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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
GroupInterventionDescription
Atreatment-
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Tumour control rate (complete response, partial response, stable disease)up to 24 months
Incidence of side effectsup to 24 months
One year survival rate of patients with first line progression within 9 months after start of first line therapyup to 24 months
Progression-free survival of patients with first line progression within 9 months after start of first line therapyup to 24 months
Median overall survivalup to 24 months
Progression-free survivalup to 24 months
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