Prospective, Open-label, Multicenter, National, Non-interventional Phase IV Trial of the Effectiveness, Safety and Tolerability of Tarceva as Second-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC), After Failure of First-line Treatment With a Pemetrexed-containing Chemotherapy Regimen
Overview
- Phase
- Not Applicable
- Intervention
- Erlotinib
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 57
- Primary Endpoint
- Progression-free Survival
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This prospective, multicenter observational study will evaluate the efficacy, safety, and tolerability of Tarceva (erlotinib) as second-line treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed after pemetrexed-containing first-line chemotherapy. Eligible patients will be followed until withdrawal of consent, lost-to-follow-up, or study termination, whichever occurs first.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult patients ≥ 18 years of age.
- •Histologically or cytologically documented locally advanced or metastatic non-small cell lung cancer (inoperable Stage III or IV according to the 7th TNM Classification of Malignant Tumors).
- •Experiencing disease progression after pemetrexed-containing first-line chemotherapy regimen.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Initiated on second-line treatment with Tarceva at the most 4 weeks prior to study entry at baseline (date of signature of informed consent).
Exclusion Criteria
- •Prior chemotherapy/targeted therapy after disease progression after first-line treatment in the advanced non-small cell lung cancer (NSCLC) setting.
- •Contraindication for Tarceva according to the Summary of Product characteristics.
Arms & Interventions
Erlotinib
Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
Intervention: Erlotinib
Outcomes
Primary Outcomes
Progression-free Survival
Time Frame: Baseline to the end of the study (up to 2 years)
Progression-free survival was defined as the time from the first dose of erlotinib to disease progression or death from any cause, whichever occurred earlier. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter of target lesions recorded since treatment started, or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Secondary Outcomes
- Percentage of Participants Who Developed Rash(Up to 2 years)
- Overall Survival(Up to 2 years)
- Percentage of Participants Who Developed Diarrhea(Up to 2 years)
- Best Overall Response(Baseline to the end of the study (up to 2 years))