University is the lead sponsor of 256 studies on the registry; 140 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The patients with locally advanced/metastatic, EGFR mutation-positive NSCLC who are intent to be prescribed Osimertinib as the first line treatment are eligible to be the study target population.
Base on the current clinical practice, it is estimated that the brain scans could be performed to approximately 350 patients at the baseline, approximately 200 patients' tissue or blood sample could be available at the baseline for de novo T790M analysis, and few patients with uncommon EGFR mutation, and/or patients with PS 2-3 could be included base on the current CSCO lung cancer guideline and clinical practice.
Exclusion Criteria:
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.
Also known as: TAGRISSO
Time to discontinuation (TTD)
Time to discontinuation (TTD), is defined as the time from the date of first dose of Osimertinib in this study until the date of Osimertinib discontinuation for any reason including disease progression, treatment toxicity, death or other reason as recorded in CRF. Subjects who are still on treatment at the time of analysis will be censored at the date of last dose received. Lost to follow-up patients will be censored at last documented contact with patient status "on treatment".
Time frame: from the date of first dose of Osimertinib in this study until the date of Osimertinib discontinuation for any reason including disease progression, treatment toxicity, death or other reason as recorded in CRF, assessed up to 36 months.
Progression-free survival (PFS) and Progression-free survival rate (PFS rate)
Progression-free survival (PFS), is defined as the time from the date of first dose of Osimertinib in this study until the date of disease progression as recorded in CRF or death (by any cause in the absence of progression) regardless of whether the subject withdraws from therapy or receives another anti-cancer therapy prior to progression, which usually refer to Response Evaluation Criteria In Solid Tumours (RECIST) in clinical practice. Subjects who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment. If the subject has no evaluable visits after the baseline visit, they will be censored at 0 days unless they die before the planned visit after the baseline visit. Lost to follow-up patients who have not progressed will be censored at last documented contact with patient status "non-progression". Progression-free survival rate (PFS rate), is defined as the percentage of patients who do not progress on Osimertinib treatment
Time frame: from the date of first dose of Osimertinib in this study until the date of disease progression, assessed up to 36 months.
Objective Response Rate (ORR) and Disease Control Rate (DCR)
Objective Response Rate (ORR), is defined as the percentage of patients with complete response or partial response by investigator assessment as recorded in the CRF, which usually refer to Response Evaluation Criteria In Solid Tumours (RECIST) in clinical practice. Disease Control Rate (DCR), is defined as the percentage of patients with non-progression by investigator assessment as recorded in the CRF, which usually refer to Response Evaluation Criteria In Solid Tumours (RECIST) in clinical practice.
Time frame: from the date of first dose of Osimertinib, assessed up to 6 months.
Overall survival rate (OS rate)
Defined as the proportion of patients who are still alive at a particular time in the study (eg, 1 year or 2 years). The patient should be contacted 1 week after the termination of the corresponding OS analysis data to determine survival status. Lost to follow-up patients who have not progressed will be censored at last documented contact with patient status "survival".
Time frame: from the date of first dose of Osimertinib in this study until the death of patients,assessed up to 48 months.
de novo T790M mutation rate
The mutation rate of de novo T790M test by high sensitive technique (analyzed by Next Generation Sequencing platform). de novo T790M
Time frame: the baseline and at the time of progression, assessed up to 36 months.
Adverse events/Serious adverse events
Incidence of Adverse Events (AEs): Nature, incidence, severity and seriousness of adverse events, Incidence of Serious Adverse Events (SAEs), which usually be graded by CTCAE v4.03 based on current clinical practice.
Time frame: from the date of first dose of Osimertinib in this study assessed up to 36 months.
Plan to share: No
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
First Affiliated Hospital of Zhejiang University