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.

Trials 1-5 of 5
  • Biomarker / ALK Inhibitor Combinations in Treating Patients with Stage IV ALK Positive Non-squamous Non-small Cell Lung Cancer (The NCI-NRG ALK Protocol)

    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: 401 locations

  • 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: 7 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). Lorlatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 4 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: 3 locations

  • 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