Spots Global Cancer Trial Database for Lorlatinib in ALK Inhibitor Treated Unresectable Advanced/Recurrent ALK-Positive Non Small Cell Lung Cancer Patients in India
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Trial Identification
Brief Title: Lorlatinib in ALK Inhibitor Treated Unresectable Advanced/Recurrent ALK-Positive Non Small Cell Lung Cancer Patients in India
Official Title: 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
Study ID: NCT04541706
Conditions
Interventions
Study Description
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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Rajiv Gandhi Cancer Institute And Research Centre, New Delhi, Delhi, India
The Gujarat Cancer and Research Institute, Ahmedabad, Gujarat, India
Hemato Oncology Clinic Ahmedabad Pvt. Ltd, Ahmedabad, Gujarat, India
Artemis hospital, Gurugram, Haryana, India
National Cancer Institute, Nagpur, Maharashtra, India
Apex Wellness Hospital, Nashik, Maharashtra, India
Grant Medical Foundation, Ruby Hall Clinic, Pune, Maharashtra, India
Sahyadri Clinical Research and Development Center, Pune, Maharashtra, India
Sahyadri Super Speciality Hospital, Pune, Maharashtra, India
Bhaktivedanta Hospital and Research Institute, Thane, Maharashtra, India
Yashoda Hospital, Hyderabad, Telangana State, India
Tata Medical Center, Kolkata, WEST Bengal, India
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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