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Completed

NCT Number: NCT02392455

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

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.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

treatment

Drug

Docetaxel plus nintedanib until progression or intolerability

Primary outcomes

  1. 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

  1. 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

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

    Time frame: up to 24 months

  3. Median overall survival

    Time frame: up to 24 months

  4. Progression-free survival

    Time frame: up to 24 months

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

    Time frame: up to 24 months

  6. Incidence of side effects

    Time frame: up to 24 months

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Vargatef in 2nd-line Therapy of Advanced or Metastatic Adenocarcinoma of the Lung

Important dates

Study start
2015
Primary completion
2025
Study completion
2025
First posted
Mar 19, 2015
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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