Clinical trials: ALK Positive Malignancies
Carcinoma, Non-Small-Cell Lung
A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer
This randomized, active-controlled, multicenter, open-label, Phase III study is designed to investigate the efficacy and safety of alectinib compared with platinum-based in the adjuvant setting.
- Trial name
- NCT03456076
- Testing
- Alectnib, Cisplatin, Vinorelbine
- Where
- 114 sites in United States, Australia and 25 more
- Volunteers
- 257 people
- Sponsor
- Hoffmann-La Roche
Non Small Cell Lung Cancer, ROS1 Proto Oncogene
Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC
To assess treatment effectiveness and safety of oral crizotinib administered to East Asian patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that is confirmed to be positive for a ROS1 positive gene mutation…
- Conditions
- Non Small Cell Lung Cancer, ROS1 Proto Oncogene, Crizotinib
- Trial name
- NCT01945021
- Testing
- Crizotinib
- Where
- 44 sites in China, Japan and 2 more
- Volunteers
- 129 people
- Sponsor
- Pfizer
Advanced Solid Tumor, Non-small Cell Lung Cancer
A Study Evaluates the Safety, Pharmacokinetics and Efficacy of WX-0593 in Advanced Solid Tumor Patients
The purpose of the study is to evaluate safety, pharmacokinetics and efficacy of WX-0593 alone in the treatment of advanced cancer.
- Trial name
- NCT03389815
- Testing
- WX-0593 Tablets
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Carcinoma, Non-Small-Cell Lung
A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC
A phase 3 study to demonstrate whether lorlatinib given as monotherapy is superior to crizotinib alone in prolonging the progression-free survival in advanced ALK-positive NSCLC patients who are treatment naïve and to compare…
- Trial name
- NCT03052608
- Testing
- Lorlatinib, Crizotinib
- Where
- 166 sites in United States, Argentina and 21 more
- Volunteers
- 296 people
- Sponsor
- Pfizer
Non Small Cell Lung Cancer ALK Positive or ROS1 Positive
Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive
This expanded access study has being designed following a demand from the FDA, given the increase in the number of request for single patient INDs for lorlatinib
- Trial name
- NCT03178071
- Testing
- Lorlatinib
- Where
- 49 sites in United States
- Sponsor
- Pfizer
NSCLC (Non-small Cell Lung Cancer)
A Study Of Crizotinib Versus Chemotherapy In Previously Untreated ALK Positive East Asian Non-Small Cell Lung Cancer Patients
This is a Phase III, Randomized, Open-label, Efficacy and Safety Study of Crizotinib single agent versus Chemotherapy Regimens (Pemetrexed/Cisplatin or Pemetrexed/Carboplatin) in First-Line ALK (Anaplastic Lymphoma Kinase)…
- Trial name
- NCT01639001
- Testing
- Crizotinib, Pemetrexed/Cisplatin, Pemetrexed/Carboplatin
- Where
- 47 sites in China, Hong Kong and 3 more
- Volunteers
- 207 people
- Sponsor
- Pfizer
Neoplasms Malignant
Studying An Investigational Drug Crizotinib (PF-02341066) In Non Non-Small Cell Lung Cancer Tumors That Are Positive For Anaplastic Lymphoma Kinase (ALK)
This is a Phase 1 trial evaluating the safety and efficacy of crizotinib in patients with tumors except non-small cell lung cancer that are positive for ALK.
- Trial name
- NCT01121588
- Testing
- Crizotinib
- Where
- 21 sites in United States, China and 5 more
- Volunteers
- 44 people
- Sponsor
- Pfizer
ALK+ Advanced NSCLC
A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer
Brigatinib is a medicine that binds to the surface of tumor cells in some cancers and delivers a dose of chemotherapy directly to the tumor.
- Trial name
- ALTA-3 (NCT03596866)
- Testing
- Brigatinib, Alectinib
- Where
- 114 sites in United States, Argentina and 18 more
- Volunteers
- 248 people
- Sponsor
- Takeda
Non-Small Cell Lung Cancer, ALK Gene Rearrangement Positive
Expanded Access to Ensartinib for Participants With ALK+ NSCLC
This is an open-label, multicenter, intermediate-sized expanded access treatment protocol to the existing IND 111,695 for ensartinib (X-396).
- Trial name
- NCT04146571
- Testing
- Ensartinib
- Where
- 4 sites in United States
- Sponsor
- Xcovery Holdings, Inc.
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, 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
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.
T Lymphoblastic Leukemia/Lymphoma, Extramedullary NK-T-cell Lymphoma, Nasal Type
CD7-CART in the Treatment of r / r CD7 Positive Hemolymph System Malignancies on Increasing Dose and Open Label Study
Phase I was a single arm, open label, dose increasing study to explore the safety, tolerance and Cytodynamic characteristics of the drug, and to preliminarily observe the efficacy of the study drug in relapsed / refractory CD7…
- Conditions
- T Lymphoblastic Leukemia/Lymphoma, Extramedullary NK-T-cell Lymphoma, Nasal Type, Peripheral T-cell Lymphoma, Nonspecific, Angioimmunoblastic T-cell Lymphoma
- Trial name
- NCT04480788
- Testing
- T cell injection targeting CD7 chimeric antigen receptor
- Where
- China
- Volunteers
- 9 people
- Sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
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
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
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.
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