Non-Small-Cell Lung CancerNCT01947868
Evaluation of Symptoms Improvement in NSCLC Patients With First-Line Therapy of EGFR Tyrosine Kinase Inhibitor
An observational study of Non-Small-Cell Lung Cancer, run by AstraZeneca at 1 site in Taiwan.
Trial summary
This is an open-label, non-interventional, single-arm, multicenter study in a real-world population to assess the clinically symptom improvement and quality of life (QoL) in patients with locally advanced or metastatic NSCLC and positive EGFR mutation who receive EGFR-TKIs as the first-line treatment. Read more about this study
- Who is it for?
- Ages 20 to 130 years
- Conditions the study is for
- Non-Small-Cell Lung Cancer
- How many people
- 346 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2013to Sep 2015
- 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 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: advanced NSCLC patients who will be treated as first line treatment with EGFR-TKI
Who may be able to join
- Patients diagnosed with symptomatic, locally advanced or metastatic (stage IIIb/IV) NSCLC.
- Patients who are positive for EGFR mutation
- Patients with a prescription of EGFR-TKI as their first-line treatment
Who cannot join
- Involvement in any planning and/or conduct of the clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Non-interventional Evaluation of Symptoms Improvement of First-Line Therapy of EGFR Tyrosine Kinase Inhibitor in Advanced NSCLC Patients With Positive EGFR Mutation - the SMILE Study
This is an open-label, non-interventional, single-arm, multicenter study in a real-world population to assess the clinically symptom improvement and quality of life (QoL) in patients with locally advanced or metastatic NSCLC and positive EGFR mutation who receive EGFR-TKIs as the first-line treatment.
The Primary Objective is to estimate symptom improvement rates in patients with locally advanced or metastatic NSCLC and positive EGFR mutation who receive EGFR-TKIs as the first-line treatment. A clinically meaningful improvement is defined as an increase from baseline of 2 or more points for LCS (Lung Cancer Scales) at Week 4.
Read the detailed description
The Secondary Objectives are:
- To estimate symptom improvement rates at weeks 2 and 12
- To estimate mean change from baseline in overall QoL scores using the FACT-L instrument and LCS score at Week 2, 4 and 12.
- To estimate the proportion of patients exhibiting an LCS change of 7 points or more at weeks 2, 4 and 12.
- Subgroup information of symptom improvement rate, QoL and disease-related symptom scores by gender, smoking status, smoking pattern, WHO performance, number of metastatic sites, female/never smokers and patients with COPD at week 2, week 4 and week 12.
- Conditions
- Non-Small-Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients demonstrating a clinically meaningful improvement post 4 weeks of EGFR-TKI therapy defined as an increase in LCS ≥ 2 points from baseline.
LCS is Lung Cancer Scale
Measured: 15 months
Secondary outcomes (4)
The proportion of patients demonstrating a clinically meaningful improvement post 2 weeks and 12 weeks of EGFR-TKI therapy as defined as an increase in LCS ≥ 2 points from baseline.
Measured: 15 months
Mean change from baseline to Week 2, 4 and 12 in FACT-L, TOI and LCS.
FACT-L is Functional Assessment of Cancer Therapy-Lung questionnaire. TOI is Treatment Outcome Index. LCS is Lung Cancer Scale.
Measured: 15 months
The proportion of patients demonstrating a clinically meaningful improvement post 2, 4 and 12 weeks of EGFR-TKI therapy as defined as an increase in LCS ≥ 7 points from baseline.
LCS is Lung Cancer Scale
Measured: 15 months
Descriptive statistics in improvement rate (defined as LCS ≥ 2 points changed from baseline), QoL and disease-related symptom scores at week 2,4 and 12 and summarized by gender, smoking status, smoking pattern, WHO performance status, etc
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startNov 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small-Cell Lung CancerStudies 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Te-Chun Hsia, Principal investigator, 886422062121
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947868
- Sponsor's protocol ID
- NIS-OTW-ATC-2013/1
- Status last verified
- Sep 2016
- First submitted
- 18 Sep 2013
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-interventional Evaluation of Symptoms Improvement of First-Line Therapy of EGFR Tyrosine Kinase Inhibitor in Advanced NSCLC Patients With Positive EGFR Mutation - the SMILE Study
- ClinicalTrials.gov ID
- NCT01947868
- Acronym / sponsor ID
- NIS-OTW-ATC-2013/1
- Conditions
- Non-Small-Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 23 Sep 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 an open-label, non-interventional, single-arm, multicenter study in a real-world population to assess the clinically symptom improvement and quality of life (QoL) in patients with locally advanced or metastatic NSCLC and positive EGFR mutation who receive EGFR-TKIs as the first-line treatment.
The Primary Objective is to estimate symptom improvement rates in patients with locally advanced or metastatic NSCLC and positive EGFR mutation who receive EGFR-TKIs as the first-line treatment. A clinically meaningful improvement is defined as an increase from baseline of 2 or more points for LCS (Lung Cancer Scales) at Week 4.
Detailed description
The Secondary Objectives are:
- To estimate symptom improvement rates at weeks 2 and 12
- To estimate mean change from baseline in overall QoL scores using the FACT-L instrument and LCS score at Week 2, 4 and 12.
- To estimate the proportion of patients exhibiting an LCS change of 7 points or more at weeks 2, 4 and 12.
- Subgroup information of symptom improvement rate, QoL and disease-related symptom scores by gender, smoking status, smoking pattern, WHO performance, number of metastatic sites, female/never smokers and patients with COPD at week 2, week 4 and week 12.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- advanced NSCLC patients who will be treated as first line treatment with EGFR-TKI
Key inclusion criteria (3 listed)
- Patients diagnosed with symptomatic, locally advanced or metastatic (stage IIIb/IV) NSCLC.
- Patients who are positive for EGFR mutation
- Patients with a prescription of EGFR-TKI as their first-line treatment
Key exclusion criteria (1 listed)
- Involvement in any planning and/or conduct of the clinical trial.
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 proportion of patients demonstrating a clinically meaningful improvement post 4 weeks of EGFR-TKI therapy defined as an increase in LCS ≥ 2 points from baseline.
Time frame: 15 months
LCS is Lung Cancer Scale
4 secondary outcomes
The proportion of patients demonstrating a clinically meaningful improvement post 2 weeks and 12 weeks of EGFR-TKI therapy as defined as an increase in LCS ≥ 2 points from baseline.
Time frame: 15 months
Mean change from baseline to Week 2, 4 and 12 in FACT-L, TOI and LCS.
Time frame: 15 months
The proportion of patients demonstrating a clinically meaningful improvement post 2, 4 and 12 weeks of EGFR-TKI therapy as defined as an increase in LCS ≥ 7 points from baseline.
Time frame: 15 months
Descriptive statistics in improvement rate (defined as LCS ≥ 2 points changed from baseline), QoL and disease-related symptom scores at week 2,4 and 12 and summarized by gender, smoking status, smoking pattern, WHO performance status, etc
Time frame: 15 months
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 23 Sep 2016.
- NIS-OTW-ATC-2013\_1\_CSR\_Synopsis.pdfLink 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.
Te-Chun Hsia principal investigator
886422062121
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 Non-Small-Cell Lung Cancer, run by AstraZeneca at 1 site 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 3 inclusion and 1 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 23 Sep 2016. 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 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 proportion of patients demonstrating a clinically meaningful improvement post 4 weeks of EGFR-TKI therapy defined as an increase in LCS ≥ 2 points from baseline. (time frame: 15 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 23 Sep 2016; AzTrials last refreshed its copy on 7 Nov 2026.