Clinical trials: ALK-positive Non-small-cell Lung Cancer
Non-small Cell Lung Cancer
TGRX-326 Chinese Phase I for Advanced Non-small Cell Lung Cancer (NSCLC)
This trial is a multi-center, single-arm, open-label, Phase I clinical trial in 3 phases: dose escalation phase, dose expansion phase and indication expansion phase, which will explore the safety, tolerability, PK and preliminary…
- Trial name
- NCT05441956
- Testing
- TGRX-326
- Where
- China
- Volunteers
- 198 people
- Sponsor
- Shenzhen TargetRx Co., Ltd.
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 Cancer, Lung Cancer
An Expanded Access Study of Brigatinib for Patients With ALK-positive Advanced Non-Small Cell Lung Cancer
The purpose of this study is to provide brigatinib for those patients with locally advanced and/or metastatic patients with ALK+ NSCLC on an expanded access basis due to their inability to meet eligibility criteria for on-going…
- Conditions
- Non-small Cell Lung Cancer, Lung Cancer, Advanced Malignancies, Carcinoma
- Trial name
- NCT02784158
- Testing
- Brigatinib
- Where
- 3 sites in United States
- Sponsor
- Ariad Pharmaceuticals
Alk-positive Non-Small Cell Lung Cancer, ALK-inhibitor Treated
ALK Digital Pathology Outcome Predition, Multi Institutional, Restrospective Study
The Goal of this observational study is to develop an AI-driven pathologic image analysis-based classifier that can identify patients unlikely to significantly benefit from the currently utilized first-line ALK inhibitors…
- Trial name
- ALKDigPath (NCT06846736)
- Where
- Israel
- Volunteers
- 200 people
- Sponsor
- Sheba Medical Center
Non-small Cell Lung Cancer
Study Comparing WX-0593 to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients
The primary purpose of this study is to evaluate the efficacy and safety of WX-0593 vs. crizotinib in patients with ALK-positive non-small cell lung cancer who had not received prior systemic therapy
- Trial name
- NCT04632758
- Testing
- WX-0593 Tablets, crizotinib
- Where
- China
- Volunteers
- 292 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Advanced Solid Tumors, Non-small Cell Lung Cancer
Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer
This is the first human study to use X-396 (ensartinib), a drug being developed for treatment of advanced cancers. The initial purpose of the study is to determine the largest amount of X-396 that can be safely given to humans…
- Trial name
- NCT01625234
- Testing
- Phase I: X-396 (ensartinib), Phase II: X-396 (ensartinib)
- Where
- 14 sites in United States
- Volunteers
- 131 people
- Sponsor
- Xcovery Holdings, Inc.
Non-small Cell Lung Cancer, ALK-Positive Lung Cancer
Plasma Molecular Profiling in ALK Inhibitor Resistant NSCLC
The investigators plan to understand a comprehensive molecular profiling via the plasma, with the primary aim of using this form on analysis to guide subsequent treatment selection.
- Trial name
- NCT04087473
- Where
- 5 sites in Hong Kong, Malaysia and 2 more
- Volunteers
- 50 people
- Sponsor
- National Cancer Centre, Singapore
Non-small Cell Lung Cancer Metastatic
Study to Evaluate Real-world Pharmacoeconomics of Crizotinib in NSCLC Patients
This is a phase IV multicenter trial to evaluate the pharmacoeconomic (PE) impact of crizotinib and its companion diagnostic test used in a real-life setting in advanced ALK-positive non-small cell lung cancer (NSCLC) patients.
- Trial name
- NCT02228421
- Where
- 3 sites in Canada
- Volunteers
- 29 people
- Sponsor
- PeriPharm
Non-small Cell Lung Cancer
Study of Safety and Efficacy of LEE011 and Ceritinib in Patients With ALK-positive Non-small Cell Lung Cancer.
This was a Phase Ib/II study of the ALK inhibitor ceritinib in combination with the CDK4/6 inhibitor LEE011 in patients with ALK-positive non-small cell lung cancer.
- Trial name
- NCT02292550
- Testing
- Ribociclib, Ceritinib
- Where
- 8 sites in United States, France and 4 more
- Volunteers
- 27 people
- Sponsor
- Novartis Pharmaceuticals
Non Small Cell Lung Cancer, ALK Gene Mutation
Study of Safety and Efficacy of Brigatinib Plus Chemotherapy or Brigatinib Only in Advanced ALK-Positive Lung Cancer (MASTERPROTOCOL ALK)
This is a phase II randomized, open-labelled, non-comparative multicenter study in which ALK+ NSCLC patients who are naïve of treatment for advanced disease will be randomized to receive brigatinib monotherapy (Arm A) or…
- Trial name
- MP-ALK (NCT05200481)
- Testing
- Brigatinib 180 MG, Carboplatin, Pemetrexed
- Where
- 29 sites in France
- Volunteers
- 110 people
- Sponsor
- Intergroupe Francophone de Cancerologie Thoracique
ALK-positive Non-small Cell Lung Cancer
A Phase II Study to Evaluate the Efficacy and Safety of Oral Ceritinib in Patients With ALK-positive NSCLC Metastatic to the Brain and/or to Leptomeninges
This was a phase II, multi-center, open-label, five-arm study in which the efficacy and safety of oral ceritinib treatment was assessed in patients with NSCLC metastatic to the brain and/or to leptomeninges harboring a confirmed…
- Trial name
- Ascend-7 (NCT02336451)
- Testing
- Ceritinib
- Where
- 57 sites in United States, Australia and 15 more
- Volunteers
- 156 people
- Sponsor
- Novartis Pharmaceuticals
Mediastinal Lymphadenopathy, Hilar Lymphadenopathy
Endobronchial Ultrasound Needle Aspiration With and Without Suction
The main purpose of the present study is to compare the diagnostic yield of different aspiration techniques in Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) in the diagnosis of hilar/mediastinal adenopathy
- Conditions
- Mediastinal Lymphadenopathy, Hilar Lymphadenopathy, Lymphoma, Lung Neoplasms
- Trial name
- NCT05110950
- Testing
- No suction EBUS-TBNA, Passive suction through dedicated EBUS-TBNA syringe, Manual applied suction EBUS-TBNA through a pistol-grip syringe holder
- Where
- Italy
- Volunteers
- 306 people
- Sponsor
- Università Politecnica delle Marche
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
NSCLC Stage IV
Alectinib-induced Endocrine Toxicity
The experimental Cohort A (male ALK+ ANSCLC patients receiving alectinib), the control Cohort B (female ALK+ ANSCLC patients receiving alectinib) and control Cohort C (male NON-ALK ANSCLC patients) were prospectively evaluated…
- Trial name
- TOSS-ALK (NCT06339554)
- Testing
- Alectinib 150 MG [Alecensa]
- Where
- Italy
- Volunteers
- 98 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lung Neoplasms
A Study of SHR-1210 in Combination With BP102 in Subjects With Non-squamous NSCLC
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is a Phase II, multicenter, open-label study designed to evaluate the safety and efficacy of SHR-1210 with BP102 in subjects who are chemotherapy naive and have…
- Trial name
- NCT03666728
- Testing
- SHR-1210, BP102
- Where
- China
- Volunteers
- 5 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Carcinoma, Advanced ALK+ or ROS1+Non-Small-Cell Lung, Neoplasm, Advanced ALK+ or ROS1+Solid Tumors
A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate, Midazolam, in Participants With ALK-Positive or ROS1-Positive Solid Tumors
The purpose of this study is to characterize the effect of repeat-dose administration of brigatinib 180 milligram (mg) once daily (QD) on the single-dose pharmacokinetics (PK) of midazolam.
- Trial name
- NCT03420742
- Testing
- Midazolam, Brigatinib
- Where
- 14 sites in France, Italy and 2 more
- Volunteers
- 24 people
- Sponsor
- Takeda
Non Small Cell Lung Cancer
TGRX-326 Chinese Phase III for Advanced Non-small Cell Lung Cancer (NSCLC)
This is a multi-center, randomized, open-label, Phase III clinical trial which compares the safety and efficacy of TGRX-326 with crizotinib in patients with ALK-positive advanced or metastatic NSCLC
- Trial name
- NCT06082635
- Testing
- TGRX-326, Crizotinib
- Where
- China
- Volunteers
- 321 people
- Sponsor
- Shenzhen TargetRx Co., Ltd.
Carcinoma, Non-Small-Cell Lung
Cerebrospinal Fluid Immune Microenvironment Mechanism in Anaplastic Lymphoma Kinase Positive Lung Cancer Patients
This is an an interventional study to explore the mechanism of cerebrospinal fluid immune microenvironment in patients with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer with brain metastases…
- Trial name
- NCT06697990
- Testing
- Iruplinalib
- Volunteers
- 12 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
Gilteritinib for the Treatment of ALK NSCLC
This phase I trial is studying the safety, side effects, and best dose of gilteritinib in treating patients with stage IV ALK positive non-small cell lung cancer (NSCLC) who have progressed on other treatments.
- Trial name
- NCT06225427
- Testing
- Biopsy, Biospecimen Collection, Computed Tomography
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- University of Michigan Rogel Cancer Center
Non-Small Cell Lung Cancer
Phase I Study of a Selective ALK Inhibitor PLB1003 in Patients With ALK+ NSCLC.
This phase I, first-in-human dose-escalation study was conducted to determine the maximum tolerated dose (MTD), recommended phase II dose (RP2D), dose-limiting toxicities (DLTs), pharmacokinetics (PK) profile, and preliminary…
- Trial name
- NCT03130881
- Testing
- PLB1003
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Beijing Pearl Biotechnology Limited Liability Company