[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07631299":3,"trial-entities:NCT07631299":113,"trial-summary:NCT07631299":119},{"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":10,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":42,"sex":47,"minimum_age":48,"maximum_age":49,"healthy_volunteers":14,"eligibility_criteria":50,"std_ages":65,"locations":68,"central_contacts":93,"overall_officials":101,"references":104,"see_also_links":109},"NCT07631299","19970P","Nebulized AER101 in Pre-op NSCLC","Nebulized AER101 to Inhibit Glycolysis for Pre-Operative Non-small Cell Lung Cancer (NSCLC)","NOT_YET_RECRUITING","2027-06","2026-06","2026-06-08","University of Oklahoma","OTHER",false,"The primary objective of this pilot study is to determine if AER101 can decrease glycolysis in non-small cell lung cancer (NSCLC). Glycolysis is the process cells use to break down sugar (glucose) into a smaller substance in the fluid part inside the cell. Many lung cancers begin in bronchi, bronchioles and alveoli cells surrounding the airways, which enables nebulization to deposit AER101 on lung tumors.\n\nParticipants in the study will self-administer AER101 via a hand-held personal nebulizer three times per day (dosing at least 4 hours apart) for 14 days prior to undergoing surgery for lung cancer.","This is a pilot study that will enroll 5 patients with Stage I or Stage II NSCLC. Each patient will receive a nebulizer and will self-administer the study drug 3 times a day for 14 days. The research team will perform a PET CT scan at the beginning of the study (no more than 30 days prior to study) and again at the last treatment. The final treatment will be done at the clinic so that the PET\u002FCT can be performed within about one hour. Patient surgery will already be scheduled to occur shortly after the treatment has been completed.\n\nPatients will also complete a daily assessment survey at each treatment time.\n\nThere is only one treatment arm and no control group.\n\nThe study is of minimal risk and the investigator expects enrollment to be completed in approximately 6 months.",[18,19],"Non-small Cell Lung Cancer Stage I","Non-small Cell Lung Cancer Stage II",[21,22],"Non-small Cell Lung Cancer","Nebulization","INTERVENTIONAL","TREATMENT",[26],"EARLY_PHASE1",{"count":28,"type":29},5,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","AER101","Nebulization of AER101",[36],"Nebulized AER 101",[38],{"measure":39,"description":40,"timeFrame":41},"PET SUVmax","decreased glycolysis","14 days",[43],{"measure":44,"description":45,"timeFrame":46},"NSCLC System Assessment Questionnaire","Patients are asked to rate coughing episodes, chest pain, shortness of breath, fatigue, and appetite. The PRO Consortium's 9 NSCLC Working Group developed the NSCLC-SAQ with consideration of the recommendations and scientific best practices set forth in the FDA guidance. The NSCLC patient symptoms are each rated from 1 (Never\u002Fno pain\u002FNo Coughing) to 5 (Always\u002FVery Severe).","Once daily during 14 day intervention","ALL","18 Years","100 Years",{"inclusion":51,"exclusion":58,"raw_text":64},[52,53,54,55,56,57],"18 years or older","Agree to sign consent and follow study requirements","Recently diagnosed with lung adenocarcinoma or squamous cell carcinoma","Primary patients prior to resection","Candidate for surgery (patients are qualified for inclusion if surgery or radiation treatment are agreed to)","Baseline PET\u002FCT imaging performed at Stephenson Cancer Center available and performed within previous 30 days",[59,60,61,62,63],"Recurrent tumor(s)","Nodal or metastatic tumor (multiple lung tumors are acceptable)","Pregnant patients","Patients unable to provide informed consent","Prisoners","Inclusion Criteria:\n\n* 18 years or older\n* Agree to sign consent and follow study requirements\n* Recently diagnosed with lung adenocarcinoma or squamous cell carcinoma\n* Primary patients prior to resection\n* Candidate for surgery (patients are qualified for inclusion if surgery or radiation treatment are agreed to)\n* Baseline PET\u002FCT imaging performed at Stephenson Cancer Center available and performed within previous 30 days\n\nExclusion Criteria:\n\n* Recurrent tumor(s)\n* Nodal or metastatic tumor (multiple lung tumors are acceptable)\n* Pregnant patients\n* Patients unable to provide informed consent\n* Prisoners",[66,67],"ADULT","OLDER_ADULT",[69,87],{"facility":70,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":84},"OU Medical Center Hospital","Oklahoma City","Oklahoma","73106","United States",[76,81],{"name":77,"role":78,"phone":79,"email":80},"Theresa J Lander","CONTACT","4054015633","theresa-lander@ou.edu",{"name":82,"role":83},"James M Reinersman, MD","PRINCIPAL_INVESTIGATOR",{"lat":85,"lon":86},35.46756,-97.51643,{"facility":88,"city":71,"state":72,"zip":73,"country":74,"contacts":89,"geoPoint":92},"Stephenson Cancer Center",[90],{"name":91,"role":78,"phone":79,"email":80},"Theresa Lander",{"lat":85,"lon":86},[94,97],{"name":77,"role":78,"phone":95,"phoneExt":96,"email":80},"405-271-8001","39509",{"name":98,"role":78,"phone":99,"email":100},"Matthew R Reinersman, MD","405-271-4505","matthew-reinersman@ou.edu",[102],{"name":103,"affiliation":12,"role":83},"Matthew Reinersman, MD",[105],{"pmid":106,"type":107,"citation":108},"34567289","RESULT","Bushnell DM, Atkinson TM, McCarrier KP, Liepa AM, DeBusk KP, Coons SJ; Patient-Reported Outcome Consortium's NSCLC Working Group. Non-Small Cell Lung Cancer Symptom Assessment Questionnaire: Psychometric Performance and Regulatory Qualification of a Novel Patient-Reported Symptom Measure. Curr Ther Res Clin Exp. 2021 Aug 26;95:100642. doi: 10.1016\u002Fj.curtheres.2021.100642. eCollection 2021.",[110],{"label":111,"url":112},"FDA instructions for when an IND is required","https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Finvestigational-new-drug-ind-application\u002Find-application-procedures-exemptions-ind-requirements",{"nct_id":4,"conditions":114,"biomarkers":118},[115,116,117],"Lung Adenocarcinoma","Lung Non-Small Cell Carcinoma","Lung Squamous Cell Carcinoma",[],{"nct_id":4,"found":14,"summary":120,"prompt_version":120},null]