Clinical trials: ALK Gene Mutation, open to volunteers
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 (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
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
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
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
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
Haematological Malignancy, Solid Tumour
DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial) - Master Screening Protocol
DETERMINE is an open-label phase II/III trial. It will look at targeted treatments in rare cancers or common cancers with rare genetic change (mutation). Patients must have a cancer with an identified mutation.
- Trial name
- DETERMINE (NCT05722886)
- Testing
- Alectinib, Atezolizumab, Entrectinib
- Where
- 27 sites in United Kingdom
- Volunteers
- 825 people
- Sponsor
- Cancer Research UK
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
Locally Advanced Solid Tumor, Metastatic Solid Tumor
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of neladalkib (NVL-655), determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced…
- Trial name
- NCT05384626
- Testing
- Neladalkib (NVL-655), Midazolam, Repaglinide
- Where
- 74 sites in United States, Australia and 13 more
- Volunteers
- 840 people
- Sponsor
- Nuvalent Inc.
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
NSCLC
Trial for Local Ablative Treatment (LAT) Optimization in Patients With Advanced Non-Small Cells Lung Cancer (NSCLC) Presenting an Anaplastic Lymphoma Kinase (ALK) Rearrangement Treated by Brigatinib
The goal of this clinical trial is to learn if the treatment by systemic Brigatinib (ALUNBRIG®) associated to local ablative therapy (LAT) treatment is improved if administered when the brigatinib works best in participants…
- Trial name
- OPTALK (NCT06620835)
- Testing
- Blood samples for Hematology, Blood samples for Chemistry, Blood sample for liver function tests
- Where
- 27 sites in France
- Volunteers
- 45 people
- Sponsor
- Groupe Francais De Pneumo-Cancerologie
Non Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
Clinical Trial of CD40L-Augmented TIL for Patients With EGFR, ALK, ROS1 or HER2-Driven NSCLC
To determine the effect of a special preparation of cells, called tumor-infiltrating lymphocytes (TIL) stimulated with CD40L, when given with the drug nivolumab, for patients with EGFR, ALK, ROS1, or HER2-genomically altered lung…
- Conditions
- Non Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, Recurrent Non Small Cell Lung Cancer
- Trial name
- NCT05681780
- Testing
- Tumor-infiltrating Lymphocytes (TIL), Nivolumab, Cyclophosphamide
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
ALK Gene Mutation, Lung Adenocarcinoma
Pembrolizumab Plus Bevacizumab and Chemotherapy for ALK-rearranged NSCLC With Persistent 5'ALK
This is an open-label, multiple centers, two-arms phase II study to evaluate the safety and efficacy Pembrolizumab,Bevacizumab in combination with Chemotherapy could improve PFS in Alectinib Failed ALK-rearranged Advanced Lung…
- Conditions
- ALK Gene Mutation, Lung Adenocarcinoma, Immunotherapy
- Trial name
- BEYOND (NCT05266846)
- Testing
- Pembrolizumab injection
- Where
- China
- Volunteers
- 78 people
- Sponsor
- Hunan Province Tumor Hospital
Non Small Cell Lung Cancer Metastatic, ALK Gene Mutation
A Study to Evaluate the Combination of Platinum-pemetrexed Based Chemotherapy Plus Lorlatinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) With Exclusively Extracranial Disease Progression on Lorlatinib
This study aims to evaluate the activity and safety of the combination of platinum-pemetrexed based chemotherapy plus Lorlatinib in ALK positive Non-Small Cell Lung Cancer (NSCLC) with exclusively extracranial disease progression…
- Trial name
- ALK-PPL (NCT06378892)
- Testing
- Lorlatinib
- Where
- 9 sites in Italy
- Volunteers
- 45 people
- Sponsor
- Centro di Riferimento Oncologico - Aviano
NSCLC (Advanced Non-small Cell Lung Cancer)
QL1706 Combined With Chemotherapy in the Treatment of Immune-mediated NSCLC
Lung cancer is the leading cause of cancer-related deaths worldwide. According to the 2023 global cancer statistics, there are approximately 2.47 million new cases and 1.76 million deaths of lung cancer annually, accounting for…
- Trial name
- NCT07330596
- Testing
- QL1706 combined with Chemotherapy, Chemotherapy
- Where
- China
- Volunteers
- 96 people
- Sponsor
- Anhui Provincial Cancer Hospital
NSCLC Stage IV Without EGFR/ALK Mutation
Study on the Optimal Combination Pattern of the Combined Treatment of Radiotherapy and Immunotherapy for the Abscopal Effect in Non-Small Cell Lung Cancer (NSCLC) With Multiple Metastases
This study aims to conduct a prospective, multicenter, umbrella clinical study to compare the abscopal effects of different radiotherapy fractionation patterns combined with Benmelstobart, and to explore an efficient and…
- Trial name
- NCT06953843
- Testing
- Benmelstobart combined with chemotherapy, Benmelstobart combined with Bevacizumab and chemotherapy
- Where
- China
- Volunteers
- 366 people
- Sponsor
- Xinqiao Hospital of Chongqing
Non Small Cell Lung Cancer, EGFR Gene Mutation
Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation
The purpose of this study is to assess the Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation.
- Conditions
- Non Small Cell Lung Cancer, EGFR Gene Mutation, ALK Gene Mutation, ROS1 Gene Mutation
- Trial name
- PIKACHU (NCT04322890)
- Testing
- Osimertinib, Alectinib 150 MG, Crizotinib 250 MG
- Where
- China
- Volunteers
- 6,000 people
- Sponsor
- Hunan Province Tumor Hospital
Non Small Cell Lung Cancer
Adjuvant Toripalimab Plus Chemotherapy for EGFR/ALK Mutation Negative Stage II-IIIB(N2) NSCLC (LungMate-008)
This is a randomized, controlled, double-blind, single-center Phase III clinical study in patients with EGFR/ALK mutation negative stage II-IIIB (N2) non-small cell lung cancer (NSCLC) after complete tumor resection.
- Trial name
- NCT04772287
- Testing
- Toripalimab
- Volunteers
- 341 people
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
Non-Small Cell Carcinoma of Lung, TNM Stage 4, Non-Small Cell Lung Cancer
Early Rebiopsy to Identify Biomarkers of Tumor Cell Survival Following EGFR, ALK, ROS1 or BRAF TKI Therapy
A comparison of baseline tumor characteristics in oncogene-driven cancers to tumor characteristics after early response to Tyrosine Kinase Inhibitor (TKI) targeted treatment will allow identification of early adaptive mechanisms…
- Conditions
- Non-Small Cell Carcinoma of Lung, TNM Stage 4, Non-Small Cell Lung Cancer, EGFR Gene Mutation, ALK Gene Mutation
- Trial name
- NCT03042221
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of Colorado, Denver