Study of Lorlatinib in ROS1 Rearranged NSCLC
A Phase II Study of Lorlatnib in ROS1 Rearranged Advanced NSCLC
1 other identifier
interventional
35
1 country
1
Brief Summary
This is a phase II, multi-center, single arm study of lorlarinib as a single agent in patients with ROS1-rearranged advanced NSCLC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 nonsmall-cell-lung-cancer
Started May 2019
Typical duration for phase_2 nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2018
CompletedFirst Posted
Study publicly available on registry
August 2, 2018
CompletedStudy Start
First participant enrolled
May 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedApril 6, 2022
April 1, 2022
3.7 years
June 14, 2018
April 4, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
ORR
To assess the clinical efficacy of lorlatinib as measured by ORR using RECIST criteria v 1.1
from Cycle1 Day 1 until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months").
Study Arms (1)
Lorlatinib
EXPERIMENTALSubjects will be treated with lorlatinib 100mg PO daily. A cycle will be defined as 28-days for the convenience of analysis.
Interventions
Subjects will be treated with lorlatinib 100mg PO daily. A cycle will be defined as 28-days for the convenience of analysis.
Eligibility Criteria
You may qualify if:
- Metastatic or recurrent NSCLC with ROS1 rearrangement identified by NGS-based target sequencing
- Treatment naïve or one prior systemic treatment with platinum doublet chemotherapy
- At least one measurable disease lesion according to RECIST 1.1
- ECOG performance status 0-2
- Age ≥ 18 years
- Adequate hematologic, hepatic, and renal function
- Written informed consent
You may not qualify if:
- Life expectancy of less than 12 weeks
- Prior treatment with a ROS1 inhibitor
- Symptomatic uncontrolled brain metastasis
- Other malignancy within 5 years, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, and ductal carcinoma in situ treated surgically with curative intent
- Uncontrolled intercurrent illness
- Pregnancy or unwillingness to use effective birth control
- Known hypersensitivity to lorlatinib and/or its excipients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cancer Center
Goyang-si, Gyeonggi-do, 10408, South Korea
Related Publications (1)
Ahn BC, Kim YJ, Lee Y, Suh KJ, Kim SH, Kim DW, Kim TM, Lee KH, Han JY. Lorlatinib in Tyrosine Kinase Inhibitor-Naive Advanced ROS1-Positive Non-Small Cell Lung Cancer: A Phase 2 Nonrandomized Clinical Trial. JAMA Oncol. 2026 Jan 1;12(1):84-89. doi: 10.1001/jamaoncol.2025.5097.
PMID: 41296331DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ji-Youn Han, MD.Ph.D.
National Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD. PhD.
Study Record Dates
First Submitted
June 14, 2018
First Posted
August 2, 2018
Study Start
May 2, 2019
Primary Completion
December 31, 2022
Study Completion
December 31, 2023
Last Updated
April 6, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share