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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01836133
Recruitment Status : Completed
First Posted : April 19, 2013
Results First Posted : May 4, 2017
Last Update Posted : May 4, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Non-Squamous Non-Small Cell Lung Cancer Drug: Erlotinib 150 mg

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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : May 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort Intervention/treatment
Erlotinib 150 mg
Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
Drug: Erlotinib 150 mg

Primary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: Approximately 3 years ]
    PFS was defined as the time from initial dose of erlotinib to progression or death from any cause.

Secondary Outcome Measures :
  1. Percentage of Participants With Overall Response [ Time Frame: 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.

  2. Proportions of Participants With Adverse Events (AEs), Serious AEs, and AEs of Special Interest (AESIs) [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with locally advanced or metastatic adenocarcinoma non-small cell lung cancer, with ECOG performance status of 0-1

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01836133

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Clinical Center of Serbia; Institute For Pulmology
Belgrade, Serbia, 11000
Institute for Oncology and Radiology of Serbia; Medical Oncology
Belgrade, Serbia, 11000
Military Medical Academy; Clinic for Pulmonology
Belgrade, Serbia, 11000
Clinical Center Nis; Clinic for pulmonary diseases Knez Selo
Knez Selo, Serbia, 18000
Institute for pulmonary diseases of Vojvodina
Sremska Kamenica, Serbia, 21204
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche Identifier: NCT01836133    
Other Study ID Numbers: ML28282
First Posted: April 19, 2013    Key Record Dates
Results First Posted: May 4, 2017
Last Update Posted: May 4, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action