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

NCT02392455 | Completed

• 2 other identifiers: 1199.2111199-0211
• Study Type: observational
• Target: 817
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

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

  up to 24 months

Secondary Outcomes (6)

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

  up to 24 months

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

  up to 24 months

• Median overall survival

  up to 24 months

• Progression-free survival

  up to 24 months

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

  up to 24 months

Study Arms (1)

A

Drug: treatment

Interventions

treatment DRUG

Docetaxel plus nintedanib until progression or intolerability

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

NSCLC patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Unknown Facility

Multiple Locations, Germany

Location

Related Publications (2)

• Grohe C, Blau W, Gleiber W, Haas S, Hammerschmidt S, Kruger S, Muller-Huesmann H, Schulze M, Wehler T, Atz J, Kaiser R. Real-World Efficacy of Nintedanib Plus Docetaxel After Progression on Immune Checkpoint Inhibitors: Results From the Ongoing, Non-interventional VARGADO Study. Clin Oncol (R Coll Radiol). 2022 Jul;34(7):459-468. doi: 10.1016/j.clon.2021.12.010. Epub 2022 Jan 7.

  PMID: 35012901 DERIVED

• Grohe C, Gleiber W, Haas S, Losem C, Mueller-Huesmann H, Schulze M, Franke C, Basara N, Atz J, Kaiser R. Nintedanib plus docetaxel after progression on immune checkpoint inhibitor therapy: insights from VARGADO, a prospective study in patients with lung adenocarcinoma. Future Oncol. 2019 Aug;15(23):2699-2706. doi: 10.2217/fon-2019-0262. Epub 2019 Jul 8.

  PMID: 31282758 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: March 19, 2015
• Study Start: March 23, 2015
• Primary Completion: July 23, 2025
• Study Completion: July 23, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
• Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.

Locations

DE (1)