Clinical trial NCT03017885: Post Marketing Surveillance of Nintedanib in Indian Patients With Non-small Cell Lung Cancer (NSCLC) After First-line Therapy
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2017-01-11
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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).

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.


Eligibility criteria: 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 outcomes:
measure: Incidence of All Adverse Drug Reactions (ADRs) in Nintedanib and Docetaxel Treated Patients
timeFrame: From first drug administration until 28 days after the last drug administration, up to 586 days.
measure: Incidence Rate of All Serious Adverse Events (SAEs) in Nintedanib and Docetaxel Treated Patients
timeFrame: From first drug administration until 28 days after the last drug administration, up to 586 days.
Secondary outcomes:
measure: Percentage of Patients Who Required Nintedanib Dose Reductions
timeFrame: From first drug administration until 28 days after the last drug administration, up to 586 days.
measure: Number of Patients Who Discontinued Study Drug Permanently Due to Adverse Events
timeFrame: From first drug administration until last drug administration, up to 558 days.
Other outcomes:
Locations:
city: Anand
country: India
facility: Zydus Hospitals and Healthcare Research Pvt. Ltd
city: Bangalore
country: India
facility: Narayana Hrudyalaya
city: Bengaluru
country: India
facility: Manipal Hospitals
city: Bengaluru
country: India
facility: HCG Hospital
city: Bhubaneshwar
country: India
facility: Sparsh Hospitals and Critical Care
city: Delhi
country: India
facility: Action Cancer Hospital, Delhi
city: Hyderabad
country: India
facility: Apollo Health City Hospital
city: Hyderabad
country: India
facility: Yashoda Hospitals
city: Kolkata
country: India
facility: Chittaranjan National Cancer Institute
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Institute and Research Centre
city: Vadapalani
country: India
facility: SRM Institute of Medical Science
Study officials:
References: