Clinical trials: ALK Positive Malignancies
ALK-Positive Non-Small Cell Lung Cancer (NSCLC)
Pharmacogenomics IND SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms
Explore the relationship between drug target ALK gene single nucleotide polymorphisms and ALECENSA - Alectinib therapeutic-effects in patients with non-small cell lung cancer, based on Oxford precisely sequencing drug targets'…
- Trial name
- Drugs-SNPs (NCT05987956)
- Testing
- ALECENSA - alectinib hydrochloride capsule
- Where
- 2 sites in United States
- Volunteers
- 600 people
- Sponsor
- Medicine Invention Design, Inc
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
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
Study of TQ-B3139 Versus Crizotinib in the First Line Treatment of Subjects With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC)
To evaluate the efficacy and safety of TQ-B3139 versus crizotinib in subjects with ALK-positive NSCLC that have received one chemotherapy regimen and have not received ALK inhibitor.
- Trial name
- NCT04009317
- Testing
- TQ-B3139, Crizotinib
- Where
- China
- Volunteers
- 260 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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
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
LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer
To compare the efficacy and safety of ceritinib with standard first-line chemotherapy (pemetrexed plus cisplatin or carboplatin) in patients with stage IIIB (not candidates for definitive multimodality therapy) or stage IV…
- Trial name
- NCT01828099
- Testing
- Ceritinib, Pemetrexed, Cisplatin
- Where
- 167 sites in Argentina, Australia and 27 more
- Volunteers
- 376 people
- Sponsor
- Novartis Pharmaceuticals
Non-Small-Cell Lung Cancer, NSCLC
Lorlatinib Continuation Study
The purpose of this protocol is to provide continued treatment access and safety follow-up for eligible participants who continue to derive a benefit from study intervention in the Pfizer sponsored lorlatinib parent studies that…
- Trial name
- NCT05144997
- Testing
- Lorlatinib
- Where
- 27 sites in United States, China and 6 more
- Volunteers
- 76 people
- Sponsor
- Pfizer
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
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.
Mature B-Cell Neoplasm, Non Hodgkin Lymphoma
Study of SGR-1505 in Mature B-Cell Neoplasms
The purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and/or recommended dose (RD) of SGR-1505.
- Conditions
- Mature B-Cell Neoplasm, Non Hodgkin Lymphoma, DLBCL, Waldenstrom Macroglobulinemia
- Trial name
- NCT05544019
- Testing
- SGR-1505
- Where
- 36 sites in United States, France and 6 more
- Volunteers
- 98 people
- Sponsor
- Schrödinger, Inc.
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.
Non-small Cell Lung Cancer (NSCLC)
A Study of Brigatinib as Preferred First Therapy for Adults With Non-Small Cell Lung Cancer (NSCLC) ENTIRETY
This is a study of brigatinib in adults with Non-Small Cell Lung Cancer (NSCLC). The main aim of this study is to learn about the time period in which the condition does not worsen after the participant has received brigatinib.
- Trial name
- ENTIRETY (NCT05735327)
- Testing
- No intervention
- Where
- 12 sites in Poland
- Volunteers
- 50 people
- Sponsor
- Takeda
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.