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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02392455
• Other study ID #: 1199.211
• Secondary ID: 1199-0211
• Status: Active, not recruiting
• Start date: March 23, 2015
• Est. completion date: January 31, 2025

Study information

• Verified date: December 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 816
• Est. completion date: January 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• treatment
Docetaxel plus nintedanib until progression or intolerability

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients alive one year after start of therapy with Vargatef and Docetaxel (1-year survival rate)		up to 24 months
Secondary	One year survival rate of patients with first line progression within 9 months after start of first line therapy		up to 24 months
Secondary	Progression-free survival of patients with first line progression within 9 months after start of first line therapy		up to 24 months
Secondary	Median overall survival		up to 24 months
Secondary	Progression-free survival		up to 24 months
Secondary	Tumour control rate (complete response, partial response, stable disease)		up to 24 months
Secondary	Incidence of side effects		up to 24 months

External Links

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