| CTRI Number |
CTRI/2018/01/011325 [Registered on: 15/01/2018] Trial Registered Prospectively |
| Last Modified On: |
26/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
PStudy with investigational drug PF-06463922 and comparator crizotinib in patients with a specific type of advanced lung cancer |
|
Scientific Title of Study
|
A Phase 3, randomized, open label study of Lorlatinib (PF 06463922) monotherapy versus Crizotinib monotherapy in the first line treatment of patients with advanced ALK positive non small cell lung cancer |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| B7461006 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
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| Affiliation |
|
| 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 Karan Thakkar |
| Designation |
Regional Clinical Site Lead |
| Affiliation |
Pfizer Limited |
| Address |
18th floor, The Capital building,
Bandra Kurla Complex,
Mumbai.
Mumbai (Suburban)
MAHARASHTRA
400051
India |
| Phone |
7045788858 |
| Fax |
|
| Email |
Karan.thakkar@pfizer.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema Pai |
| Designation |
Director - India Cluster (India, Thailand and Philippines) |
| Affiliation |
Pfizer Limited |
| Address |
18th floor, The Capital building,
Bandra Kurla Complex,
Mumbai.
Mumbai (Suburban)
MAHARASHTRA
400051
India |
| Phone |
8826422322 |
| Fax |
|
| Email |
Seema.Pai@pfizer.com |
|
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Source of Monetary or Material Support
|
| Pfizer Limited, The Capital - A Wing, 1802, 18th Floor, Plot No. C-70, G Block, Bandra - Kurla Complex,
Bandra (East), Mumbai 400051 (India) |
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Primary Sponsor
|
| Name |
Pfizer Inc |
| Address |
235 East 42nd Street, New York,10017, USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
|
| Name |
Address |
| Pfizer Limited |
The Capital - A Wing, 1802, 18th Floor, Plot No. C-70, G Block, Bandra - Kurla Complex, Bandra (East), Mumbai 400051 (India) |
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Countries of Recruitment
|
Argentina
Australia
Austria
Belgium
Canada
China
Czech Republic
Denmark
France
Germany
Hong Kong
India
Italy
Japan
Mexico
Netherlands
Poland
Russian Federation
Singapore
Spain
Taiwan
Turkey
United Kingdom
United States of America |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr MudduVamshi Krishna |
Apollo Research and Innovations |
1st floor, Clinical Trial Unit, AIMSR building, Apollo Hospitals,Jubilee Hills, Hyderabad. 500096
Hyderabad
ANDHRA PRADESH |
8106667893
drmvkrishnaonco@gmail.com |
| Dr Hari Goyal |
Artemis Hospital |
Medical Oncology Department, Sector 51, Gurgaon
Gurgaon
HARYANA |
9811773708
harig@artemishospitals.com |
| Dr Poonam Patil |
Manipal Hospitals |
Oncology Department, #98, HAL , Airport Road , Bengaluru, Karnataka , 560017
Bangalore
KARNATAKA |
9945687185
poonam.patil@manipalhospitals.com |
| Dr Tushar Patil |
Sahyadri Clinical Research and Development Center |
Clinical research Department, 30 C Erandwane Karve Road Pune, 411004
Pune
MAHARASHTRA |
9552522556
tussipats@hotmail.com |
| Dr Shyam Aggarwal |
Sir Ganga Ram Hospital |
Department of medical oncology. Rajinder Nagar. Delhi
New Delhi
DELHI |
9811075870
Drshyam_aggarwal@yahoo.com |
| Dr K C Lakshmaiah |
Srinivasam Cancer Care Hosptials India Pvt.Ltd |
# 36, 1st – A Main, 5th Cross (Nethravathi Street)
Maruthinagar, Nagarbhavi Main Road
Bangalore – 560072
Bangalore
KARNATAKA |
9448055949
kcluck@gmail.com |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Artemis Health Sciences Institutional Ethics Committee |
Approved |
| Ethics Committee - Sir Ganga Ram Hospital |
Not Applicable |
| Institutional Ethics Committee |
Not Applicable |
| Institutional Ethics Committee - Clinical Studies |
Approved |
| Sahyadri Hospital Limited Ethics Committee |
Approved |
| Srinivasam Cancer Care MultiSpecilaity Hospitals Institutional Ethics Committe |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients with advanced ALK positive non small cell lung cancer, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Crizotinib |
This study will randomize approximately 280 patients in a 1:1 ratio to receive: 1. Arm A: Lorlatinib single agent; 2. Arm B: Crizotinib single agent. A cycle duration will be 4 weeks (28 days) and will always be considered 4 weeks irrespective of any dose delays/dosing interruptions or missed doses which may affect nominal days of each cycle.
Arm B: Crizotinib monotherapy at the registered starting dose of 250 mg BID,administered as 1 x 250 oral capsules/twice daily, continuously.
Crizotinib will be supplied for oral administration as capsules containing 200 mg or 250 mg of investigational product and will be packaged in -High-Density polyethylene (HDPE) bottles and labeled according to local regulatory requirements |
| Intervention |
Lorlatinib (PF 06463922) |
This study will randomize approximately 280 patients in a 1:1 ratio to receive:
1. Arm A: Lorlatinib single agent;
2. Arm B: Crizotinib single agent.
A cycle duration will be 4 weeks (28 days) and will always be considered 4 weeks
irrespective of any dose delays/dosing interruptions or missed doses which may affect nominal days of each cycle.
Arm A: Lorlatinib monotherapy at the RP2D of 100 mg QD, administered as 4 x 25 mg oral tablets, continuously.
Lorlatinib will be supplied for oral administration as 25 mg tablets in High-Density Polyethylene (HDPE) bottles with desiccant and labeled according to local regulatory requirements. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients with histologically or cytologically confirmed diagnosis of locally advanced or metastatic ALK-positive NSCLC where ALK status is determined by the FDA-approved (for use in US) and CE (Conformité Européene) marked (for use ex-US) Ventana ALK (D5F3) CDx Assay; |
|
| ExclusionCriteria |
| Details |
-Spinal cord compression unless the patient has good pain control attained through therapy
-Major surgery within 4 weeks prior to randomization
-Radiation therapy within 2 weeks prior to randomization, including stereotactic or partial brain irradiation
-Gastrointestinal abnormalities, including inability to take oral medication
-Known prior or suspected severe hypersensitivity to study drugs or any component in their formulations
-Active and clinically significant bacterial, fungal, or viral infection including hepatitis B virus (HBV) or hepatitis C virus (HCV) (eg, in case of known HBsAg or HCV antibody (positivity), known human immunodeficiency virus (HIV), or acquired immunodeficiency
syndrome (AIDS)-related illness |
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
|
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
To demonstrate that lorlatinib as a single
agent (Arm A) is superior to crizotinib alone (Arm B) in prolonging Progression-Free Survival (PFS) in advanced ALK-positive NSCLC patients who are treatment naïve. |
PFS based on blinded independent central review (BICR) assessment (RECIST v.1.1). |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| All analyses will be performed using the FA set. The analysis of PFS will be repeated based on the Investigator’s assessment. |
NA |
|
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Target Sample Size
|
Total Sample Size="280"
Sample Size from India="9"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/01/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/05/2017 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
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
|
Published in clinicaltrials.gov (NCT 03052608);
US IND (FDA): 118,296;
EudraCT (EU clinical trials registrar): 2016-003315-35 |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This is a Phase 3, multinational, multicenter (at approximately 160 sites) , randomized, openlabel, parallel 2-arm study in which approximately 280 patients with previously untreated advanced ALK-positive NSCLC will be randomized 1:1 to receive lorlatinib monotherapy or crizotinib monotherapy
This study will randomize approximately 280 patients in a 1:1 ratio to receive: - Arm A: Lorlatinib single agent;
- Arm B: Crizotinib single agent.
A cycle duration will be 4 weeks (28 days) and will always be considered 4 weeks irrespective of any dose delays/dosing interruptions or missed doses which may affect nominal days of each cycle. |