Clinical trials: ALK Positive Malignancies
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
Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive
Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers
This phase II trial studies how well talimogene laherparepvec and nivolumab work in treating patients with lymphomas that do not responded to treatment (refractory) or non-melanoma skin cancers that have spread to other places in…
- Conditions
- Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Apocrine Carcinoma, Carcinoma Arising From Cylindroma
- Trial name
- NCT02978625
- Testing
- Biopsy Procedure, Biospecimen Collection, Computed Tomography
- Where
- 36 sites in United States
- Volunteers
- 68 people
- Sponsor
- National Cancer Institute (NCI)
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
ALK Positive Malignancies
Roll-over Study to Allow Access to Certinib (LDK378) for Patients Who Are on Ceritinib Treatment in a Novartis-sponsored Study
The rollover study will provide ceritinib to patients who are currently receiving treatment with ceritinib within a Novartis-sponsored study and in the opinion of the investigator, would benefit from continued treatment with…
- Trial name
- NCT02584933
- Testing
- ceritinib
- Where
- 71 sites in United States, Australia and 19 more
- Volunteers
- 233 people
- Sponsor
- Novartis Pharmaceuticals
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
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
This phase II trial studies the side effects and how well brentuximab vedotin and combination chemotherapy work in treating patients with CD30-positive peripheral T-cell lymphoma.
- Conditions
- Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative, Anaplastic Large Cell Lymphoma, ALK-Positive, Angioimmunoblastic T-Cell Lymphoma
- Trial name
- NCT03113500
- Testing
- Brentuximab Vedotin, Cyclophosphamide, Doxorubicin
- Where
- 5 sites in United States, Canada
- Volunteers
- 48 people
- Sponsor
- City of Hope Medical Center
Anaplastic Lymphoma Kinase-positive Non-small Cell Lung Cancer
A Study to Evaluate and Compare the Efficacy and Safety of Alectinib Versus Crizotinib and to Evaluate the Pharmacokinetics of Alectinib in Asian Participants With Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC)
This randomized, multicenter, Phase III, open-label study will evaluate the efficacy and safety of alectinib versus crizotinib and to evaluate the pharmacokinetics of alectinib in asian participants with treatment-naive…
- Trial name
- NCT02838420
- Testing
- Alectinib, Crizotinib
- Where
- 19 sites in China, South Korea and 1 more
- Volunteers
- 187 people
- Sponsor
- Hoffmann-La Roche
Solid Tumor
PF-07284892 in Participants With Advanced Solid Tumors
The purpose of this first-in-patient, open label study is to determine the maximum tolerated dose and/or recommended dose for further study of PF-07284892 as a single agent and in combination with lorlatinib, encorafenib and…
- Trial name
- NCT04800822
- Testing
- PF-07284892, lorlatinib, binimetinib
- Where
- 11 sites in United States
- Volunteers
- 53 people
- Sponsor
- Pfizer
Lung Non-Squamous Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer
This National Cancer Institute (NCI)-NRG ALK Protocol phase II trial studies how well a combination of different biomarker/ALK inhibitors work in treating patients with stage IV ALK positive non-squamous non-small cell lung…
- Conditions
- Lung Non-Squamous Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8
- Trial name
- NCT03737994
- Testing
- Alectinib, Brigatinib, Carboplatin
- Where
- 491 sites in United States
- Volunteers
- 10 people
- Sponsor
- National Cancer Institute (NCI)
Cholangiocarcinoma
A Phase II Trial of LDK378 in ROS1 and /or ALK Over-expressed Advanced Intrahepatic or Hilar Cholangiocarcinoma
Primary objective: To investigate the objective response rate in patients with ROS1 or ALK over-expressed locally advanced, or metastatic intrahepatic or hilar cholangiocarcinoma receiving LDK378 Secondary objectives:The…
- Trial name
- NCT02374489
- Testing
- LDK378
- Where
- 2 sites in Taiwan
- Volunteers
- 9 people
- Sponsor
- National Health Research Institutes, Taiwan
Non Squamous Lung Cancer
A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung
This study will evaluate the anti-cancer effects of crizotinib when compared with standard chemotherapy in patients with ALK positive lung cancer.
- Trial name
- PROFILE 1014 (NCT01154140)
- Testing
- treatment
- Where
- 249 sites in United States, Australia and 29 more
- Volunteers
- 343 people
- Sponsor
- Pfizer
ALK, NSCLC
Neoadjuvant Iruplinalkib and Bevacizumab in ALK-positive NSCLC: A Phase II Single-arm Trial
This is a single-center, single-arm, prospective phase II trial evaluating iruplinalkib plus bevacizumab as neoadjuvant therapy in ALK-positive NSCLC.
- Conditions
- ALK, NSCLC, Neoadjuvant Therapy
- Trial name
- NCT07870733
- Testing
- Bevacizumab combined with iruplinalkib as neoadjuvant therapy in ALK-positive NSCLC:
- Volunteers
- 40 people
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
Solid Tumor, Non-Small Cell Lung Cancer Metastatic
Ensartinib in Non-small Cell Lung Cancer Patients With Positive ALK
This study is aimed to determine the maximum tolerated dose of ensartinib, an oral ALK inhibitor in Chinese patients with ALK-positive non-small cell lung cancer
- Trial name
- NCT02959619
- Testing
- Ensartinib
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Non-Small Cell Lung Cancer
Neoadjuvant Ensartinib in ALK Positive Resectable Stage II to III Non-Small Cell Lung Cancer
This single-arm, prospective, multicenter, phase II study is designed to evaluate the efficacy and safety of ensartinib as neoadjuvant treatment in ALK positive, resectable for stage II to III non-small cell lung cancer patients.
- Trial name
- NCT06779539
- Testing
- Ensartinib
- Volunteers
- 33 people
- Sponsor
- West China Hospital