Clinical trial NCT01535729: An Observational Study of Tarceva (Erlotinib) in Elderly Patients With Advanced Non-Small Cell Lung Cancer
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-02-20
Enrollment: 465
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elderly patients with advanced non-small cell lung cancer after first-line platinum-based chemotherapy

Brief 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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants Who Were Alive 1 Year After Start of Treatment
timeFrame: Year 1
Secondary outcomes:
measure: Median Overall Survival: Age
timeFrame: From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)
measure: Percentage of Participants With Fatigue
timeFrame: Months 3, 6, 9, 12
measure: Percentage of Participants With Rash
timeFrame: Months 3, 6, 9, 12
measure: Percentage of Participants With Diarrhea
timeFrame: Months 3, 6, 9, 12
measure: Percentage of Participants With Rash Based on Severity During the Course of Time
timeFrame: Months 3, 6, 9, 12
measure: Percentage of Participants With Diarrhea Based on Severity During the Course of Time
timeFrame: Months 3, 6, 9, 12
measure: Percentage of Participants With Fatigue Based on Severity During the Course of Time
timeFrame: Months 3, 6, 9, 12
measure: Percentage of Participants With Dose Modifications by Reason
timeFrame: Months 3, 6, 9, 12
measure: Percentage of Participants With Dose Withdrawals by Reason
timeFrame: Months 3, 6, 9, 12
measure: Percentage of Participants With Cough by Severity
timeFrame: Baseline, Months 3, 6, 9, 12
measure: Percentage of Participants With Dyspnea by Severity
timeFrame: Baseline, Months 3, 6, 9, 12
measure: Percentage of Participants With Complete Response (CR), Partial Response (PR) and Stable Disease (SD)
timeFrame: Months 3, 6, 9, 12
measure: Time to Start of Erlotinib Therapy After End of First Line Therapy
timeFrame: Baseline
measure: Percentage of Participants With Remission of CR and PR
timeFrame: Months 3, 6, 9, 12
measure: Median Progression Free Survival: Overall
timeFrame: From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)
measure: Median Progression Free Survival: Age
timeFrame: From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)
measure: Median Progression Free Survival: Gender
timeFrame: From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)
measure: Median Progression Free Survival: Smoking Status
timeFrame: From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)
measure: Median Progression Free Survival: Best Response to Prior Chemotherapy
timeFrame: From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)
measure: Median Overall Survival: Overall
timeFrame: From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)
measure: Median Overall Survival: Gender
timeFrame: From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)
measure: Median Overall Survival: Smoking Status
timeFrame: From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)
measure: Median Overall Survival: Best Response to Prior Chemotherapy
timeFrame: From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)
Other outcomes:
Locations:
city: Nürnberg
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Brueckl WM, Achenbach HJ, Ficker JH, Schuette W. Erlotinib treatment after platinum-based therapy in elderly patients with non-small-cell lung cancer in routine clinical practice - results from the ElderTac study. BMC Cancer. 2018 Mar 27;18(1):333. doi: 10.1186/s12885-018-4208-x.