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

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

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 Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• India
  • Anand, India, 388001
    • Zydus Hospitals and Healthcare Research Pvt. Ltd
  • Bangalore, India, 560099
    • Narayana Hrudyalaya
  • Bengaluru, India, 560017
    • Manipal Hospitals
  • Bengaluru, India, 560027
    • HCG Hospital
  • Bhubaneshwar, India, 751007
    • Sparsh Hospitals and Critical Care
  • Delhi, India, 110063
    • Action Cancer Hospital, Delhi
  • Hyderabad, India, 500033
    • Apollo Health City Hospital
  • Hyderabad, India, 500082
    • Yashoda Hospitals
  • Kolkata, India, 700026
    • Chittaranjan National Cancer Institute
  • New Delhi, India, 110085
    • Rajiv Gandhi Cancer Institute and Research Centre
  • Vadapalani, India, 600026
    • SRM Institute of Medical Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Group A; 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; 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; Patients who have been newly prescribed nintedanib & docetaxel at the time of participation in the active surveillance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2017
• Primary Completion (Actual): September 24, 2022
• Study Completion (Actual): September 24, 2022

Study Registration Dates

• First Submitted: January 10, 2017
• First Submitted That Met QC Criteria: January 10, 2017
• First Posted (Estimated): January 11, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 1199-0272

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

• IPD Sharing Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
• IPD Sharing Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No