VARGADO - Vargatef in 2nd-line Therapy of Non-Small Cell Lung Cancer (NSCLC)

Boehringer Ingelheim817 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

817

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

treatmentDRUG

Docetaxel plus nintedanib until progression or intolerability

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: * age 18 or older * men and women locally advanced, metastastic and/or recurrent NSCLC with adenocarcinoma histology for which vargatef treatment is indicated according to Summary of Product Characteristics (SmPC) * after first line chemotherapy. This includes also combinations of immune- and chemotherapy. * standard 21-day-cycles docetaxel treatment according to SmPC possible * written informed consent Exclusion criteria: * contraindications according to the SmPC of Vargatef or Docetaxel * more than one chemotherapy for treatment of NSCLC in palliative setting * current partcipation in a clinical trial * pregnancy * breastfeeding

Locations (1)

Unnamed facility

Multiple Locations, Germany

Outcomes

Primary Outcomes

Percentage of patients alive one year after start of therapy with Vargatef and Docetaxel (1-year survival rate)

Time frame: up to 24 months

Secondary Outcomes

One year survival rate of patients with first line progression within 9 months after start of first line therapy

Time frame: up to 24 months

Progression-free survival of patients with first line progression within 9 months after start of first line therapy

Time frame: up to 24 months

Median overall survival

Time frame: up to 24 months

Progression-free survival

Time frame: up to 24 months

Tumour control rate (complete response, partial response, stable disease)

Time frame: up to 24 months

Incidence of side effects

Time frame: up to 24 months

Data from ClinicalTrials.gov

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