Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT02392455
Recruitment Status : Recruiting
First Posted : March 19, 2015
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date March 17, 2015
First Posted Date March 19, 2015
Last Update Posted Date April 25, 2019
Actual Study Start Date March 23, 2015
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 17, 2015)
Percentage of patients alive one year after start of therapy with Vargatef and Docetaxel (1-year survival rate) [ Time Frame: up to 24 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02392455 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 17, 2015)
  • 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 ]
  • Progression-free survival of patients with first line progression within 9 months after start of first line therapy [ Time Frame: up to 24 months ]
  • Median overall survival [ Time Frame: up to 24 months ]
  • Progression-free survival [ Time Frame: up to 24 months ]
  • Tumour control rate (complete response, partial response, stable disease) [ Time Frame: up to 24 months ]
  • Incidence of side effects [ Time Frame: up to 24 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title VARGADO - Vargatef in 2nd-line Therapy of Non-Small Cell Lung Cancer (NSCLC)
Official Title Vargatef in 2nd-line Therapy of Advanced or Metastatic Adenocarcinoma of the Lung
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population NSCLC patients
Condition Carcinoma, Non-Small-Cell Lung
Intervention Drug: treatment
Docetaxel plus nintedanib until progression or intolerability
Study Groups/Cohorts A
Intervention: Drug: treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 17, 2015)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02392455
Other Study ID Numbers 1199.211
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor Boehringer Ingelheim
Collaborators Not Provided
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date April 2019