Home / Central Data Catalog / FRESH-PEF74127-EN
central

A prospective cohort study assessing the efficacy and safety of Tarceva® in 2nd line in patients with locally advanced or metastatic squamous Non-Small Cell Lung Cancer (NSCLC) – PEPiTA study

France, 2012 - 2014
Reference ID
FRESH-PEF74127-en
Metadata
DDI/XML JSON
Created on
Nov 15, 2025
Last modified
Nov 15, 2025
Page views
4
  • Identification
  • Scope
  • Coverage
  • Producers and sponsors
  • Study authorization
  • Sampling
  • Survey instrument
  • Data collection
  • Study activities
  • Quality standards
  • Data Access
  • Contacts
  • Metadata production

    • Identification

    Survey ID number

    FRESH-PEF74127-en
    Title

    A prospective cohort study assessing the efficacy and safety of Tarceva® in 2nd line in patients with locally advanced or metastatic squamous Non-Small Cell Lung Cancer (NSCLC) – PEPiTA study
    Abbreviation or Acronym

    PEPITA
    Country
    Name
    France
    Abstract

    Primary objective: To describe Progression Free Survival (PFS) in patients with stage IIIB or IV squamous NSCLC initiating treatment with Tarceva® after failure of first-line platinum-based chemotherapy. Secondary objectives: - To describe characteristics of patients treated with Tarceva®; - To describe Tarceva® treatment modalities in patients with squamous NSCLC after failure of first-line platinum-based chemotherapy; - To evaluate Overall Survival (OS); - To describe the evolution of QoL; - To describe the safety profile of Tarceva®.
    Kind of Data

    ['Clinical data','Biological data']
    Unit of Analysis

    Individuals

    Scope

    Topics
    Topic Vocabulary URI
    Oncology health theme
    cim-11 http://id.who.int/icd/entity/846453488
    Healthcare system determinants: Use of care health determinant
    Healthcare system determinants health determinant
    Keywords
    ERLOTINIB

    Coverage

    Universe

    {
    "level_sex_clusion_I": [
    "Male",
    "Female"
    ],
    "level_age_clusion_I": [
    "Young Adult (19 to 24 years)",
    "Adult (25 to 44 years)",
    "Middle Aged (45 to 64 years)",
    "Aged (65 to 79 years)",
    "Aged, 80 and over (80 years and more)"
    ],
    "level_type_clusion_I": [
    "Patients population"
    ],
    "level_type_clusion_other": "",
    "clusion_I": "",
    "clusion_E": ""
    }

    Producers and sponsors

    Producers
    Name Role
    F. HOFFMANN-LA ROCHE AG sponsor

    Study authorization

    Agency
    Agency name
    Autre

    Sampling

    Sample frame

    Unit Type

    ['Through organizations (health services or institutions, schools, businesses, etc.)']
    Sampling Procedure

    ['Other']

    Survey instrument

    Questionnaires

    Access on specific project only
    Methodology notes

    Observational Study

    Data collection

    Dates of Data Collection
    Start End
    2012 2014
    Time Method

    Longitudinal or cohort study
    Mode of data collection
    • Converting or copying information into a structured record

    Study activities

    Study activities
    Type
    primary evaluation
    Description
    Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception

    Quality standards

    Quality standards
    Standard
    ['CDISC']
    Other quality statement

    GCP/GVP

    Data Access

    Availability Status

    Restricted access

    Contacts

    Contacts
    Name Email
    Medical data center data_sharing.france@roche.com

    Metadata production

    DDI Document ID

    FRESH-PEF74127-en
    Back to Catalog