- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01535729
An Observational Study of Tarceva (Erlotinib) in Elderly Patients With Advanced Non-Small Cell Lung Cancer
October 1, 2015 updated by: Hoffmann-La Roche
Erlotinib (Tarceva®) in Routine Clinical Practice in Patients With Advanced Non Small Cell Lung Cancer (NSCLC) After Failure of at Least One Prior Chemotherapy Regimen With Focus on the Elderly Patient.
This prospective observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in elderly patients with advanced non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.
Data of patients treated with Tarceva in routine clinical practice will be collected for 1 year.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
465
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nürnberg, Germany, 90419
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Elderly patients with advanced non-small cell lung cancer after first-line platinum-based chemotherapy
Description
Inclusion Criteria:
- Adult patients, > 65 years of age
- Locally advanced or metastatic non-small cell lung cancer (Stage IIIb or IV)
- Failure of at least one prior standard platinum-based chemotherapy
Exclusion Criteria:
- Age < 65 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Cohort
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants Who Were Alive 1 Year After Start of Treatment
Time Frame: Year 1
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Overall survival was defined as the time from the date of first medication to the date of death from any cause.
If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year).
Overall percentage of participants who were alive 1 year after study treatment and those based on the factor of age (65-69, 70-74, 75-79, ≥ 80 years) were reported.
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Year 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Median Overall Survival: Age
Time Frame: From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)
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Overall Survival was defined as the time from the date of first medication to the date of death from any cause.
If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year).
Overall Survival was analyzed by means of Kaplan-Meier Methods.
Median survival based on the factor of age (65-69, 70-74, 75-79, ≥80 years) were reported.
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From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)
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Percentage of Participants With Fatigue
Time Frame: Months 3, 6, 9, 12
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Months 3, 6, 9, 12
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Percentage of Participants With Rash
Time Frame: Months 3, 6, 9, 12
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Months 3, 6, 9, 12
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Percentage of Participants With Diarrhea
Time Frame: Months 3, 6, 9, 12
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Months 3, 6, 9, 12
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Percentage of Participants With Rash Based on Severity During the Course of Time
Time Frame: Months 3, 6, 9, 12
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Severity was categorized as Grades 1, 2, 3, 4 and 5. Grade 1= mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2= moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL).
Grade 3= severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.
Grade 4= life-threatening consequences; urgent intervention indicated.
Grade 5= death related to adverse event.
Only participants that were included in any of the specified categories were reported.
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Months 3, 6, 9, 12
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Percentage of Participants With Diarrhea Based on Severity During the Course of Time
Time Frame: Months 3, 6, 9, 12
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Severity was categorized as Grades 1, 2, 3, 4 and 5. Grade 1= mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2= moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL).
Grade 3= severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.
Grade 4= life-threatening consequences; urgent intervention indicated.
Grade 5= death related to adverse event.
Only participants that were included in any of the specified categories were reported.
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Months 3, 6, 9, 12
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Percentage of Participants With Fatigue Based on Severity During the Course of Time
Time Frame: Months 3, 6, 9, 12
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Severity was categorized as Grades 1, 2, 3, 4 and 5. Grade 1= mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2= moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL).
Grade 3= severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.
Grade 4= life-threatening consequences; urgent intervention indicated.
Grade 5= death related to adverse event.
Only participants that were included in any of the specified categories were reported.
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Months 3, 6, 9, 12
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Percentage of Participants With Dose Modifications by Reason
Time Frame: Months 3, 6, 9, 12
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Dose modification included increase or decreased in the dose of the drug and interrupted dose.
Reasons for dose modification included progression, participants' wish, intolerance and others.
Only participants that were included in any of the specified categories were reported.
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Months 3, 6, 9, 12
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Percentage of Participants With Dose Withdrawals by Reason
Time Frame: Months 3, 6, 9, 12
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Reasons for dose withdrawals included progression, participants' wish, intolerance, others and not known.
Only participants that were included in any of the specified categories were reported.
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Months 3, 6, 9, 12
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Percentage of Participants With Cough by Severity
Time Frame: Baseline, Months 3, 6, 9, 12
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Severity of cough was categorized as mild, moderate, severe and unknown.
Only participants that were included in any of the specified categories in the course of time were reported.
Participants with no cough were not included.
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Baseline, Months 3, 6, 9, 12
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Percentage of Participants With Dyspnea by Severity
Time Frame: Baseline, Months 3, 6, 9, 12
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Severity of dyspnea was categorized as mild, moderate, severe, life-threatening and unknown.
Only participants that were included in any of the specified categories in the course of time were reported.
Participants with no dyspnea were not included.
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Baseline, Months 3, 6, 9, 12
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Percentage of Participants With Complete Response (CR), Partial Response (PR) and Stable Disease (SD)
Time Frame: Months 3, 6, 9, 12
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Response rate was observed during the treatment period according to Response Evaluation Criteria in Solid Tumors (RECIST).
It consisted of CR, PR, SD and progressive disease (PD).
Participants with CR, PR and SD were reported.
CR: disappearance of all target lesions (TLs) and non-TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 millimeters (mm).
PR: at least a 30 percent (%) decrease in the sum of diameters of TLs, taking as reference the baseline (BL) sum diameters.
SD was defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
PD: at least 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study).
In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm.
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Months 3, 6, 9, 12
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Time to Start of Erlotinib Therapy After End of First Line Therapy
Time Frame: Baseline
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Baseline
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Percentage of Participants With Remission of CR and PR
Time Frame: Months 3, 6, 9, 12
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Remission was defined as participants with CR or PR.
CR: disappearance of all TLs and non-TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 mm.
PR: at least a 30% decrease in the sum of diameters of TLs, taking as reference the BL sum diameters.
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Months 3, 6, 9, 12
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Median Progression Free Survival: Overall
Time Frame: From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)
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Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause.
If neither progression no death was observed during the study, PFS time was censored at the last day of observation.
PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study).
In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm.
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From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)
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Median Progression Free Survival: Age
Time Frame: From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)
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Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause.
If neither progression nor death was observed during the study, PFS time was censored at the last day of observation.
PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study).
In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm.
Median progression-free survival based on the factor of age (65-69, 70-74, 75-79, ≥80 years) were reported.
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From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)
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Median Progression Free Survival: Gender
Time Frame: From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)
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Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause.
If neither progression nor death was observed during the study, PFS time was censored at the last day of observation.
PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study).
In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm.
Median progression-free survival based on the factor of gender (male and female) were reported.
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From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)
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Median Progression Free Survival: Smoking Status
Time Frame: From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)
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Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause.
If neither progression nor death was observed during the study, PFS time was censored at the last day of observation.
PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study).
In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm.
Median progression-free survival based on the factor of smoking status (smoker, non-smoker and ex-smoker) were reported.
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From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)
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Median Progression Free Survival: Best Response to Prior Chemotherapy
Time Frame: From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)
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Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause.
If neither progression nor death was observed during the study, PFS time was censored at the last day of observation.
PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study).
In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm.
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From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)
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Median Overall Survival: Overall
Time Frame: From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)
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Overall Survival was defined as the time from the date of first medication to the date of death from any cause.
If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year).
Overall Survival was analyzed by means of Kaplan-Meier Methods.
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From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)
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Median Overall Survival: Gender
Time Frame: From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)
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Overall Survival was defined as the time from the date of first medication to the date of death from any cause.
If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year).
Overall Survival was analyzed by means of Kaplan-Meier Methods.
Median survival based on the factor of gender (male and female) were reported.
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From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)
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Median Overall Survival: Smoking Status
Time Frame: From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)
|
Overall Survival was defined as the time from the date of first medication to the date of death from any cause.
If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year).
Overall Survival was analyzed by means of Kaplan-Meier Methods.
Median survival based on the factor of smoking status (smoker, non-smoker and ex-smoker) were reported.
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From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)
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Median Overall Survival: Best Response to Prior Chemotherapy
Time Frame: From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)
|
Overall Survival was defined as the time from the date of first medication to the date of death from any cause.
If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year).
Overall Survival was analyzed by means of Kaplan-Meier Methods.
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From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
February 15, 2012
First Submitted That Met QC Criteria
February 15, 2012
First Posted (Estimate)
February 20, 2012
Study Record Updates
Last Update Posted (Estimate)
October 29, 2015
Last Update Submitted That Met QC Criteria
October 1, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ML23023
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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