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

Hoffmann-La Roche70 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Interventions

Erlotinib 150 mgDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Clinical Center of Serbia; Institute For Pulmology

Belgrade, Serbia

Institute for Oncology and Radiology of Serbia; Medical Oncology

Belgrade, Serbia

Military Medical Academy; Clinic for Pulmonology

Belgrade, Serbia

Institute for pulmonary diseases of Vojvodina

Kamenitz, Serbia

Outcomes

Primary Outcomes

Progression-Free Survival (PFS)

PFS was defined as the time from initial dose of erlotinib to progression or death from any cause.

Time frame: Approximately 3 years

Secondary Outcomes

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.

Time frame: 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.

Time frame: Baseline up to 3 years

Data from ClinicalTrials.gov

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