Clinical trials: ALK-positive Advanced Tumors
Non-Small Cell Lung Cancer
A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants
This randomized, active controlled, multicenter phase III open-label study is designed to evaluate the efficacy and safety of alectinib compared with crizotinib treatment in participants with treatment-naive anaplastic lymphoma…
- Trial name
- ALEX (NCT02075840)
- Testing
- Alectinib, Crizotinib
- Where
- 97 sites in United States, Australia and 27 more
- Volunteers
- 303 people
- Sponsor
- Hoffmann-La Roche
Advanced Lung Cancer
Crizotinib and Ganetespib (STA-9090) in ALK Positive Lung Cancers
About 18 patients will take part in the phase 1 portion of the trial. In the beginning of the study, 3 patients will be treated with a low dose of ganetespib (STA-9090) and the standard dose of crizotinib.
- Trial name
- NCT01579994
- Testing
- Ganetespib (STA-9090) and crizotinib
- Where
- 5 sites in United States
- Volunteers
- 13 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Non-small-cell Lung Carcinoma
Phase II Study of SY-3505 in Patients With ALK-positive NSCLC Who Have Failed Prior Second-Generation ALK TKI
This is an open-label, single-arm, multicenter, phase II study to evaluate the efficacy and safety of SY-3505 capsule in patients with locally advanced or metastatic NSCLC who have progressed on or are intolerant to…
- Trial name
- NCT05869162
- Testing
- SY-3505
- Where
- China
- Volunteers
- 153 people
- Sponsor
- Shouyao Holdings (Beijing) Co. LTD
Non-Small Cell Lung Cancer
Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)
Phase 2 Platform Study in Patients with Advanced Non-Small Lung Cancer who progressed on First-Line Osimertinib Therapy. This study is modular in design, allowing evaluation of the efficacy, safety and tolerability of multiple…
- Trial name
- ORCHARD (NCT03944772)
- Testing
- Osimertinib, Savolitinib, Gefitinib
- Where
- 47 sites in United States, Denmark and 7 more
- Volunteers
- 247 people
- Sponsor
- AstraZeneca
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
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
Patients Must Have Histologically or Cytologically Confirmed Locally Advanced or Metastatic NSCLC, EGFR Mutation-negative and ALK Rearrangement-negative
Efficacy and Safety of Ivonescimab Monotherapy as First-Line Treatment for PD-L1-Positive, Driver Gene-Negative, Locally Advanced or Metastatic NSCLC: A Multicenter, Prospective, Real-World Cohort Study
The treatment decisions, assessment schedule, and study procedures in this research will adhere to the routine clinical practice of each participating center.
- Conditions
- Patients Must Have Histologically or Cytologically Confirmed Locally Advanced or Metastatic NSCLC, EGFR Mutation-negative and ALK Rearrangement-negative, Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score of 0 to 2, No Prior Systemic Therapy Received for the Advanced or Metastatic Disease
- Trial name
- PROMISE (NCT07696832)
- Testing
- Ivonescimab Injection
- Where
- China
- Volunteers
- 265 people
- Sponsor
- Guangdong Association of Clinical Trials
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
ALK Positive, NSCLC Stage IIIB
Ensatinib in alK-positive Patients Undergoing Initial Treatment for Advanced Non-small Cell Lung Cancer
The experimental design is exploratory, single-arm, multi-center, real-world research. Ensatinib 225mg qd A prospective and exploratory real-world study of Ensatinib for ALK-positive advanced non-small cell lung cancer patients…
- Conditions
- ALK Positive, NSCLC Stage IIIB, NSCLC Stage IV
- Trial name
- EFLRWR (NCT05132218)
- Testing
- Ensatinib
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Peking University Cancer Hospital & Institute
Locally Advanced Solid Tumors, Metastatic Solid Tumors
Study of Oral RXDX-101 in Adult Patients With Locally Advanced or Metastatic Cancer Targeting NTRK1, NTRK2, NTRK3, ROS1, or ALK Molecular Alterations.
Entrectinib (RXDX-101) is an orally available inhibitor of the tyrosine kinases TrkA (coded by the gene NTRK1), TrkB (coded by the gene NTRK2), TrkC (coded by the gene NTRK3), ROS1 (coded by the gene ROS1), and ALK (coded by the…
- Trial name
- STARTRK-1 (NCT02097810)
- Testing
- Entrectinib
- Where
- 10 sites in United States, South Korea
- Volunteers
- 84 people
- Sponsor
- Hoffmann-La Roche
ALK Positive Non-small Cell Lung Cancer
Lorlatinib Plus Sacituzumab Tirumotecan With Peripheral ctDNA Guidance as First-Line Therapy for ALK Fusion-Positive NSCLC
This investigator-initiated, open-label, prospective Phase II clinical trial, planned to take place across multiple centers in China.
- Trial name
- NCT07750704
- Testing
- Lorlatinib, sacituzumab tirumotecan plus lorlatinib
- Where
- China
- Volunteers
- 153 people
- Sponsor
- Guangdong Association of Clinical Trials
Neoplasms, Colorectal Neoplasms
A Home-Based Approach Study to Evaluate the Efficacy and Safety of Alectinib in Locally-Advanced or Metastatic ALK-Positive Solid Tumors
This study will evaluate the efficacy and safety of alectinib in participants with Anaplastic Lymphoma Kinase (ALK)-positive locally advanced or metastatic solid tumors other than lung cancer.
- Conditions
- Neoplasms, Colorectal Neoplasms, Melanoma, Pancreatic Neoplasms
- Trial name
- ALpha-T (NCT04644315)
- Testing
- Alectinib
- Where
- 29 sites in United States
- Volunteers
- 1 people
- Sponsor
- Hoffmann-La Roche
Advanced Malignancies, Positive for Anaplastic Lymphoma Kinase
Study of an Investigational Drug, ASP3026, in Patients With Advanced Malignancies (Solid Tumors and B-Cell Lymphoma)
This study is to evaluate the safety and anti-tumor activity of ASP3026 in patients with advanced malignancies (solid tumors and B-cell lymphoma).
- Conditions
- Advanced Malignancies, Positive for Anaplastic Lymphoma Kinase, Positive for Proto-Oncogene Tyrosine-Protein Kinase ROS, Solid Tumor
- Trial name
- NCT01284192
- Testing
- ASP3026
- Where
- 6 sites in United States
- Volunteers
- 46 people
- Sponsor
- Astellas Pharma Inc
ALK-positive Advanced NSCLC
A Study of Brigatinib in Participants With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib
The primary purpose of this study is to determine the efficacy of brigatinib by confirmed objective response rate (ORR) by response evaluation criteria in solid tumors (Response Evaluation Criteria in Solid Tumors [RECIST]), in…
- Trial name
- ALTA-2 (NCT03535740)
- Testing
- Brigatinib
- Where
- 80 sites in United States, Australia and 13 more
- Volunteers
- 103 people
- Sponsor
- Ariad Pharmaceuticals
ALK Positive Advanced Malignancies
A Phase 1/2 Study of SY-12321 in Patients With ALK-positive Advanced Malignancies
A phase 1/2 clinical trial to evaluate the safety, tolerability, pharmacokinetic profiles, and preliminary efficacy of SY-12321 in trial participants with ALK-positive advanced malignancies, including non-small cell lung cancer…
- Trial name
- NCT07810933
- Testing
- SY-12321
- Where
- 2 sites in China
- Volunteers
- 330 people
- Sponsor
- Shouyao Holdings (Beijing) Co. LTD
Non-small Cell Lung Cancer, Lung Cancer
ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants
The purpose of the study is to compare the efficacy of brigatinib to that of crizotinib in ALK+ locally advanced or metastatic non-small cell lung cancer (NSCLC) participants naive to ALK inhibitors, as evidenced by…
- Conditions
- Non-small Cell Lung Cancer, Lung Cancer, Advanced Malignancies, Carcinoma
- Trial name
- ALTA-1L (NCT02737501)
- Testing
- Brigatinib, Crizotinib
- Where
- 91 sites in United States, Australia and 17 more
- Volunteers
- 275 people
- Sponsor
- Ariad Pharmaceuticals
Non-small Cell Lung Cancer
Alectinib Versus Pemetrexed or Docetaxel in Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Participants Previously Treated With Platinum-Based Chemotherapy and Crizotinib
This randomized active-controlled multicenter Phase III open-label study will evaluate and compare between treatment groups the efficacy of alectinib versus chemotherapy in participants with ALK-positive advanced NSCLC who were…
- Trial name
- NCT02604342
- Testing
- Alectinib, Docetaxel, Pemetrexed
- Where
- 54 sites in Belgium, Bulgaria and 13 more
- Volunteers
- 119 people
- Sponsor
- Hoffmann-La Roche
Advanced Cancer, Advanced Solid Tumor
A Phase I/II Clinical Study of SAF-189s in Non-small Cell Lung Cancer (NSCLC) Patients
The study comprises two phases: phase I dose escalation (including PK run-in period and treatment period) and phase II study.
- Conditions
- Advanced Cancer, Advanced Solid Tumor, Lung Cancer, Nonsmall Cell
- Trial name
- NCT04237805
- Testing
- SAF-189s
- Where
- 41 sites in China
- Volunteers
- 280 people
- Sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
ALK or ROS1-positive NSCLC
Long Term Safety Observation of Crizotinib in Chinese NSCLC Population
This study is to allow access to crizotinib who were treated in previous Pfizer-sponsored studies in China.
- Trial name
- NCT03672643
- Testing
- Crizotinib
- Where
- 14 sites in China
- Volunteers
- 41 people
- Sponsor
- Pfizer
Advanced Solid Tumors
A Study of TAS-116 in Patients With Solid Tumors
A First-in-Human (FIH) study of TAS-116 in patients with advanced solid tumors was first initiated in Japan in April 2014 and has been ongoing since then. The study consists of a dose escalation phase and a dose expansion phase.
- Trial name
- NCT02965885
- Testing
- TAS-116
- Where
- 12 sites in United States, Italy and 1 more
- Volunteers
- 31 people
- Sponsor
- Taiho Oncology, Inc.