An Observational Study of Tarceva (Erlotinib) in Participants With Locally Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer (ELEMENT)
- Registration Number
- NCT01836133
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Erlotinib 150 mg Erlotinib 150 mg Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) Approximately 3 years PFS was defined as the time from initial dose of erlotinib to progression or death from any cause.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Overall Response Approximately 3 years 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.
Proportions of Participants With Adverse Events (AEs), Serious AEs, and AEs of Special Interest (AESIs) Baseline up to 3 years 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.
Trial Locations
- Locations (5)
Clinical Center Nis; Clinic for pulmonary diseases Knez Selo
🇷🇸Knez Selo, Serbia
Institute for Oncology and Radiology of Serbia; Medical Oncology
🇷🇸Belgrade, Serbia
Military Medical Academy; Clinic for Pulmonology
🇷🇸Belgrade, Serbia
Clinical Center of Serbia; Institute For Pulmology
🇷🇸Belgrade, Serbia
Institute for pulmonary diseases of Vojvodina
🇷🇸Sremska Kamenica, Serbia