Clinical trials: ALK-positive Advanced Tumors
Non-small Cell Lung Cancer
A Study Of SY-3505 Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC
A phase 3 study to evaluate the efficacy and safety of SY-3505 vs. crizotinib in patients with ALK-positive non-small cell lung cancer who had not received prior systemic therapy.
- Trial name
- NCT06254599
- Testing
- SY-3505 Capsules, Crizotinib Capsules
- Where
- China
- Volunteers
- 255 people
- Sponsor
- Shouyao Holdings (Beijing) Co. LTD
ALK-positive, Locally Advanced or Metastatic (TNM Stage IIIB-IV) Non-small Cell Lung Cancer That Has Developed Resistance to Prior Treatment With Lorlatinib
Efficacy and Safety of Ensartinib Combined With Anlotinib in Lorlatinib-Resistant ALK-Positive NSCLC
ALK TKIs, particularly second- and third-generation ALK TKIs, have significantly improved progression-free survival (PFS) in patients with advanced ALK-positive non-small cell lung cancer (NSCLC).
- Trial name
- NCT07671560
- Testing
- Combined group of ensatinib and arotinib
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Qiming Wang
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
Carcinoma, Non-Small-Cell Lung, Anaplastic Lymphoma Kinase I1171N
A Real World Study of Ensartinib in Advanced ALK-positive NSCLC
The primary objective of this study is to evaluate the efficacy and safety of Ensartinib in advanced ALK-positive non-small cell lung cancer, and the mechanisms of population pharmacokinetics and resistance to Ensartinib.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Anaplastic Lymphoma Kinase I1171N, Ensartinib
- Trial name
- NCT05498064
- Testing
- Ensartinib
- Where
- China
- Volunteers
- 490 people
- Sponsor
- Peking Union Medical College Hospital
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
Ensartinib in Combination With Bevacizumab in ALK-positive NSCLC Patients With TP53 Mutation
This is a prospective, single-arm, multicenter, phase II study to investigate the efficacy and safety of Ensartinib plus Bevacizumab in metastatic anaplastic lymphoma kinase (ALK)-rearranged Non-Small Cell Lung Cancer (NSCLC)…
- Trial name
- EAGLE (NCT05491811)
- Testing
- Ensartinib, Bevacizumab
- Where
- China
- Volunteers
- 47 people
- Sponsor
- Sun Yat-sen University
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
Non-small Cell Lung Cancer
Brigatinib Plus Chemotherapy or Local Consolidation Therapy in ALK Positive Advanced Non-small Cell Lung Cancer (BrightStar-2)
The goal of this clinical research study is to learn if the combination of brigatinib and either local consolidation therapy (such as radiotherapy or surgery) or chemotherapy (pemetrexed and carboplatin) can help to control the…
- Trial name
- NCT06522360
- Testing
- Brigatinib, Carboplatin, Pemetrexed
- Sponsor
- M.D. Anderson Cancer Center
ALK Gene Rearrangement Positive, Non-Squamous Non-Small Cell Neoplasm of Lung
Alectinib in Combination With Bevacizumab in ALK Positive NSCLC
This single-arm, open-label, phase II clinical study aims to evaluate the progression-Free Survival (PFS) of the combination of Alectinib plus Bevacizumab in untreated and first and second-line chemotherapy failed subjects with…
- Trial name
- NCT03779191
- Testing
- Alectinib, Bevacizumab
- Where
- Mexico
- Volunteers
- 41 people
- Sponsor
- Instituto Nacional de Cancerologia de Mexico
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
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
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 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, 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
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.