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

Boehringer Ingelheim28 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Non-small Cell Lung Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (11)

Zydus Hospitals and Healthcare Research Pvt. Ltd

Anand, India

Narayana Hrudyalaya

Bangalore, India

Manipal Hospitals

Bengaluru, India

HCG Hospital

Outcomes

Primary Outcomes

Incidence of All Adverse Drug Reactions (ADRs) in Nintedanib and Docetaxel Treated Patients

Incidence of all Adverse drug reactions (ADRs) in nintedanib and docetaxel treated patients. An Adverse Event (AE) was considered as an Adverse drug reaction (ADR) if either the physician who reported the AE or the sponsor assessed its causal relationship as 'related'. The incidence rate were calculated using number of patients with respective events divided by time at risk expressed as \[100 pt -yrs\].

Time frame: From first drug administration until 28 days after the last drug administration, up to 586 days.

Incidence Rate of All Serious Adverse Events (SAEs) in Nintedanib and Docetaxel Treated Patients

Incidence rate of all Serious Adverse Events (SAEs) in nintedanib and docetaxel treated patients. All Adverse Events (AEs) that occurred between the first intake of nintedanib plus docetaxel and within 28 days (inclusive) after the last intake were considered 'treatment emergent'. The incidence rate were calculated using number of patients with respective events divided by time at risk expressed as \[100 pt -yrs\].

Time frame: From first drug administration until 28 days after the last drug administration, up to 586 days.

Secondary Outcomes

Percentage of Patients Who Required Nintedanib Dose Reductions

Percentage of patients who required nintedanib dose reductions.

Time frame: From first drug administration until 28 days after the last drug administration, up to 586 days.

Number of Patients Who Discontinued Study Drug Permanently Due to Adverse Events

Number of patients who discontinued study drug permanently due to adverse events.

Time frame: From first drug administration until last drug administration, up to 558 days.

Data from ClinicalTrials.gov

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