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CTRI Number  CTRI/2017/02/007857 [Registered on: 14/02/2017] Trial Registered Prospectively
Last Modified On: 23/01/2024
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   An active surveillance to monitor the real world safety of Nintedanib in Indian NSCLC patients  
Scientific Title of Study   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 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Pavitra Wagh 
Designation  Manager - Local Clinical Trials 
Affiliation  Boehringer Ingelheim India Pvt. Ltd. 
Address  Boehringer Ingelheim India Pvt. Ltd. 1102, 11th Floor, Hallmark Business Plaza,Gurunanak Hospital Road, Near Gurunanak Hospital, Bandra East, Mumbai

Mumbai
MAHARASHTRA
400051
India 
Phone  9967088793  
Fax    
Email  pavitra.wagh@boehringer-ingelheim.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajesh Naik 
Designation  Head - Medical Oncology 
Affiliation  Boehringer Ingelheim India Pvt. Ltd. 
Address  Boehringer Ingelheim India Pvt. Ltd. 10th Floor, Hallmark Business Plaza,Gurunanak Hospital Road, Near Gurunanak Hospital, Bandra East, Mumbai

Mumbai
MAHARASHTRA
400051
India 
Phone  9930804426  
Fax    
Email  rajesh.naik@boehringer-ingelheim.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajesh Naik 
Designation  Head - Medical Oncology 
Affiliation  Boehringer Ingelheim India Pvt. Ltd. 
Address  Boehringer Ingelheim India Pvt. Ltd. 10th Floor, Hallmark Business Plaza,Gurunanak Hospital Road, Near Gurunanak Hospital, Bandra East, Mumbai

Mumbai
MAHARASHTRA
400051
India 
Phone  9930804426  
Fax    
Email  rajesh.naik@boehringer-ingelheim.com  
 
Source of Monetary or Material Support  
Boehringer Ingelheim India Pvt Ltd 
 
Primary Sponsor  
Name  Boehringer Ingelheim India Pvt Ltd 
Address  Boehringer Ingelheim India Pvt. Ltd. 1102, 11th Floor, Hallmark Business Plaza, Gurunanak Hospital Road, Near Gurunanak Hospital,Bandra East, Mumbai- 400051 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 15  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sushant Mittal  Action Cancer Hospital  Action Cancer Hospital A-4, Pashim Vihar,New Delhi- 110063
West
DELHI 
9818930805

sushantmittal80@gmail.com 
Dr Indranil Ghosh  Apollo Gleneagles Hospital   Apollo Gleneagles Hospital Kolkata, 58, Canal Circular Road, Kolkata-700054
Kolkata
WEST BENGAL 
9163223215

dr.indraghosh@gmail.com 
Dr Rekha Bansal  Apollo Hospitals  Apollo Health City Hospital, Road No 72, Opp. Bharatiya Vidya Bhavan School, Film Nagar, Jubilee Hills, Hyderabad, 500033
Hyderabad
TELANGANA 
9652403953

agarwal.rekhoo@gmail.com 
Dr Senthil Jagannathan Rajappa  Basavatarakam Indo American Cancer Hospital & Research Institute  Road No. 10, Banjara Hills, Hyderabad - 500 034, Andhra Pradesh, India
Hyderabad
ANDHRA PRADESH 
040-23551235

senthiljrajappa@gmail.com 
Dr Shekar Gowda Patil  HCG Hospital  HCG Towers, No:8, P. Kalinga Rao Road, Sampangirama Nagar, Bengaluru - 560027, Karnataka, India
Bangalore
KARNATAKA 
9341245961

spassociates6@gmail.com 
Dr Rajankumar Mohapatra  Institute of Oncology & BMT, SIMS   Institute of Oncology and BMT, SRM Institutes for Medical Science (SIMS Hospital), No. 1 Jawaharlal Nehru Salai, Vadaplani – 600026, Chennai
Chennai
TAMIL NADU 
9840033512

realpv60@hotmail.com 
Dr Sourjya Banerjee  KMC Hospital  Department of Radiotherapy and Oncology, KMC Hospital, Attavar, Mangalore - 575001, Karnataka
Chikmagalur
KARNATAKA 
9880345339

sourjya.banerjee@gmail.com 
Dr Vinayak V Maka  M.S. Ramaiah Medical College and Hospitals  M.S. Ramaiah Medical College and Hospitals, M.S.R.I.T Post, MSR Nagar, Bengalore
Bangalore
KARNATAKA 
9986618191

drvinayak.msr@gmail.com 
Dr Poonam Patil  Manipal Hospitals  Manipal Hospital, #98 HAL Airport Road, Bangalore 560017
Bangalore
KARNATAKA 
9945687185

poonampatil@yahoo.com 
Dr Chanchal Goswami  Medica Superspecialty Hospital  127 Mukundapur, E.M. Bypass Kolkata-700099, West Bengal, India
Kolkata
WEST BENGAL 
033-66520000

drcgoswami@gmail.com 
Dr Pradnya Coca  Narayana Health  Mazumdar Shaw Medical Center, Unit of Narayana Health, #258/A, Bommasandra Industrial Area, Anekal Taluk, Bangalore 560099
Bangalore
KARNATAKA 
8050004989

pragnya.11@gmail.com 
Dr Pankaj Goyal  Rajiv Gandhi Cancer Institute & Research Centre  Rajiv Gandhi Cancer Institute and Research Centre, Sector- V, Rohini - 110085, Delhi
New Delhi
DELHI 
9711996969

pankaj155@yahoo.com 
Dr Ghanashyam Biswas  Sparsh Hospitals & Critical Care (P) Ltd   Plot No. A/407, Sahid Nagar, Bhubaneswar – 751007, Odisha, India
Khordha
ORISSA 
0674-2540183

drghanshyambiswas@gmail.com 
Dr Nikhil S Ghadyalpatil   Yashoda Hospital  Yashoda Hospital, Raj Bhavan Road, Somajiguda, Hyderabad - 50082
Hyderabad
ANDHRA PRADESH 
8008037474

nikhilghadyalpatil@gmail.com 
Dr Mithun Shah  Zydus Hospital & Healthcare Research Pvt. Ltd.   Zydus Hospitals and Healthcare Research Pvt. Ltd., Zydus Road Off. S. G. Highway, Thaltej, Ahmedabad – 380054, Gujarat
Ahmadabad
GUJARAT 
9879770127

mithunshah@zydushospitals.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 15  
Name of Committee  Approval Status 
Action Cancer Hospital Ethics Committee  Approved 
Clinical research ethics committee – Medica Superspecialty Hospital, Kolkata   Approved 
Ethics Committee – M S Ramaiah Medical College and Hospital, Bangalore   Approved 
Ethics Committee of Manipal Hospitals, Bangalore   Approved 
HCG Central ethics committee, Bangalore   Approved 
Institutional Ethics Committee - clinical studies, Apollo Hospitals, Hyderabad   Approved 
Institutional Ethics Committee – BIACH & RI, Hyderabad  Approved 
Institutional Ethics Committee – YAMER, Hyderabad   Approved 
Institutional Ethics Committee SRM  Approved 
Institutional Ethics Committee, Apollo Gleneagles, Kolkata  Approved 
Institutional Ethics Committee, Sparsh Hospital & Critical Care, Bhubaneswar   Approved 
Institutional Review Board Rajiv Gandhi Cancer Institute & Research Centre,  Approved 
Manipal University Ethics Committee, Mangalore  Approved 
Narayana Health Medical Ethics Committee, Bangalore   Approved 
Zydus Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
No Objection Certificate 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  NSCLC (Non Small Cell Lung Cancer),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nintedanib  This is not an interventional study but this is 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. Patient registration will continue until it is confirmed that 100 patients treated with nintedanib are included and that baseline characteristics of 100 additional patients (or as many patients as in the nintedanib group if 100) planned to be treated with single agent docetaxel are collected from the same centers during the same time frame, or until a maximum of two years, whichever occurs first. 
Comparator Agent  Not Applicable  Not Applicable  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients ≥18 years of age with locally advanced and/or metastatic NSCLC of stage IIIB or IV, or recurrent NSCLC and adenocarcinoma histology after relapse or failure of first line of chemotherapy who are newly prescribed nintedanib according to the package insert.
2. Willing to provide the informed consent
3. Patients in whom further visit/contact is possible during the planned period of active surveillance
4. Patients in whom information mentioned in the section 9.2.2.2 of the protocol is available  
 
ExclusionCriteria 
Details  1. Patients who have taken nintedanib before participation in the study
2. Patients who are positive for EGFR mutation
3. Patients who are positive for ALK rearrangements
4. Patients who are participating in a clinical trial 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Occurrence of ADRs (serious and non-serious)
2. Occurrence of AEs (serious and fatal) 
2 Years 
 
Secondary Outcome  
Outcome  TimePoints 
Percentage of patients who require nintedanib dose reductions and discontinuations due to adverse events  2 Years 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "28"
Final Enrollment numbers achieved (India)="28" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   14/02/2017 
Date of Study Completion (India) 24/09/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Will be updated later. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

This is an active surveillance to monitor the real world safety in Indian patients of locally advanced and/or metastatic NSCLC of stage IIIB or IV, or recurrent NSCLC and adenocarcinoma histology after relapse or failure of first line chemotherapy, who are newly prescribed nintedanib according to the package insert. Patient registration will continue until it is confirmed that 100 patients treated with nintedanib are included and that baseline characteristics of 100 additional patients (or as many patients as in the nintedanib group if <100) planned to be treated with single agent docetaxel are collected from the same centers during the same time frame, or until a maximum of two years, whichever occurs first.

The primary outcome:

  1. Occurrence of ADRs (serious and non-serious)

  2. Occurrence of AEs (serious and fatal)

Secondary outcome:

Percentage of patients who require nintedanib dose reductions and discontinuations due to adverse events

 
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