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

Study Overview
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Brief Summary
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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.

Official 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

Conditions
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Non-small Cell Lung Cancer

Participation Criteria
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Eligibility 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>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<br>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<br>Patients who have been newly prescribed nintedanib & docetaxel at the time of participation in the active surveillance. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of all Adverse Drug Reactions (ADRs) in nintedanib & docetaxel treated patients |  | 2 years | 
| Incidence of all Serious Adverse Events (SAEs) in nintedanib & docetaxel treated patients |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who require nintedanib dose reductions and discontinuations due to adverse events. |  | 2 years |