An Observational Study of Tarceva (Erlotinib) in Elderly Patients With Advanced Non-Small Cell Lung Cancer

Non-Squamous Non-Small Cell Lung Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01535729
• Other study ID #: ML23023
• Status: Completed
• Phase: N/A
• First received: February 15, 2012
• Last updated: October 1, 2015
• Start date: May 2011
• Est. completion date: June 2014

Study information

• Verified date: October 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 465
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Squamous Non-Small Cell Lung Cancer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Were Alive 1 Year After Start of Treatment	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.	Year 1	No
Secondary	Median Overall Survival: Age	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.	From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)	No
Secondary	Percentage of Participants With Fatigue		Months 3, 6, 9, 12	No
Secondary	Percentage of Participants With Rash		Months 3, 6, 9, 12	No
Secondary	Percentage of Participants With Diarrhea		Months 3, 6, 9, 12	No
Secondary	Percentage of Participants With Rash Based on Severity During the Course of Time	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.	Months 3, 6, 9, 12	No
Secondary	Percentage of Participants With Diarrhea Based on Severity During the Course of Time	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.	Months 3, 6, 9, 12	No
Secondary	Percentage of Participants With Fatigue Based on Severity During the Course of Time	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.	Months 3, 6, 9, 12	No
Secondary	Percentage of Participants With Dose Modifications by Reason	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.	Months 3, 6, 9, 12	No
Secondary	Percentage of Participants With Dose Withdrawals by Reason	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.	Months 3, 6, 9, 12	No
Secondary	Percentage of Participants With Cough by Severity	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.	Baseline, Months 3, 6, 9, 12	No
Secondary	Percentage of Participants With Dyspnea by Severity	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.	Baseline, Months 3, 6, 9, 12	No
Secondary	Percentage of Participants With Complete Response (CR), Partial Response (PR) and Stable Disease (SD)	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.	Months 3, 6, 9, 12	No
Secondary	Time to Start of Erlotinib Therapy After End of First Line Therapy		Baseline	No
Secondary	Percentage of Participants With Remission of CR and PR	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.	Months 3, 6, 9, 12	No
Secondary	Median Progression Free Survival: Overall	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.	From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)	No
Secondary	Median Progression Free Survival: Age	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.	From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)	No
Secondary	Median Progression Free Survival: Gender	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.	From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)	No
Secondary	Median Progression Free Survival: Smoking Status	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.	From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)	No
Secondary	Median Progression Free Survival: Best Response to Prior Chemotherapy	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.	From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)	No
Secondary	Median Overall Survival: Overall	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.	From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)	No
Secondary	Median Overall Survival: Gender	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.	From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)	No
Secondary	Median Overall Survival: Smoking Status	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.	From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)	No
Secondary	Median Overall Survival: Best Response to Prior Chemotherapy	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.	From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)	No