Pilot Study of Inhaled Cromolyn Sodium in Patients With Locally Advanced Lung Cancer

Part of paid clinical trials in Denver, Colorado.

Sponsor
Carcinex Inc
Study ID
NCT07675876
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cromolyn Sodium — DRUG
    Cromolyn 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.

Study Details

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.

Key Dates

Start date
Aug 31, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Inhaled Cromolyn Sodium
    Participants with locally advanced lung cancer will receive cromolyn sodium administered by oral inhalation using a dry powder inhaler according to the study protocol.

Primary Outcome Measure

Safety and Tolerability of Inhaled Cromolyn Sodium [ Time Frame: Up to 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
In home ttreatmentDenverColorado80220-4425-
Treated at homeDenverColorado80220-4425-

Find similar trials in Denver, CO

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
In home ttreatment· Denver, COTreated at home· Denver, CO

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