Clinical trials: ALK-Positive Non-Small Cell Lung Cancer (NSCLC), 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
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
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
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
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 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
Advanced ALK/ROS1-positive NSCLC, Carcinoma, Non-Small-Cell Lung (NSCLC)
Vortioxetine for Cognitive Function in ALK-positive NSCLC Treated With Lorlatinib
This observational study evaluates whether vortioxetine - an antidepressant medication with cognitive-enhancing properties - can reduce the neurological and cognitive side effects associated with lorlatinib treatment in patients…
- Conditions
- Advanced ALK/ROS1-positive NSCLC, Carcinoma, Non-Small-Cell Lung (NSCLC), Lung Adenocarcinoma, ALK-positive Non-small Cell Lung Cancer (NSCLC)
- Trial name
- NCT07633626
- Where
- Colombia
- Volunteers
- 24 people
- Sponsor
- Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo
NSCLC
Explore the Mechanisms Underlying Disease Resistance and Potential Primary Resistance Mechanism of Induction Therapy Lorlatinib in Resectable Non-small Cell Lung Cancer (NSCLC) Harboring ALK Positive Mutation Revealed by Single-cell RNA Sequencing and Spatial Transcriptomics
This is an open-label, randomized, single-center study. This translational study aims to explore tumor microenvironment remodelling after induction therapy lorlatinib and identify mechanisms of disease persistence and potential…
- Trial name
- NCT06893354
- Testing
- lorlatinib, lorlatinib plus chemotherapy
- Volunteers
- 20 people
- Sponsor
- The First Affiliated Hospital of Guangzhou Medical University
Non-Small Cell Lung Cancer, ALK
Iruplinalkib in ALK-Positive Advanced Lung Adenocarcinoma After Lorlatinib
This observational study aims to evaluate the real-world effectiveness and safety of iruplinalkib in patients with advanced ALK-positive lung adenocarcinoma who have progressed on or are intolerant to prior lorlatinib therapy.
- Conditions
- Non-Small Cell Lung Cancer, ALK, Iruplinalkib, Lorlatinib
- Trial name
- SAILOR (NCT07374614)
- Testing
- Iruplinalkib tablets
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Peking University Shenzhen Hospital
Non-small Cell Lung Cancer
Adjuvant Therapy of Ensartinib in Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer
This is a prospective, multi-center, single-arm, phase 2 study aiming to assess the efficacy and safety of adjuvant use of Ensartinib in stage IB-IIIA non-small cell lung cancer (NSCLC) with positive ALK-fusion.
- Trial name
- NCT05241028
- Testing
- Ensartinib
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Hebei Medical University Fourth Hospital
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
ALK, NSCLC
The Incidence and Risk Factors of Central Nervous System Adverse Events of Lorlatinib in Patients with ALK-positive Advanced Non-small Cell Lung Cancer: a Real-world Study
The goal of this study is to investigate the incidence and risk factors of central nervous system adverse events of Lorlatinib in patients with ALK-positive advanced non-small cell lung cancer.
- Trial name
- NCT06652555
- Testing
- Group 1
- Volunteers
- 100 people
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
Non-small Cell Lung Cancer, ALK Gene Rearrangement Positive
Analysis of Biological Characteristics of Advanced ALK-rearranged NSCLC
BioEXALK is a prospective study evaluating the biological characteristics of advanced ALK-rearranged NSCLC treated with next generation TKIs in first line, included in the national EXPLORE ALK cohort (GFPC 03-2019), a…
- Trial name
- BIOEXALK (NCT05122806)
- Testing
- RNAseq
- Where
- 46 sites in France
- Volunteers
- 100 people
- Sponsor
- Groupe Francais De Pneumo-Cancerologie