First Line Osimertinib for EGFR Mutation-positive Non-Small Cell Lung Cancer in Real World Chinese Setting
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|ClinicalTrials.gov Identifier: NCT04391283|
Recruitment Status : Recruiting
First Posted : May 18, 2020
Last Update Posted : January 12, 2021
|Condition or disease||Intervention/treatment|
|Carcinoma, Non-Small-Cell Lung||Drug: Osimertinib|
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.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||A Prospective, National, Multi-centric, Non-interventional Study of First Line Osimertinib in Chinese Patients With Locally Advanced/Metastatic，EGFR Mutation-positive NSCLC in Real World Setting|
|Actual Study Start Date :||July 27, 2020|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
- Drug: 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.Other Name: TAGRISSO
- Time to discontinuation (TTD) [ 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. ]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".
- Progression-free survival (PFS) and Progression-free survival rate (PFS rate) [ Time Frame: from the date of first dose of Osimertinib in this study until the date of disease progression, assessed up to 36 months. ]
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
- Objective Response Rate (ORR) and Disease Control Rate (DCR) [ Time Frame: from the date of first dose of Osimertinib, assessed up to 6 months. ]
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.
- Overall survival rate (OS rate) [ Time Frame: from the date of first dose of Osimertinib in this study until the death of patients,assessed up to 48 months. ]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".
- de novo T790M mutation rate [ Time Frame: the baseline and at the time of progression, assessed up to 36 months. ]
The mutation rate of de novo T790M test by high sensitive technique (analyzed by Next Generation Sequencing platform).
de novo T790M
- Adverse events/Serious adverse events [ Time Frame: from the date of first dose of Osimertinib in this study assessed up to 36 months. ]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.
Biospecimen Retention: None Retained
Blood Sample Collection and Retention: about 10 mL Whole human blood samples will be collected using streck tube, sent to the NGS lab and plasma will be extracted for storage at -80℃. until test.
Tissue Sample Collection and Retention At baseline, fresh tissue samples (or cytological samples) will be collected or 6 slices of tissue sample olefin resections obtained from surgery or 10 slices of tissue samples olefin resection obtained from puncture biopsy will be provide to central laboratory for biomarker analysis. Before tissue sample olefin resection sent to central laboratory, a pathological quality should be conducted to ensure the percentage of tumor cells is greater than 10%. Tissue sample olefin resection will be labeled and put in a box and store at room temperature
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): NCT04391283