Clinical trials: ALK Positive
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
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
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
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
Lung Cancer, Nonsmall Cell, Brain Metastases
X-396 (Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases
To assess efficacy and safety of oral X-396 (Ensartinib) capsule in Chinese ALK-positive NSCLC patients with brain metastases, eligible patients will be enrolled with objective responses being primary outcome measures.
- Trial name
- NCT04415320
- Testing
- X-396(Ensartinib)
- Where
- China
- Volunteers
- 37 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
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.
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
Non-small Cell Lung Cancer
A Study to Evaluate and Compare the Efficacy and Safety of XZP-3621 Versus Crizotinib
This randomized, multicenter, Phase III, open-label study will evaluate the efficacy and safety of XZP-3621 versus crizotinib and to evaluate the pharmacokinetics of XZP-3621 in Chinese participants with treatment-naive…
- Trial name
- NCT05204628
- Testing
- XZP-3621, Crizotinib
- Where
- China
- Volunteers
- 238 people
- Sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
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.
ALK-positive NSCLC
A Study of XZP-3621 in Chinese Patients With ALK Positive NSCLC
This was a single-arm, open-label, multicenter, phase II study to evaluate the efficacy and safety of the ALK inhibitor XZP-3621 when used as single agent in patients with ALK-rearranged stage IIIB, IIIC or IV NSCLC previously…
- Trial name
- NCT05482087
- Testing
- XZP-3621
- Where
- China
- Volunteers
- 190 people
- Sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
Non-small Cell Lung Cancer, Anaplastic Lymphoma Kinase-positive
Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic…
- Trial name
- ALKAZAR (NCT06765109)
- Testing
- Neladalkib (NVL-655), Alectinib
- Where
- 159 sites in United States, Argentina and 27 more
- Volunteers
- 450 people
- Sponsor
- Nuvalent Inc.
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
Anaplastic Lymphoma Kinase Positive (ALK +) Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors
Pharmacokinetics, Safety, and Efficacy of Brigatinib Monotherapy in Pediatric and Young Adult Participants With ALK+ Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors or Other Solid Tumors
The purpose of this study is to estimate the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) regimen and characterize the pharmacokinetics (PK) of brigatinib monotherapy (film-coated tablets and age-appropriate…
- Conditions
- Anaplastic Lymphoma Kinase Positive (ALK +) Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors, Solid Tumors
- Trial name
- NCT04260009
- Testing
- Brigatinib, Brigatinib AAF
- Sponsor
- Takeda
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
Neoplasms
A Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer
The purpose of this study is to provide continued treatment with alectinib or crizotinib as applicable to participants with ALK- or RET positive cancer who were previously enrolled in any Roche-sponsored alectinib study and who…
- Trial name
- NCT03194893
- Testing
- Alectinib, Crizotinib
- Where
- 29 sites in United States, France and 7 more
- Volunteers
- 50 people
- Sponsor
- Hoffmann-La Roche
Non-small Cell Lung Cancer
eXalt3: Study Comparing X-396 (Ensartinib) 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 X-396 (ensartinib) vs. crizotinib in patients with ALK-positive non-small cell lung cancer that have received up to 1 prior chemotherapy regimen and no…
- Trial name
- NCT02767804
- Testing
- X-396 (ensartinib), crizotinib
- Where
- 72 sites in United States, Argentina and 18 more
- Volunteers
- 290 people
- Sponsor
- Xcovery Holdings, Inc.
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, 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