PEPITA - 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
Head :
Roche Medical Data Center
Last update : 07/01/2022 | Version : 1 | ID : 74127
| General | |
| Identification | |
| Detailed name | 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 |
| Sign or acronym | PEPITA |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | ML28195 |
| General Aspects | |
| Medical area |
Cancer research |
| Study in connection with Covid-19 |
No |
| Pathology (details) | Non-Small Cell Lung Cancer (NSCLC) |
| Health determinants |
Iatrogenic Medicine |
| Keywords | ERLOTINIB |
| Scientific investigator(s) (Contact) | |
| Name of the director | Roche Medical Data Center |
| Address | 4 cours de l'Ile Seguin - 92650 BOULOGNE-BILLANCOURT |
| data_sharing_france@roche.com | |
| Organization | Roche SAS |
| Collaborations | |
| Participation in projects, networks and consortia |
No |
| Funding | |
| Funding status |
Private |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Roche SAS |
| Organisation status |
Private |
| Presence of scientific or steering committees |
Yes |
| Additional contact | |
| Name of the contact | https://www.roche.fr/fr/innovation-recherche-medicale/data-sharing-portail-d-information-partage-des-donnees.html |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is is made on the basis of: |
Medication(s) taken |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective |
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®. |
| Inclusion criteria |
Inclusion criteria:
1. Adult patients (age >= 18 years); 2. Histologically and/or cytologically confirmed advanced (stage IIIB) or metastatic (stage IV) NSCLC with predominant squamous component (basaloid carcinomas allowed), after failure of first-line platinum-based chemotherapy; 3. For whom the treating physician decided to initiate treatment with Tarceva®; 4. Having received oral and written information about the study and having raised no objections to the collection and analysis of his/her personal data. Exclusion criteria: 1. Mixed non-small cell and small cell lung carcinoma or mixed squamous cell carcinoma with a predominant adenocarcinoma component; 2. Concomitant participation in a clinical trial evaluating an antineoplastic treatment. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Pathology | D02 - Carcinoma in situ of middle ear and respiratory system |
| Gender |
Male Woman |
| Geography area |
National |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2012 |
| Date of last collection (YYYY or MM/YYYY) | 2014 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 152 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Biological data |
| Clinical data (detail) |
Medical registration |
| Details of collected clinical data | Date of visit - Inclusion/eclusion criteria - Demographic data - ECOG - SAP/DAP - Social and occupational data - Risk factors (tobacco use) - Medical history and concomitant diseases - Treatment associated with initiation of Tarceva® - Disease history: primary lung tumor evaluation - Disease history: diagnosis of locally advanced or metastatic disease - EGFR mutation status - First-line treatment of metastatic NSCLC. |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Medicines consumption |
| Procedures | |
| Data collection method | eCRF |
| Classifications used | CDISC |
| Quality procedure(s) used | GCP/GVP |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by contact with the referring doctor |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Dedicated website | https://www.roche.fr/fr/innovation-recherche-medicale/data-sharing-portail-d-information-partage-des-donnees.html |
| Presence of document that lists variables and coding procedures |
Yes |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
