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CTRI Number  CTRI/2020/07/026826 [Registered on: 27/07/2020] Trial Registered Prospectively
Last Modified On: 09/10/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Lorlatinib in ALK Inhibitor Treated Unresectable Advanced/Recurrent ALK-Positive Non Small Cell Lung Cancer Patients in India 
Scientific Title of Study   Single-arm study to evaluate the safety of Lorlatinib in ALK Inhibitor-treated unresectable advanced and/or recurrent ALK-positive non-small cell lung cancer participants in India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
B7461030 (Original Protocol dated 30 March 2020)  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
 
Name  Dr Seema Pai 
Designation  Director (Site Relationship and Excellence Partner) 
Affiliation  Pfizer Products India Private Limited 
Address  Global Site & Study Operations, Clinical Development & Operations, Global Product Development,
Pfizer Products India Private Limited, The Capital, 1802/1901, Plot No. C-70, G Block, Bandra Kurla Complex, Bandra (E), Mumbai, MAHARASHTRA, 400051, India
Mumbai
MAHARASHTRA
400051
India 
Phone  8826422322  
Fax    
Email  seema.pai@pfizer.com  
 
Details of Contact Person
Public Query
 
Name  Dr Seema Pai 
Designation  Director (Site Relationship and Excellence Partner) 
Affiliation  Pfizer Products India Private Limited 
Address  Global Site & Study Operations, Clinical Development & Operations, Global Product Development,
Pfizer Products India Private Limited, The Capital, 1802/1901, Plot No. C-70, G Block, Bandra Kurla Complex, Bandra (E), Mumbai, MAHARASHTRA, 400051, India
Mumbai
MAHARASHTRA
400051
India 
Phone  8826422322  
Fax    
Email  seema.pai@pfizer.com  
 
Source of Monetary or Material Support  
Pfizer Inc. 235 East 42nd Street, New York, NY 10017 
 
Primary Sponsor  
Name  Pfizer Inc 
Address  235 East 42nd Street New York NY 10017 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Pfizer Products India Private Limited  The Capital, 1802/1901, Plot No. C-70, G Block, Bandra Kurla Complex, Bandra(E), Mumbai 400051, INDIA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shailesh Arjun Bondarde   Apex Wellness Hospital   Survey No. 799, Plot No. 187, Behind Prakash Petrol pump, Govind Nagar, Nashik – 422009, Maharashtra, India
Nashik
MAHARASHTRA 
9822012427

shaileshbondarde1971@gmail.com 
Dr Vineet Govinda Gupta   Artemis Hospital   Sector 51, Gurugram - 122001, Haryana, India
Gurgaon
HARYANA 
9958418121

vineet.gupta@artemishospitals.com 
Dr Nirmal Vivek Raut  Bhaktivedanta Hospital and Research Institute   Srishti Complex, Bhaktivedanta Swami Marg, Mira Road (East) Thane - 401107, Maharashtra, India
Thane
MAHARASHTRA 
9930398156

drnirmalraut@gmail.com 
Dr Chanchal Goswami  Medica Superspecialty Hospital  127, Mukundapur, E.M. Bypass, Kolkata - 700 099, West Bengal, India Kolkata
Kolkata
WEST BENGAL 
9830055035

drcgoswami@gmail.com 
Dr Tushar Vishwasrao Patil   Sahyadri Super Speciality Hospital  30-C Erandwane, Karve Road, Pune - 411004, Maharashtra, India
Pune
MAHARASHTRA 
9552522556

tussipats@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 13  
Name of Committee  Approval Status 
Artemis Health Sciences IEC   Approved 
Bhaktivedanta Hospital Ethics committee   Approved 
Clinical Research Ethics Committee, Medica Superspecialty Hospital   Submittted/Under Review 
Ethics Committee of Care Institute of Medical Sciences  Approved 
GCRI/GCS Ethics Committee  Approved 
IEC- Poona Medical and Research Foundation   Approved 
Institutional Ethics Committee - Tata Memorial Centre  Submittted/Under Review 
Institutional Ethics Committee, Yashoda Hospitals  Approved 
Institutional Review Board - Rajiv Gandhi Cancer Institute and Research Centre  Approved 
National Cancer Institute Ethics Committee  Approved 
Sahyadri Hospitals Limited Ethics Committee   Submittted/Under Review 
Shatabdi Hospital Ethics Committee   Approved 
Tata Medical Center - Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  C349||Malignant neoplasm of unspecifiedpart of bronchus or lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lorlatinib (PF-06463922)  100 mg orally QD, with or without food, until disease progression, unacceptable toxicity, or participant refusal/lost to follow-up. 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  (1)Evidence of histologically or cytologically confirmed diagnosis of unresectable advanced and/or recurrent NSCLC that carries an ALK rearrangement, as detected by an appropriate test.
(2)Disease progression or intolerance to 1 previous treatment with ALK TKI. Participants may have also had prior chemotherapy for their advanced and/or recurrent disease.
(3)Participants with asymptomatic CNS metastases (including participants controlled with stable or decreasing steroid use within the last 2 weeks prior to study enrollment) will be eligible.
(4)Age ≥18 years.
(5)ECOG performance status (PS) 0, 1, or 2.
(6)Adequate hematologic and renal function as defined
(7)Adequate liver function, including: Total serum bilirubin ≤1.5 × upper limit of normal (ULN); AST & ALT ≤2.5 × ULN (≤5.0 × ULN in case of liver metastases).
(8)Adequate pancreatic function, including: Serum total amylase ≤1.5 × ULN; Serum lipase <1.5 × ULN.
(9)Acute effects of any prior therapy resolved to baseline severity or to CTCAE Grade <1 except for AEs that in the Investigator’s judgment do not constitute a safety risk for the participant.
(10)Systemic anticancer therapy completed within a minimum of 5 half-lives of study enrollment
(11)Pregnancy test for females of childbearing potential negative at Screening or female participants who are not of childbearing potential. Male and female participants of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception from the time of Screening, throughout the study and for 3 months after the last dose of assigned treatment, 6 months if female participants. 
 
ExclusionCriteria 
Details  (1)Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study enrollment. Palliative radiation (<10 fractions) must have been completed at least 48 hours prior to study enrollment. Stereotactic or small field brain irradiation must have completed at least 2 weeks prior to study enrollment. Whole brain radiation must have completed at least 4 weeks prior to study enrollment. Prior irradiation to >25% of the bone marrow.
(2)Major surgery within 4 weeks prior to enrollment. Minor surgical procedures (eg, port insertion) are not excluded, but sufficient time should have passed for adequate wound healing.
(3)Known prior or suspected severe hypersensitivity to study drug or any component in its formulation.
(4)Active and clinically significant bacterial, fungal, or viral infection.
(5)Clinically significant vascular (both arterial and venous) and non-vascular cardiac conditions (active or within 3 months prior to enrollment)
(6)History or known presence of interstitial fibrosis, interstitial lung disease (ILD), pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative bronchiolitis, and pulmonary fibrosis.
(7)Other severe acute or chronic medical or psychiatric condition, including recent (within the past year) or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the participant inappropriate for enrollment in this study.
(8)Evidence of active malignancy (other than current NSCLC, non-melanoma skin cancer, in situ cervical cancer, papillary thyroid cancer, ductal carcinoma in situ [DCIS] of the breast or localized and presumed cured prostate cancer) within the last 3 years prior to enrollment.
(9)Concurrent use of any of the following food or drugs (consult the Sponsor if in doubt whether a food or a drug falls into any of the categories described below) within 12 days prior to the first dose of Lorlatinib:
(10)Known strong cytochrome (CYP)3A inducers (eg, carbamazepine, enzalutamide, mitotane, rifampin, St. John’s Wort).
(11)Known strong CYP3A inhibitors (eg, grapefruit juice or grapefruit/grapefruit related citrus fruits [eg, Seville oranges, pomelos], boceprevir, cobicistat, clarithromycin, conivaptan, diltiazem, idelalisib, indinavir, itraconazole, ketoconazole, lopinavir, nelfinavir, paritaprevir, posaconazole, ritonavir alone and with elvitegravir or indinavir or lopinavir or paritaprevir or ombitasvir or dasabuvir or saquinavir or tipranavir, telaprevir and voriconazole). The topical use of these medications (if applicable), such as 2% ketoconazole cream, is allowed.
(12)Known CYP3A substrates with narrow therapeutic index, such as pimozide, quinidine, tacrolimus, cyclosporine, sirolimus, alfentanil, fentanyl (including transdermal patch) or ergot alkaloids (ergotamine, dihydroergotamine).
(13)Known permeability glycoprotein (P-gp) substrates with a narrow therapeutic index (eg, digoxin).
(14)Participation in other studies involving investigational drug(s) (Phases 1-4) during study participation.
(15)Breastfeeding female participants. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Incidence of adverse events (AEs).  From the time of first dose to at most 35 days post last dosing date or the date of initiation of a new anticancer therapy. 
 
Secondary Outcome  
Outcome  TimePoints 
Percentage of Participants with Objective Responses based on Investigators’ assessments  From time of first dose (Day 1) until progression is met, death or subsequent anticancer therapy is administered. 
Percentage of Participants with Intracranial Objective Responses based on Investigators’ assessments  From time of first dose (Day 1) until progression is met, death or subsequent anticancer therapy is administered. 
Duration of response(DoR)  From time of first response until progression is met, death or subsequent anticancer therapy is administered 
Intracranial duration of response (IC-DoR)  From time of first response until progression is met, death or subsequent anticancer therapy is administered 
 
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   Phase 4 
Date of First Enrollment (India)   03/08/2020 
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   Years="3"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Brief Summary  

 
Lorlatinib is a third-generation, oral, reversible, ATP-competitive, macrocyclic TKI of ALK and ROS1. Lorlatinib was specifically designed to penetrate the CNS and to overcome known secondary resistance mutations in the ALK
tyrosine kinase domain.

This is a Phase 4, open-label, multicenter, non-randomized, prospective, single arm study to evaluate the safety and tolerability of Lorlatinib in adult participants with unresectable advanced and/or recurrent ALK-positive NSCLC with resistance or intolerance to at least 1 prior ALK inhibitor treatment.
This study is being conducted as a post approval study to fulfill  Central Drugs Standard Control Organization (CDSCO)  request relating to additional information on use of Lorlatinib in Indian patients. This study will enroll a sufficient number of participants to ensure that 100 participants are treated with Lorlatinib.

 
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