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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02392455
Recruitment Status : Recruiting
First Posted : March 19, 2015
Last Update Posted : January 11, 2022
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment
Carcinoma, Non-Small-Cell Lung Drug: treatment

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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vargatef in 2nd-line Therapy of Advanced or Metastatic Adenocarcinoma of the Lung
Actual Study Start Date : March 23, 2015
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
A Drug: treatment
Docetaxel plus nintedanib until progression or intolerability

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
NSCLC patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02392455

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Contact: Boehringer Ingelheim Call Center 1-800-243-0127

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Multiple Locations, Germany
Sponsors and Collaborators
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Boehringer Ingelheim Identifier: NCT02392455    
Other Study ID Numbers: 1199.211
1199-0211 ( Other Identifier: Boehringer Ingelheim )
First Posted: March 19, 2015    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link 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 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

Supporting Materials: 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'.
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases