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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03017885
Collaborator
(none)
100
Enrollment
12
Locations
67.3
Anticipated Duration (Months)
8.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Feb 28, 2017
    Anticipated Primary Completion Date :
    Oct 8, 2022
    Anticipated Study Completion Date :
    Oct 8, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Primary Outcome Measures

    1. Incidence of all Adverse Drug Reactions (ADRs) in nintedanib & docetaxel treated patients [2 years]

    2. Incidence of all Serious Adverse Events (SAEs) in nintedanib & docetaxel treated patients [2 years]

    Secondary Outcome Measures

    1. Percentage of patients who require nintedanib dose reductions and discontinuations due to adverse events. [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Zydus Hospitals and Healthcare Research Pvt. Ltd Anand India 388001
    2 Narayana Hrudyalaya Bangalore India 560099
    3 Manipal Hospitals Bengaluru India 560017
    4 HCG Hospital Bengaluru India 560027
    5 Sparsh Hospitals and Critical Care Bhubaneshwar India 751007
    6 Action Cancer Hospital, Delhi Delhi India 110063
    7 Apollo Health City Hospital Hyderabad India 500033
    8 Yashoda Hospitals Hyderabad India 500082
    9 Chittaranjan National Cancer Institute Kolkata India 700026
    10 Kasturba Medical College and Hospital Mangalore India 575001
    11 Rajiv Gandhi Cancer Institute and Research Centre New Delhi India 110085
    12 SRM Institute of Medical Science Vadapalani India 600026

    Sponsors and Collaborators

    • Boehringer Ingelheim

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Boehringer Ingelheim
    ClinicalTrials.gov Identifier:
    NCT03017885
    Other Study ID Numbers:
    • 1199-0272
    First Posted:
    Jan 11, 2017
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Aug 25, 2022