| CTRI Number |
CTRI/2023/01/048804 [Registered on: 06/01/2023] Trial Registered Prospectively |
| Last Modified On: |
01/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study With Prospective Data Collection Only to Investigate The Outcome and Safety of ATEZOLIZUMAB in NSCLC and HCC Patients Treated In Routine Clinical Practice
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Scientific Title of Study
|
A NON-INTERVENTIONAL, MULTICENTER, MULTIPLE COHORT STUDY INVESTIGATING THE OUTCOMES AND SAFETY OF ATEZOLIZUMAB UNDER REAL- WORLD
CONDITIONS IN PATIENTS TREATED IN ROUTINE CLINICAL PRACTICE |
| Trial Acronym |
IMreal |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT03782207 |
ClinicalTrials.gov |
| Version 3 dated 18 Dec 2020 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Viraj Suvarna |
| Designation |
Medical Chapter Lead |
| Affiliation |
Roche Products India Pvt. Ltd |
| Address |
Roche Products (India) Pvt. Ltd. 146-B, 166 A, Unit No. 7,8,9,
8th Floor, R City Office, R City Mall
Lal Bahadur Shastri Marg,
Ghatkopar
Mumbai
MAHARASHTRA
400 086
India |
| Phone |
9820006317 |
| Fax |
|
| Email |
viraj.suvarna@roche.com |
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Details of Contact Person
Public Query
Modification(s)
|
| Name |
Manjula Ujagiri |
| Designation |
Manager-Clinical Operations |
| Affiliation |
Roche Products (India) Pvt. Ltd. |
| Address |
Roche Products (India) Pvt. Ltd. 146-B, 166 A, Unit No. 7,8,9,
8th Floor, R City Office, R City Mall
Lal Bahadur Shastri Marg,
Ghatkopar
Mumbai
MAHARASHTRA
400 086
India |
| Phone |
9819154456 |
| Fax |
|
| Email |
manjula.ujagiri@roche.com |
|
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Source of Monetary or Material Support
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| Roche Products (India) Pvt. Ltd. 146-B, 166 A, Unit No. 7, 8, 9 8th Floor, R City Office, R City
Mall Lal Bahadur Shastri Marg Ghatkopar, Mumbai - 400 086 Maharashtra ,India |
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Primary Sponsor
|
| Name |
F HoffmanLa Roche Ltd |
| Address |
CH-4070 Basel, Switzerland.
Type of Sponsor Pharmaceutical industry-Global |
| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
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Countries of Recruitment
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Argentina
Austria
Belgium
Brazil
Bulgaria
Chile
Colombia
Croatia
Egypt
Estonia
France
Hungary
Italy
Kuwait
Lebanon
Lithuania
Mexico
Oman
Philippines
Poland
Portugal
Romania
Russian Federation
Serbia
Singapore
Slovenia
Spain
United Arab Emirates
United Kingdom
India
Netherlands
Pakistan |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anand V Kulkarni |
AIG Hospital |
Room No 136, Plot No 2/3/4/5 Survey, 1, Mindspace Rd, Gachibowli, Hyderabad, Telangana 500032
1st Floor, Cluster M, Room no 2
Hyderabad
TELANGANA |
8553322434
anandvk90@gmail.com |
| Dr Arun R Warrier |
Aster Medcity, Aster DM Healthcare Pvt Ltd. |
Kuttisahib Road, Near Kothad Bridge, South Chittoor P.O, Cheranalloor, Kochi, kerala 682027, India
Ernakulam
KERALA |
9400515000
drarun.warrier@asterhospital.com |
| Dr Mansi Mohitbhai Shah |
HCG Cancer Centre |
Sola Science city Road, Near Sola Bridge, S. G. Highway, Ahmedabad Ahmadabad GUJARAT - 380060
Ahmadabad
GUJARAT |
7096012800
mansi1227@gmail.com |
| Dr Ashish Mangilal Kaushal |
Kusum Dhirajlal (KD) Hosiptal |
Vaishnodevi circle, S.G. Highway, Ahmedabad-382421, Gujarat, India
Ahmadabad
GUJARAT |
9978297842
drashish4@yahoo.co.in |
| Dr Akhil Kapoor |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre (Unit of Tata Memorial Centre, Mumbai) |
Sundar Bagiya, BHU Campus, Sundarpur, Varanasi, Uttar Pradesh -221005
Varanasi
UTTAR PRADESH |
9950482121
kapoorakhil1987@gmail.com |
| Dr Amit Deenbandhu Rauthan |
Manipal Hospital |
#98, Hal Airport Road, Manipal Hospital, Bangalore-560017
Bangalore
KARNATAKA |
9880463958
amit.rauthan@manipalhospitals.com |
| Dr Ashish Anand Joshi |
MOC Cancer Care & Research Centre |
1st Floor, SS House, Nehru Rd, Navpada, Vile Parle East, Vile Parle, Mumbai, Maharashtra 400057
Mumbai
MAHARASHTRA |
9167009042
ashjoshi44@mocindia.co.in |
| Dr Narayanankutty Warrier |
MVR Cancer Centre and Research Institute |
CP 13/516 B.C/Vellalasseri, NIT(Via), Poolacode, Kozhikode, Kerala-673601
Kozhikode
KERALA |
9495617585
enkwarrier@gmail.com |
| Dr Ajay Duseja |
Post Graduate Institute of Medical Education and Research |
Department of Hepatology, Room no. 36 Ground floor, Nehru Extension building, Post Graduate Institute of Medical Education and Research, Sector-12 Chandigarh-160012
Chandigarh
CHANDIGARH |
9417007416
ajayduseja@yahoo.co.in |
| Dr Dinesh Jothimani |
Rela Institute |
7, CLC Works Rd, Nagappa Nagar, Chromepet, Chennai, Tamil Nadu 600044
Chennai
TAMIL NADU |
9176599555
dinesh.jothimani@relainstitute.com |
| Dr Kaushal Patel |
Sunshine Global Hospital |
Dumas road, beside Big Bazar, Piplod, Surat, Gujarat 395007
Surat
GUJARAT |
9723431102
kpatel291980@gmail.com |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Ethics Committee of Manipal Hospitals |
Approved |
| HCG MULTI SPECIALTY ETHICS COMMITTEE HCG Hospitals |
Approved |
| IEC, MPMMCC and HBCH Varanasi Mahamana Pandit Madan Mohan Malaviya Cancer Centre |
Approved |
| Institutional Ethics Committee Asian Institute of Gastroenterology |
Approved |
| Institutional Ethics Committee Aster DM Health Care Limited, |
Approved |
| Institutional Ethics Committee Post Graduate Institute of Medical Education and Research |
Approved |
| Institutional Ethics Committee Sunshine Global Hospital |
Approved |
| Institutional Ethics Committee, MVR Cancer Centre |
Approved |
| KD Hospital Institutional Ethics Committee |
Approved |
| Mumbai Oncocare Centre IEC |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung, (2) ICD-10 Condition: C220||Liver cell carcinoma, |
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Confirmed diagnosis for which atezolizumab is locally approved
2. Patient is prescribed atezolizumab therapy for the first time
3. Decision to prescribe atezolizumab must be made and documented prior to inclusion into the study and must follow local clinical practice
4. Patient is 18 years or older at the index date
5. Patient has signed an informed consent form
6. Initiation of atezolizumab is not more than 28 days before signing informed consent. In countries where enrollment is only allowed after starting treatment, enrollment must be preceded by the administration of the first cycle of atezolizumab
|
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| ExclusionCriteria |
| Details |
1. Treatment with atezolizumab for an indication that is not included in the study cohorts
2. Concomitant anti-cancer therapy at the time of starting atezolizumab on the index date, as per locally approved SmPC
3. Treatment with atezolizumab as part of a clinical trial or as compassionate use as part of an access or compassionate use program
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
To estimate overall survival (OS) at two years and at the end of the study.
|
Timepoint - 2 years & End of study
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Secondary Outcome
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| Outcome |
TimePoints |
Secondary Outcome-
Time to loss of clinical benefit - TTLCB, Progression-free survival - PFS, Objective response rate - ORR, Time to response, Duration of response - DoR, Disease control rate - DCR, Duration of DCR, EQ-5D questionnaire evaluation, Patient characteristics, Study site characteristics, Characteristics of atezolizumab treatment, and prior/subsequent cancer-related therapies
|
upto 6 years |
Exploratory outcome-
1. PD-L1 testing, type, status, result
2. Health care resource utilization and cost
3. Cost of non-health care outcomes
|
upto 6 years |
Safety Outcome-
Incidence, seriousness, severity and relatedness of all AEs
|
upto 6 years |
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Target Sample Size
|
Total Sample Size="3400"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
31/01/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/02/2019 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="6"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
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Publication Details
|
Not Applicable at present |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
This is a non-interventional, multi-country, multi-center, multiple cohort prospective study, with retrospective collection of prior medical/treatment history data from medical records, designed to assess the real-world outcomes and safety of atezolizumab for indications in the existing label in the real-world setting of routine clinical practice. The study will collect data before, during and after treatment with atezolizumab. As this is a non-interventional study (NIS), treatment choice, including atezolizumab (used according to the SmPC), will be at the discretion of the treating physician per local guidelines and independently of participation in this study. In countries where inclusion is only permitted after the start of treatment, patients may be included after the start of treatment but no later than 28 days after the first administration of atezolizumab. The index date (D1) is the date of administration of the first ever dose of atezolizumab for each patient. During treatment with atezolizumab, patient data will be collected at clinic visits when atezolizumab is administered. No visits will be
mandated by the protocol. After cessation of treatment, patient data will be collected from each participant at approximately 3 months, 6 months, 12 months and every 12 months thereafter until the end of the study, coinciding with routine clinical practice visits, or remote contact, and from medical notes, until the earliest of death, loss to follow-up, withdrawal of consent, or end of the study, when data from last routine clinic practice visit will be collected with the exception of withdrawal of consent.The study will be split into separate cohorts based on the approved indications for atezolizumab treatment, excluding cisplatin ineligible patients receiving atezolizumab as first line of therapy (LOT1) for locally advanced/metastatic urothelial cancer (locally advanced/metastatic UC). |