Clinical trials: ALK Positive Malignancies, open to volunteers
ALK Positive, Ensartinib
A Multicenter Real-world Clinical Study on the Efficacy and Safety of Ensartinib As Neoadjuvant Treatment for Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer (NSCLC) Patients.
Explore the efficacy and safety of Ensartinib in neoadjuvant treatment for ALK-positive non-small cell lung cancer in the real world.This is a real-world study of patients receiving enshatinib-based neoadjuvant therapy with R0…
- Conditions
- ALK Positive, Ensartinib, NSCLC, Neoadjuvant Therapy
- Trial name
- NCT06736561
- Volunteers
- 100 people
- Sponsor
- Harbin Medical University
Non-Small Cell Lung Cancer(NSCLC)
Neoadjuvant WX-0593 in Resectable ALK-positive or ROS1-positive Non-small Cell Lung Cancer
This is a single-arm, exploratory trial to evaluate the efficacy and safety of neoadjuvant WX-0593 in patients with resectable ALK-positive or ROS1- positive non-small cell lung cancer(NSCLC).
- Trial name
- NCT05765877
- Testing
- WX-0593 Tablets
- Where
- China
- Volunteers
- 26 people
- Sponsor
- Pingping Song
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
Solid Tumors
Ensartinib in the Treatment of ALK Positive or MET Exon 14 Skipping Anvanced Solid Tumors Excluded Lung Cancer
In lung cancer, ensartinib is effective in improving the prognosis of ALK positive /MET exon 14 skipping patients. However, patients with ALK positive /MET14 exon skipping non-lung cancer solid tumors have limited treatment…
- Trial name
- NCT06762327
- Testing
- Ensartinib
- Volunteers
- 20 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
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
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
Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
Gilteritinib for the Treatment of ALK NSCLC
This phase I trial is studying the safety, side effects, and best dose of gilteritinib in treating patients with stage IV ALK positive non-small cell lung cancer (NSCLC) who have progressed on other treatments.
- Trial name
- NCT06225427
- Testing
- Biopsy, Biospecimen Collection, Computed Tomography
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- University of Michigan Rogel Cancer Center
Non-Small Cell Lung Cancer (NSCLC), Hyperlipidemia
Management Strategy of 1L Lorlatinib With Hyperlipidemia in Stage IIIB-IV ALK Positive NSCLC
For Patients and Families Brief Title: Management of 1L Lorlatinib with Hyperlipidemia in ALK+ Advanced NSCLC What is this study about? This study is for people with ALK-positive non-small cell lung cancer (NSCLC) who are taking…
- Conditions
- Non-Small Cell Lung Cancer (NSCLC), Hyperlipidemia, ALK Gene Mutation, ALK-positive
- Trial name
- NCT07674524
- Testing
- For Part A - Observational Cohort:, Part B: Intensive Lipid-Lowering Group, For Part B - Intensive Group
- Where
- China
- Volunteers
- 160 people
- Sponsor
- Sun Yat-sen University
ALK-Positive or ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Study of SIM0518 in Participants With ALK-Positive or ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
This is a multicenter, open-label, Phase I study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetic /pharmacodynamic characteristics of SIM0518 in trial participants with ALK-positive or ROS1-positive…
- Trial name
- NCT07912268
- Testing
- SIM0518, SIM0518+Bupropion, SIM0518+Midazolam
- Where
- 8 sites in China
- Volunteers
- 270 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Carcinoma, Non-Small-Cell Lung
Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy
This study is a multicenter, prospective, cohort study designed to evaluate the clinical outcomes and characteristics of resected stage II-IIIB anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) adult…
- Trial name
- NCT06862869
- Testing
- Alectinib
- Where
- 44 sites in China
- Volunteers
- 800 people
- Sponsor
- Hoffmann-La Roche
Large B-Cell Lymphoma With IRF4 Rearrangement, Recurrent Aggressive B-Cell Non-Hodgkin Lymphoma
Golcadomide and Rituximab as Bridging Therapy for Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma Before CAR T-cell Therapy
This phase II trial tests the effectiveness of golcadomide and rituximab as bridging treatment before chimeric antigen receptor (CAR) T-cell therapy in patients with aggressive B-cell non-Hodgkin lymphoma that has come back after…
- Conditions
- Large B-Cell Lymphoma With IRF4 Rearrangement, Recurrent Aggressive B-Cell Non-Hodgkin Lymphoma, Recurrent ALK-Positive Large B-Cell Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma Activated B-Cell Type
- Trial name
- NCT06834373
- Testing
- Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy
- Where
- 7 sites in United States
- Volunteers
- 41 people
- Sponsor
- Mayo Clinic
Oncogene-addicted Non Small Cell Lung Cancer, EGFR Mutation
Integrated Genomics in Oncogene-driven NSCLC With Acquired Resistance
Currently, tyrosine kinase inhibitor (TKI) remains the standard of care for oncogene-driven non-small cell lung cancer (NSCLC). However, almost all oncogene-driven NSCLCs would develop acquired resistance against TKI in clinical…
- Conditions
- Oncogene-addicted Non Small Cell Lung Cancer, EGFR Mutation, ALK Fusion-positive Solid or CNS Tumors, ROS1 Fusion Positive
- Trial name
- NCT07122882
- Where
- Taiwan
- Volunteers
- 40 people
- Sponsor
- Chang Gung Memorial Hospital
Asymptomatic Brain Metastases, Driver Mutation Positive Non-small Cell Lung Cancer
Observation or Upfront Cranial RT in Oncogene Mutated NSCLC With Asymptomatic BM: A Phase III RCT
Tyrosine Kinase Inhibitors (TKIs) especially higher generation TKI have higher CNS penetration rates and have shown favorable response rates in brain metastases.
- Trial name
- NCT05236946
- Testing
- Stereotactic radiosurgery/whole brain radiotherapy, Tyrosine kinase inhibitor
- Where
- India
- Volunteers
- 190 people
- Sponsor
- Tata Memorial Hospital
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
Bone Cancer
Treatment of Truncated ALK-positive Bone Cancer Using Crizotinib (Xalkori) or Alectinib (Alecensa)
This is an investigator-initiated, single-center clinical trial evaluating the efficacy and safety of ALK inhibitors in patients with locally advanced or metastatic bone cancer harboring truncated ALK (ALKATI) alterations.
- Trial name
- NCT07560410
- Testing
- Alectinib
- Where
- Taiwan
- Volunteers
- 10 people
- Sponsor
- China Medical University Hospital
Haematological Malignancy, Malignant Neoplasm
DETERMINE Trial Treatment Arm 01: Alectinib in Adult, Paediatric and Teenage/Young Adult Patients With ALK Positive Cancers
This clinical trial is looking at a drug called alectinib. Alectinib is approved as standard of care treatment for adult patients with certain types of lung cancer.
- Conditions
- Haematological Malignancy, Malignant Neoplasm, Lymphoproliferative Disorders, Neoplasms by Histologic Type
- Trial name
- DETERMINE (NCT05770037)
- Testing
- Alectinib
- Where
- 27 sites in United Kingdom
- Volunteers
- 30 people
- Sponsor
- Cancer Research UK
Non-Small Cell Lung Cancer
Neoadjuvant Ensartinib in ALK Positive Resectable Stage II to III Non-Small Cell Lung Cancer
This single-arm, prospective, multicenter, phase II study is designed to evaluate the efficacy and safety of ensartinib as neoadjuvant treatment in ALK positive, resectable for stage II to III non-small cell lung cancer patients.
- Trial name
- NCT06779539
- Testing
- Ensartinib
- Volunteers
- 33 people
- Sponsor
- West China Hospital
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
Anaplastic Large Cell Lymphoma, ALK-Positive
Chemoimmunotherapy for ALK+ Relapsed/Refractory ALCL
Children, adolescents, and young adults (CAYA) with relapsed/refractory (R/R) high-risk ALK+ Anaplastic Large Cell Lymphoma (ALCL) have a low incidence of overall survival.
- Trial name
- ACCELERATE (NCT07013565)
- Testing
- Vinblastine (Velban), Brentuximab vedotin (Adcetris), Nivolumab (Opdivo)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- New York Medical College
Maintenance Treatment of Peripheral T-cell Lymphoma
Golidocitinib Versus Placebo as Maintenance Therapy for Peripheral T-Cell Lymphoma
This is a multicenter, randomized, double-blind, placebo-controlled phase III trial evaluating golidocitinib as maintenance therapy in adult patients with peripheral T-cell lymphoma (PTCL) who achieved complete response (CR) or…
- Trial name
- T-START-M1 (NCT07300514)
- Testing
- PET-CTandct- DNAdetection, golidocitinib
- Where
- China
- Volunteers
- 136 people
- Sponsor
- Fudan University