| CTRI Number |
CTRI/2021/07/035023 [Registered on: 20/07/2021] Trial Registered Prospectively |
| Last Modified On: |
03/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Multicountry Study to assess EGFR Mutations in Patients With Non-small Cell Lung Cancer |
|
Scientific Title of Study
|
A Multicountry, Multicentre, Non-interventional, Prospective Study to
Determine the Prevalence of EGFR Mutations in Patients With Early-stage,
Surgically Resected, Non-squamous, Non-small Cell Lung Cancer |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| D5161R00028 Version 2.0 Dated 22 November 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijay Patil |
| Designation |
National Coordinating Investigator |
| Affiliation |
Tata Memorial Centre (TMC) |
| Address |
Tata Memorial Center (TMC), Room no 304,3rd floor,HBB Bock, Department of Medical Oncology, Dr. Ernest Borges Rd, Parel (East), Mumbai, Maharashtra-400012, India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09567105817 |
| Fax |
|
| Email |
vijaypgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankush Vikas Gaikwad |
| Designation |
Study Physician |
| Affiliation |
AstraZeneca Pharma India Ltd |
| Address |
AstraZeneca Pharma India Ltd Block N1 12th Floor Manyata Embassy Business Park Rachenahalli Outer Ring Road Bangalore
Bangalore
KARNATAKA
560045
India
Bangalore
KARNATAKA
560045
India |
| Phone |
8451800603 |
| Fax |
|
| Email |
ankush.vikasgaikwad@astrazeneca.com |
|
Details of Contact Person
Public Query
|
| Name |
Amit Kumar |
| Designation |
Project Delivery Lead |
| Affiliation |
AstraZeneca Pharma India Ltd |
| Address |
AstraZeneca Pharma India Ltd Block N1 12th Floor Manyata Embassy Business Park Rachenahalli Outer Ring Road Bangalore
Bangalore
KARNATAKA
560045
India
Bangalore
KARNATAKA
560045
India |
| Phone |
9972365541 |
| Fax |
|
| Email |
amit.kumarak@astrazeneca.com |
|
|
Source of Monetary or Material Support
|
| AstraZeneca Pharma India Ltd. |
|
|
Primary Sponsor
|
| Name |
AstraZeneca Pharma India Limited |
| Address |
AstraZeneca Pharma India Ltd Block N1 12th Floor Manyata Embassy Business Park Rachenahalli Outer Ring Road Bangalore
Bangalore
KARNATAKA
560045
India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
Singapore
Taiwan |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramakant Deshpande |
ACI-Cumballa Hill Hospital |
93-95 August Kranti Marg,
Kemps Corner 400036
Mumbai
MAHARASHTRA |
9820422222
ramandeshpande@gmail.com |
| Dr Sachin Khurana |
All India Institute of Medical Sciences (AIIMS) |
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI |
9769030180
dr.sachinkhurana@gmail.com |
| Dr Sajjan Rajpurohit |
Dr B. L. Kapur Memorial Hospital |
Dr B. L. Kapur Memorial Hospital,
Pusa Road, Rajendra Place,
New Delhi, Delhi 110005
New Delhi
DELHI |
9999660200
sajjanrajpurohit@yahoo.com |
| Dr Rajesh Mistry |
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute (KDAH), |
Rao Saheb, Achutrao Patwardhan Marg, Four Bungalows, Andheri (West)-400053, Mumbai, Maharashtra, India
Mumbai
MAHARASHTRA |
9320361267
Rajesh.Mistry@kokilabenhospitals.com |
| Dr Vivek Agarwala |
Narayana Superspeciality Hospital |
Narayana Superspeciality Hospital,
120/1, Andul Road, Howrah-711103
Haora
WEST BENGAL |
8879222875
drvivekagarwala@gmail.com |
| Dr Ullas Batra |
Rajiv Gandhi Cancer Institute |
Sir Chotu Ram Marg, Rohini Institutional Area, Sector 5, Rohini, New Delhi, Delhi 110085
New Delhi
DELHI |
9711080001
ullasbatra@gmail.com |
| Dr Saquib Zaffar |
Sher-i-Kashmir Institute of Medical Sciences (SKIMS) |
SKIMS Main Rd, Soura, Srinagar, Jammu and Kashmir 190011
Srinagar
JAMMU & KASHMIR |
9906653815
msaquibzb@gmail.com |
| Dr Vijay Patil |
Tata Memorial Center (TMC) |
Room no. 304, 3rd Floor, HBB Block, Department of Medical Oncology, Dr. Ernest Borges Rd, Parel (East), Mumbai, Maharashtra-400012, India
Mumbai
MAHARASHTRA |
09567105817
vijaypgi@gmail.com |
| Dr Bhavesh Pradeep Poladia |
Thangam Hospital and Thangam Cancer Center |
54, Dr Sankaran Road, - Nammakal 637001
Namakkal
TAMIL NADU |
98191515554
bhaveshpolaida@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Dr. BL Kapur Memorial Hospital Ethics Committee |
Approved |
| Institutional Ethics Commitee Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute |
Approved |
| Institutional Ethics Commitee Tata Memorial Centre |
Approved |
| Institutional Ethics Committee All India Institute of Medical Sciences |
Approved |
| institutional Ethics Committee new health care nursing home |
Approved |
| Institutional Ethics Committee Sher-i-Kashmir Institute of Medical Sciences |
Approved |
| Institutional Review Board Rajiv Gandhi Cancer Institute and Research Centre |
Approved |
| NSH Ethics Committee, Narayana Super Speciality Hospital, 120/1, Andul Road, Howrah - 711103 |
Approved |
| Thangam Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C342||Malignant neoplasm of middle lobe,bronchus or lung, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult male or female patients ≥18 years old or ‘adults’ according to age of majority as
defined by the local regulations
2. Patient or next of kin/legal representative is willing and able to provide informed
consent according to the local regulations, where applicable
3. Patients with stage IA to IIIB (on the basis of pathologic criteria) NSCLC with
adenocarcinoma, or mixed histology with an adenocarcinoma component who have
undergone surgical resection of the tumour during the preceding 6 weeksa
4. Availability of FFPE tissue specimen suitable for EGFRm testing (either the primary
diagnostic sample or the surgically resected tumour specimen)
5. Availability of medical records at the participating site detailing the initial diagnosis,
staging, and surgical management of NSCLC |
|
| ExclusionCriteria |
| Details |
1. Histology of the tumour is considered not to be of primary lung in origin
2. Histology is pure squamous cell carcinoma, pure small cell carcinoma, or large cell
carcinoma origin lacking any immunohistochemistry evidence of adenocarcinoma
differentiation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Overall proportion of patients with EGFRm
• Proportion of EGFRm by the following subgroups:
Histology,
Pathologic stage, Age, Gender
Tobacco smoking, Ethnicity, Family history of lung cancer in first-degree relative, Geographical location. |
One day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Proportion of patients with the following EGFRm types:
Exon19 deletions, Exon21 L858R
o Exon20 T790M
o Others (compound mutations, uncommon mutations [including G719X, L861Q,
S768I, and 20 insertions])
Proportion of patients who were prescribed these modalities:
Only surgical resection, Surgical resection and radiotherapy, Surgical resection and systemic therapy (neoadjuvant and/or adjuvant),Surgical resection, radiotherapy and systemic therapy (neoadjuvant and/or adjuvant) |
One day |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/07/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/05/2021 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective, sequential non-interventional study aims to determine the prevalence and nature of EGFRm in patients with surgically resected early-stage (IA to IIIB on the basis of pathologic criteria) non-squamous NSCLC. This study will also determine the surgical management, surgical outcome, and neoadjuvant and adjuvant therapies prescribed for early-stage disease. |