Clinical trials: Lorlatinib
Stage III NSCLC, Surgery
Induction Lorlatinib in Stage III Non-small Cell Lung Cancer
A prospective, single-arm, open-label phase 2 study that evaluates the efficacy and safety of induction Lorlatinib in stage III non-small cell lung cancer and explores the clinical feasibility of dynamic ctDNA and…
- Trial name
- NCT05740943
- Testing
- Lorlatinib
- Where
- 4 sites in China
- Volunteers
- 48 people
- Sponsor
- Guangdong Provincial People's Hospital
Non Small Cell Lung Cancer Metastatic, ALK Gene Mutation
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
This study aims to evaluate the activity and safety of the combination of platinum-pemetrexed based chemotherapy plus Lorlatinib in ALK positive Non-Small Cell Lung Cancer (NSCLC) with exclusively extracranial disease progression…
- Trial name
- ALK-PPL (NCT06378892)
- Testing
- Lorlatinib
- Where
- 9 sites in Italy
- Volunteers
- 45 people
- Sponsor
- Centro di Riferimento Oncologico - Aviano
Non-Small Cell Lung Carcinoma
A Study to Learn About Lorlatinib in Patients With Non-Small Cell Lung Cancer Which Could Not Be Controlled
The purpose of this study is to learn about lorlatinib for the possible treatment of lung cancer which could not be controlled. This study is seeking participants who: have lung cancer that could not be controlled.
- Trial name
- NCT06282991
- Testing
- Lorlatinib
- Where
- 6 sites in Taiwan
- Volunteers
- 73 people
- Sponsor
- Pfizer
Ganglioneuroblastoma, Ganglioneuroblastoma, Nodular
Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)
This phase III trial studies iobenguane I-131 or lorlatinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma.
- Conditions
- Ganglioneuroblastoma, Ganglioneuroblastoma, Nodular, Neuroblastoma
- Trial name
- NCT03126916
- Testing
- Autologous Hematopoietic Stem Cell Transplantation, Biospecimen Collection, Bone Marrow Aspiration and Biopsy
- Where
- 164 sites in United States, Canada and 1 more
- Volunteers
- 750 people
- Sponsor
- Children's Oncology Group
NSCLC
Explore the Mechanisms Underlying Disease Resistance and Potential Primary Resistance Mechanism of Induction Therapy Lorlatinib in Resectable Non-small Cell Lung Cancer (NSCLC) Harboring ALK Positive Mutation Revealed by Single-cell RNA Sequencing and Spatial Transcriptomics
This is an open-label, randomized, single-center study. This translational study aims to explore tumor microenvironment remodelling after induction therapy lorlatinib and identify mechanisms of disease persistence and potential…
- Trial name
- NCT06893354
- Testing
- lorlatinib, lorlatinib plus chemotherapy
- Volunteers
- 20 people
- Sponsor
- The First Affiliated Hospital of Guangzhou Medical University
Non-Small Cell Lung Cancer, Hyperlipidemia
LORLATINIB-related HYPERLIPIDEMIA in ALK+ Non-Small Cell Lung Cancer
The goal of this observational study is to learn about the long-term effects of Lorlatinib related hyperlipidemia in NSCLC patients who take Lorlatinib for at least 21 days.
- Trial name
- NCT06876675
- Testing
- Lorlatinib
- Where
- China
- Volunteers
- 167 people
- Sponsor
- Peking University Third Hospital
Non-small Cell Lung Cancer Metastatic, ALK Gene Rearrangement Positive
Efficacy of Treatment Sequences in Patients With Non-small Cell Lung Cancer Receiving Lorlatinib
The study will evaluate progression-free survival, overall survival, best response and duration of treatment in patients with advanced ALK- and ROS1-positive non-small cell lung cancer who received lorlatinib as part of the…
- Conditions
- Non-small Cell Lung Cancer Metastatic, ALK Gene Rearrangement Positive, ROS-1 Gene Rearrangement Positive
- Trial name
- LORLATU (NCT03727477)
- Where
- 30 sites in France
- Volunteers
- 291 people
- Sponsor
- Intergroupe Francophone de Cancerologie Thoracique
Healthy
A Study To Evaluate The Effect Of Itraconazole On Pharmacokinetics Of PF-06463922 In Healthy Volunteers
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.
- Trial name
- NCT02838264
- Testing
- PF-06463922, Itraconazole
- Where
- Belgium
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Pfizer
High Grade Glioma, Diffuse Intrinsic Pontine Glioma
Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion
The goal of this study is to determine the response of the study drug loratinib in treating children who are newly diagnosed high-grade glioma with a fusion in ALK or ROS1.
- Conditions
- High Grade Glioma, Diffuse Intrinsic Pontine Glioma, Anaplastic Astrocytoma, Infant Type Hemispheric Glioma
- Trial name
- NCT06333899
- Testing
- Lorlatinib, Lorlatinib with chemotherapy1, Lorlatinib with chemotherapy 2
- Where
- 18 sites in United States, Australia and 4 more
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Nationwide Children's Hospital
Non-Small Cell Lung Cancer (NSCLC), Hyperlipidemia
Management Strategy of 1L Lorlatinib With Hyperlipidemia in Stage IIIB-IV ALK Positive NSCLC
For Patients and Families Brief Title: Management of 1L Lorlatinib with Hyperlipidemia in ALK+ Advanced NSCLC What is this study about? This study is for people with ALK-positive non-small cell lung cancer (NSCLC) who are taking…
- Conditions
- Non-Small Cell Lung Cancer (NSCLC), Hyperlipidemia, ALK Gene Mutation, ALK-positive
- Trial name
- NCT07674524
- Testing
- For Part A - Observational Cohort:, Part B: Intensive Lipid-Lowering Group, For Part B - Intensive Group
- Where
- China
- Volunteers
- 160 people
- Sponsor
- Sun Yat-sen University
Non-Small Cell Lung Cancer, ALK
Iruplinalkib in ALK-Positive Advanced Lung Adenocarcinoma After Lorlatinib
This observational study aims to evaluate the real-world effectiveness and safety of iruplinalkib in patients with advanced ALK-positive lung adenocarcinoma who have progressed on or are intolerant to prior lorlatinib therapy.
- Conditions
- Non-Small Cell Lung Cancer, ALK, Iruplinalkib, Lorlatinib
- Trial name
- SAILOR (NCT07374614)
- Testing
- Iruplinalkib tablets
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Peking University Shenzhen Hospital
Lung Cancer (NSCLC)
Lorlatinib in ROS1+ NSCLC With Brain Metastasis
The goal of this Phase II, multicenter, open-label, single-arm clinical trial is to evaluate the intracranial efficacy and safety of lorlatinib in adults with TKI-naïve, advanced ROS1-positive non-small cell lung cancer (NSCLC)…
- Trial name
- NCT07083687
- Testing
- Lorlatinib 100 mg
- Volunteers
- 21 people
- Sponsor
- Hunan Cancer Hospital
Non-Small Cell Lung Cancer ALK-positive
A Study to Learn About Study Medicine Lorlatinib, as a First-line Treatment in Chinese Adults With ALK-positive a/mNSCLC
The purpose of this retrospective study is to learn about the real-world effects of the study medicine lorlatinib for the first-line treatment of Chinese adult patients who were diagnosed with ALK-positive a/mNSCLC.
- Trial name
- NCT07556549
- Testing
- Lorlatinib
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Pfizer
ALK+ Non-Small-Cell Lung Carcinoma
Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World Context
Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World context
- Trial name
- LOREA (NCT06487078)
- Testing
- Lorlatinib
- Where
- 32 sites in France
- Volunteers
- 90 people
- Sponsor
- Pfizer
Carcinoma, Non-Small-Cell Lung
A Study of Lorlatinib in ALK Inhibitor-Treated ALK-Positive NSCLC in China
A Phase 2, multi center, open label, dual cohort study to evaluate the efficacy and safety of lorlatinib (PF 06463922) monotherapy in ALK inhibitor treated locally advanced or metastatic ALK positive non small cell lung cancer…
- Trial name
- NCT03909971
- Testing
- Lorlatinib
- Where
- 21 sites in China
- Volunteers
- 109 people
- Sponsor
- Pfizer
Adult, Drug Interactions
Effect of Multiple Doses of Modafinil on the Pharmacokinetics of Single Dose Lorlatinib in Healthy Participants
The primary purpose of the study is to characterize the safety profile of lorlatinib in the presence of a moderate CYP3A4/5 inducer, modafinil.
- Conditions
- Adult, Drug Interactions, Healthy Volunteers, Humans
- Trial name
- NCT03961997
- Testing
- Lorlatinib 50 mg, Lorlatinib 75 mg, Lorlatinib 100 mg
- Where
- Belgium
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Pfizer
Non Small Cell Lung Cancer Metastatic
Lorlatinib After Failure of First-line Second-generation ALK Kinase Inhibitor in Patients With Advanced ALK-positive Non-small Cell Lung Cancer
Crizotinib is a first-generation ALK tyrosine kinase inhibitor (ITK-ALK). It is the standard first-line treatment for patients with advanced NSCLC with ALK gene rearrangement.
- Trial name
- ORAKLE (NCT04111705)
- Testing
- Lorlatinib
- Where
- 32 sites in France
- Volunteers
- 23 people
- Sponsor
- Intergroupe Francophone de Cancerologie Thoracique
Non-Small Cell Lung Cancer
Study to Evaluate Safety, Efficacy, Pharmacokinetics And Pharmacodynamics Of Avelumab In Combination With Either Crizotinib Or PF-06463922 In Patients With NSCLC. (Javelin Lung 101)
The purpose of this study is to evaluate the safety and efficacy of avelumab when combined with either crizotinib or PF-06463922.
- Trial name
- NCT02584634
- Testing
- Avelumab, PF-06463922, Crizotinib
- Where
- 20 sites in United States, Australia and 3 more
- Volunteers
- 43 people
- Sponsor
- Pfizer
Neuroblastoma
Real World Data Collection Pediatric Neuroblastoma Treated With Lorlatinib
The overall goal of this real-world data collection is to assess demographic, clinical characteristics and real-world effectiveness of pediatric neuroblastoma patients treated with lorlatinib through the expanded access program.
- Trial name
- NCT04753658
- Testing
- lorlatinib
- Where
- 11 sites in United States, Australia and 4 more
- Volunteers
- 15 people
- Sponsor
- Pfizer
Carcinoma, Non-Small-Cell Lung
PF-06463922 for Crizotinib Pretreated ROS1 Positive Non-small-cell Lung Cancer
This is a phase II study assessing response rate to PF-06463922 in patients with ROS1 translocation resistant to previous crizotinib therapy.
- Trial name
- PFROST (NCT03439215)
- Testing
- Lorlatinib
- Where
- 20 sites in Italy
- Volunteers
- 20 people
- Sponsor
- Fondazione Ricerca Traslazionale