Inhaled Cromolyn Sodium in Patients With Locally Advanced Lung Cancer

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.

Timeline

Start

2026-08

Primary completion

2027-06

Completion

2027-08

Publications

• Background 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

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Indications