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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Jul 1, 2026 · Source: ClinicalTrials.gov
The study is not accepting participants yet.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Carcinex Inc
- Interventions being studied
- Drug: Cromolyn Sodium
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- In home ttreatmentDenver, Colorado
- Treated at homeDenver, Colorado
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 1, 2026. Always confirm current availability with the study team.