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

Non-small Cell Lung Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03017885
• Other study ID #: 1199-0272
• Status: Completed
• Start date: February 28, 2017
• Est. completion date: September 24, 2022

Study information

• Verified date: September 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 24, 2022
• Est. primary completion date: September 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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].	From first drug administration until 28 days after the last drug administration, up to 586 days.
Primary	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].	From first drug administration until 28 days after the last drug administration, up to 586 days.
Secondary	Percentage of Patients Who Required Nintedanib Dose Reductions	Percentage of patients who required nintedanib dose reductions.	From first drug administration until 28 days after the last drug administration, up to 586 days.
Secondary	Number of Patients Who Discontinued Study Drug Permanently Due to Adverse Events	Number of patients who discontinued study drug permanently due to adverse events.	From first drug administration until last drug administration, up to 558 days.

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