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

Completed

Brief Summary: 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.

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
Incidence of All Adverse Drug Reactions (ADRs) in Nintedanib and Docetaxel Treated Patients	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	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 Outcome Measures

Name	Time	Method
Percentage of Patients Who Required Nintedanib Dose Reductions	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	From first drug administration until last drug administration, up to 558 days.	Number of patients who discontinued study drug permanently due to adverse events.

Locations (11): Action Cancer Hospital, Delhi
🇮🇳
Delhi, India
Apollo Health City Hospital
🇮🇳
Hyderabad, India
Chittaranjan National Cancer Institute
🇮🇳
Kolkata, India
Narayana Hrudyalaya
🇮🇳
Bangalore, India
Zydus Hospitals and Healthcare Research Pvt. Ltd
🇮🇳
Anand, India
Sparsh Hospitals and Critical Care
🇮🇳
Bhubaneshwar, India
Manipal Hospitals
🇮🇳
Bengaluru, India
HCG Hospital
🇮🇳
Bengaluru, India
Yashoda Hospitals
🇮🇳
Hyderabad, India
SRM Institute of Medical Science
🇮🇳
Vadapalani, India
Rajiv Gandhi Cancer Institute and Research Centre
🇮🇳
New Delhi, India