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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zydus Hospitals and Healthcare Research Pvt. Ltd, Anand, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

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

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

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.

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].

Secondary outcomes

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.

Percentage of patients who required nintedanib dose reductions.
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.

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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2022
Study completion: 2022
First posted: Jan 11, 2017
Registry last updated: Mar 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed