Study of Lorlatinib in ROS1 Rearranged NSCLC

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase II, multi-center, single arm study of lorlarinib as a single agent in patients with ROS1-rearranged advanced NSCLC.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Center, Korea

Criteria

4.1. Inclusion criteria

1. Metastatic or recurrent NSCLC with ROS1 rearrangement identified by NGS-based target sequencing

2. Treatment naïve or one prior systemic treatment with platinum doublet chemotherapy

3. At least one measurable disease lesion according to RECIST 1.1

4. ECOG performance status 0-2

5. Age ≥ 18 years

6. Adequate hematologic, hepatic, and renal function

7. Written informed consent

4.2. Exclusion criteria

1. Life expectancy of less than 12 weeks

2. Prior treatment with a ROS1 inhibitor

3. Symptomatic uncontrolled brain metastasis

4. 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

5. Uncontrolled intercurrent illness

6. Pregnancy or unwillingness to use effective birth control

7. Known hypersensitivity to lorlatinib and/or its excipients