Inhaled Cromolyn Sodium in Patients With Locally Advanced Lung Cancer

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.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

Patients with local advanced stage 3 lung cancer or lung adenocarcinoma will be eligible for the study only if they meet the following criteria:

* 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

Exclusion Criteria:

* 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.
* Patients with any other medical condition that in the opinion of the Investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in or completing the study.
* Known allergy or history of serious adverse event with Cromolyn Sodium

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