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Last Updated: September 23, 2021

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CLINICAL TRIALS PROFILE FOR LORLATINIB

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All Clinical Trials for Lorlatinib

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02804399 ↗ A Study To Evaluate The Effect Of Rifampin On Pharmacokinetics Of PF-06463922 In Healthy Volunteers Completed Pfizer Phase 1 2016-07-01 The purpose of this study is to estimate the effect of rifampin on the single dose PK of PF-06463922.
NCT02838264 ↗ A Study To Evaluate The Effect Of Itraconazole On Pharmacokinetics Of PF-06463922 In Healthy Volunteers Suspended Pfizer Phase 1 2016-08-01 The purpose of this study is to estimate the effect of itraconazole on the single dose pharmacokinetics of PF-06463922 in healthy volunteers in the fasted state.
NCT02927340 ↗ A Study of Lorlatinib in Advanced ALK and ROS1 Rearranged Lung Cancer With CNS Metastasis in the Absence of Measurable Extracranial Lesions Recruiting Massachusetts General Hospital Phase 2 2016-10-01 This research study is studying a drug as a possible treatment for ALK-positive or ROS1-positive non-small cell lung cancer (NSCLC). The following drug will be involved in this study : - Lorlatinib
NCT03052608 ↗ A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC Recruiting Pfizer Phase 3 2017-04-07 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
NCT03107988 ↗ Study of Lorlatinib (PF-06463922) Recruiting Children's Neuroblastoma Cancer Foundation Phase 1 2017-09-01 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).
NCT03107988 ↗ Study of Lorlatinib (PF-06463922) Recruiting Cookies for Kids' Cancer Phase 1 2017-09-01 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).
NCT03107988 ↗ Study of Lorlatinib (PF-06463922) Recruiting Pfizer Phase 1 2017-09-01 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).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Lorlatinib

Condition Name

Condition Name for Lorlatinib
Intervention Trials
Non Small Cell Lung Cancer 2
Healthy Volunteers 2
Healthy 2
Carcinoma, Non-Small-Cell Lung 2
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Condition MeSH

Condition MeSH for Lorlatinib
Intervention Trials
Carcinoma, Non-Small-Cell Lung 9
Lung Neoplasms 7
Lymphoma 3
Neoplasms 2
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Clinical Trial Locations for Lorlatinib

Trials by Country

Trials by Country for Lorlatinib
Location Trials
United States 20
Japan 6
France 3
India 3
Belgium 2
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Trials by US State

Trials by US State for Lorlatinib
Location Trials
Massachusetts 3
Colorado 2
California 2
Washington 2
Texas 2
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Clinical Trial Progress for Lorlatinib

Clinical Trial Phase

Clinical Trial Phase for Lorlatinib
Clinical Trial Phase Trials
Phase 4 2
Phase 3 1
Phase 2 9
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Clinical Trial Status

Clinical Trial Status for Lorlatinib
Clinical Trial Phase Trials
Not yet recruiting 13
Recruiting 7
Completed 1
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Clinical Trial Sponsors for Lorlatinib

Sponsor Name

Sponsor Name for Lorlatinib
Sponsor Trials
Pfizer 15
Massachusetts General Hospital 2
Intergroupe Francophone de Cancerologie Thoracique 2
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Sponsor Type

Sponsor Type for Lorlatinib
Sponsor Trials
Other 19
Industry 18
NIH 2
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