Clinical Trials Using Lorlatinib
Clinical trials are research studies that involve people. The clinical trials on this list are studying Lorlatinib. All trials on the list are supported by NCI.
NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.
Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer
This National Cancer Institute (NCI)-NRG ALK Protocol phase II trial studies how well a combination of different biomarker / ALK inhibitors work in treating patients with stage IV ALK positive non-squamous non-small cell lung cancer. Lorlatinib, ceritinib, alectinib, brigatinib, ensartinib, and crizotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as pemetrexed, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether a combination of biomarker / ALK inhibitors or chemotherapy may work better in treating patients with ALK positive non-squamous non-small cell lung cancer.
Location: 484 locations
NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922)
Lorlatinib is a novel inhibitor across ALK variants, including those resistant to crizotinib. In this first pediatric phase 1 trial of lorlatinib, the drug will be utilized as a single agent and in combination with chemotherapy in patients with relapsed / refractory neuroblastoma. The dose escalation phase of this study (Cohort A1) uses a traditional Phase I 3+3 design. Once a recommended phase 2 pediatric dose is identified, an expansion cohort of 6 patients (Cohort B1), within which ALKi naïve patients will be prioritized, will be initiated. Parallel cohorts will be initiated in adults or patients with large BSA (Cohort A2) and in combination with chemotherapy upon establishing RP2D (Cohort B2).
Location: 8 locations
Hepatic Impairment Study for Lorlatinib in Cancer Patients
This is a phase 1 study in advanced cancer patients with varied hepatic fucntions to evaluate the potential effect of hepatic impairment on pharmacokinetics and safety of lorlatinib and provide dose recommendation for patients with hepatic impairment if possible.
Location: 6 locations
Lorlatinib in Treating Patients with Advanced ALK and ROS1 Rearranged Metastatic Non-small Cell Lung Cancer
This phase II trial studies how well lorlatinib works in treating patients with ALK and ROS1 rearranged non-small cell lung cancer that has spread to other places including the central nervous system (CNS) (metastatic). Lorlatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Location: 4 locations
Temozolomide with Osimertinib or Lorlatinib for the Treatment of Stage IV Non-small Cell Lung Cancer in Patients with CNS Progression on Either Osimertinib or Lorlatinib
This phase I trial is to find out the best dose of temozolomide when given together with osimertinib or lorlatinib in treating patients with stage IV non-small cell lung cancer that becomes worse or spreads to the central nervous system (CNS) under the treatment of osimertinib or lorlatinib. Temozolomide may help block the formation of growths that may become cancer. Osimertinib may bind to and inhibit the activity of mutant forms of EGFR. Lorlatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Adding temozolomide to osimetinib or lorlatinib may kill more tumor cells.
Location: University of Colorado Hospital, Aurora, Colorado
Lorlatinib with Crizotinib or Binimetinib for the Treatment of Refractory Stage IV Non-small Cell Lung Cancer with ALK or ROS1 Gene Rearrangement
This phase Ib / II trial studies the side effects and best dose of lorlatinib and how well it works with crizotinib or binimetinib in treating patients with stage IV non-small cell lung cancer that has not responded to treatment (refractory) with ALK or ROS1 gene rearrangement. Lorlatinib is an oral ALK and ROS1 inhibitor that may help stop the growth and spread of ALK-positive and ROS1-positive lung cancer cells. Binimetinib is an oral inhibitor of MEK, a signaling protein that may cause some types of lung cancer to grow. Combining binimetinib with drugs targeting these growth signals has been shown to prevent lung cancer cells from growing. Crizotinib is an oral inhibitor of a number of proteins, including MET, a signaling protein that may cause some types of cancer to grow. Adding crizotinib to lorlatinib may be able to control the growth of lung cancer cells that have also become dependent on growth signals from MET. Giving lorlatinib with crizotinib or binimetinib may work better in treating patients with non-small cell lung cancer.
Location: 2 locations
Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial
This phase Ib trial determines if samples from a patient’s cancer can be tested to find combinations of drugs that provide clinical benefit for the kind of cancer the patient has. This study is also being done to understand why cancer drugs can stop working and how different cancers in different people respond to different types of therapy.
Location: OHSU Knight Cancer Institute, Portland, Oregon
Study of Lorlatinib In Participants With Anaplastic Lymphoma Kinase (ALK) -Positive NSCLC
A Phase 4 study to assess Overall and Intracranial Response Rate of single-agent lorlatinib in participants with advanced ALK-positive NSCLC whose disease has progressed on alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI)therapy.
Location: UC Irvine Health / Chao Family Comprehensive Cancer Center, Orange, California
A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC
A phase 3 study to demonstrate whether lorlatinib given as monotherapy is superior to crizotinib alone in prolonging the progression-free survival in advanced ALK-positive NSCLC patients who are treatment naïve and to compare lorlatinib to crizotinib with respect to overall survival in the same population
Location: See Clinical Trials.gov