An Observational Study of Tarceva (Erlotinib) in Participants With Locally Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer (ELEMENT)

Study Overview
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Brief Summary
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This multicenter, observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in participants with locally advanced or metastatic adenocarcinoma non-small cell lung cancer and an ECOG performance status of 0-1. Eligible participants receiving Tarceva according to the Summary of Product Characteristics and local label will be followed for the duration of their treatment.

Official Title
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Efficacy and Safety of Erlotinib (Tarceva® ) Therapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) , Subtype Adenocarcinoma, Who Have Good Performance Status (PS 0-1) - ELEMENT

Conditions
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Non-Squamous Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Erlotinib 150 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult participants, >/= 18 years of age Histologically or cytologically confirmed, locally advanced (Stage IIIb) or metastatic (Stage IV) adenocarcinoma non-small cell lung cancer Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Adequate hematologic, renal and liver function Participant initiating treatment with Tarceva according to the Summary of Product Characteristics Exclusion Criteria: Any contraindications to treatment with Tarceva according to the Summary of Product Characteristics and local label Any other malignancies within the previous 5 years, except for in situ carcinoma of the cervix and basal and squamous cell carcinoma of the skin Previous systemic anti-cancer treatment with HER1/EGFR inhibitor

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 150 mg<br>Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years. | Drug: Erlotinib 150 mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) | PFS was defined as the time from initial dose of erlotinib to progression or death from any cause. | Approximately 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Overall Response | Overall response was defined, based on response evaluation criteria in solid tumours (RECIST) v 1.1, as complete response (CR) plus partial response (PR). CR: complete disappearance of all target lesions; PR: at least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions. | Approximately 3 years | 
| Proportions of Participants With Adverse Events (AEs), Serious AEs, and AEs of Special Interest (AESIs) | An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant, according to national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) criteria version 4.0. An AESI was defined as interstitial pulmonary disease. | Baseline up to 3 years |