Inhaled Cromolyn Sodium in Patients With Locally Advanced Lung Cancer

NCT07675876 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: CROM-LC-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Locally Advanced Non-Small Cell Lung Cancer; Lung Adenocarcinoma

Keywords

local advanced lung cancer; Stage 3 lung cancer; Lung Adenocarcinoma; Cromolyn Sodium; Dry Powder Inhaler(DPI)

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of Inhaled Cromolyn Sodium

  Incidence, severity, and frequency of treatment-emergent adverse events and serious adverse events during study participation.

  Up to 12 months

Secondary Outcomes (2)

• Radiographic Tumor Response

  Baseline through 12 months

• Feasibility of Treatment Administration

  Up to 12 months

Study Arms (1)

Inhaled Cromolyn Sodium

EXPERIMENTAL

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

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.

Also known as: Sodium Cromoglycate

Inhaled Cromolyn Sodium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carcinex Inc: lead

Study Sites (2)

In home ttreatment

Denver, Colorado, 80220-4425, United States

Location

Treated at home

Denver, Colorado, 80220-4425, United States

Location

Related Publications (7)

• Abd-Elaziz K, Oude Elberink H, Diamant Z. Improved bioavailability of cromolyn sodium using inhaled PA101 delivered via eFlow(R) nebulizer. Eur Clin Respir J. 2020 Aug 20;7(1):1809083. doi: 10.1080/20018525.2020.1809083.

  PMID: 32944204 BACKGROUND

• Hemmati AA, Nazari Z, Motlagh ME, Goldasteh S. The role of sodium cromolyn in treatment of paraquat-induced pulmonary fibrosis in rat. Pharmacol Res. 2002 Sep;46(3):229-34. doi: 10.1016/s1043-6618(02)00122-6.

  PMID: 12220965 BACKGROUND

• Larsson K, Larsson BM, Sandstrom T, Sundblad BM, Palmberg L. Sodium cromoglycate attenuates pulmonary inflammation without influencing bronchial responsiveness in healthy subjects exposed to organic dust. Clin Exp Allergy. 2001 Sep;31(9):1356-68. doi: 10.1046/j.1365-2222.2001.01193.x.

  PMID: 11591185 BACKGROUND

• Blumenthal MN, Selcow J, Spector S, Zeiger RS, Mellon M. A multicenter evaluation of the clinical benefits of cromolyn sodium aerosol by metered-dose inhaler in the treatment of asthma. J Allergy Clin Immunol. 1988 Apr;81(4):681-7. doi: 10.1016/0091-6749(88)91038-x.

  PMID: 3128589 BACKGROUND

• Dreyer CJ. Fluoridation: a review of the 1976/1977 literature. J Dent Assoc S Afr. 1979 Mar;34(3):145-54. No abstract available.

  PMID: 397628 BACKGROUND

• Arumugam T, Ramachandran V, Logsdon CD. Effect of cromolyn on S100P interactions with RAGE and pancreatic cancer growth and invasion in mouse models. J Natl Cancer Inst. 2006 Dec 20;98(24):1806-18. doi: 10.1093/jnci/djj498.

  PMID: 17179482 BACKGROUND

• Moroni M, Porta C, Gualtieri G, Nastasi G, Tinelli C. Inhaled sodium cromoglycate to treat cough in advanced lung cancer patients. Br J Cancer. 1996 Jul;74(2):309-11. doi: 10.1038/bjc.1996.358.

  PMID: 8688342 BACKGROUND

Related Links

• Carboxamil (Cromolyn Sodium) for pancreatic cancer and other solid tumor cancers

MeSH Terms

Conditions

Adenocarcinoma of Lung; Lung Neoplasms

Interventions

Cromolyn Sodium

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Charles Owen

  Carcinex Inc

  STUDY DIRECTOR

Central Study Contacts

Svitlana Nesterenko, AGCP-Nurse Practitioner

CONTACT

7204721934; nesterenko13@gmail.com

Charles CEO

CONTACT

303-875-7402; charles@carcinex.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Practitioner- MSN, ACPC-C

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 30, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

US (2)