Phase II study of Lorlatinib in LTK fusion-positive advanced non-small cell Lung cancer

JRCT ID: jRCT2031220600

Registered date:01/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: LTK fusion-positive advanced non-small cell lung cancer (NSCLC)
• Date of first enrollment: 28/02/2022
• Target sample size: 10
• Study type: Interventional
• Intervention(s): The dosing regimen is once-daily oral dosing of lorlatinib 100 mg.

Outcome(s)

• Primary Outcome: Objective Response Rate

Secondary Outcome

1.Progression Free Survival, Disease Control Rate, Duration Of Response, Overall Survival
2.Safety and tolerability of oral lorlatinib monotherapy

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Histologically or cytologically diagnosed as NSCLC.
2. Unresectable stage III without any indications for radical radiotherapy, stage IV or post-operative recurrence.
3. LTK fusion positivity was identified by analyzing tissue specimen using a measurement method validated in the LC-SCRUM-Asia.
4. Having at least 1 measurable lesion according to RECIST ver. 1.1.
5. Males and females aged 18 years or older at the time of informed consent for participation in the study.
6. Having ECOG PS of 0 to 2.
7. Having adequate organ function as defined in the laboratory criteria:
8. Patients who have been explained in writing about study-related information and signed the informed consent form before enrollment.
9. Patients who are able to visit the hospital on the scheduled dates and to actively cooperate and receive treatment, examinations and other procedures related to the study.
10. Patients who agree to effective contraception during the study period and for at least 97 days for men and 21 days for women of childbearing potential from the last dose of lorlatinib.

Exclude criteria

1. Participating in another clinical trial and receiving treatment.
2. Being positive for ALK or ROS1 fusion genes
3. Receiving systemic chemotherapy or radiotherapy within 2 weeks prior to enrollment, or undergoing major surgery within 4 weeks before enrollment.
4. Patients with acute toxicities associated with prior treatment have not resolved to grade 1 or baseline levels.
5. Patients who have symptomatic brain metastases. Those who are asymptomatic, or who are receiving treatment and neurologically stable for at least 2 weeks, requiring no increase in corticosteroid dose, are eligible for enrollment.
6. Patients with spinal cord compression, carcinomatous meningitis, or leptomeningeal disease that do not have good pain control and have not maintained or restored neurologic function by treatment.
7. Patients with CT-confirmed or a history of pulmonary fibrosis or interstitial lung disease.
8. Patients with any of the history/comorbidities of cerebrovascular/cardiovascular diseases within 3 months before the start of the investigational drug administration;
9. Having active arrhythmia of >=Grade 2 according to CTCAE ver. 5.0, uncontrolled atrial fibrillation of any grade, and QTc > 470 msec, or congenital long QT syndrome.
10. Having an active and clinically significant bacterial, fungal, or viral infection, such as hepatitis B, hepatitis C and acquired immunodeficiency syndrome-related disease.
11. Patients who are pregnant or breastfeeding.
12. Use of any of the drugs or foods within 12 days before the initial administration of the investigational drug.
13. Affected by active malignancy in the past 3 years.
14. Patients with other serious acute or chronic medical conditions, psychiatric diseases, or laboratory abnormalities who are deemed by the principal investigator or sub-investigator to have a higher risk of progression by participating in the study or by receiving the investigational drug.

Related Information

• Primary Sponsor: Yoh Kiyotaka
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development