Clinical trial · Interventional
Study of Lorlatinib in ROS1 Rearranged NSCLC
A Phase II Study of Lorlatnib in ROS1 Rearranged Advanced NSCLC
NCT03612154CI-TRIAL-00057588unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase II, multi-center, single arm study of lorlarinib as a single agent in patients with ROS1-rearranged advanced NSCLC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nonsmall Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lorlatinib | Drug | Lorlatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lorlatinib
- description
- Subjects will be treated with lorlatinib 100mg PO daily. A cycle will be defined as 28-days for the convenience of analysis.
- interventionNames
- Drug: Lorlatinib
Primary outcomes (1)
- measure
- ORR
- timeFrame
- 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").
- description
- To assess the clinical efficacy of lorlatinib as measured by ORR using RECIST criteria v 1.1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDAhn 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 41296331