NCT07675876Not yet recruitingPhase 1
Inhaled Cromolyn Sodium in Patients With Locally Advanced Lung Cancer
An Open-Label Pilot Study Evaluating the Safety, Feasibility, and Preliminary Clinical Activity of Inhaled Cromolyn Sodium in Participants With Locally Advanced Lung Cancer
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 16 Jun 2026
- Start date
- Aug 2026
- Primary completion date
- Jun 2027
- Lead sponsor
- Carcinex Inc
- Diseases
- Lung cancer
- NCT number
- NCT07675876
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 10
- From Aug 2026 to the primary completion date, Jun 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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.
Other illness
- 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.
Lab values
- Known allergy or history of serious adverse event with Cromolyn Sodium
Other
- Patients with known pericardial effusion
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Treated at home Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| In home ttreatment Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.