A non-interventional biomarker study in patients with NSCLC of adenocarcinoma tumour histology eligible for treatment with Vargatef according to the approved label
Phase 4
Completed
- Conditions
- lung cancerNon small-cell lung carcinoma10029107
- Registration Number
- NL-OMON46049
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 34
Inclusion Criteria
- Women and men with locally advanced, metastatic or locally recurrent NSCLC with histology of adenocarcinoma
- Vargatef is initiated and administered in accordance with the SPC
- Available fixed and paraffin embedded (FPE) tumour tissue routinely obtained at diagnosis and/or re-biopsy before the initiation of the first line treatment (either block or slides, minimum of 10 slides and up to 20 slides if possible at 5 um thickness).
Exclusion Criteria
- Any contraindication to Vargatef or docetaxel as specified in their respective labels
- Vargatef initiated from more than 7 days prior to inclusion in this NIS
- Patients participating simultaneously in another NIS or a clinical trial
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Overall Survival (OS). OS is defined as the time from start of entering the<br /><br>study to time of death (irrespective of reason). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Time since start of first line therapy until start of Vargatef® therapy<br /><br>Time since start of first line therapy until start of Vargatef® therapy is<br /><br>divided into 2 subgroups as follows:<br /><br>• *Late progression group*: time from start of first line therapy until start<br /><br>of Vargatef® >=9 months (T>=9)<br /><br>• *Early progression group*: time from start of first line therapy until start<br /><br>of Vargatef® <9 months (T<9)</p><br>