Clinical trials: ALK+ Non-Small-Cell Lung Carcinoma, 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
Non-small Cell Lung Cancer
ALK Tyrosine Kinase Inhibitors in ALK-rearranged Advanced Squamous Cell Carcinoma
This study was to explore the efficacy of ALK-TKI in lung squamous cell carcinoma. Approximately 5% of lung adenocarcinomas have oncogenic fusions of EML-4 and ALK a mutation associated with tumorigenesis and migration.
- Trial name
- ATPase (NCT05014464)
- Testing
- Crizotinib
- Where
- China
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Hunan Province Tumor Hospital
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
Neoadjuvant Non-Small Cell Lung Cancer
Lorlatinib as Neoadjuvant Treatment in Stage IB-IIIB ALK-rearranged Non-Small Cell Lung Cancer
This project was designed To explore the pathological complete response (pCR) of lorlatinib as neoadjuvant treatment. Twenty-five patients will be involved in this study.
- Trial name
- NEOLORA (NCT06682884)
- Testing
- Lorlatinib 100 mg
- Volunteers
- 25 people
- Sponsor
- Peking University People's Hospital
Drug Monitoring, Carcinoma, Non-Small-Cell Lung
Comparison of Standard Dose Alectinib to Alectinib in Adjusted Dose Based on Alectinib Bloodlevels
The ADAPT ALEC randomized controlled trial (RCT) is performed in patients with Anaplastic Lymphoma Kinase (ALK) positive non-small cell lung cancer (NSCLC).
- Conditions
- Drug Monitoring, Carcinoma, Non-Small-Cell Lung, Lung Cancer, Anaplastic Lymphoma Kinase Gene Mutation
- Trial name
- ADAPT ALEC (NCT05525338)
- Testing
- Alectinib
- Where
- 8 sites in France, Netherlands
- Volunteers
- 196 people
- Sponsor
- University Medical Center Groningen
Non-small Cell Lung Cancer
Savolitinib Plus Docetaxel as 2L in EGFR/ALK/ROS1/MET ex14m-wildtype NSCLC With MET Overexpression
This is a prospective, pilot, single-arm, single-center study exploring the efficacy and safety of savolitinib plus docetaxel as second-line therapy in patients with MET overexpressed, EGFR/ALK/ROS1/MET ex14m-wildtype advanced…
- Trial name
- NCT05777278
- Testing
- Savolitinib, Docetaxel
- Where
- China
- Volunteers
- 29 people
- Sponsor
- The First Affiliated Hospital of Guangzhou Medical University
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
NSCLC Stage IV Without EGFR/ALK Mutation
A Study on Exploring the Abscopal Effect Induced by Different Radioimmunotherapy Combination Patterns in the Treatment of Non-Small Cell Lung Cancer With Multiple Metastases
It is planned to carry out a multicenter umbrella study to find the optimal organ combination and the best radioimmunotherapy combination pattern, so as to improve the survival of NSCLC patients with multiple metastases.
- Trial name
- NCT06947694
- Testing
- chemotherapy + PD-1 inhibitors
- Where
- China
- Volunteers
- 427 people
- Sponsor
- Xinqiao Hospital of Chongqing
Lung Cancer, Non-Small Cell
Real-world Study of Local Therapy Changes During 1L Lorlatinib in Unresectable ALK+ NSCLC
This real-word study is designed to prospectively explore whether local treatment (surgery, ablation, radiotherapy and others) can prolong the time to treatment discontinuation during 1L lorlatinib treatment in Chinese patients…
- Trial name
- COMLORLA (NCT06690541)
- Testing
- Lorlatinib 100 mg
- Volunteers
- 100 people
- Sponsor
- Peking University Cancer Hospital & Institute
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
Lung Cancer, Nonsmall Cell
ctDNA-MRD Guided Consolidation Toripalimab in Stage IB-IIIA NSCLC
This study aims to incorporate circulating tumor DNA (ctDNA)-minimal residual disease (MRD) to personalize the administration of consolidation toripalimab therapy in resected stage IB-IIIA non-small-cell lung cancer (NSCLC) after…
- Trial name
- CONTINUE (NCT06426511)
- Testing
- Toripalimab+Chemotherapy, Toripalimab+Chemotherapy followed by consolidation toripalimab
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Sun Yat-sen University
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