VARGADO - Vargatef in 2nd-line Therapy of Non-Small Cell... | NCT02392455

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

NCT02392455

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Jul 28, 2025Actual

Enrollment

817Actual

Phase

Not provided

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

treatment

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1199-0211	Other Identifier	Boehringer Ingelheim

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 23, 2015Actual

Primary Completion Date

Jul 23, 2025Actual

Completion Date

Jul 23, 2025Actual

First Submitted Date

Mar 17, 2015

First Submission Date that Met QC Criteria

Mar 17, 2015

First Posted Date

Mar 19, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2025

Last Update Posted Date

Jul 28, 2025Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

817Actual

Label	Type	Description	Intervention Names
A			Drug: treatment

Name	Type	Description	Arm Group Labels	Other Names
treatment	Drug	Docetaxel plus nintedanib until progression or intolerability	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of patients alive one year after start of therapy with Vargatef and Docetaxel (1-year survival rate)		up to 24 months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

NSCLC patients

Sampling Method

Probability Sample

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35012901	Derived	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.
31282758

See Also Links

Label	URL
Related Info	View source

Available IPD Information

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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'.

URL

https://www.mystudywindow.com/msw/datasharing

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided