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Not 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests cromolyn sodium, a dry powder medicine breathed into the lungs, in people with locally advanced lung cancer (cancer that has spread nearby). It will check how safe the treatment is, how well people tolerate it, and whether it is practical to use. It will also look for early signs that it may help treat the 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have locally advanced stage 3 lung cancer or lung adenocarcinoma, a type of lung cancer.
  • Be age 18 or older.
  • Sign a consent form before screening.
  • Have lung cancer confirmed by testing tissue or cells.
  • Have a past scan showing a tumor in the lung.

Who can't join

  • Used another experimental drug or device within 4 weeks before screening, or a biological treatment within 6 weeks. A longer wait may apply based on how long the treatment stays in the body.
  • Have known fluid buildup around the heart.
  • Have an active infection or a serious illness, such as heart failure, that the study doctor says makes participation unsuitable.
  • Plan to join another trial of an experimental treatment, vaccine, or device at the same time.
  • Have another health condition that the study doctor says makes joining unsuitable or could prevent you from taking part or finishing.
  • Have a known allergy to cromolyn sodium or have had a serious harmful reaction to it.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (2)

CO