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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

Study Description
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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.

Condition or disease
Non-small Cell Lung Cancer

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Other
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
Actual Study Start Date : February 28, 2017
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Nintedanib

Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of all Adverse Drug Reactions (ADRs) in nintedanib & docetaxel treated patients [ Time Frame: 2 years ]
  2. Incidence of all Serious Adverse Events (SAEs) in nintedanib & docetaxel treated patients [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Percentage of patients who require nintedanib dose reductions and discontinuations due to adverse events. [ Time Frame: 2 years ]

Eligibility Criteria
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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:   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).
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.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03017885


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
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India
Narayana Hrudyalaya Recruiting
Bangalore, India, 560099
Contact: Pragya Coca    080 71 222 222    pragnya.coca.dr@narayanahealth.org   
Manipal Hospitals Recruiting
Bengaluru, India, 560017
Contact: Poonam Patil    +91 9945687185    poonampatil@yahoo.com   
HCG Hospital Recruiting
Bengaluru, India, 560027
Contact: Shekar Patil    080 40206000    spassociates6@gmail.com   
Sparsh Hospitals and Critical Care Recruiting
Bhubaneshwar, India, 751007
Contact: Ghanshyam Biswas    91-9937500878    drgbiswas@gmail.com   
Apollo Health City Hospital Recruiting
Hyderabad, India, 500033
Contact: Vamshi Krishna    +91 9959778112    drmvkrishnaonco@gmail.com   
Basavatarakam Indo - American Cancer Hospital & Research Ins Recruiting
Hyderabad, India, 500034
Contact: Senthil Rajappa    +91-40-23551235    senthiljrajappa@gmail.com   
Yashoda Hospitals Recruiting
Hyderabad, India, 500082
Contact: Nikhil Ghadyalpatil    +91-40-67779999    nikhilghadyalpatil@gmail.com   
Chittaranjan National Cancer Institute Recruiting
Kolkata, India, 700026
Contact: Indranil Ghosh    +91-9163223215    dr.indraghosh@gmail.com   
Kasturba Medical College and Hospital Recruiting
Mangalore, India, 575001
Contact: Sourjya Banerjee    +919880345339    sourjya.banerjee@gmail.com   
SRM Institute of Medical Science Recruiting
Vadapalani, India, 600026
Contact: Ranjankumar Mohapatra       realpv60@hotmail.com   
Sponsors and Collaborators
Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03017885    
Other Study ID Numbers: 1199-0272
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms