Inhaled Cromolyn Sodium in Patients With Locally Advanced Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCarcinex Inc
About this trial
Brief Summary
This prospective, open-label pilot study is designed to evaluate the safety, tolerability, feasibility, and preliminary clinical activity of inhaled cromolyn sodium administered by dry powder inhalation in participants with locally advanced lung cancer.
Cromolyn sodium is an FDA-approved mast cell stabilizer with an established safety profile in respiratory disease. Increasing evidence suggests that inflammatory signaling, mast cell activation, and stromal remodeling contribute to tumor progression, immune dysregulation, and resistance to therapy within the lung tumor microenvironment. Modulation of these pathways may represent a novel therapeutic strategy in lung cancer.
Approximately 5 to 10 participants with locally advanced lung cancer will receive inhaled cromolyn sodium according to the study protocol. Participants will undergo clinical assessments, safety monitoring, laboratory evaluations, and radiographic imaging in accordance with protocol-defined procedures and standard oncologic care.
The primary objective of this pilot study is to evaluate the safety, tolerability, and feasibility of inhaled Cromolyn sodium administration in this patient population. Secondary objectives include exploratory assessment of radiographic response, clinical outcomes, biomarker trends, and potential signals of biological activity. Data generated from this study are intended to support the development of future clinical investigations evaluating the role of mast cell stabilization and tumor microenvironment modulation in lung cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provide written informed consent prior to screening.
Male or female patients, age ≥ 18 years
Histological- or cytological-confirmed diagnosis of Lung cancer
Previous tumor scan location in lung
Disqualifiers
Treatment with another investigational drug, biological agent, or device within 4 weeks (6 weeks for biological agents) before screening or 5 half-lives of study agent, whichever is longer.
Patients with known pericardial effusion
Patients with active infection or serious concomitant systemic disorder (for example, heart failure) incompatible with the study (at the discretion of the Investigator)
Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device.
Trial design
Design model
Single group
Treatments tested in this trial
Cromolyn Sodium
DrugCromolyn sodium administered by oral inhalation using a dry powder inhaler. Treatment will be administered according to the protocol-defined dosing schedule throughout the study period.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Inhaled Cromolyn SodiumExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and Tolerability of Inhaled Cromolyn Sodium
Incidence, severity, and frequency of treatment-emergent adverse events and serious adverse events during study participation.
Time frame
Up to 12 monthsSecondary outcomes
1
Radiographic Tumor Response
Exploratory assessment of changes in tumor burden based on clinically obtained imaging studies.
Time frame
Baseline through 12 months2
Feasibility of Treatment Administration
Assessment of participant completion of protocol-defined treatment and study procedures.
Time frame
Up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: