| CTRI Number |
CTRI/2024/03/063721 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
19/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Non-Interventional Study |
| Study Design |
Other |
|
Public Title of Study
|
Real world study of lorlatinib in previously untreated ALK positive lung cancer |
|
Scientific Title of Study
|
Non-Interventional Study - Use of lorlatinib in treatment-naïve adult patients with metastatic or locally advanced anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC) from India. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| B7461047 version 1 dated31 August 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
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| Fax |
|
| Email |
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Harish Thanusubramanian |
| Designation |
Manager - Area Medical Advisor |
| Affiliation |
Pfizer Products India Private Limited |
| Address |
Pfizer Products India Private Limited, The Capital, B-wing, 1802, 18th Floor, Plot No. C-70, G block, Bandra Kurla Complex, Bandra (East),Mumbai
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02266932000 |
| Fax |
|
| Email |
Harish@pfizer.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Harish Thanusubramanian |
| Designation |
Manager - Area Medical Advisor |
| Affiliation |
Pfizer Products India Private Limited |
| Address |
Pfizer Products India Private Limited, The Capital, B-wing, 1802, 18th Floor, Plot No. C-70, G block, Bandra Kurla Complex, Bandra (East),Mumbai
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02266932000 |
| Fax |
|
| Email |
Harish@pfizer.com |
|
|
Source of Monetary or Material Support
|
| Pfizer Products India Private Limited |
|
|
Primary Sponsor
|
| Name |
Pfizer Products India Private Limited |
| Address |
The Capital, 1802/1901, Plot no-c-70, G block, Bandra- kurla Complex, Bandra-East, Mumbai-400051 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Raja Thirumalairaj |
Apollo Cancer Centre |
Medical Oncology, C - Block, Room No: 21, Apollo Cancer Centre, Nandanam, 320, Anna Salai Teynampet - 600 035
Chennai
TAMIL NADU |
9176640195
drtrajaopd_ash@apollohospitals.com |
| Dr Rajappa Senthil Jagannathan |
Basavatrakam Indo American Hospital and Research Institute |
Medical Oncology, OPD Block, Room no 123 Basavatrakam Indo American Hospital and Research Institute, Road no. 10, Banjara hill, Hyderabad - 500034
Hyderabad
TELANGANA |
9849213102
senthiljrajappa@gmail.com |
| Dr Chandragouda Dodagoudar |
BLK-MAX, OPD-9, 1st floor Super Speciality Hospital |
Medical Oncology, 1st Floor, BLK MAX Super Speciality Hospital, Pusa Rd, Radha Soami Satsang, Rajendra Place, New Delhi, Delhi, 110005
New Delhi
DELHI |
9958450124
drchandragoudatrials@gmail.com |
| Dr Bal Krishna Mishra |
Mahamana Pandit Madan Mohan Malavyia Cancer Centre & Homi Bhabha Cancer Hospital |
Department of Medical Oncology
OPD 28 D&T BLOCK, Ground floor, Mahamana Pandit Madan Mohan Malavyia Cancer Centre. Sunadr Bagiya, Near Nariya Gate, BHU Campus, Varanasi, Uttar Pradesh-221005
Varanasi
UTTAR PRADESH |
9415214254
bkmmishra@hotmail.com |
| Dr Narayanankutty Warrier |
MVR Cancer Centre and Research Institute |
Medical Oncology, OPD Room no - 04, MVR Cancer Centre and Research Institute, CP 13/516 B.C, Vellalasseri, Poolocode, Kozhikode - 673601
Kozhikode
KERALA |
9495617585
drnkwarrier@mvrccri.com |
| Dr Abhinav Dewan |
Rajiv Gandhi Cancer Institute and Research centre |
Medical Oncology, Room No 3152, Rajiv Gandhi Cancer Institute and Research centre D-18, Sir Chotu Ram Marg, Rohini Institutional Area, Sector 5, Rohini New Delhi, 110085
South
DELHI |
8860100008
drabhinavdewan@gmail.com |
| Dr Suresh H Advani |
Sushrut Hospital and Research Centre |
Daycare Angels under AOH, 3rd floor, Sushrut Hospital and Research Center, Swastik park, Chembur (East),Mumbai-400071
Mumbai
MAHARASHTRA |
66573232
24950508
shadvani2000@yahoo.com |
| Dr Somnath Roy |
Tata Medical Centre |
Medical Oncology, Room no-102, Tata Medical Centre, 14 Major Arterial Road (EW)
Newtown, Rajarhat, Kolkata - 700 160
Kolkata
WEST BENGAL |
9051732283
somnath.roy1@tmckolkata.com |
| Dr Nandini Menon |
Tata Memorial Centre |
Medical Oncology Solid unit, OPD Room No 204, 2nd floor Homi Bhabha Block, Tata Memorial Hospital, Dr. E Borges Road, Parel, Mumbai - 400 012
Mumbai
MAHARASHTRA |
9769178270
nandini.menon1412@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| DR B L KAPUR MEMORIAL HOSPITAL ETHICS COMMITTEE |
Approved |
| Institutional Ethics Committee - Clinical Studies, Apollo Hospitals Enterprises Limited |
Approved |
| Institutional Ethics Committee, Basavatrakam Indo American Hospital and Research Institute |
Approved |
| Institutional Ethics Committee, MPMMCC & HBCH Varanasi |
Approved |
| Institutional Ethics Committee, MVR Cancer Centre & Research Institute |
Approved |
| Institutional Review Board, Rajiv Gandhi Cancer Institute and Research Centre |
Approved |
| Institutional Review Board, Tata Medical Centre |
Approved |
| Mumbai Oncocare Centre Institutional Ethics Committee |
Approved |
| TMH, Institutional Ethics Committee-I |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with histologically or cytologically confirmed diagnosis of locally advanced or metastatic (Stage IV) NSCLC with positive ALK-rearrangement
No prior systemic treatment for metastatic disease, however up to 2 cycles of chemotherapy are permitted. |
|
| ExclusionCriteria |
| Details |
Patients who fail to meet the predefined criteria for inclusion will be excluded from the
study |
|
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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 |
| Progression Free Survival (PFS) rate, Time Points- 18 months |
18-months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Estimation of overall survival (OS), PFS, objective response rate (ORR), intra-cranial ORR (IC-ORR), duration of response (DR, overall and intracranial duration of response), intracranial time to progression (for patients with and without brain metastases at diagnosis), Time to symptomatic response, PFS 2, Subsequent treatment and duration
Safety (Including rates of dose interruption/dose reduction and treatment discontinuation), Frequency and nature of all-causality adverse events (AEs)
To evaluate patient-reported outcomes (PROs) of health-related quality of life, disease/treatment-related symptoms of lung cancer, and general health status using EORTC QLQ C30 and LC13 questionnaires. |
Estimation of 18-months |
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/03/2024 |
| 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
Modification(s)
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
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
|
The proposed study is multicenter, ambispective (retrospective and prospective) non-interventional, real-world study will be designed to gather and analyze safety and effectiveness data from treatment-naïve metastatic or locally advanced ALK-positive NSCLC patients with or without brain metastases.
The objective is to record safety and effectiveness of lorlatinib as 1L treatment for treatment naïve metastatic or locally advanced ALK-positive NSCLC patients with or without brain metastases under the setting of routine clinical practice in India. |