| CTRI Number |
CTRI/2024/07/071046 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
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Drug |
| Study Design |
Single Arm Study |
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Public Title of Study
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The purpose of this protocol is to provide continued treatment access and safety follow-up for eligible participants who continue to receive benefit from study intervention in the Pfizer sponsored lorlatinib ongoing studies that will be closed. |
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Scientific Title of Study
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An Open-label, Single-arm Continuation study for participants with ALKpositive or ROS1positive Non-small Cell Lung Cancer (NSCLC) continuing from Pfizer sponsored Lorlatinib clinical studies |
| Trial Acronym |
NIL |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| 2021-005569-42 |
EudraCT |
| B7461039 Protocol Amendment Version 1 dated 19-Jul-2022 |
Protocol Number |
| NCT05144997 |
ClinicalTrials.gov |
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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 Seema Pai |
| Designation |
Director-Clinical Site Operations |
| Affiliation |
Pfizer Limited |
| Address |
Global Site and Study Operations, Clinical Development and Operations, Global Product Development, Pfizer Limited, The Capital, 1802/1901, Plot No. C70, G Block,
Bandra Kurla Complex,
Bandra(E)
Mumbai
MAHARASHTRA
400051
India |
| Phone |
918826422322 |
| Fax |
|
| Email |
seema.pai@pfizer.com |
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Details of Contact Person
Public Query
|
| Name |
Dr Seema Pai |
| Designation |
Director-Clinical Site Operations |
| Affiliation |
Pfizer Limited |
| Address |
Global Site and Study Operations, Clinical Development and Operations, Global Product Development, Pfizer Limited, The Capital, 1802/1901, Plot No. C70, G Block,
Bandra Kurla Complex,
Bandra(E)
Mumbai
MAHARASHTRA
400051
India |
| Phone |
918826422322 |
| Fax |
|
| Email |
seema.pai@pfizer.com |
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Source of Monetary or Material Support
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| Pfizer Inc., 66 Hudson Boulevard East, New York, NY 10001 |
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Primary Sponsor
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| Name |
Pfizer Inc. |
| Address |
66 Hudson Boulevard East, New York, NY 10001 |
| 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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China
France
India
Singapore
Spain
Taiwan
United States of America |
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Sites of Study
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| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nirmal Raut |
Bhaktivedanta Hospital & Research Institute |
Oncology Dept, OPD 3, 1st floor, Srishti Complex, Bhaktivedanta Swami Marg, Mira Road East
Thane
MAHARASHTRA |
9930398156
pinirmal123@gmail.com |
| Satheesh CT |
Healthcare Global Enterprises Limited |
Clinical Research Dept. Tower 4 room no 512, Tower 8, P Kalinga Rao Road, Sampangiramnagar, Pin no 560011
Bangalore
KARNATAKA |
9242698750
drsatheesh.ct@hcgel.com |
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Details of Ethics Committee
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| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| BhaktiVedanta Hospital Ethics Committee |
Submittted/Under Review |
| HCG Central Ethics Committee |
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: C783||Secondary malignant neoplasm of other and unspecified respiratory organs, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Lorlatinib (PF-06463922) |
Lorlatinib single agent, 100 mg (4 x 25 mg) oral tables, QD, continuously. The starting dose for this continuation protocol will be the dose at the time of end of trial for each participant in the Parent Study. |
| Comparator Agent |
Not Applicable |
This is an open label study, Comparator details not applicable |
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
- Any participant who is receiving study treatment and deriving clinical benefit (as determined by the Principal Investigator) in a Pfizer-sponsored Lorlatinib Parent Study
- Participants must agree to follow the reproductive criteria as outlined in Protocol
- Adequate organ function- Adequate Bone Marrow, Liver, Renal, Pancreatic Function.
- Participants who are willing and able to comply with all scheduled visits, treatment plan,
and other study procedures. Capable of giving signed informed consent |
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| ExclusionCriteria |
| Details |
- Female participants who are pregnant or breastfeeding.
- Any medical reason that, in the opinion of the Investigator or Sponsor, precludes the participant from inclusion in the study. |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Centralized |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
1) Number of participants with adverse events leading to permanent discontinuation of study intervention
- Safety collection in this study will permit further characterization of the safety profile of lorlatinib
2) Number of serious adverse events reported for all participants
Safety collection in this study will permit further characterization of the safety profile of lorlatinib |
1) AEs leading to permanent
discontinuation of lorlatinib: Time Frame- Baseline up to approximately 5 years
2) All SAEs: Time Frame- Baseline up to approximately 5 years
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Secondary Outcome
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| Outcome |
TimePoints |
| Not provided |
Not provided |
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Target Sample Size
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Total Sample Size="200"
Sample Size from India="10"
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
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Phase 4 |
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Date of First Enrollment (India)
|
12/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/12/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="0"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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The purpose of this protocol is to provide continued treatment access and safety follow-up for eligible participants who continue to derive a benefit from study intervention and no ongoing safety events in the Pfizer-sponsored lorlatinib parent studies (eg, B7461001, B7461006, B7461024, B7461027) that will be closed. This is an open-label continuation study for participants in the qualifying Parent Studies who are receiving lorlatinib as a single agent.
Lorlatinib will be self-administered by the participant at home in 28-day cycles, unless otherwise specified. Compliance will be assessed by counting returned tablets during the site visits and documented in the source documents and CRF.
The end of study is defined as when the last participant has discontinued from lorlatinib and has completed the safety follow-up period or 5 years after First Participant Dosed of the continuation study (whichever is sooner).
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