Carcinoma, Non-Small-Cell LungNCT04391283
First Line Osimertinib for EGFR Mutation-positive Non-Small Cell Lung Cancer in Real World Chinese Setting
An observational study of Carcinoma, Non-Small-Cell Lung, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Osimertinib
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 27 Jul 2020to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of College of Medicine Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
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
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).
Read the 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
- Being tested
- Osimertinib
- Keywords
- Carcinoma, Non-Small-Cell Lung, Epidermal Growth Factor Receptor mutation, Osimertinib, Real World evidence, non-interventional
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsimertinibDrug
Also called TAGRISSO
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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.
Secondary outcomes (5)
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
Measured: 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.
Measured: 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".
Measured: 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
Measured: 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.
Measured: from the date of first dose of Osimertinib in this study assessed up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start27 Jul 2020
- Primary completion26 Apr 2022
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391283
- Sponsor's protocol ID
- Osimertinib-RWE-01
- Status last verified
- Feb 2023
- First submitted
- 21 Apr 2020
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goss G, Tsai CM, Shepherd FA, Bazhenova L, Lee JS, Chang GC, Crino L, Satouchi M, Chu Q, Hida T, Han JY, Juan O, Dunphy F, Nishio M, Kang JH, Majem M, Mann H, Cantarini M, Ghiorghiu S, Mitsudomi T. Osimertinib for pretreated EGFR Thr790Met-positive advanced non-small-cell lung cancer (AURA2): a multicentre, open-label, single-arm, phase 2 study. Lancet Oncol. 2016 Dec;17(12):1643-1652. doi: 10.1016/S1470-2045(16)30508-3. Epub 2016 Oct 14.
PubMed 27751847Zhou C. Lung cancer molecular epidemiology in China: recent trends. Transl Lung Cancer Res. 2014 Oct;3(5):270-9. doi: 10.3978/j.issn.2218-6751.2014.09.01.
PubMed 25806311Shi Y, Au JS, Thongprasert S, Srinivasan S, Tsai CM, Khoa MT, Heeroma K, Itoh Y, Cornelio G, Yang PC. A prospective, molecular epidemiology study of EGFR mutations in Asian patients with advanced non-small-cell lung cancer of adenocarcinoma histology (PIONEER). J Thorac Oncol. 2014 Feb;9(2):154-62. doi: 10.1097/JTO.0000000000000033.
PubMed 24419411Arcila ME, Oxnard GR, Nafa K, Riely GJ, Solomon SB, Zakowski MF, Kris MG, Pao W, Miller VA, Ladanyi M. Rebiopsy of lung cancer patients with acquired resistance to EGFR inhibitors and enhanced detection of the T790M mutation using a locked nucleic acid-based assay. Clin Cancer Res. 2011 Mar 1;17(5):1169-80. doi: 10.1158/1078-0432.CCR-10-2277. Epub 2011 Jan 19.
PubMed 21248300Jenkins S, Yang JC, Janne PA, Thress KS, Yu K, Hodge R, Weston S, Dearden S, Patel S, Cantarini M, Shepherd FA. EGFR Mutation Analysis for Prospective Patient Selection in Two Phase II Registration Studies of Osimertinib. J Thorac Oncol. 2017 Aug;12(8):1247-1256. doi: 10.1016/j.jtho.2017.05.002. Epub 2017 May 17.
PubMed 28527899John T, Akamatsu H, Delmonte A, Su WC, Lee JS, Chang GC, Huang X, Jenkins S, Wu YL. EGFR mutation analysis for prospective patient selection in AURA3 phase III trial of osimertinib versus platinum-pemetrexed in patients with EGFR T790M-positive advanced non-small-cell lung cancer. Lung Cancer. 2018 Dec;126:133-138. doi: 10.1016/j.lungcan.2018.10.027. Epub 2018 Nov 1.
PubMed 30527177Reungwetwattana T, Nakagawa K, Cho BC, Cobo M, Cho EK, Bertolini A, Bohnet S, Zhou C, Lee KH, Nogami N, Okamoto I, Leighl N, Hodge R, McKeown A, Brown AP, Rukazenkov Y, Ramalingam SS, Vansteenkiste J. CNS Response to Osimertinib Versus Standard Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors in Patients With Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2018 Aug 28:JCO2018783118. doi: 10.1200/JCO.2018.78.3118. Online ahead of print.
PubMed 30153097Liu Y, Sun L, Xiong ZC, Sun X, Zhang SL, Ma JT, Han CB. Meta-analysis of the impact of de novo and acquired EGFR T790M mutations on the prognosis of patients with non-small cell lung cancer receiving EGFR-TKIs. Onco Targets Ther. 2017 Apr 24;10:2267-2279. doi: 10.2147/OTT.S133082. eCollection 2017.
PubMed 28479857Su KY, Chen HY, Li KC, Kuo ML, Yang JC, Chan WK, Ho BC, Chang GC, Shih JY, Yu SL, Yang PC. Pretreatment epidermal growth factor receptor (EGFR) T790M mutation predicts shorter EGFR tyrosine kinase inhibitor response duration in patients with non-small-cell lung cancer. J Clin Oncol. 2012 Feb 1;30(4):433-40. doi: 10.1200/JCO.2011.38.3224. Epub 2012 Jan 3.
PubMed 22215752Zheng R, Zeng H, Zhang S, Chen W. Estimates of cancer incidence and mortality in China, 2013. Chin J Cancer. 2017 Aug 17;36(1):66. doi: 10.1186/s40880-017-0234-3.
PubMed 28818111
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04391283
- Acronym / sponsor ID
- Osimertinib-RWE-01
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Carcinoma, Non-Small-Cell Lung, Epidermal Growth Factor Receptor mutation, Osimertinib, Real World evidence, non-interventional
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 26 Apr 2022 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OsimertinibAlso: TAGRISSOThe 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. | Drug | – |
Primary outcome
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".
5 secondary outcomes
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.
Objective Response Rate (ORR) and Disease Control Rate (DCR)
Time frame: from the date of first dose of Osimertinib, assessed up to 6 months.
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.
de novo T790M mutation rate
Time frame: the baseline and at the time of progression, assessed up to 36 months.
Adverse events/Serious adverse events
Time frame: from the date of first dose of Osimertinib in this study assessed up to 36 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Background: PubMed 27751847Goss G, Tsai CM, Shepherd FA, Bazhenova L, Lee JS, Chang GC, Crino L, Satouchi M, Chu Q, Hida T, Han JY, Juan O, Dunphy F, Nishio M, Kang JH, Majem M, Mann H, Cantarini M, Ghiorghiu S, Mitsudomi T. Osimertinib for pretreated EGFR Thr790Met-positive advanced non-small-cell lung cancer (AURA2): a multicentre, open-label, single-arm, phase 2 study. Lancet Oncol. 2016 Dec;17(12):1643-1652. doi: 10.1016/S1470-2045(16)30508-3. Epub 2016 Oct 14.
- Background: PubMed 25806311Zhou C. Lung cancer molecular epidemiology in China: recent trends. Transl Lung Cancer Res. 2014 Oct;3(5):270-9. doi: 10.3978/j.issn.2218-6751.2014.09.01.
- Background: PubMed 24419411Shi Y, Au JS, Thongprasert S, Srinivasan S, Tsai CM, Khoa MT, Heeroma K, Itoh Y, Cornelio G, Yang PC. A prospective, molecular epidemiology study of EGFR mutations in Asian patients with advanced non-small-cell lung cancer of adenocarcinoma histology (PIONEER). J Thorac Oncol. 2014 Feb;9(2):154-62. doi: 10.1097/JTO.0000000000000033.
- Background: PubMed 21248300Arcila ME, Oxnard GR, Nafa K, Riely GJ, Solomon SB, Zakowski MF, Kris MG, Pao W, Miller VA, Ladanyi M. Rebiopsy of lung cancer patients with acquired resistance to EGFR inhibitors and enhanced detection of the T790M mutation using a locked nucleic acid-based assay. Clin Cancer Res. 2011 Mar 1;17(5):1169-80. doi: 10.1158/1078-0432.CCR-10-2277. Epub 2011 Jan 19.
- Background: PubMed 28527899Jenkins S, Yang JC, Janne PA, Thress KS, Yu K, Hodge R, Weston S, Dearden S, Patel S, Cantarini M, Shepherd FA. EGFR Mutation Analysis for Prospective Patient Selection in Two Phase II Registration Studies of Osimertinib. J Thorac Oncol. 2017 Aug;12(8):1247-1256. doi: 10.1016/j.jtho.2017.05.002. Epub 2017 May 17.
- Background: PubMed 30527177John T, Akamatsu H, Delmonte A, Su WC, Lee JS, Chang GC, Huang X, Jenkins S, Wu YL. EGFR mutation analysis for prospective patient selection in AURA3 phase III trial of osimertinib versus platinum-pemetrexed in patients with EGFR T790M-positive advanced non-small-cell lung cancer. Lung Cancer. 2018 Dec;126:133-138. doi: 10.1016/j.lungcan.2018.10.027. Epub 2018 Nov 1.
- Background: PubMed 30153097Reungwetwattana T, Nakagawa K, Cho BC, Cobo M, Cho EK, Bertolini A, Bohnet S, Zhou C, Lee KH, Nogami N, Okamoto I, Leighl N, Hodge R, McKeown A, Brown AP, Rukazenkov Y, Ramalingam SS, Vansteenkiste J. CNS Response to Osimertinib Versus Standard Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors in Patients With Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2018 Aug 28:JCO2018783118. doi: 10.1200/JCO.2018.78.3118. Online ahead of print.
- Background: PubMed 28479857Liu Y, Sun L, Xiong ZC, Sun X, Zhang SL, Ma JT, Han CB. Meta-analysis of the impact of de novo and acquired EGFR T790M mutations on the prognosis of patients with non-small cell lung cancer receiving EGFR-TKIs. Onco Targets Ther. 2017 Apr 24;10:2267-2279. doi: 10.2147/OTT.S133082. eCollection 2017.
- Background: PubMed 22215752Su KY, Chen HY, Li KC, Kuo ML, Yang JC, Chan WK, Ho BC, Chang GC, Shih JY, Yu SL, Yang PC. Pretreatment epidermal growth factor receptor (EGFR) T790M mutation predicts shorter EGFR tyrosine kinase inhibitor response duration in patients with non-small-cell lung cancer. J Clin Oncol. 2012 Feb 1;30(4):433-40. doi: 10.1200/JCO.2011.38.3224. Epub 2012 Jan 3.
- Results publication: PubMed 28818111Zheng R, Zeng H, Zhang S, Chen W. Estimates of cancer incidence and mortality in China, 2013. Chin J Cancer. 2017 Aug 17;36(1):66. doi: 10.1186/s40880-017-0234-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04391283, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.