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

Not Applicable

Completed

• Conditions: NSCLC (Non Small Cell Lung Cancer)

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

Brief Summary

This is an active surveillance to monitor the real world safety in Indian patients of locally advanced and/or metastatic NSCLC of stage IIIB or IV, or recurrent NSCLC and adenocarcinoma histology after relapse or failure of first line chemotherapy, who are newly prescribed nintedanib according to the package insert. Patient registration will continue until it is confirmed that 100 patients treated with nintedanib are included and that baseline characteristics of 100 additional patients (or as many patients as in the nintedanib group if <100) planned to be treated with single agent docetaxel are collected from the same centers during the same time frame, or until a maximum of two years, whichever occurs first.

The primary outcome:



1. Occurrence of ADRs (serious and non-serious)

2. Occurrence of AEs (serious and fatal)

Secondary outcome:

Percentage of patients who require nintedanib dose reductions and discontinuations due to adverse events

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-14
• Study Completion: 2022-09-24
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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 relapse or failure of first line of chemotherapy who are newly prescribed nintedanib according to the package insert.
• 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

• 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.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Occurrence of ADRs (serious and non-serious)	2 Years
2. Occurrence of AEs (serious and fatal)	2 Years

Secondary Outcome Measures

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

Trial Locations

Locations (15)

Action Cancer Hospital; 🇮🇳 West, DELHI, India

Apollo Gleneagles Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

Apollo Hospitals; 🇮🇳 Hyderabad, TELANGANA, India

Basavatarakam Indo American Cancer Hospital & Research Institute; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

HCG Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Institute of Oncology & BMT, SIMS; 🇮🇳 Chennai, TAMIL NADU, India

KMC Hospital; 🇮🇳 Chikmagalur, KARNATAKA, India

M.S. Ramaiah Medical College and Hospitals; 🇮🇳 Bangalore, KARNATAKA, India

Manipal Hospitals; 🇮🇳 Bangalore, KARNATAKA, India

Medica Superspecialty Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

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Action Cancer Hospital

🇮🇳West, DELHI, India

Dr Sushant Mittal

Principal investigator

9818930805

sushantmittal80@gmail.com