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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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24 October 2022 |
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Main ID: |
NCT03017885 |
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Date of registration:
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10/01/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Post Marketing Surveillance of Nintedanib in Indian Patients With Non-small Cell Lung Cancer (NSCLC) After First-line Therapy
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Scientific title:
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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 |
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Date of first enrolment:
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February 28, 2017 |
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Target sample size:
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28 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03017885 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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India
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Non-small Cell Lung Cancer
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Primary Outcome(s)
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Incidence of all Adverse Drug Reactions (ADRs) in nintedanib & docetaxel treated patients
[Time Frame: 2 years]
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Incidence of all Serious Adverse Events (SAEs) in nintedanib & docetaxel treated patients
[Time Frame: 2 years]
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Secondary Outcome(s)
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Percentage of patients who require nintedanib dose reductions and discontinuations due to adverse events.
[Time Frame: 2 years]
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Secondary ID(s)
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1199-0272
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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