Locally Advanced or Metastatic EGFR Mutated NSCLC.SEQUENCENCT01955681
A Retrospective, Non-interventional, Multicenter, Observational Chart Review Study to Explore the Clinical Benefits of Retreatment With TKI in the Real World.
An observational study of Locally Advanced or Metastatic EGFR Mutated NSCLC., run by AstraZeneca at 6 sites in Taiwan.
Trial summary
This is a retrospective, non-interventional, multicenter, observational chart review study to explore the clinical benefits of retreatment with TKI in the real world. Read more about this study
- Who is it for?
- Ages 20 to 150 years
- Conditions the study is for
- Locally Advanced or Metastatic EGFR Mutated NSCLC.
- How many people
- 200 participants
- Where
- 6 sitesTaiwan
- Study dates
- Dec 2013to Aug 2014
- 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 20 to 150 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with locally advanced or metastatic Epidermal Growth Factor Receptor mutated Non-small-cell Lung Cancer who Previously Treated with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as First-line therapy and chemotherapy as second-line Therapy - SEQUENCE study
Who may be able to join
- Patients diagnosed with advanced adenocarcinoma or positive result of thyroid transcription factor 1 NSCLC
- Positive Epidermal Growth Factor Receptor mutation result with sensitive mutation
- Female or male aged ≧20 years
- Patients treated with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor and subsequently treated with chemotherapy before re-administration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor. Exclusion Criteria:
- 1. Patients with EGFR mutation status of positive exon 20 T790M mutation only. 2. Patients who are confirmed of squamous type NSCLC
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Taiwan6 sites
Study site
Chiayi City
Study site
Kaohsiung City
Study site
Taichung
Research Site
Taipei
Study site
Taipei
Study site
Taoyuan
About this study
Official title: A Retrospective, Non-interventional Study to Evaluate EGFR-Tyrosine Kinase Inhibitor Retreatment in Patients With Locally Advanced or Metastatic EGFR Mutated NSCLC Who Previously Treated With EGFR-TKI as First-line Therapy and Chemotherapy as Second-line Therapy - SEQUENCE Study
This is a retrospective, non-interventional, multicenter, observational chart review study to explore the clinical benefits of retreatment with TKI in the real world.
Read the detailed description
This study is designed to retrospectively review the medical and chemotherapy records of 300 patients with EGFR mutation positive adenocarcinoma NSCLC. Eligible patients are as follows: histologically or cytologically confirmed NSCLC, undergone EGFR-TKI retreatment sometime after the failure of the initial EGFR-TKI. After initial treatment, patients had been treated with chemotherapy and subsequently re-treated with EGFR-TKI will be identified. The target population will be derived from multicentre in Taiwan. The study aim is to evaluate clinical effect in re-administration of EGFR-TKI using retrospectively collected data from these eligible patients to provide valuable information.
- Keywords
- Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor retrement.
What is being measured
The primary outcome is the main question the study is designed to answer.
The treatment duration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor re-administration
The median duration of re-administration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor will be summarized by days or months, if applicable. The range of this treatment duration will also be presented. All analyses will be performed on all eligible patients in this study.
Measured: From the start of re-administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
Secondary outcomes (10)
Assessment of progression-free survival for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments.
The outcome of progression-free survival will be presented with median values and associated 95% CIs by Kaplan-Meier curve. PFS is defined as the time interval (in weeks) from the start date of a given treatment to the date of disease progression or death, respectively, which one is observed first. Subjects who did not progress or die without a reported progression will be censored on the date of their last tumor assessment.
Measured: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
Assessment of overall survival for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments.
The outcome of overall survival will be presented with median values and associated 95% CIs by Kaplan-Meier curve. OS is defined as the time interval (in weeks) from the beginning of treatment until the date when death or lost to follow up is observed. For those subjects who have not died or lost to follow-up, survival duration will be censored at the last date the subject was known to be alive.
Measured: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
Assessment of response rate for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments.
The outcome about response rate and the proportion of response rate are estimated by all evaluable patients. The 95% exact confidence interval will be constructed around the rates. The best response during treatment sequences is determined in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.
Measured: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
Assessment of disease control rate for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments.
The outcome of disease control rate are estimated by all evaluable patients. The 95% exact confidence interval will be constructed around the rates. Disease Control Rate is defined as patients who are respond to treatment (including CR-complete respond, PR-partial respond or SD- Stable Disease).
Measured: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
Record treatment duration in the initial EGFR-TKI therapy and first time chemotherapy.
Treatment duration in the initial EGFR-TKI therapy and first time chemotherapy.
Measured: Between the initial EGFR-TKI therapy and first time chemotherapy.
Record the reason(s) for treatment change for initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment).
Record the reason(s) for treatment change for initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment).
Measured: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
Explore relationships between efficacy of EGFR-TKI initial and re-administration and patient characteristics or EGFR TKI treatment characteristics.
Explore relationships between efficacy of EGFR-TKI initial and re-administration and patient characteristics (including demographics, histology, disease stage, sites of metastasis, ECOG PS) or EGFR TKI treatment characteristics (including EGFR mutation pattern, response to initial EGFR TKI or not, length of duration between first and second EGFR-TKI treatment)
Measured: EGFR-TKI initial and re-administration
overall survival (OS), plasma CEA level and chemotherapy regimens ever used.
Explore overall survival (OS), plasma CEA level and chemotherapy regimens ever used between first time chemotherapy and EGFR-TKI re-administration (including the types and number of chemotherapy regimens, and treatment duration) for those patients who have the above data available.
Measured: between first time chemotherapy and EGFR-TKI re-administration
image peer review to evaluate tumour size retrospectively in different sequences of treatment
If the images are available, conduct image peer review to evaluate tumour size retrospectively in different sequences of treatment: (1) initial and re-administration of EGFR-TKI therapy, (2) first time chemotherapy ever used (second-line treatment) after initial EGFR-TKI treatment. Peer review time point includes baseline, best response and progression of last image while stopping treatment at each treatment mentioned above.
Measured: (1) initial and re-administration of EGFR-TKI therapy, (2) first time chemotherapy ever used (second-line treatment) after initial EGFR-TKI treatment.
The reason(s) for the treatment change for initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment) after peer review
Evaluate the reason(s) for the treatment change for initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment) after peer review and compare the difference of reason(s) for the treatment change between initiatial evaluation and after peer review.
Measured: Initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment) after peer review.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startDec 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic EGFR Mutated NSCLC.Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuh-Min Chen, Principal investigator, Taipei Veterans General Hospital, TaiwanGee-Chen Chang, Principal investigator, Veterans General Hospital -TaichungChong-Jen Yu, Principal investigator, National Taiwan University HospitalCheng-Ta Yang, Principal investigator, Chang Gung Memorial HospitalTe-Chun Hsia, Principal investigator, China Medical University HospitalMeng-Chih Lin, Principal investigator, Chang-Gung Memorial Hospital KaohsiungYing-Huang Tsai, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955681
- Sponsor's protocol ID
- NIS-OTW-XXX-2013/1
- Acronym
- SEQUENCE
- Status last verified
- Nov 2015
- First submitted
- 30 Sep 2013
- Last updated
- 4 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Non-interventional Study to Evaluate EGFR-Tyrosine Kinase Inhibitor Retreatment in Patients With Locally Advanced or Metastatic EGFR Mutated NSCLC Who Previously Treated With EGFR-TKI as First-line Therapy and Chemotherapy as Second-line Therapy - SEQUENCE Study
- ClinicalTrials.gov ID
- NCT01955681
- Acronym / sponsor ID
- SEQUENCE / NIS-OTW-XXX-2013/1
- Keywords
- Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor retrement.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 7 Oct 2013 (estimated)
- 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.
This is a retrospective, non-interventional, multicenter, observational chart review study to explore the clinical benefits of retreatment with TKI in the real world.
Detailed description
This study is designed to retrospectively review the medical and chemotherapy records of 300 patients with EGFR mutation positive adenocarcinoma NSCLC. Eligible patients are as follows: histologically or cytologically confirmed NSCLC, undergone EGFR-TKI retreatment sometime after the failure of the initial EGFR-TKI. After initial treatment, patients had been treated with chemotherapy and subsequently re-treated with EGFR-TKI will be identified. The target population will be derived from multicentre in Taiwan. The study aim is to evaluate clinical effect in re-administration of EGFR-TKI using retrospectively collected data from these eligible patients to provide valuable information.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 150 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with locally advanced or metastatic Epidermal Growth Factor Receptor mutated Non-small-cell Lung Cancer who Previously Treated with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor as First-line therapy and chemotherapy as second-line Therapy - SEQUENCE study
Key inclusion criteria (5 listed)
- Patients diagnosed with advanced adenocarcinoma or positive result of thyroid transcription factor 1 NSCLC
- Positive Epidermal Growth Factor Receptor mutation result with sensitive mutation
- Female or male aged ≧20 years
- Patients treated with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor and subsequently treated with chemotherapy before re-administration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor. Exclusion Criteria:
- 1. Patients with EGFR mutation status of positive exon 20 T790M mutation only. 2. Patients who are confirmed of squamous type NSCLC
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The treatment duration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor re-administration
Time frame: From the start of re-administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
The median duration of re-administration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor will be summarized by days or months, if applicable. The range of this treatment duration will also be presented. All analyses will be performed on all eligible patients in this study.
10 secondary outcomes
Assessment of progression-free survival for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments.
Time frame: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
Assessment of overall survival for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments.
Time frame: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
Assessment of response rate for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments.
Time frame: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
Assessment of disease control rate for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments.
Time frame: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
Record treatment duration in the initial EGFR-TKI therapy and first time chemotherapy.
Time frame: Between the initial EGFR-TKI therapy and first time chemotherapy.
Record the reason(s) for treatment change for initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment).
Time frame: From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
Explore relationships between efficacy of EGFR-TKI initial and re-administration and patient characteristics or EGFR TKI treatment characteristics.
Time frame: EGFR-TKI initial and re-administration
overall survival (OS), plasma CEA level and chemotherapy regimens ever used.
Time frame: between first time chemotherapy and EGFR-TKI re-administration
image peer review to evaluate tumour size retrospectively in different sequences of treatment
Time frame: (1) initial and re-administration of EGFR-TKI therapy, (2) first time chemotherapy ever used (second-line treatment) after initial EGFR-TKI treatment.
The reason(s) for the treatment change for initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment) after peer review
Time frame: Initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment) after peer review.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2015.
- CSR\_Synopsis\_NIS-OTW-XXX-2013\_1Link provided by the sponsor.
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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.
Yuh-Min Chen principal investigator
Taipei Veterans General Hospital, Taiwan
Gee-Chen Chang principal investigator
Veterans General Hospital -Taichung
Chong-Jen Yu principal investigator
National Taiwan University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced or Metastatic EGFR Mutated NSCLC., run by AstraZeneca at 6 sites in Taiwan.
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 5 inclusion and 0 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: finished, as of the sponsor's last update on 4 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The treatment duration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor re-administration (time frame: From the start of re-administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2015.