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

June 23, 2026 updated by: Svitlana Nesterenko, Carcinex Inc

An Open-Label Pilot Study Evaluating the Safety, Feasibility, and Preliminary Clinical Activity of Inhaled Cromolyn Sodium in Participants 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Scientific Background and Rationale

Lung cancer remains a leading cause of cancer-related mortality worldwide despite substantial advances in molecularly targeted therapies, immunotherapy, radiation therapy, and multimodality treatment approaches. Increasing evidence indicates that, in addition to intrinsic tumor biology, the tumor microenvironment plays a critical role in disease progression, immune evasion, therapeutic resistance, and metastatic dissemination. Consequently, there is growing interest in therapeutic strategies designed to modulate tumor-associated inflammatory and stromal processes that contribute to cancer progression.

Mast cells are resident immune cells that participate in both innate and adaptive immune responses and are increasingly recognized as important components of the tumor microenvironment. In lung cancer, mast cell infiltration has been observed within both primary tumor tissue and surrounding stromal compartments. Experimental and translational studies have suggested that mast cells may contribute to tumor-associated inflammation through the release of cytokines, chemokines, growth factors, angiogenic mediators, and proteolytic enzymes capable of influencing immune regulation, angiogenesis, extracellular matrix remodeling, and cellular proliferation.

Cromolyn sodium is an FDA-approved mast cell stabilizing agent with a long-established clinical safety profile following inhalational administration for allergic respiratory disorders. The drug inhibits mast cell degranulation and reduces the release of multiple inflammatory mediators involved in downstream immune and inflammatory signaling pathways. In addition to its effects on mast cells, preclinical investigations have suggested broader effects on inflammatory processes involving macrophages, eosinophils, neutrophils, and other immune-regulatory cell populations implicated in tumor-associated inflammation.

Preclinical studies evaluating mast cell inhibition and modulation of inflammatory signaling pathways have generated interest in the potential role of tumor microenvironment-directed therapeutic strategies in solid tumors. Although the clinical significance of these observations remains uncertain, available experimental data provide a biologically plausible rationale for exploratory clinical investigation of cromolyn sodium in lung cancer.

The pulmonary route of administration offers additional scientific rationale for evaluation in this setting. Inhaled drug delivery permits direct deposition of therapeutic agents within the respiratory tract and may facilitate local exposure within pulmonary tissues while limiting systemic drug exposure. Administration by dry powder inhaler may provide efficient pulmonary delivery and represents a practical, non-invasive method of drug administration that can be implemented in both clinical and home-based settings.

Cromolyn sodium has demonstrated a favorable safety profile during decades of clinical use. Systemic absorption following inhalation is limited, systemic toxicity is uncommon, and the drug is not associated with many of the adverse effects characteristic of conventional cytotoxic anticancer therapies. Nevertheless, the use of inhaled cromolyn sodium for the treatment of lung cancer remains investigational and has not been established as safe or effective for this indication.

Given the established clinical safety profile of inhaled cromolyn sodium, its biologic activity as a mast cell stabilizer, the emerging understanding of inflammatory and stromal mechanisms in lung cancer progression, and the potential advantages of localized pulmonary drug delivery, a pilot clinical investigation is warranted to evaluate the safety, feasibility, tolerability, and preliminary clinical activity of inhaled cromolyn sodium in participants with locally advanced lung cancer.

Safety Considerations

Participants enrolled in this study will undergo protocol-defined safety monitoring throughout the treatment and follow-up periods. Safety assessments will include evaluation of treatment-emergent adverse events, respiratory symptoms, hypersensitivity reactions, clinically significant laboratory abnormalities, and other changes in clinical status. Given the investigational nature of this treatment approach, ongoing safety surveillance will be conducted throughout study participation.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80220-4425
        • In home ttreatment
      • Denver, Colorado, United States, 80220-4425
        • Treated at home

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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. 2. Male or female patients, age ≥ 18 years 3. Histological- or cytological-confirmed diagnosis of Lung cancer 4. Previous tumor scan location in lung

Exclusion Criteria:

  1. 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.
  2. Patients with known pericardial effusion
  3. Patients with active infection or serious concomitant systemic disorder (for example, heart failure) incompatible with the study (at the discretion of the Investigator)
  4. Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device.
  5. 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.
  6. Known allergy or history of serious adverse event with Cromolyn Sodium

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Cromolyn Sodium
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.
Other Names:
  • Sodium Cromoglycate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability of Inhaled Cromolyn Sodium
Time Frame: Up to 12 months
Incidence, severity, and frequency of treatment-emergent adverse events and serious adverse events during study participation.
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Tumor Response
Time Frame: Baseline through 12 months
Exploratory assessment of changes in tumor burden based on clinically obtained imaging studies.
Baseline through 12 months
Feasibility of Treatment Administration
Time Frame: Up to 12 months
Assessment of participant completion of protocol-defined treatment and study procedures.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carcinex Inc

Investigators

  • Study Director: Charles Owen, Carcinex Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

June 16, 2026

First Submitted That Met QC Criteria

June 23, 2026

First Posted (Actual)

June 30, 2026

Study Record Updates

Last Update Posted (Actual)

June 30, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CROM-LC-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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