Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07140016 · ClinicalTrials.gov registry record · Phase 1
A Study of Gilteritinib in Adults With Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)
A Phase 1 study of Non-small Cell Lung Cancer (NSCLC) and Anaplastic Lymphoma Kinase (ALK) Positive, sponsored by Astellas Pharma Global Development.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 8
- Study locations
NCT07140016: Recruiting Phase 1 study of Non-small Cell Lung Cancer (NSCLC) and Anaplastic Lymphoma Kinase (ALK) Positive, sponsored by Astellas Pharma Global Development.
NCT07140016 is a Phase 1 study of Non-small Cell Lung Cancer (NSCLC) and Anaplastic Lymphoma Kinase (ALK) Positive that is actively recruiting participants, run by Astellas Pharma Global Development. The registered enrollment target is 40 participants, below the 284-participant average among 59 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (86% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07140016, a Phase 1 study of Non-small Cell Lung Cancer (NSCLC) and Anaplastic Lymphoma Kinase (ALK) Positive, is actively recruiting participants, sponsored by Astellas Pharma Global Development.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 8
- Study locations
Study Summary
Genes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many types of cancer are caused by changes in certain genes, making them faulty. Some people with non small cell lung cancer (NSCLC) have a faulty ALK gene. ALK stands for anaplastic lymphoma kinase. People with NSCLC who have the faulty ALK gene are called ALK-positive. ALK inhibitors are an approved treatment for people with ALK positive NSCLC. Some people stop responding to treatment with ALK inhibitors over time due to more changes happening in their faulty ALK gene, so there is an unmet medical need. Gilteritinib is an approved treatment for people with acute myeloid leukemia (AML) with the faulty FLT3 gene who haven't responded to previous treatment, or their cancer came back after previous treatment. Gilteritinib also blocks changes in the ALK gene which could help people with ALK-positive NSCLC. A study needs to be done with gilteritinib in people with ALK-positive NSCLC. The main aim of the study is to check the safety of gilteritinib in people with ALK-positive NSCLC and if they tolerate gilteritinib. People in this study will be adults with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC). Locally advanced means the cancer has spread to nearby tissue. Metastatic means the cancer has spread to other parts of the body. They have stopped responding to treatment with ALK inhibitors, including alectinib or lorlatinib, over time. The key reasons people cannot take part are if they have symptomatic cancers in the brain or nervous system, their cancer has spread to the thin tissue that covers the brain and spinal cord (leptomengingeal metastasis), have recently had or planning to have major surgery, have certain heart conditions, or have recently had an infection, a stroke or mini-stroke. People in the study will take tablets of gilteritinib once a day in a 28-day cycle. They may be given up to 2 different doses of gil
Primary Outcome
A Dose Limiting Toxicity is defined as any event meeting the DLT criteria occurring within 28 days of first dose.
Conditions Studied
Interventions
- DRUG gilteritinib
Study Locations (8)
Other
- Site ES34006 - Madrid
- Site ES34011 - Madrid
- Site ES34008 - Málaga
Illinois
- OSF Health Care - Peoria
Michigan
- University of Michigan Health Systems - Ann Arbor
Missouri
- Washington University School of Medicine - St Louis
New Jersey
- Hackensack University Medical Center - Hackensack
Virginia
- Virginia Cancer Specialists PC - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-09-22 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 1 |
What NCT07140016 shows while recruiting
NCT07140016 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 284-participant average among 59 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (86% lower).
The record links to 2 conditions, with Non-small Cell Lung Cancer (NSCLC) appearing as the primary indexed condition, and to 1 intervention - of which gilteritinib is the first listed.
NCT07140016 lists 8 locations in 6 states (Other, Illinois, Michigan).
Frequently Asked Questions
What is clinical trial NCT07140016 about?
NCT07140016 is a clinical study titled "A Study of Gilteritinib in Adults With Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)". Genes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many types of cancer are caused by changes in certain genes, making them faulty. Some people with non small cell lung cancer (NSCLC) have a faulty ALK gene. ALK stands for anaplastic lym...
What is the current status of trial NCT07140016?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2025-09-22. Estimated completion is 2029-12-31.
What conditions does trial NCT07140016 study?
This clinical trial studies the following conditions: Non-small Cell Lung Cancer (NSCLC), Anaplastic Lymphoma Kinase (ALK) Positive.
What interventions are being tested in trial NCT07140016?
The interventions under investigation include: gilteritinib (DRUG).
Who is sponsoring clinical trial NCT07140016?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07140016 being conducted?
This trial has 8 study locations across Illinois, Michigan, Missouri, New Jersey, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Non-small Cell Lung Cancer (NSCLC)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07140016's enrollment target sits among peer trials
40 47th of 59 higher than 12 of 59 other Non-small Cell Lung Cancer (NSCLC) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-small Cell Lung Cancer (NSCLC) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors
RECRUITING · Phase 1
-
Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
RECRUITING · Phase 1
-
A Study of MT-4561 in Patients With Various Advanced Solid Tumors
RECRUITING · Phase 1
-
A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies
RECRUITING · Phase 1
-
Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors
RECRUITING · Phase 1
-
Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Cancer or Other Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01306019 · 40 participants · Phase 1
Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID)
- NCT01608152 · 40 participants
Development of a Video Game for the Improvement of Outcomes in Stem Cell Transplant Survivors
- NCT01668082 · 40 participants · NA
An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection
- NCT02015013 · 40 participants · Phase 2
Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI