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

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Nintedanib

Criteria

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