Lorlatinib for Non-Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a drug called lorlatinib for individuals with advanced non-small cell lung cancer (NSCLC) that hasn't been treated with certain other drugs. The research aims to evaluate lorlatinib's effectiveness alone or combined with other local treatments for cancer with a specific genetic change, known as ALK rearrangement. Suitable participants have stage IV NSCLC with this ALK change, have had little to no treatment with similar drugs, and their doctor considers them suitable for additional local cancer treatments.
As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer treatment.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot receive other anti-cancer agents while on treatment in this study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that lorlatinib is safe for people with ALK-positive non-small cell lung cancer, which involves a specific gene change. In studies, most patients tolerated the treatment well. Common side effects include weight gain, high cholesterol, and swelling in the hands and feet, but these were usually manageable. Importantly, recent trials have not identified any new or unexpected safety issues. When combined with local consolidation therapy, a type of radiation treatment, lorlatinib remains safe and tolerable. Overall, evidence suggests that lorlatinib, whether used alone or with local consolidation therapy, is a safe treatment option for people with this type of lung cancer.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about lorlatinib for non-small cell lung cancer because it targets a specific genetic alteration known as ALK (anaplastic lymphoma kinase), which is not addressed by many existing treatments. Unlike traditional chemotherapy that attacks all rapidly dividing cells, lorlatinib selectively inhibits the ALK protein, potentially reducing side effects and improving effectiveness for patients with this mutation. Additionally, lorlatinib is taken orally, which can be more convenient compared to intravenous treatments. For some patients, lorlatinib is also combined with Local Consolidation Therapy (LCT) to enhance its impact, offering a comprehensive approach to managing the disease.
What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?
Research has shown that lorlatinib effectively treats ALK-positive non-small cell lung cancer (NSCLC). Studies have found that 76% of patients who took lorlatinib without prior treatment survived for five years. Additionally, 60% of these patients lived without their cancer worsening over the same period. Lorlatinib also extends the time patients live without disease progression compared to treatments like crizotinib. In this trial, some participants will receive lorlatinib alone, while others will receive a combination of lorlatinib and local consolidation therapy, which targets remaining cancer cells. This combination might further improve outcomes, although more information is still being gathered.12567
Who Is on the Research Team?
Yasir Y Elamin, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults (18+) with advanced non-small cell lung cancer that has a specific ALK gene change. Participants must have good blood counts, kidney and liver function, and be able to receive local therapy. They should not have had prior tyrosine kinase inhibitor treatment unless specified.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Treatment
Participants receive lorlatinib orally daily for an induction period of 12 weeks
Randomization and Treatment
Participants are randomized to receive either continued lorlatinib or lorlatinib plus Local Consolidation Therapy (LCT)
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Local Consolidation Therapy
- Lorlatinib
Trial Overview
The study tests lorlatinib, a targeted pill for ALK-positive lung cancer, given alone at first and then possibly combined with local treatments like radiation or surgery. Patients are randomly assigned to groups in this phase 2 trial.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
All patients will receive lorlatinib orally daily for an induction period of 12 weeks prior to randomization, for patients treated for another first line ALK TKI for 4 weeks or less and switched to lorlatinib, they will receive lorlatinib up to a total time of 12 weeks on an ALK TKI pre-randomization.
All patients will receive lorlatinib orally daily for an induction period of 12 weeks prior to randomization, for patients treated for another first line ALK TKI for 4 weeks or less and switched to lorlatinib, they will receive lorlatinib up to a total time of 12 weeks on an ALK TKI pre-randomization.
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Citations
Efficacy and safety of lorlatinib in first-line and subsequent-line ...
Lorlatinib demonstrated high efficacy in anaplastic lymphoma kinase (ALK)-positive (ALK+) non-small cell lung cancer (NSCLC): first-line median ...
Final Overall Survival and Long-Term Safety of Lorlatinib in ...
At a median follow-up of 72.7 months, the median OS was NR with lorlatinib with a five-year OS probability of 76% in patients with treatment-naïve, advanced, ...
US Population-Level Clinical Impact of Lorlatinib Treatment ...
Compared to no lorlatinib use, lorlatinib treatment resulted in 1,620-5,170 and 1,590-4,880 more life-years (LYs) and quality-adjusted life-years (QALYs), ...
Lorlatinib in ALK-positive non-small cell lung cancer
The fact that lorlatinib's 5-year OS in a small phase II first-line cohort reached 76%—exceeding historical results with alectinib—is ...
5.
cancer.gov
cancer.gov/news-events/cancer-currents-blog/2024/lorlatinib-alk-positive-lung-cancer-initial-treatmentLorlatinib Slows Growth of ALK-Positive Lung Cancers ...
After 5 years of follow-up data, the investigators found, 60% of the participants in the lorlatinib group were alive without the disease having ...
LORBRENA® (lorlatinib) First Line Efficacy | Safety Info
Find efficacy information for a first line study of LORBRENA® in patients with ALK+ metastatic non-small cell lung cancer (NSCLC). See risks and benefits.
Lorlatinib atypical safety profile in ALK-positive aNSCLC - PMC
Real-world analysis of the efficacy and safety of lorlatinib in ALK-positive non-small cell lung cancer patients in China. Front Oncol. 2025 ...
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