CTRI Number	CTRI/2018/10/015941 [Registered on: 08/10/2018] Trial Registered Prospectively
Last Modified On:	29/01/2021
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study Modification(s)	Drug
Study Design	Single Arm Study
Public Title of Study Modification(s)	A prospective, multicentre study to see the safety of Osimertinib in Indian adult patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive nonsmall cell lung cancer.
Scientific Title of Study	A prospective, multicenter, Phase-IV clinical trial to assess safety of TAGRISSO (Osimertinib) in Indian adult patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive nonsmall cell lung cancer (NSCLC)
Secondary IDs if Any Modification(s)	Secondary ID  Registry  D5161C00005 , Version 1 , 06 November 2017  Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Dr Prabhat singh malik  Address  Dr. B. R. Ambedkar Institute Rotary Cancer Hospital, Room no-245, 2nd floor, Dr. B. R. Ambedkar Institute Rotary Cancer Hospital, AIIMS, Ansari Nagar, New Delhi New Delhi DELHI 110029. India  Phone  9968325318   Fax     Email  drprabhatsm@gmail.com
Details Contact Person Scientific Query Modification(s)	Name  Dr Mangesh Sheshrao Kamle  Address  AstraZeneca Pharma India Ltd Block N1 12th Floor Manyata Embassy Business Park Rachenahalli Outer Ring Road Bangalore Bangalore KARNATAKA 560045 India  Phone     Fax     Email  mangesh.sheshraokamle@astrazeneca.com
Details Contact Person Public Query Modification(s)	Name  Amit Kumar   Address  AstraZeneca Pharma India Ltd Block N1 12th Floor Manyata Embassy Business Park Rachenahalli Outer Ring Road Bangalore Bangalore KARNATAKA 560045 India  Phone     Fax     Email  amit.kumarak@astrazeneca.com
Source of Monetary or Material Support	AstraZeneca Pharma India Limited
Primary Sponsor	Name  AstraZeneca Pharma India Limited  Address  Block N1 12th Floor Manyata Embassy Business Park Rachenahalli Outer Ring Road Bangalore-560045  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 = 8   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Prabhat Singh Malik  All India Institute Of Medical Sciences  Dr B R Ambedkar Institute Rotary Cancer Hospital Room no 245 2nd floor Dr B R Ambedkar Institute Rotary Cancer Hospital AIIMS Ansari Nagar New Delhi 110029 New Delhi   9968325318 drprabhatsm@gmail.com  Dr M Vamshi Krishna  Apollo Cancer Institute  Jubilee Hills Hyderabad 500096 Hyderabad   9959778112 drmvkrishnaonco@gmail.com  Dr Senthil Rajappa  Basavatarakam Indo-American Cancer Hospital and Research Institute  Basavatarakam Indo-American Cancer Hospital and Research Institute Road No 14 Banjara Hills Hyderabad   9849213102 drshyam_aggarwal@yahoo.com  Dr Sewanti Limaye  Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute  2nd floor Medical Research Department Mumbai   9619607339 sewanti@yahoo.com  Dr Ullas Batra  Rajiv Gandhi Cancer Institute & Researcg Centre  Room No 2251 Rajiv Gandhi Cancer Institute and Research Centre Sector V Rohini New Delhi New Delhi   9711080001 ullasbatra@gmail.com  Dr Shyam Aggarwal  Sir Ganga Ram Hospital   Rajinder Nagar New Delhi 110060 New Delhi   9811075870 drshyam_aggarwal@yahoo.com  Dr Deepak Dabkara  Tata Medical Center  Medical Oncology Room No 23 14 Tata Medical Center MAR(E-W) New Town Kolkata   8697268292 deepakdabkara@yahoo.com  Dr Vanita Noronha  Tata Memorial Center  Department of Medical Oncology HBB Bock Room no 304 3rd floor Dr E Borges road Parel Mumbai Mumbai   9769328047 vanita.noronha@gmail.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 8   Name of Committee  Approval Status  Institute Ethics Commitee All India Institute Of Medical sciences  Approved  Institutional Ethics Committee Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute  Approved  Institutional Ethics Committee Tata Memorial Hospital   Approved  Institutional Ethics Committee, Apollo Cancer Institute  Approved  Institutional Ethics Committee, Basavatarakam Indo-American Cancer Hospital and Research Institute  Approved  Institutional Ethics Committee, Sir Ganga Ram Hospital  Approved  Institutional Ethics Committee, Tata Medical Center, Kolkata  Approved  Institutional Review Board Rajiv Gandhi Cancer Institute and Research Centre   Approved
Regulatory Clearance Status from DCGI	Status  Approved/Obtained
Health Condition / Problems Studied Modification(s)	Health Type  Condition  Patients  Metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive nonsmall cell lung cancer (NSCLC)  Patients  Malignant neoplasm of upper lobe,bronchus or lung
Intervention / Comparator Agent	Type  Name  Details
Inclusion Criteria Modification(s)	Age From  18.00 Year(s) Age To  99.00 Year(s) Gender  Both  Details  1 Patient of either sex and ≥18 years of age 2 Patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an appropriate test, who have progressed on or after EGFR TKI therapy by an independent clinical judgment of treating physician based on locally approved prescribing information 3 Each patient (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Patients must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, as referenced in the informed consent form (ICF).
ExclusionCriteria	Details  Patient with either the history of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug. 2 Pregnant and/or lactating women 3 Patients participating in any current or future interventional trial will not be enrolled in the current study
Method of Generating Random Sequence	Not Applicable
Method of Concealment	Not Applicable
Blinding/Masking	Not Applicable
Primary Outcome	Outcome  TimePoints  Number frequency and proportion of patients with adverse events (AEs) serious adverse events (SAEs) and AEs of special interest (AESI) including interstitial lung disease or pneumonitis like events and on study deaths  NA
Secondary Outcome	Outcome  TimePoints  NA  NA
Target Sample Size	Total Sample Size="60" Sample Size from India="60"
Phase of Trial	Phase 4
Date of First Enrollment (India) Modification(s)	18/04/2019
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details	NA
Brief Summary	This is a prospective, single-arm, multicenter, phase-IV trial investigating the safety of osimertinib in Indian adult patients with locally advanced or metastatic EGFR-T790M mutation-positive NSCLC. Investigator will be trained on the locally approved prescribing information before the enrolment of the first patient at their site to ensure compliant and proper dosing of the study drug. Patients will be monitored throughout the study period for AEs of osimertinib. The decision of patients to participate in this study must not, in any way, impact upon the standard of care that they are receiving or any benefits to which they are otherwise entitled. Prior to data collection, all patients must sign an informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements and sponsor policy.