[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07675876":3,"trial-entities:NCT07675876":128,"trial-summary:NCT07675876":132},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":41,"secondary_outcomes":46,"sex":54,"minimum_age":55,"maximum_age":15,"healthy_volunteers":56,"eligibility_criteria":57,"std_ages":71,"locations":74,"central_contacts":87,"overall_officials":97,"references":101,"see_also_links":124},"NCT07675876","CROM-LC-001","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","NOT_YET_RECRUITING","2027-08","2026-06","2026-07-01","2026-08","Carcinex Inc","INDUSTRY",null,"Brief Summary\n\nThis 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.\n\nCromolyn 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.\n\nApproximately 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.\n\nThe 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.","Scientific Background and Rationale\n\nLung 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.\n\nMast 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.\n\nCromolyn 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.\n\nPreclinical 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.\n\nThe 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.\n\nCromolyn 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.\n\nGiven 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.\n\nSafety Considerations\n\nParticipants 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.",[19,20],"Locally Advanced Non-Small Cell Lung Cancer","Lung Adenocarcinoma",[22,23,20,24,25],"local advanced lung cancer","Stage 3 lung cancer","Cromolyn Sodium","Dry Powder Inhaler(DPI)","INTERVENTIONAL","TREATMENT",[29],"PHASE1",{"count":31,"type":32},10,"ESTIMATED",[34],{"type":35,"name":24,"description":36,"armGroupLabels":37,"otherNames":39},"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.",[38],"Inhaled Cromolyn Sodium",[40],"Sodium Cromoglycate",[42],{"measure":43,"description":44,"timeFrame":45},"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",[47,51],{"measure":48,"description":49,"timeFrame":50},"Radiographic Tumor Response","Exploratory assessment of changes in tumor burden based on clinically obtained imaging studies.","Baseline through 12 months",{"measure":52,"description":53,"timeFrame":45},"Feasibility of Treatment Administration","Assessment of participant completion of protocol-defined treatment and study procedures.","ALL","18 Years",false,{"inclusion":58,"exclusion":63,"raw_text":70},[59,60,61,62],"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",[64,65,66,67,68,69],"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","Inclusion Criteria:\n\nPatients with local advanced stage 3 lung cancer or lung adenocarcinoma will be eligible for the study only if they meet the following criteria:\n\n* Provide written informed consent prior to screening.\n* Male or female patients, age ≥ 18 years\n* Histological- or cytological-confirmed diagnosis of Lung cancer\n* Previous tumor scan location in lung\n\nExclusion Criteria:\n\n* 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.\n* Patients with known pericardial effusion\n* Patients with active infection or serious concomitant systemic disorder (for example, heart failure) incompatible with the study (at the discretion of the Investigator)\n* Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device.\n* 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.\n* Known allergy or history of serious adverse event with Cromolyn Sodium",[72,73],"ADULT","OLDER_ADULT",[75,84],{"facility":76,"city":77,"state":78,"zip":79,"country":80,"geoPoint":81},"In home ttreatment","Denver","Colorado","80220-4425","United States",{"lat":82,"lon":83},39.73915,-104.9847,{"facility":85,"city":77,"state":78,"zip":79,"country":80,"geoPoint":86},"Treated at home",{"lat":82,"lon":83},[88,93],{"name":89,"role":90,"phone":91,"email":92},"Svitlana Nesterenko, AGCP-Nurse Practitioner","CONTACT","7204721934","nesterenko13@gmail.com",{"name":94,"role":90,"phone":95,"email":96},"Charles CEO","303-875-7402","charles@carcinex.org",[98],{"name":99,"affiliation":13,"role":100},"Charles Owen","STUDY_DIRECTOR",[102,106,109,112,115,118,121],{"pmid":103,"type":104,"citation":105},"32944204","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\u002F20018525.2020.1809083.",{"pmid":107,"type":104,"citation":108},"12220965","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\u002Fs1043-6618(02)00122-6.",{"pmid":110,"type":104,"citation":111},"11591185","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\u002Fj.1365-2222.2001.01193.x.",{"pmid":113,"type":104,"citation":114},"3128589","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\u002F0091-6749(88)91038-x.",{"pmid":116,"type":104,"citation":117},"397628","Dreyer CJ. Fluoridation: a review of the 1976\u002F1977 literature. J Dent Assoc S Afr. 1979 Mar;34(3):145-54. No abstract available.",{"pmid":119,"type":104,"citation":120},"17179482","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\u002Fjnci\u002Fdjj498.",{"pmid":122,"type":104,"citation":123},"8688342","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\u002Fbjc.1996.358.",[125],{"label":126,"url":127},"Carboxamil (Cromolyn Sodium) for pancreatic cancer and other solid tumor cancers","https:\u002F\u002Fcarcinex.org\u002F",{"nct_id":4,"conditions":129,"biomarkers":131},[20,130],"Lung Non-Small Cell Carcinoma",[],{"nct_id":4,"found":133,"summary":134,"prompt_version":144},true,{"design":135,"status":136,"heading":137,"summary":138,"follow_up":139,"word_count":140,"commitments":141,"compensation":142,"drugs_mentioned":143},"This is an open-label pilot study, meaning both you and the study team will know you are receiving cromolyn sodium. It plans to include 10 participants.","completed","Inhaled Cromolyn Sodium for Locally Advanced Lung Cancer","This study is looking at inhaled cromolyn sodium for people with locally advanced non-small cell lung cancer or lung adenocarcinoma. Cromolyn sodium is a medication already approved for other breathing problems. Researchers want to see if this drug, which helps stabilize mast cells (a type of immune cell), can be safe and well-tolerated in lung cancer patients. They are also looking for early signs that it might help by affecting how tumors grow and interact with the immune system. The study plans to enroll 10 participants and will check for safety and how well people tolerate the treatment for up to 12 months.","Participants will be followed for safety and tolerability for up to 12 months.",103,"Not specified in the trial record.","Not stated in the trial record.",[24],"v2"]