VARGADO - Vargatef in 2nd-line Therapy of Non-Small Cell Lung Cancer (NSCLC)
Active, not recruiting
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Drug: treatment
- Registration Number
- NCT02392455
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This observational study will investigate the efficacy and tolerability of Vargatef (Nintedanib) plus docetaxel in daily routine second-line treatment in patients with locally advanced, metastatic or locally recurrent NSCLC. Treatment with Vargatef in eligible NSCLC patients, for whom the treating physician has decided to initiate treatment with Vargatef in second line according to the local label, will be observed for up to 24 months. Survial follow-up will be done until the end of the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 816
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description A treatment -
- Primary Outcome Measures
Name Time Method Percentage of patients alive one year after start of therapy with Vargatef and Docetaxel (1-year survival rate) up to 24 months
- Secondary Outcome Measures
Name Time Method Tumour control rate (complete response, partial response, stable disease) up to 24 months Incidence of side effects up to 24 months One year survival rate of patients with first line progression within 9 months after start of first line therapy up to 24 months Progression-free survival of patients with first line progression within 9 months after start of first line therapy up to 24 months Median overall survival up to 24 months Progression-free survival up to 24 months