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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01535729
First received: February 15, 2012
Last updated: October 1, 2015
Last verified: October 2015
  Purpose
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.

Condition
Non-Squamous Non-Small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants Who Were Alive 1 Year After Start of Treatment [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Median Overall Survival: Age [ Time Frame: From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Fatigue [ Time Frame: Months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Rash [ Time Frame: Months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Diarrhea [ Time Frame: Months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Rash Based on Severity During the Course of Time [ Time Frame: Months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Diarrhea Based on Severity During the Course of Time [ Time Frame: Months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Fatigue Based on Severity During the Course of Time [ Time Frame: Months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Dose Modifications by Reason [ Time Frame: Months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Dose Withdrawals by Reason [ Time Frame: Months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Cough by Severity [ Time Frame: Baseline, Months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Dyspnea by Severity [ Time Frame: Baseline, Months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Complete Response (CR), Partial Response (PR) and Stable Disease (SD) [ Time Frame: Months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    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.

  • Time to Start of Erlotinib Therapy After End of First Line Therapy [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Percentage of Participants With Remission of CR and PR [ Time Frame: Months 3, 6, 9, 12 ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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 Overall Survival: Overall [ Time Frame: From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40) ] [ Designated as safety issue: No ]
    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 Overall Survival: Gender [ Time Frame: From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40) ] [ Designated as safety issue: No ]
    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.

  • Median Overall Survival: Smoking Status [ Time Frame: From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 465
Study Start Date: May 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Elderly patients with advanced non-small cell lung cancer after first-line platinum-based chemotherapy
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535729

Locations
Germany
Nürnberg, Germany, 90419
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01535729     History of Changes
Other Study ID Numbers: ML23023 
Study First Received: February 15, 2012
Results First Received: October 1, 2015
Last Updated: October 1, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2016