Clinical trials: ALK-positive Advanced NSCLC
Non-small Cell Lung Cancer (NSCLC), Anaplastic Lymphoma Kinase (ALK) Positive
A Study of Gilteritinib in Adults With Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)
Genes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many types of cancer are caused by changes in certain genes, making them faulty.
- Trial name
- NCT07140016
- Testing
- gilteritinib
- Where
- 17 sites in United States, France and 1 more
- Volunteers
- 40 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Non-Small Cell Lung Cancer
LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib
The primary purpose of the study was to compare the antitumor activity of LDK378 vs. chemotherapy in patients previously treated with chemotherapy (platinum doublet) and crizotinib.
- Trial name
- NCT01828112
- Testing
- Ceritinib, Pemetrexed, Docetaxel
- Where
- 97 sites in United States, Belgium and 18 more
- Volunteers
- 231 people
- Sponsor
- Novartis Pharmaceuticals
Non-Small Cell Lung Cancer, ALK-positive
Study Of Comparing SAF-189s With Crizotinib In First Line ALK-Positive Advanced and Metastatic NSCLC
This randomized, multicenter, Phase III, open-label study will evaluate the efficacy and safety of SAF-189s versus crizotinib treatment in participants with treatment-naive ALK-positive advanced NSCLC.
- Conditions
- Non-Small Cell Lung Cancer, ALK-positive, SAF-189s
- Trial name
- NCT06569420
- Testing
- Drug: Foritinib Succinate, Drug: Crizotinib
- Where
- China
- Volunteers
- 275 people
- Sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Non-Small Cell Lung Cancer
LDK378 in Adult Chinese Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib
A single-Arm, open-label, multi-center, phase I/II study in which the pharmacokinetics, safety, tolerability and efficacy of LDK378 will be assessed in adult Chinese patients with locally advanced or metastatic NSCLC harboring a…
- Trial name
- NCT02040870
- Testing
- LDK378
- Where
- 15 sites in China
- Volunteers
- 103 people
- Sponsor
- Novartis Pharmaceuticals
Non Small Cell Lung Cancer, ALK-positive Non-small Cell Lung Cancer (NSCLC)
Expanded Access Program of Neladalkib (NVL-655) for Patients With Advanced ALK+ NSCLC or Other ALK+ Solid Tumors
The Expanded Access Program will provide an alternate mechanism for patients, who lack satisfactory therapeutic alternatives and cannot participate in a neladalkib clinical trial, to access investigational neladalkib.
- Trial name
- NVL-655-EAP (NCT06834074)
- Testing
- NVL-655
- Where
- 50 sites in United States, Australia and 10 more
- Sponsor
- Nuvalent Inc.
ALK-positive Advanced Tumors
A Phase I, Multi-center, Open Label, Drug-drug Interaction Study to Assess the Effect of Ceritinib on the Pharmacokinetics of Warfarin and Midazolam in Patients With ALK-positive Advanced Tumors
The purpose of this study was to evaluate the potential inhibitory effects of ceritinib on the CYP3A4- and CYP2C9-mediated metabolism of the probe drugs midazolam and warfarin, respectively, when administered simultaneously as a…
- Trial name
- NCT02422589
- Testing
- ceritinib, warfarin, midazolam
- Where
- 11 sites in United States, Denmark and 2 more
- Volunteers
- 33 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.
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.
ALK Positive Non-small Cell Lung Cancer
Lorlatinib as the First-line Treatment in China Advanced ALK+ NSCLC
This phase II study is aim to investigate the efficacy, resistance mechanism, safety profile of first-line lorlatinib in China advanced ALK+ non-small cell lung cancer (NSCLC).
- Trial name
- NCT06092086
- Testing
- Loratinib
- Where
- China
- Volunteers
- 126 people
- Sponsor
- Guangdong Association of Clinical Trials
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.
ALK-positive Non-small Cell Lung Cancer, Real World Study
Real World Study of Lolatinib for Advanced ALK+ NSCLC Patients
This study was a multicenter, prospective, non-interventional clinical study that included first-line and late-line patients with advanced non-small cell lung cancer with ALK fusions treated with the third generation ALK-TKI…
- Trial name
- NCT06361589
- Testing
- Lorlatinib
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Sichuan Cancer Hospital and Research Institute
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-positive Advanced NSCLC Patients, Primary Resistance
Primary Resistance Mechanisms of ALK TKIs
Anaplastic lymphoma kinase (ALK) gene rearrangement is a known oncogenic driver in non-small cell lung cancer (NSCLC). ALK tyrosine kinase inhibitors (TKIs) have been clearly shown to produce excellent therapeutic effects and…
- Conditions
- ALK-positive Advanced NSCLC Patients, Primary Resistance, NGS
- Trial name
- NCT07045610
- Testing
- re-biopsy tumor with primary ALK tKI resistance for NGS
- Where
- Taiwan
- Volunteers
- 20 people
- Sponsor
- National Taiwan University Hospital
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.
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.
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
Neoadjuvant Non-Small Cell Lung Cancer
Lorlatinib Compared with Concurrent/ Sequential Chemoradiotherapy in Stage III ALK Positive Lung Adenocarcinoma
The project is a Phase III, randomized, open-label, multicenter study in which approximately 36 patients with unresectable Stage III ALK positive Lung Adenocarcinoma will be randomized 1:1 to receive lorlatinib or…
- Trial name
- NCT06858410
- Testing
- lorlatinib, concurrent/sequential platinum-based chemoradiotherapy
- Volunteers
- 36 people
- Sponsor
- Guangdong Association of Clinical Trials
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
ALK-positive Advanced NSCLC, ALK-positive Non-small Cell Lung Cancer (NSCLC)
Efficacy and Safety of Ensartinib in Neoadjuvant Therapy for Stage IIA - IIIB (Operable or Potentially Operable) ALK-Positive Lung Adenocarcinoma ：A Multicenter, Real-World Clinical Study
According to the Global Cancer Statistics 2022 report, lung cancer is the most common type of cancer (12.4% of the total) and the leading cause of cancer deaths (18.7% of total cancer deaths).
- Conditions
- ALK-positive Advanced NSCLC, ALK-positive Non-small Cell Lung Cancer (NSCLC), MPR, Neoadjuvant Therapy
- Trial name
- NCT06785584
- Testing
- Ensartinib
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Fujian Medical University Union Hospital
Non-Small Cell Lung Cancer (NSCLC)
Phase I/II Trial of Alectinib and Bevacizumab in Patients With Advanced, Anaplastic Lymphoma Kinase (ALK)-Positive, Non-Small Cell Lung Cancer
This research study is evaluating two drugs, alectinib and bevacizumab, as possible treatments for Advanced Non-Small Cell Lung Cancer (NSCLC).
- Trial name
- NCT02521051
- Testing
- Alectinib, Bevacizumab
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Massachusetts General Hospital