An active surveillance to monitor the real world safety of Nintedanib in Indian NSCLC patients

Phase 4

Completed

• Conditions: Health Condition 1: null- NSCLC (Non Small Cell Lung Cancer)

• Registration Number: CTRI/2017/02/007857
• Lead Sponsor: Boehringer Ingelheim India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-09-24
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 28

Inclusion Criteria

1. Patients =18 years of age with locally advanced and/or metastatic NSCLC of stage IIIB or IV, or recurrent NSCLC and adenocarcinoma histology after relapse or failure of first line of chemotherapy who are newly prescribed nintedanib according to the package insert.

2. Willing to provide the informed consent

3. Patients in whom further visit/contact is possible during the planned period of active surveillance

4. Patients in whom information mentioned in the section 9.2.2.2 of the protocol is available

Exclusion Criteria

1. Patients who have taken nintedanib before participation in the study

2. Patients who are positive for EGFR mutation

3. Patients who are positive for ALK rearrangements

4. Patients who are participating in a clinical trial

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Occurrence of ADRs (serious and non-serious) <br/ ><br>2. Occurrence of AEs (serious and fatal)Timepoint: 2 Years

Secondary Outcome Measures

Name	Time	Method
Percentage of patients who require nintedanib dose reductions and discontinuations due to adverse eventsTimepoint: 2 Years