How many clinical trials are studying Lorlatinib?

6 recruiting trials in our tracked data involve Lorlatinib.

What conditions is Lorlatinib being studied for?

In our tracked recruiting trials, Lorlatinib is being studied in trials for Lung cancer, ALK Positive Non-small Cell Lung Cancer, ALK+ Non-Small-Cell Lung Carcinoma.

Lorlatinib: clinical trials recruiting now

Q: Is Lorlatinib FDA-approved?

Yes. According to the FDA drug label available through openFDA, Lorlatinib is an FDA-approved drug.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Lorlatinib appears in the FDA drug-label database. Marketed as Lorbrena.
Drug class: Kinase Inhibitor (FDA established pharmacologic class)
Mechanism of action: Kinase Inhibitors; Cytochrome P450 3A Inducers; P-Glycoprotein Inducers; Cytochrome P450 2B6 Inducers; Organic Cation Transporter 1 Inhibitors; Organic Anion Transporter 3 Inhibitors; Multidrug and Toxin Extrusion Transporter 1 Inhibitors; Breast Cancer Resistance Protein Inhibitors (as stated on the FDA label)

FDA-approved use

LORBRENA ® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. LORBRENA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. ( 1 , 2.1 )

FDA label via openFDA

Phase breakdown

Phase 1 2 Phase 2 2 Not applicable 2

Conditions being studied

Condition	Trials
Lung cancer · Lorlatinib for Lung cancer	6
ALK Positive Non-small Cell Lung Cancer · Lorlatinib for ALK Positive Non-small Cell Lung Cancer	3
ALK+ Non-Small-Cell Lung Carcinoma	2
ALK Gene Mutation	1
ALK Positive	1
Advanced Non-Small Cell Lung Cancer	1
NSCLC	1
Non Small Cell Lung Cancer Metastatic	1
Real World Study	1

Recruiting trials involving Lorlatinib

A Study to Evaluate the Combination of Platinum-pemetrexed Based Chemotherapy Plus Lorlatinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) With Exclusively Extracranial Disease Progression on Lorlatinib
NCT06378892 · Phase: Phase 2 · Ages: 18 Years and older · Sex: All (male and female) · 9 locations
AQUA07 in Patients With ALK-Positive Non-Small Cell Lung Cancer
NCT07617337 · Phase: Phase 1 · Ages: 18 Years and older · Sex: All (male and female) · 5 locations
Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World Context
NCT06487078 · Phase: Not applicable (e.g. observational or device study) · Ages: 18 Years and older · Sex: All (male and female) · 31 locations
Lorlatinib Plus Local Consolidation Therapy In ALK Positive Advanced Non-Small Cell Lung Cancer
NCT07415005 · Phase: Phase 2 · Ages: 18 Years and older · Sex: All (male and female) · 1 location
Real World Study of Lolatinib for Advanced ALK+ NSCLC Patients
NCT06361589 · Phase: Not specified · Ages: 18 Years and older · Sex: All (male and female) · 1 location
Study of NXP900 With Lorlatinib in ALK+ Lung Cancer
NCT07784959 · Phase: Phase 1 · Ages: No age limits stated · Sex: All (male and female) · 1 location

Common questions

Is Lorlatinib FDA-approved?

Yes, marketed as Lorbrena.

How many recruiting trials involve Lorlatinib?

6 recruiting trials across 9 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.