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Post Marketing Surveillance of Nintedanib in Indian Patients With Non-small Cell Lung Cancer (NSCLC) After First-line Therapy

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: NCT03017885
Recruitment Status : Recruiting
First Posted : January 11, 2017
Last Update Posted : January 13, 2021
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date January 10, 2017
First Posted Date January 11, 2017
Last Update Posted Date January 13, 2021
Actual Study Start Date February 28, 2017
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 9, 2018)
  • Incidence of all Adverse Drug Reactions (ADRs) in nintedanib & docetaxel treated patients [ Time Frame: 2 years ]
  • Incidence of all Serious Adverse Events (SAEs) in nintedanib & docetaxel treated patients [ Time Frame: 2 years ]
Original Primary Outcome Measures
 (submitted: January 10, 2017)
  • Occurrence of ADRs (serious and non-serious) [ Time Frame: 2 years ]
  • Occurrence of AEs (serious and fatal) [ Time Frame: 2 years ]
Change History
Current Secondary Outcome Measures
 (submitted: August 9, 2018)
Percentage of patients who require nintedanib dose reductions and discontinuations due to adverse events. [ Time Frame: 2 years ]
Original Secondary Outcome Measures
 (submitted: January 10, 2017)
Percentage of patients who require dose reductions (nintedanib and docetaxel, docetaxel [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post Marketing Surveillance of Nintedanib in Indian Patients With Non-small Cell Lung Cancer (NSCLC) After First-line Therapy
Official Title An Active Surveillance to Monitor the Real World Safety in Indian Patients Prescribed Nintedanib for the Treatment of Locally Advanced, Metastatic or Locally Recurrent Non Small Cell Lung Cancer (NSCLC) of Adenocarcinoma Tumor Histology After First Line Chemotherapy
Brief Summary This active surveillance aims to collect the safety data of 100 NSCLC patients treated with nintedanib per the approved Indian label within 2 years from the date of commercial availability of the drug in India (23rd January 2017). The objective is to look at the safety of nintedanib in the real world setting.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population This active surveillance aims to collect the safety data of 100 NSCLC patients treated with nintedanib per the approved Indian label within 2 years from the date of commercial availability of the drug in India (23rd January 2017).
Condition Non-small Cell Lung Cancer
Intervention Not Provided
Study Groups/Cohorts
  • Group A
    Patients who started treatment with nintedanib & docetaxel after 23rd January, 2017 and have discontinued the drug at the time of participation in the active surveillance.
  • Group B
    Patients who started treatment with nintedanib & docetaxel after 23rd January, 2017 and are continuing the drug at the time of participation in the active surveillance .
  • Group C
    Patients who have been newly prescribed nintedanib & docetaxel at the time of participation in the active surveillance.
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: April 3, 2017)
100
Original Estimated Enrollment
 (submitted: January 10, 2017)
40
Estimated Study Completion Date September 1, 2021
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients ≥18 years of age with locally advanced and/or metastatic NSCLC of stage IIIB or IV, or recurrent NSCLC and adenocarcinoma histology after first line chemotherapy who have initiated or will initiate nintedanib & docetaxel according to the package insert after the commercial availability of drug in India (23rd January 2017).
  • Patients in whom it is possible to obtain voluntary informed consent from either the patient or patient's legally authorised representative (applicable for Group B and C patients).
  • Patients in whom data collection is possible from the medical records (applicable for Group A and B patients).
  • Further inclusion criteria apply.

Exclusion Criteria:

  • Patients who were previously treated with nintedanib.
  • Patients who are positive for endothelial growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements
  • Patients who are participating in a clinical trial.
  • Further exclusion criteria apply.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
Listed Location Countries India
Removed Location Countries  
 
Administrative Information
NCT Number NCT03017885
Other Study ID Numbers 1199-0272
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Boehringer Ingelheim
Study Sponsor Boehringer Ingelheim
Collaborators Not Provided
Investigators Not Provided
PRS Account Boehringer Ingelheim
Verification Date January 2021