An active surveillance to monitor the real world safety in Indian patients prescribed nintedanib for the treatment of locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy.

Study identification

• EU PAS number:
  EUPAS17078
• Study ID:
  40195
• Official title and acronym:
  An active surveillance to monitor the real world safety in Indian patients prescribed nintedanib for the treatment of locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy.
• DARWIN EU® study:
  No
• Study countries:
  India
• Study description:
  An active surveillance based on newly collected data. This active surveillance will include 100 consecutive patients with locally advanced, metastatic or recurrent NSCLC and adenocarcinoma histology who have been newly prescribed nintedanib according to approved Indian label at the twenty (20) participating centres and 100 consecutive locally advanced, metastatic or recurrent NSCLC patients of adenocarcinoma histology who have progressed after first line chemotherapy and are planned to be treated with single agent docetaxel from the same centres and during the same time frame. At visit 1, baseline characteristics will be recorded for all patients. Patients who are prescribed nintedanib are suggested to have further visits every 3 weeks for the first 6 visits and every 6 weeks till the discontinuation of the treatment and an additional follow up visit 30 days after the last dose of nintedanib. At each visit ADRs with nintedanib (serious or non-serious) and AEs (serious and fatal) will be recorded. Patients who are treated with single agent docetaxel will not be followed. The patient registration will continue until it is confirmed that 100 patients treated with nintedanib are included in this active surveillance and that baseline characteristics of 100 additional patients planned to be treated with single agent docetaxel at the same centres and during the same time frame are collected, or until a maximum of two years, whichever occurs first.
• Study status:
  Finalised

Research institutions and networks

Institutions

Boehringer Ingelheim

HCG Hospital Bangalore, Medica Superspecialty Hospital Kolkata, Sparsh Hospitals & Critical Care (P) Ltd Bhubhaneshwar, Sir Ganga Ram Hospital New Delhi, Manipal Hospitals Bangalore, Apollo Healthcity Hospital Telangana, Zydus Hospital Gujarat, Yashoda Hospital Hyderabad, Mazumdar Shaw Medical Centre Bangalore, SRM-SIMS Tamil Nadu

Study timelines

Date when funding contract was signed

Planned: 21/01/2017

Actual: 21/01/2017

Study start date

Planned: 30/06/2017

Actual: 30/06/2017

Date of final study report

Planned: 31/05/2023

Actual: 27/11/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only