FRESH-PEF74127-en
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
PEPITA
| Name | Country code |
|---|---|
| France | fr |
['Clinical data','Biological data']
Individuals
| Topic | Vocabulary |
|---|---|
| Oncology | health theme |
| Carcinoma in situ of middle ear or respiratory system | cim-11 |
| Healthcare system determinants: Use of care | health determinant |
| Healthcare system determinants | health determinant |
{"level_sex_clusion_I":[{"value":"Male","concept":{"vocab":"MeSH","vocabURI":"D008297"}},{"value":"Female","concept":{"vocab":"MeSH","vocabURI":"D005260"}}],"level_age_clusion_I":[{"value":"Young Adult (19 to 24 years)","concept":{"vocab":"MeSH","vocabURI":"D055815"}},{"value":"Adult (25 to 44 years)","concept":{"vocab":"MeSH","vocabURI":"D000328"}},{"value":"Middle Aged (45 to 64 years)","concept":{"vocab":"MeSH","vocabURI":"D008875"}},{"value":"Aged (65 to 79 years)","concept":{"vocab":"MeSH","vocabURI":"D000368"}},{"value":"Aged, 80 and over (80 years and more)","concept":{"vocab":"MeSH","vocabURI":"D000369"}}],"level_type_clusion_I":"Patients population","level_type_clusion_other":"","clusion_I":"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. ","clusion_E":"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."}
| Name | Role |
|---|---|
| F. HOFFMANN-LA ROCHE AG | sponsor |
| Agency name |
|---|
| Other |
['Through organizations (health services or institutions, schools, businesses, etc.)']
['{"concept":{"vocabURI":"Other","vocab":"CESSDA"},"value":"Other"}']
Access on specific project only
Observational Study
| Start | End |
|---|---|
| 2012-01-01 | 2014-01-01 |
| Standard |
|---|
| ['CDISC'] |
['GCP/GVP']
{"value":"Restricted access","extLink":[{"title":"COAR","uri":"http://purl.org/coar/access_right/c_16ec"}]}
| Name | |
|---|---|
| ;Medical data center | data_sharing.france@roche.com |