lorlatinib

Generic Name: lorlatinib

Brand Names: Lorbrena, Lorviqua

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₁₉FN_₆O_₂

CAS Number: 1454846-35-5

Unique Ingredient Identifier: OSP71S83EU

Background: Lorlatinib is a third-generation ALK tyrosine kinase inhibitor (TKI) for patients with ALK-positive metastatic non-small cell lung cancer which was first approved by the US FDA in November of 2018. It was subsequently approved by the EMA in 2019 for the treatment of select patients with previously treated advanced ALK-positive non-small cell lung cancer, fol...

Indication: Lorlatinib is indicated for the treatment of adult patients with ALK-positive metastatic non-small cell lung cancer (NSCLC). In the EU, it is indicated for the treatment of adult patients with ALK-positive advanced NSCLC not previously treated with an ALK inhibitor, or whose disease has progressed after using either alectinib or ceritinib, or crizotinib and ...

Associated Conditions: Advanced Non-Small Cell Lung Cancer (NSCLC), Metastatic Non-Small Cell Lung Cancer

Associated Therapies: -

Clinical Trials

Study of Lorlatinib in ROS1 Rearranged NSCLC

Phase 2

Conditions: Nonsmall Cell Lung Cancer

Interventions: Drug: Lorlatinib

First Posted Date: 2018-08-02

Last Posted Date: 2022-04-06

Lead Sponsor: National Cancer Center, Korea

Target Recruit Count: 35

Registration Number: NCT03612154

Locations: 🇰🇷
National Cancer Center, Goyang-Si, Gyeonggi-do, Korea, Republic of

A Study to Determine Progression-free Survival (PFS) and Evaluate Participant Experience for Participants With Metastatic Anaplastic Lymphoma Kinase-positive (ALK+) Non-Small Cell Lung Cancer (NSCLC) Treated With Anaplastic Lymphoma Kinase (ALK) Inhibitors

Completed

Conditions: Anaplastic Lymphoma Kinase-positive
Carcinoma Non-small-cell Lung

Interventions: Drug: Brigatinib
Drug: Alectinib
Drug: Ceritinib
Drug: Lorlatinib
Drug: Any FDA Approved ALK Inhibitors

First Posted Date: 2018-06-06

Last Posted Date: 2024-07-15

Lead Sponsor: Takeda

Target Recruit Count: 111

Registration Number: NCT03546894

Locations: 🇺🇸
EmpiraMed, Inc., Maynard, Massachusetts, United States

Lorlatinib Renal Impairment Study

Phase 1

Completed

Conditions: Renal Impairment

Interventions: Drug: Lorlatinib

First Posted Date: 2018-05-31

Last Posted Date: 2021-02-21

Lead Sponsor: Pfizer

Target Recruit Count: 29

Registration Number: NCT03542305

Locations: 🇺🇸
Anaheim Clinical Trials, LLC, Anaheim, California, United States
🇺🇸
Prism Clinical Research, LLC, Saint Paul, Minnesota, United States

A Study of Oral Lorlatinib in Patients With Relapsed ALK Positive Lymphoma

Phase 2

Recruiting

Conditions: Anaplastic Large Cell Lymphoma, ALK-Positive

Interventions: Drug: Lorlatinib

First Posted Date: 2018-04-23

Last Posted Date: 2023-08-07

Lead Sponsor: University of Milano Bicocca

Target Recruit Count: 12

Registration Number: NCT03505554

Locations: 🇮🇹
UOC Ematologia, Ospedale S. Eugenio, Roma, Italy
🇮🇹
Asst-Monza, Monza, Italy/MB, Italy

PF-06463922 for Crizotinib Pretreated ROS1 Positive Non-small-cell Lung Cancer

Phase 2

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: Lorlatinib

First Posted Date: 2018-02-20

Last Posted Date: 2021-07-19

Lead Sponsor: Fondazione Ricerca Traslazionale

Target Recruit Count: 20

Registration Number: NCT03439215

Locations: 🇮🇹
IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)- Oncologia Medica, Meldola, Forlì- Cesena, Italy
🇮🇹
Istituto Toscano Tumori Ospedale San Donato- U.O.C. di Oncologia Medica Dipartimento di Oncologia USL-8, Arezzo, Italy
🇮🇹
Azienda Ospedaliera di Rilievo Nazionale "S.G. Moscati", Avellino, Italy

and more 17 locations

Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive

Conditions: Non Small Cell Lung Cancer ALK Positive or ROS1 Positive

First Posted Date: 2017-06-06

Last Posted Date: 2019-11-04

Lead Sponsor: Pfizer

Registration Number: NCT03178071

Locations: 🇺🇸
Memorial Cancer Institute at Memorial Hospital West, Pembroke Pines, Florida, United States
🇺🇸
Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
🇺🇸
The Ohio State University, Columbus, Ohio, United States

and more 40 locations

Lorlatinib - PF-06463922

First Posted Date: 2017-04-25

Last Posted Date: 2020-05-15

Lead Sponsor: Pfizer

Registration Number: NCT03127618

Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)

Phase 3

Active, not recruiting

Conditions: Ganglioneuroblastoma
Neuroblastoma

First Posted Date: 2017-04-25

Last Posted Date: 2024-12-04

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 724

Registration Number: NCT03126916

Locations: 🇺🇸
Children's Healthcare of Atlanta - Arthur M Blank Hospital, Atlanta, Georgia, United States
🇺🇸
Henry Ford Health Saint John Hospital, Detroit, Michigan, United States
🇺🇸
Children's Hospital of Alabama, Birmingham, Alabama, United States

and more 158 locations

NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922)

Phase 1

Active, not recruiting

Conditions: Neuroblastoma

Interventions: Drug: Lorlatinib
Drug: Cyclophosphamide
Drug: Topotecan
Drug: Filgrastim/pegfilgrastim

First Posted Date: 2017-04-11

Last Posted Date: 2024-02-09

Lead Sponsor: New Approaches to Neuroblastoma Therapy Consortium

Target Recruit Count: 65

Registration Number: NCT03107988

Locations: 🇬🇧
Royal Marsden Hospital, Sutton, Surrey, United Kingdom
🇺🇸
Cook Children's Healthcare System, Fort Worth, Texas, United States
🇺🇸
Children's Healthcare of Atlanta, Atlanta, Georgia, United States

and more 10 locations

A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC

Phase 3

Active, not recruiting

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: Lorlatinib
Drug: Crizotinib

First Posted Date: 2017-02-14

Last Posted Date: 2024-06-26

Lead Sponsor: Pfizer

Target Recruit Count: 296

Registration Number: NCT03052608

Locations: 🇺🇸
The William P. Beetham Eye Institute, Joslin Diabetes Center, Boston, Massachusetts, United States
🇺🇸
Ophthalmic Consultants of Boston Inc, Boston, Massachusetts, United States
🇺🇸
University of Washington Medical Center, Seattle, Washington, United States

and more 136 locations

Drug Development Updates

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