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

Boehringer Ingelheim

Status: Completed

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: treatment

Study type: Observational

Funder types: Industry

Identifiers

NCT02392455

1199-0211 (Other Identifier)

1199.211

Details and patient eligibility

About

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.

Enrollment: 817 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

817 participants in 1 patient group

A

Treatment:

Drug: treatment