[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nob Hill Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100659520","phase-1-study-using-a-drug-device-combination-product-to-determine-safety-tolerability-and-antitumor-activity-for-patients-with-advanced-non-small-cell-lung-cancer-100659520",false,"NCT07864584","Study Using a Drug-device Combination Product to Determine Safety, Tolerability and Antitumor Activity for Patients With Advanced, Non-small Cell Lung Cancer","A Phase 1\u002F2 Open-label, Multi-Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of NHT102 (5-Azacytidine Dry Powder Formulation Delivered by a Novel Inhalation Delivery System) in Patients With Advanced Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Age ≥18 years\n* Able to provide informed consent\n* Able to perform acceptable and reproducible spirometry per ATS criteria\n* Able to perform inhalation maneuver\n* Histologically or cytologically confirmed NSCLC (squamous, adenocarcinoma, or large cell undifferentiated)\n* Stage I-III NSCLC per AJCC 9th edition with recurrent or persistent thoracic confined disease\n* Prior therapy with curative intent completed\n* Actionable genomic alterations must have been treated or offered appropriate targeted therapy\n* Not eligible for additional curative therapy\n* At least one measurable lung lesion per RECIST v1.1 (measurable extra-pulmonary thoracic lesions do not qualify unless a measurable lung lesion is also present)\n* ECOG performance status ≤2\n* Life expectancy ≥12 weeks\n* Adequate hematologic, renal, hepatic, and cardiovascular function\n* Washout from prior therapy ≥30 days or ≥5 half lives\n* Adequate pulmonary reserve: FEV1 ≥50% predicted, FEV1\u002FFVC ≥45%, and DLCO ≥50% predicted\n* No growth factor support, transfusions, or albumin within 14 days prior to first dose\n* Resolution of adverse effects of prior therapy to Grade ≤1 (except fatigue, alopecia, and peripheral neuropathy)\n* Contraception requirements for WOCBP and fertile men\n* Agreement to refrain from smoking or inhaled substances during treatment\n\nExclusion Criteria:\n\n* Systemic metastases beyond the lung, thoracic lymph nodes, or mediastinum region\n* Anticancer therapy within 30 days or 5 half-lives, or current immunomodulator requirement\n* Hypersensitivity to study drug or device components\n* Concurrent anticancer therapy or immunomodulators\n* Systemic or inhaled corticosteroids (exceptions apply)\n* Active smokers within past 6 months\n* Severe airway disease (criteria defined)\n* Radiation therapy within 6 months\n* Contraindication to study procedures\n* Other malignancies except specified low risk types\n* Major surgery within 4 weeks\n* Clinically significant cardiovascular disease\n* Uncontrolled medical conditions\n* Active infection requiring IV therapy\n* Live vaccine within 2 weeks of Cycle 1 Day 1\n* Bleeding disorder unrelated to cancer\n* Pregnancy or breastfeeding","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","There are 3 parts to this clinical trial. The goal of this clinical trial (NHT102-001) is to learn how safe NHT102 is, what dose works best, and whether it can help treat advanced non-small cell lung cancer (NSCLC) that has come back or remained after earlier treatment and is still confined to the lung \u002F chest region by providing targeted inhaled treatment directly to the lungs. NHT102 is a dry powder that participants breathe in through a mouthpiece using an investigational inhalation device. Doses are given at the study site by trained staff, not at home. NHT102 is taken on days 1-5 and days 15-19 of a 28-day cycle.\n\nThe main questions this clinical trial aims to answer are:\n\nPart 1 (Dose Escalation): To look at up to five different increasing dose levels of NHT102 to see if they are safe and well-tolerated and if the body absorbs the medicine from the lungs. To see if up to two dose levels studied are not only safe, but also make the cancer slow its growth or lessen its spread. And to see the highest dose that is tolerated by participants.\n\nPart 2 (Dose Optimization): To further study at up to two dose levels from Part 1 and randomly assign participants in equal numbers to one of them to learn more about NHT102's safety, how well the drug is absorbed from the lungs and how well each dose level works against the NSCLC after at least 4 months. Then identify which of the two doses is chosen for further study.\n\nPart 3 (Dose Expansion): Take the dose chosen in from Part 2 and study it in more patients to continue look at the drug safety, how much of it is absorbed into the body from the lungs and if it works to stop or reduce the spread of NSCLC.\n\nParticipants will:\n\n* Take NHT102 at the study site daily on days 1-5 days and days 15-19 during a 28-day cycle for as long as it is helping them and they can tolerate it. Treatment stops if the cancer worsens, if side effects become too difficult to manage, or if the participant or their doctor decides to stop.\n* Tell doctors and staff about all medications they are taking, any issues with their study medication and all side effects they may be having whether they are taking the medication that day or not.\n* Return for a safety visit about 30 days after their last dose, then receive phone calls about 3 months and 6 months later to check on their health.",[27],"NSCLC (Advanced Non-small Cell Lung Cancer)",[29,30],"Lung Cancer","Non-small cell","NOT_YET_RECRUITING","2026-10-02",{"date":34,"type":35},"2026-10-08","ACTUAL",{"date":37,"type":20},"2027-01-11",{"date":39,"type":20},"2030-07-12",{"name":41,"class":42},"Nob Hill Therapeutics, Inc.","INDUSTRY",""]