CTRI Number CTRI/2024/01/061362 [Registered on: 11/01/2024] Trial Registered Prospectively
Last Modified On: 17/02/2026
Post Graduate Thesis No
Type of Trial Observational
Type of Study
Cohort Study
Study Design Other
Public Title of Study
Data collection of lung cancer patients prescribed on Atezolizumab.
Scientific Title of Study
Modification(s)
Real-World Indian Study of Atezolizumab in Lung Cancer
Trial Acronym
Secondary IDs if Any
Modification(s)
Secondary ID Identifier
ML45036 Version 2.0 dated 11 Nov 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name Dr Jaishid Ahdal
Designation Medical Lead
Affiliation Roche Product India Pvt Ltd
Address 146B, 166A, Unit No 7, 8, 9, 8th Floor, R City Mall, Lal Bahadur Shastri Marg, Ghatkopar
Phone 9930696711
Fax
Email jaishid.ahdal@roche.com
Details of Contact Person
Modification(s)
Name
Dr Jaishid Ahdal
Designation Medical Chapter Lead
Affiliation Roche Products (India) Pvt. Ltd.
Address 146B, 166A, Unit No 7, 8, 9, 8th Floor, R City Mall, Lal Bahadur Shastri Marg, Ghatkopar
Phone 9930696711
Fax
Email jaishid.ahdal@roche.com
Details of Contact Person
Modification(s)
Name Dr Jaishid Ahdal
Designation Medical Chapter Lead
Affiliation Roche Products (India) Pvt. Ltd.
Address 146B, 166A, Unit No 7, 8, 9, 8th Floor, R City Mall, Lal Bahadur Shastri Marg, Ghatkopar
Phone 9930696711
Fax
Email jaishid.ahdal@roche.com
Source of Monetary or Material Support
Roche Products (India) Pvt. Ltd.
Primary Sponsor
Name Roche Products (India) Pvt. Ltd.
Address 146-B, 166 A, Unit No. 7, 8, 9 8th Floor,
R City Mall Lal Bahadur Shastri Marg,
Ghatkopar, Mumbai - 400086
Type of Sponsor Pharmaceutical industry-Indian
Details of Secondary Sponsor
Countries of Recruitment
India
Sites of Study
Modification(s)
No of Sites = 36
Name of Principal
Investigator Name of Site Site Address Phone/Fax/Email
Dr Sushant Mittal
Action Cancer hospital
Marvela, A4 Paschim Vihar, New Delhi 110063
9818930805
Dr Vamsi Krishna
AIG Hospitals, Hyderabad
Survey No 136, 4/5, Plot No 2/3, Mindspace Rd, P Janardhan Reddy Nagar, Gachibowli, Hyderabad, Telangana 500032
9959778112
Dr K Pavithran
Amrita Institute of Medical Sciences
AIMS, Ponekkara P O, Edappally, Kochi-682041, Kerala, India
9895367090
Dr Suresh S
Apollo Hospital
Vanagaram,
No. 64, off P.H.., Road, Vanagaram to Ambattur Main Road, Ayanambakkam, Chennai 600095. Tamil Nadu
9841217666
Dr PN Mohapatra
Apollo Multispeciality Hospitals Limited
58 Canal Circular Road, Road, Kolkata, West Bengal 700054.
9674311610
Dr Arun Chandrasekharan
Aster Malabar Institute of Medical Sciences
Mini By-pass Road, Govindapuram P.O. Calicut, Kerala, 673016
9619340036
Dr Arun Warrier
Aster Medcity
Kuttiusalib Road, Near Kothad bridge, South Chittoor, P O, Cheranalloor, Kochi - 682027
9400515000
Dr Srinivas K G
Bharath Hospital and Institute of Oncology
No. 438, Outer
Ring Road, Hebbal, Mysuru, Karnataka -
570017
9663121728
Dr Unni Pillai
Caritas Hospital & Institute of Health science
Thellakom PO Kottayam Kerala 686630, India
7598563161
Dr Kaushal Patel
First Cure Hospital
2nd floor VIP Galleria, Althan, Surat, Gujarat 395017
9723431102
Dr Rajeev Bedi
Fortis Hospital
Sector 62, Shahibzada Ajit Singh Nagar, Mohali, Punjab - 160062
9815855338
Dr Nitesh Rohatgi
Fortis Memorial Research Institute
Sec-44, Opp Huda City Centre Metro Station, Gurugram, Haryana -122002
9910003730
Dr Debanti Banerjee
HCG Cancer Centre
Plot DG 4, Premises No. 03-358, Action Area 1D, New Town, Kolkata - 700 156
9051068774
Dr V Santhosh
Kailash Cancer Hospital and Research Center
Muni seva Ashram goraj, Waghodia, Vadodara, Gujarat 391760
9427423693
Dr Bipinesh Sansar
Mahamana pandit madan mohan malviya Cancer
Sundar bagiya, near nariya gate BHU campus, Varanasi, Uttar pradesh 221005
8002583913
Dr Krishna Prasad
Mangalore Institute of Oncology
Pinto lane, Karangalpady, KARNATAKA, 575003
9880345666
Dr Waseem Abbas
Max Super Speciality Hospital
C and D Block, Shalimar Place Site, Shalimar Bagh, New Delhi, Delhi, 110088
9810619717
Dr Nagendra Sharma
Max Super Speciality Hospital (A unit of Devki Devi Foundation)
2, Press Enclave Road, Saket,
New Delhi- 110017
8130030452
Dr Sachin Gupta
Max Super Speciality Hospital, Mohali
A unit of Hometrail Buildtech Pvt. Ltd., Dept of Oncology and Oncosurgery, Near Civil Hospital, Phase-6, Mohali, Punjab- 160055
8968839911
Dr Udip Maheshwari
MOC Cancer care & Research centre
1st floor, Shreepati Arcade, August Kranti Rd, nana Chowk, Grant Road West, Kemps Corner, Grant Road, Mumbai, Maharashtra 400036
9769142268
Dr Narayankutti Warrier
MVR Cancer Centre and Research Institute
MVR Cancer Centre and Research Institute, CP13 516B, C, Vellalasseri
9495617585
Dr Randeep Singh
Narayan Speciality Hospital
Medical Oncology Depart., Plot3201, Block V, DLF Pahse III, Sector 4
9582449448
Dr Chandrakanth M V
Narayana Super-speciality Hospital
120/1, Andul Road, Howrah, West Bengal - 711103
7003206633
Dr Sachin Almel
P.D. Hinduja Hospital and Medical Research Centre
Veer Savarkar marg, Mahim, Mumbai, Maharashtra, India. 400016
9820229481
Dr Ullas Batra
Rajiv Gandhi Cancer Institute and Research Centre
Sir Chotu Ram Marg, sector - 5, Rohini west, Delhi - 110085
9711080001
Dr Vikas Talreja
Regency Hospital
Regency Hospital, A4 Tower-2, Sarvodaya Nagar, Kanpur, U.P - 208005
9769890961
Dr Shyam Aggarwal
Sir Ganga Ram Hospital
old Rajinder nagar New delhi- 110060
9811075870
Dr Syed Nisar Ahmad
SKIMS, Soura
Soura, Srinagar, 190011, J and K
9469664186
Dr Naresh Somani
Somani Hospital
277, Shri Gopal Nagar, 80 ft. Road, Gopalpura Byepass, Jaipur, Rajasthan 302019
8104124996
Dr Satheesh C T
Spandana Oncology Centre
919, New no. 28, Main Road, 9th Block, Jayanagar. Bengaluru 560069
9242698750
Dr Suresh Advani
Sushrut Hospital, Mumbai
Sushrut Hospital, 365, Swastik Park, Chembur (East), Mumbai, Maharashtra 400071
9821157706
Dr Somnath Roy
Tata Medical Centre
14 MAR (EW), New Town, Kolkata - 700160
9051732283
Dr Kumar Prabhash
Tata Memorial Centre
HBB Block 204. 2nd Floor, Dr E Borges Road, Parel, Mumbai , Maharashtra 400012.
9224182898
Dr Sameer S
Travancore Medicity Medical College Hospital
NH BYPASS MYLAPORE,KOLLAM - 691020
9995109995
Dr Sundaram Subramanian
V.S Hospitals
13 East, Spurtank Road, Chetpet, Chennai, Tamil Nadu- 600031
9444076494
Dr G Vamshi Krishna Reddy
Yashoda Hospitals
16-10-29, Nalgonda X Roads, Malakpet, Hyderabad- 500036
4067777888
Details of Ethics Committee
Modification(s)
No of Ethics Committees= 33
Name of Committee Approval Status
Action Cancer Hospital Ethics Committee
Approved
Aster CMI Institutional Ethics Committee
Approved
Aster Medcity institutional Ethics Committee
Approved
Ethics Committee Caritas Hospital
Approved
Institution Ethics Committee Narayana Superspeciality Hospital
Approved
Institutional Ethics Committee All India Institute of Medical Sciences Rishikesh
Approved
Institutional Ethics Committee Bharath Hospital and Institute of Oncology
Approved
Institutional Ethics Committee Devki Devi Foundation
Approved
Institutional Ethics Committee Fortis Hospital Mohali
Approved
Institutional Ethics Committee Fortis Memorial Research Institute
Approved
Institutional Ethics Committee Malabar Institute of Medical Sciences
Approved
Institutional Ethics Committee Max Super speciality Hospital Mohali
Approved
Institutional Ethics Committee P. D. Hinduja Hospital and Medical Research Centre
Approved
Institutional Ethics Committee Regency Hospital
Approved
Institutional Ethics Committee Sher-i-Kashmir Intitute of Medical Sciences Srinagar
Approved
Institutional Ethics Committee Travancore Medical College
Approved
Institutional Ethics Committee Yashoda Academy of Medical Education and Research
Approved
Institutional Ethics Committee, AIG Hospitals
Approved
Institutional Ethics Committee- Apollo Multispecialty Hospital Limited
Approved
Institutional Ethics Committee-II Tata Memorial Hospital
Approved
Institutional Review Board Rajiv Gandhi Cancer Institute and Research Centre
Approved
Kailash Cancer Hospital and research Centre Institutional Ethics Committee
Approved
Mangala Institutional Ethics Committee
Approved
Max Healthcare Ethics Committee
Approved
Mumbai Oncocare Centre Institutional Ethics Committee
Approved
Mumbai Oncocare Centre Institutional Ethics Committee (For Dr. Suresh Advani)
Approved
MVR Cancer Centre and Research institute Institutional Ethics Committee
Approved
NSH Ethics Committee
Approved
Sir Ganga Ram Hospital Ethics Committee
Approved
Somani Hospital Ethics Committee
Approved
Sri Venkateshwara Hospital Ethics Committee
Approved
Tata Medical Center Institutional Review Board
Approved
VMH Institutional Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Health Condition / Problems Studied
Health Type Condition
Patients
(1) ICD-10 Condition:
Intervention / Comparator Agent
Type Name Details
Intervention
NIL
NIL
Inclusion Criteria
Modification(s)
Age From 18.00 Year(s)
Age To 99.00 Year(s)
Gender Both
Details 1. Written informed consent. 2. Male and female patients of NSCLC/SCLC, more than equal to 18 years of age. 3. Patients who have been prescribed Tecentriq® for the medical management in routine clinical practice according to the standard of care and in line with the current Indian prescribing information (local label). Patients who have received less than equal to 3 cycle of Tecentriq® therapy at screening visit.
ExclusionCriteria
Details 1. Patients not receiving treatment for lung cancer with Tecentriq® according to standard of care and in line with the current prescribing information. 2. Known or suspected hypersensitivity to Tecentriq® 3. Pregnant or lactating women
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Modification(s)
Outcome TimePoints
To estimate the overall survival (OS) at two years in patients who receive Tecentriq® for the treatment of lung cancer in routine clinical practice. The OS will be estimated separately for the first-line metastatic non-small cell lung cancer (1LmNSCLC), adjuvant NSCLC, and first-line extensive-stage small cell lung cancer (1LES SCLC).
OS at two years
Secondary Outcome
Modification(s)
Outcome TimePoints
1. To estimate PFS in patients treated with Tecentriq for metastatic lung cancer (1L mNSCLC, 1L ES SCLC) & DFS in those treated with Tecentriq® in an adjuvant NSCLC setting in routine clinical practice. 2. To estimate the ORR, DCR, & DoR in patients who receive Tecentriq for the treatment of approved indications in metastatic setting (1L mNSCLC, 1L ES SCLC) in routine clinical practice. 3. To evaluate the Safety of Atezolizumab for the treatment of lung cancer (NSCLC & SCLC) in routine clinical practices on the basis of the following endpoint: Incidence, nature, & severity of all AEs, SAEs, & AESIs according to NCI CTCAE v5.0. 4. To estimate the proportion of patients who are prescribed Tecentriq & undergo PD-L1 testing & molecular testing in routine clinical practice along with details on the assay type & results. 5. To evaluate the association between patient characteristics & treatment outcomes in routine clinical practice.
From the date of start of Tecentriq therapy to the first date of objectively determined response or death from any cause
Target Sample Size
Total Sample Size= "500"Sample Size from India= "500" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)= "Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
18/01/2024
Date of Study Completion (India) Applicable only for Completed/Terminated trials
Date of First Enrollment (Global) Date Missing
Date of Study Completion (Global) Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years= "3"Months= "0"Days= "0"
Recruitment Status of Trial (Global)
Modification(s)
Not Applicable
Recruitment Status of Trial (India) Open to Recruitment
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Modification(s)
IMPACT is a REAL-WORLD INDIAN STUDY OF ATEZOLIZUMAB IN LUNG CANCER of Atezolizumab in patients with Lung Cancer treated as per routine clinical practice. The study will be conducted with 40 centers across India with an estimated sample size of 500 patients. Primary objective of the study is to estimate the overall survival (patients who receive Tecentriq for the treatment of lung cancer (NSCLC and SCLC) in routine clinical practice. Inclusion criteria for the study is patients of NSCLC and SCLC, above 18 years of age, Patients who have been prescribed Tecentriq for the medical management of their disease practice, Written informed consent. Exclusion criteria for the study is Known or suspected hypersensitivity to Tecentriq, Pregnant or lactating who decline consent
Close