An Observational Study of Tarceva (Erlotinib) in Routine Daily Clinical Practice as Second Line Treatment in Patients With Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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This observational study will evaluate the safety and efficacy of Tarceva (erlotinib) in routine clinical practice as second-line treatment in patients with recurrent or metastatic non-small dell lung cancer (NSCLC). Data will be collected from patients who have received 1 course of standard systemic chemotherapy, experienced disease progression, and who are receiveingTarceva in a second-line setting. Patients will also be followed through third-line treatment if there is disease progression on Tarceva therapy.

Official Title
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A Non-interventional Study to Follow and Evaluate Patients With Advanced NSCLC Who Are Treated in Second Line Setting With Tarceva (Erlotinib) in a Real Life Clinical Setting

Conditions
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Nonsquamous Nonsmall Cell Neoplasm of Lung

Intervention / Treatment
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* Drug: Erlotinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients ≥ 18 years of age. Written informed consent. Recurrent or metastatic, Stage III or IV non-small cell lung cancer (NSCLC). Measurable disease (Response Evaluation Criteria In Solid Tumors). Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Prior course of standard systemic chemotherapy. Exclusion Criteria: - Contra-indications to treatment with Tarceva.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Erlotinib<br>Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily. | Drug: Erlotinib<br>* Erlotinib was provided in the retail versions of the product.<br>* Other names: Tarceva;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) | The best overall response to treatment was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started for TLs and the persistence of 1 or more non-TL(s). PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. For the best overall responses of CR and PR, a response was confirmed if a subsequent RECIST evaluation also showed a CR or PR. | Baseline to the end of the study (up to 4 years, 4 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Disease Progression | The time to disease progression was defined as the time from Baseline until disease progression as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. 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 recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. | Baseline to the end of the study (up to 4 years, 4 months) | 
| Progression-free Survival | Progression-free survival was defined as the time from Baseline until disease progression or death from any cause. Progressive disease was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. 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 recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. | Baseline to the end of the study (up to 4 years, 4 months) | 
| Overall Survival | Overall survival was defined as the time from Baseline until or death from any cause | Baseline to the end of the study (up to 4 years, 4 months) | 
| Change From Baseline in the Lung Cancer Symptom Scale (LCSS) Scores | Study participants and treating physicians completed the LCSS, a measure of Quality of Life (QoL), at Baseline and throughout the study. The patient LCSS measures 6 major symptoms, the Symptom Burden Index (SBI), associated with lung malignancies (3 thoracic [cough, dyspnea, haemoptysis] and 3 general symptoms [loss of appetite, fatigue, pain]) and 3 additional scores (overall symptomatic distress, interference with daily activities, global QoL), each on a 100 mm visual analogue scale (0=no impairment, 100=maximum impairment). The physician LCSS evaluates the 6 lung malignancy associated symptoms, the SBI, on an ordinal scale (100=none, 75=mild, 50=moderate, 25=marked, 0=severe). The average of the patient and physician SBI scores (6 symptoms) and the average of the patient total score (9 symptoms) ranged from 0 to 100, with a higher patient and a lower physician score indicating more impairment. A negative patient and a positive physician change score indicates improvement. | Baseline to the end of the study (up to 4 years, 4 months) | 
| Percentage of Participants Who Developed Rash | At each study visit, the presence of skin rash was graded using the Common Toxicity Criteria (CTC), with grade 0 = no rash, grade 1 = mild, grade 2 = moderate, grade 3 = severe, and grade 4 = life threatening or disabling rash. Reported is the percentage of participants who developed a grade ≥ 1 rash. | Baseline to the end of the study (up to 4 years, 4 months) |