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

Boehringer Ingelheim

Status: Completed

Conditions: Non-small Cell Lung Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT03017885

1199-0272

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

28 participants in 3 patient groups

Group A

Description:

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

Description:

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

Description:

Patients who have been newly prescribed nintedanib \& docetaxel at the time of participation in the active surveillance.