Actively Recruiting
Lorlatinib Plus Local Consolidation Therapy In ALK Positive Advanced Non-Small Cell Lung Cancer
Led by M.D. Anderson Cancer Center · Updated on 2026-05-05
30
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, multicenter, randomized phase 2 trial for patients with tyrosine kinase inhibitor-naïve ALKrearranged advanced NSCLC. Subjects are initially treated with lorlatinib for 12 weeks.
CONDITIONS
Official Title
Lorlatinib Plus Local Consolidation Therapy In ALK Positive Advanced Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with stage IV non-small cell lung cancer or recurrent NSCLC not eligible for definitive multimodality therapy
- Documented ALK rearrangement by FISH, IHC, tissue NGS, or cfDNA NGS
- TKI-naive or treated with lorlatinib for up to 12 weeks without disease progression, or treated with alectinib, brigatinib, or ensartinib for up to 4 weeks without disease progression and switched to lorlatinib
- Considered a candidate for local consolidation therapy by the treating physician
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Males or females aged 18 or older
- Adequate organ function as defined by blood counts, liver and kidney tests, and coagulation parameters
- Negative pregnancy test for women of childbearing potential at screening
- Women who are postmenopausal, surgically sterile, or agree to use effective contraception during the study and for 4 months after last dose
- Men agree to use effective contraception or abstain from heterosexual intercourse during the study and for 4 months after last dose
- Normal QT interval on ECG (QTcF ≤450 ms in males, ≤470 ms in females)
- Able and willing to provide informed consent and comply with study procedures
You will not qualify if you...
- Diagnosed with another primary cancer except certain treated cancers or if at least 2 years have passed since treatment
- Received prior tyrosine kinase inhibitors other than allowed ongoing first-line treatments
- Received more than 1 cycle of chemotherapy or immunotherapy for advanced disease
- Symptomatic central nervous system metastases or requiring increasing corticosteroids
- Current spinal cord compression
- Pulmonary interstitial disease, drug-related or radiation pneumonitis
- Known allergy or hypersensitivity to lorlatinib or its ingredients
- Gastrointestinal conditions affecting drug absorption
- Uncontrolled hypertension
- Radiation therapy within 14 days before randomization except stereotactic radiosurgery
- Major surgery within 30 days before enrollment
- Significant uncontrolled cardiovascular disease or recent myocardial infarction, angina, heart failure, or arrhythmias
- Cerebrovascular accident within 6 months before first dose
- Active infections requiring intravenous antibiotics
- Use of other anti-cancer agents during the study
- Allergic reactions to similar compounds
- Known HIV infection
- Pregnant or breastfeeding women due to potential risks of lorlatinib and study drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
Y
Yasir Y Elamin, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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