Clinical trials: Alk-positive Non-Small Cell Lung Cancer
ALK Fusion Protein Expression, Adjuvant Therapy
A Study Comparing Ensatinib Versus Platinum-Based Chemotherapy as Adjuvant Treatment for Stage II-IIIA ALK -Positive Non-Small Cell Lung Cancer
This randomized, active-controlled, multicenter, open-label, Phase II study is designed to evaluate the efficacy and safety of ensatinib compared with Platinum-Based Chemotherapy as adjuvant treatment in ALK fusion positive…
- Conditions
- ALK Fusion Protein Expression, Adjuvant Therapy, Non-Small Cell Lung Cancer
- Trial name
- NCT05186506
- Testing
- Ensatinib, chemotherapy
- Volunteers
- 152 people
- Sponsor
- Sichuan University
Non-Small Cell Lung Cancer
Pharmacokinetic and Safety Study of Lower Doses of Ceritinib Taken With a Low-fat Meal Versus 750 mg of Ceritinib in the Fasted State in Adult Patients With (ALK-positive) Metastatic Non-small Cell Lung Cancer (NSCLC)
A Phase I study to assess the systemic exposure, effiacy, and safety of 450 mg ceritinib taken with a low-fat meal and 600 mg ceritinib taken with a low-fat meal as compared with that of 750 mg ceritinib taken in the fasted state…
- Trial name
- NCT02299505
- Testing
- ceritinib
- Where
- 73 sites in United States, Australia and 22 more
- Volunteers
- 306 people
- Sponsor
- Novartis Pharmaceuticals
Non-Small Cell Lung Cancer
A Clinical Study Testing The Safety And Efficacy Of Crizotinib In East Asian Patients With Anaplastic Lymphoma Kinase (ALK) Positive Advanced Non-Small Cell Lung Cancer
This is an open-label multi-center Phase 2 efficacy and safety study of crizotinib in East Asian patients with advanced Non-Squamous NSCLC harboring a translocation or inversion event involving the ALK gene locus who have…
- Trial name
- NCT01500824
- Testing
- Crizotinib
- Sponsor
- Pfizer
Non Small Cell Lung Cancer
A Study of Ganetespib in Subjects With ALK-Positive Non-Small-Cell Lung Cancer (NSCLC)
Phase 2 study of subjects with ALK positive, advanced NSCLC who have failed up to 3 prior therapies. The study will take place globally at multiple study centers.
- Trial name
- CHIARA (NCT01562015)
- Testing
- Ganetespib
- Where
- 5 sites in United States, Canada
- Volunteers
- 12 people
- Sponsor
- Synta Pharmaceuticals Corp.
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-positive NSCLC
Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer
This is an open label multi center trial to determine the safety and efficacy of ceritinib in combination with nivolumab in ALK-positive NSCLC patients
- Trial name
- NCT02393625
- Testing
- Ceritinib (LDK378), Nivolumab
- Where
- 12 sites in United States, Australia and 6 more
- Volunteers
- 57 people
- Sponsor
- Novartis Pharmaceuticals
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.
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
ALK-positive Advanced NSCLC
Crizotinib Plus Pembrolizumab In Alk-Positive Advanced Non Small Cell Lung Cancer Patients
The purpose of this study has 2 phases, a Dose Finding Phase will determine the maximum tolerated dose . The Dose Expansion Phase will explore the safety, tolerability, and anti-tumor activity of the combination.
- Trial name
- NCT02511184
- Testing
- Crizotinib, Pembrolizumab
- Where
- 15 sites in United States
- Volunteers
- 9 people
- Sponsor
- Pfizer
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
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.
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.
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.
Immunotherapy, Chemotherapy
Clinical Study of Chemotherapy and Immunotherapy Combined With Lactobacillus Johnsonii in Patients With Multiple Irresectable Solid Tumors
This study plans to enroll 156 patients aged 18-75, who will be randomly divided into two groups to evaluate the clinical efficacy and safety of chemotherapy and immune therapy combined with Lactobacillus johnsonii in patients…
- Trial name
- NCT07191405
- Testing
- oral Lactobacillus johnsonii (1×10¹¹ CFU, twice daily)
- Volunteers
- 156 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
ALK Positive Non-small Cell Lung Cancer
AQUA07 in Patients With ALK-Positive Non-Small Cell Lung Cancer
This is a first-in-human, Phase I, open-label, multicenter, multinational study, designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of AQUA07 when administered as…
- Trial name
- NCT07617337
- Testing
- AQUA07, Lorlatinib
- Where
- 7 sites in United States, Japan
- Volunteers
- 102 people
- Sponsor
- Chugai Pharmaceutical
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
Study of Lorlatinib In People With ALK-positive Non-small Cell Lung Cancer
The purpose of this clinical trial is to learn whether the study medicine (called lorlatinib) is safe and effective for the treatment of non-small cell lung cancer that is caused by an abnormal anaplastic lymphoma kinase (ALK)…
- Trial name
- NCT04362072
- Testing
- Lorlatinib
- Where
- 31 sites in United States, India and 5 more
- Volunteers
- 71 people
- Sponsor
- Pfizer
The Diagnosis Was ALK Positive NSCLC, Second Generation ALK-TKI is Resistant
Ensatinib Treat Second-generation ALK-TKI Resistance After Second-generation ALK-TKI Resistance
After the use of second-generation ALK-TKI drug resistance, about 50% of tissue biopsies showed mutations in the ALK kinase domain, and appropriate ALK-TKI could be selected according to different mutation sites .Phase I/II…
- Conditions
- The Diagnosis Was ALK Positive NSCLC, Second Generation ALK-TKI is Resistant, Efficacy of Ensatinib in This Subset of Patients
- Trial name
- ERSGATR (NCT05178511)
- Testing
- Ensartinib
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Li Zhang, MD
Non-small Cell Lung Cancer
Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC)
This is a phase I/II study of ceritinib and trametinib in Stage IIIB or IV anaplastic lymphoma kinase (ALK) rearranged non-small cell lung cancer (NSCLC).
- Trial name
- NCT03087448
- Testing
- Ceritinib, Trametinib
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- University of California, San Francisco
ALK Positive, Locally Advanced Malignant Solid Neoplasm
Ceritinib and Everolimus in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIB-IV Non-small Cell Lung Cancer
This phase I trial studies the side effects and best dose of ceritinib and everolimus in treating patients with solid tumors that have spread from where they started to nearby tissue or lymph nodes (locally advanced) or to other…
- Conditions
- ALK Positive, Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, ROS1 Gene Rearrangement
- Trial name
- NCT02321501
- Testing
- Ceritinib, Everolimus, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- M.D. Anderson Cancer Center