[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-non-small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-non-small-cell-lung-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,47,87,114,138,158,181,209,231,260,281,314,337],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100644960","phase-1-inhaled-cromolyn-sodium-in-patients-with-locally-advanced-lung-cancer-100644960",false,"NCT07675876","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","CS","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","ALL","18 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","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.",[27,28],"Locally Advanced Non-Small Cell Lung Cancer","Lung Adenocarcinoma",[30,31,28,32,33],"local advanced lung cancer","Stage 3 lung cancer","Cromolyn Sodium","Dry Powder Inhaler(DPI)","NOT_YET_RECRUITING","2026-06-29",{"date":37,"type":38},"2026-07-01","ACTUAL",{"date":40,"type":21},"2026-08",{"date":42,"type":21},"2027-08",{"name":44,"class":45},"Carcinex Inc","INDUSTRY",2,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":70,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":86},"100521172","phase-1-a-study-of-therapeutic-drug-monitoring-based-atezolizumab-dosing-100521172","NCT06066138","A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing","A Feasibility Phase I Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing","* INCLUSION CRITERIA:\n* Participants with a locally advanced or metastatic pathologically confirmed cancer whose NCI Licensed Independent Practitioner (LIP) determined they are candidates for treatment with atezolizumab, either alone or in combination with other FDA-approved drug(s), for example, TMB-high, PDL-1 positive, or other disease states that respond to PD(L)-1 inhibitors. Regimens with atezolizumab alone or in combination with agents that have previously demonstrated safety in published clinical trials may be used. An LIP may be either an MD, DO, PA, or NP and must be qualified for oncologic management per institutional practice.\n* Age \\>=18 years old.\n* Measurable disease per RECIST 1.1 criteria.\n* ECOG performance status of 0-2.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count (ANC) \\>=1,200\u002Fmicroliter\n  * Hemoglobin \\>9.0 g\u002FdL\n  * Platelets \\>=75,000\u002Fmicroliter\n  * Total bilirubin \\\u003C= 1.5 mg\u002FdL, except in participants with Gilbert s Syndrome who must have a total bilirubin less than 3.0 mg\u002FdL\n  * Aspartate aminotransferase (AST) \u002F Alanine aminotransferase (ALT) \\\u003C=2.5 X institutional upper limit of normal (ULN)\n  * Creatinine Clearance (CrCl) \\>=30 mL\u002Fmin\u002F1.73 m\\^2 (calculated using the Cockcroft-Gault formula).\n  * Serum albumin \\> 3 g\u002FdL\n* Individuals of child-bearing potential (IOCBP) must agree to use a highly effective method of contraception (hormonal, intrauterine device (IUD), surgical sterilization) for the duration of the study treatment and up to 5 months after the last dose of the atezolizumab (restriction period). NOTE: abstinence, defined as no vaginal heterosexual intercourse within 6 months prior to the treatment initiation and willingness to continue abstinence for restriction period is also acceptable.\n\nIndividuals who can father children must agree to use an effective method of contraception (barrier, surgical sterilization) at study entry and up to 5 months after the last dose of the atezolizumab.\n\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through 5 months after atezolizumab treatment discontinuation.\n* Participants with history of human immunodeficiency virus (HIV) infection must be on effective anti-retroviral therapy and have undetectable viral load.\n* Participants with history of chronic hepatitis B virus (HBV) infection must be on suppressive therapy, if indicated, and have undetectable HBV viral load.\n* Participants with history of hepatitis C virus (HCV) infection must have an undetectable HCV viral load.\n* Participants with history of treated brain metastases must have follow-up brain imaging after central nervous system (CNS)-directed therapy with no evidence of progression.\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible.\n* All participants must have the ability to understand and willingness to sign a written informed consent.\n\nEXCLUSION CRITERIA:\n\nParticipants who have received an investigational agent for treating participants' disease not approved by FDA within 28 days prior to study treatment initiation.\n\n* Participants who have received immunostimulatory agents, including, but not limited to, IFN-alpha, IFN-gamma, or IL-2, immunosuppressive medications, and any herbal medicines within 1 month prior to study treatment initiation. NOTE: Physiologic doses of systemic steroids (\\\u003C= 10 mg prednisone or equivalent) or local (e.g., topical, nasal, intraarticular, inhaled) steroid use is permitted.\n* Prior treatment with CD137 agonists\n* Prior treatment with immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies; (including atezolizumab) within 28 days prior to study treatment initiation.\n* History or risk of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions:\n\n  * Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone.\n  * Participants with controlled Type 1 diabetes mellitus on a stable insulin regimen.\n  * Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., participants with psoriatic arthritis would be excluded) are permitted provided all of the following conditions are met:\n\n    * Rash must cover less than 10% of body surface area (BSA)\n    * Disease is well controlled at screening and only requiring low potency topical steroids\n    * No acute exacerbations of underlying condition within 12 months prior to study treatment initiation (not requiring psoralen plus ultraviolet A radiation \\[PUVA\\], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids) within 12 months prior to study treatment initiation.\n* Persisting toxicity related to prior therapy of Grade \\>1 per Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 unless deemed not clinically significant or irreversible. NOTE: alopecia and sensory neuropathy Grade \\\u003C= 2 are acceptable.\n* Participants with prior allogeneic bone marrow transplantation or prior solid organ transplantation.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment\n* Active tuberculosis at screening\n* History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. Note: History of radiation pneumonitis in the radiation field (fibrosis) is permitted\n* Participants with significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident (https:\u002F\u002Fwww.heart.org\u002Fen\u002Fhealth-topics\u002Fheart-failure\u002Fwhat-isheart-failure\u002Fclasses-of-heart-failure), unstable arrhythmia, or unstable angina within 3 months prior to study treatment initiation.\n* Pregnancy (confirmed with Beta-Human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test in IOCBP performed at screening).\n* Uncontrolled intercurrent illness or situation that would limit compliance with study requirements.","120 Years",{"count":56,"type":21},30,[24],"Background:\n\nA type of drug called monoclonal antibody immune checkpoint inhibitors are often used in cancer treatment. These drugs help the body s immune system fight cancer by blocking proteins that cause cancer cells to grow. One of these drugs (atezolizumab) is approved to treat certain cancers. Researchers want to find out if lower doses of this drug might provide the same benefit with fewer adverse effects.\n\nObjective:\n\nTo test different doses and timing of atezolizumab for people with cancer.\n\nEligibility:\n\nPeople aged 18 years and older with cancer that has spread locally or to other organs. They must be eligible for treatment with the study drug.\n\nDesign:\n\nParticipants will be screened. They will have blood tests and imaging scans. They will provide a sample of tissue from their tumor.\n\nAtezolizumab is administered through a tube attached to a needle inserted into a vein in the arm. Participants will take this drug alone or combined with other drugs prescribed for their care.\n\nThe first 2 treatments will be done per the FDA recommended dose and schedule. Before administering the second dose of the study drug, researchers will check the level of the drug in the participant s blood. Depending on those results, their 3rd dose will be scheduled 2 to 6 weeks later.\n\nFor the 3rd dose of the study drug, participants will switch to the FDA minimum dosage. Dosages of any other drugs will not change.\n\nResearchers will continue to test the levels of the drug in participants blood before each treatment for 16 weeks. After that, these levels will be tested every 3 months.\n\nStudy treatment may last up to 2 years.",[60,61,62,63,64,65,66,67,68,69],"Locally Advanced Alveolar Soft Part Sarcoma","Metastatic Alveolar Soft Part Sarcoma","Locally Advanced Non Small Cell Lung Cancer","Metastatic Non Small Cell Lung Cancer","Locally Advanced Small Cell Lung Cancer","Metastatic Small Cell Lung Cancer","Locally Advanced Hepatocellular Carcinoma","Metastatic Hepatocellular Carcinoma","Locally Advanced Melanoma","Metastatic Melanoma",[71,72,73,74],"PD-L1","PD-1","Tecentriq","Immunotherapy","RECRUITING","2026-06-03",{"date":78,"type":38},"2026-06-04",{"date":80,"type":38},"2025-11-04",{"date":82,"type":21},"2028-01-31",{"name":84,"class":85},"National Cancer Institute (NCI)","NIH",1,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":86},"100616772","phase-2-neoadjuvant-sbrt-followed-by-sintilimab-plus-chemotherapy-for-n3-positive-nsclc-100616772","NCT07309952","Neoadjuvant SBRT Followed by Sintilimab Plus Chemotherapy for N3-Positive NSCLC","Neoadjuvant Stereotactic Body Radiotherapy Followed by Sintilimab Plus Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer With Contralateral Mediastinal (N3) Lymph Node Metastasis: A Prospective Phase II Clinical Trial","SACTION 2501","Inclusion Criteria:\n\n1. Voluntary Participation: The patient volunteers to participate and signs a written informed consent form.\n2. Pathology and Staging: Cytologically or histologically confirmed, previously untreated non-small cell lung cancer (NSCLC) with contralateral mediastinal lymph node involvement (N3), classified as stage IIIB or IIIC according to the 9th edition of the International Association for the Study of Lung Cancer (IASLC) staging manual. Baseline staging must be performed with either PET\u002FCT or a combination of contrast-enhanced CT of chest\u002Fabdomen + bone scan + brain MRI.\n3. Surgical Feasibility: The lung lesion is considered \\*\\*potentially resectable as evaluated by a multidisciplinary team that includes a thoracic surgeon.\n4. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n5. Adequate Organ Function:\n\n(1) Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL (2) Platelet count ≥ 100 x 10\\^9\u002FL (3) Hemoglobin \\> 9.0 g\u002FdL (4) Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) ≥ 40 mL\u002Fmin (5) Aspartate aminotransferase (AST)\u002FAlanine aminotransferase (ALT) ≤ 3 x ULN (6) Total bilirubin ≤ 1.5 x ULN (7) Forced expiratory volume in 1 second (FEV1) ≥ 1.2 L or \\> 40% of predicted value (8) International normalized ratio (INR) and activated partial thromboplastin time (aPTT) within normal limits.\n\n6\\. Age: Between 18 and 75 years old.\n\nExclusion Criteria\n\n1. Autoimmune Disease: Active or suspected autoimmune disease. Exception: Patients with vitiligo, type I diabetes mellitus, or hypothyroidism requiring only hormone replacement therapy (e.g., Hashimoto's thyroiditis) with no signs of active disease may be enrolled.\n2. Immunosuppressive Therapy: Requires systemic corticosteroid therapy (\\>10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days prior to enrollment.\n3. Prior Chest Radiotherapy: History of prior radiotherapy to the chest.\n4. Active Bleeding: Presence of clinically significant active bleeding prior to treatment.\n5. Severe Organ Dysfunction: Severe cardiac, pulmonary, hepatic, or renal dysfunction, hematopoietic system disease, or cachexia, as judged by the investigator to be intolerable to chemo-radiotherapy.\n6. Poorly Controlled Diabetes: History of diabetes mellitus for \\>10 years with unsatisfactory glycemic control.\n7. Interstitial Lung Disease: History of interstitial lung disease or non-infectious pneumonitis.\n8. Driver Gene Mutations: NSCLC with known activating EGFR mutations or ALK fusion gene positivity.\n9. Other Malignancies:\n\n   Excluded: History of other active malignancies within the past 2 years, except for adequately treated non-melanoma skin cancer or carcinoma in situ (e.g., bladder, gastric, colorectal, endometrial, cervical, melanoma, or breast).\n\n   Exception: Patients with other malignancies who have achieved complete remission for ≥2 years and do not require additional anti-tumor therapy during this study may be enrolled.\n10. Compliance\u002FUnderstanding: Medical, psychological, or physiological conditions that, in the investigator's judgment, prevent the patient from completing the study or understanding the study information.\n11. Prior Immune Therapy: Previous treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other drug targeting T-cell co-stimulation or checkpoint pathways.\n12. Active Viral Infection:\n\n(1) Active Hepatitis B (HBsAg positive AND HBV DNA ≥ 2000 IU\u002FmL or 10\\^4 copies\u002FmL).\n\n(2) Active Hepatitis C (HCV antibody positive AND HCV RNA above the lower limit of detection).\n\n13\\. HIV\u002FAIDS: Known positive test for human immunodeficiency virus (HIV) or diagnosed acquired immunodeficiency syndrome (AIDS).\n\n14\\. Allergy: Known history of hypersensitivity to sintilimab, any of the chemotherapy agents used, or any of their excipients.\n\n15\\. Pregnancy\u002FLactation: Pregnant or breastfeeding women. 16. Metastatic Disease: Presence of supraclavicular lymph node metastasis or distant metastasis.","75 Years",{"count":97,"type":21},28,[99],"PHASE2","This is a Phase II clinical trial evaluating the efficacy and safety of a new treatment approach for patients with locally advanced non-small cell lung cancer (NSCLC) that has spread to lymph nodes on the opposite side of the chest (known as N3 lymph node involvement).\n\nThe study will enroll 28 patients aged 18 to 75 years with previously untreated, potentially resectable NSCLC classified as stage IIIB-IIIC. Participants will receive a combination of stereotactic body radiation therapy (SBRT) to the primary lung tumor, followed by two cycles of sintilimab (an immunotherapy drug) plus platinum-based chemotherapy before surgery.\n\nThe main goals of the study are to see whether this treatment can shrink or eliminate cancer in the contralateral mediastinal lymph node (lymph node downstaging) and allow more patients to undergo curative surgery. Secondary goals include assessing pathological response rates, surgical outcomes, survival, and safety.\n\nPatients will be closely monitored during and after treatment, with follow-up visits planned for up to 5 years after surgery.",[27,102,103],"Stage IIIb Non-small Cell Lung Cancer","Stage IIIC Non-Small Cell Lung Cancer","2026-04-24",{"date":106,"type":38},"2026-04-30",{"date":108,"type":38},"2025-12-31",{"date":110,"type":21},"2032-10-31",{"name":112,"class":113},"Yang Hong","OTHER",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":95,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":4},"100633190","phase-1-centrally-confined-8gy1f-to-tumor-core-followed-by-concurrent-chemoradiotherapy-for-unresectable-stage-iii-nsclc-100633190","NCT07523464","Centrally Confined 8Gy\u002F1f to Tumor Core Followed by Concurrent Chemoradiotherapy for Unresectable Stage III NSCLC","A Single-Arm Phase I Clinical Study of Centrally Confined 8 Gy\u002F1 Fraction Immune-Priming Radiotherapy to the Tumor Core Followed by Definitive Concurrent Chemoradiotherapy in Unresectable Stage III Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Age 18 to 75 years;\n* Histologically or cytologically confirmed NSCLC;\n* Unresectable stage III disease according to the AJCC 8th edition;\n* Negative for driver gene alterations;\n* Considered suitable for definitive cCRT by MDT discussion or investigator judgment;\n* ECOG performance status 0-1;\n* Presence of a clearly delineable pulmonary primary lesion allowing centrally confined priming treatment planning;\n* Adequate major organ function as required by the study;\n* Willingness to participate and provision of written informed consent.\n\nExclusion Criteria:\n\n* Presence of distant metastasis;\n* Positive driver gene alterations;\n* Prior definitive thoracic radiotherapy or prior systemic antitumor treatment for the current disease;\n* Active autoimmune disease or need for long-term systemic immunosuppressive therapy;\n* Active interstitial lung disease, prior severe radiation pneumonitis, or immune-related pneumonitis;\n* Special primary tumor location such that safety constraints for centrally confined priming radiotherapy cannot be met;\n* Primary lesion immediately adjacent to the main bronchus, carina, major vessels, or esophagus, such that the investigator judges the lead-in intervention to be excessively risky;\n* Pregnancy or lactation;\n* Any other condition that, in the opinion of the investigator, makes the patient unsuitable for this study.",{"count":122,"type":21},24,[24],"This is a single-center, prospective, open-label, single-arm phase I exploratory study designed to evaluate the safety and feasibility of a novel central immune-priming radiotherapy strategy in patients with unresectable stage III non-small cell lung cancer (NSCLC). The investigational approach consists of a single 8 Gy\u002F1 fraction radiotherapy dose delivered to the central subregion of the primary tumor, with rapid dose fall-off to keep the peripheral tumor margin dose below 4 Gy, followed by one cycle of PD-(L)1 inhibitor, and then standard concurrent chemoradiotherapy (cCRT) approximately one week later. Patients without disease progression after cCRT will subsequently receive consolidation immune checkpoint inhibitor therapy.\n\nThe primary objective is to assess the safety and feasibility of this lead-in immune-priming strategy, particularly whether it can be integrated into standard cCRT and subsequent immunotherapy without unacceptable toxicity or treatment delay. The primary endpoint is the dose-limiting toxicity (DLT) rate, with the DLT observation window defined from initiation of the priming radiotherapy to 6-8 weeks after completion of cCRT. Secondary objectives include the on-time initiation rate of cCRT, cCRT completion rate, initiation rate of consolidation immunotherapy, acute and subacute toxicity profile, preliminary efficacy signals, and dynamic changes in peripheral lymphocyte counts. Exploratory analyses will investigate peripheral immune cell subsets, circulating tumor DNA (ctDNA), T-cell receptor (TCR) clonality, cytokine changes, and their associations with toxicity and clinical outcomes. The study will adopt a safety run-in plus expansion design, with an initial cohort of 6 patients and expansion to 24 patients if safety is acceptable.",[126,127],"Locally-Advanced Non-Small Cell Lung Cancer","Radiotherapy","2026-04-05",{"date":130,"type":38},"2026-04-13",{"date":132,"type":21},"2026-06-01",{"date":134,"type":21},"2028-12-30",{"name":136,"class":137},"Anhui Provincial Hospital","OTHER_GOV",{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":86},"100610174","phase-1-nbtxr3-with-radiation-therapy-alone-for-locally-advanced-non-small-cell-lung-cancer-100610174","NCT07224152","NBTXR3 With Radiation Therapy Alone for Locally-advanced Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. Signed informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.\n2. Age ≥ 18 years.\n3. ECOG Performance Status 0-2\n4. Biopsy proven stage I-III NSCLC.\n5. Participant deemed medically inoperable by the investigator or treating physician, or patient declines surgery.\n6. No prior or concurrent systemic therapies within 4 weeks of injection. Patient may receive up to 1 line of prior systemic therapy prior to starting RT.\n7. Amenable to undergo bronchoscopic (EBUS, CBCT) or CT-guided injection of NBTXR3 as per investigator or treating physician.\n\n   a. Up to 4 lung lesions may be injected with NBTXR3, including the primary tumor and involved lymph node(s) All injected lesions must be radiated.\n8. The target lesion(s) should be measurable on cross sectional imaging (RECIST 1.1), Nodal target lesions must be ≥15mm (short axis) based on CT (slice thickness of 5mm or less) or MRI.\n9. Adequate screening laboratory values\n\n   1. Hemoglobin ≥ 8.0 g\u002FdL\n   2. Absolute Neutrophil Count (ANC) ≥ 1,500\u002Fmm3\n   3. Platelet Count ≥ 100,000\u002Fmm3\n   4. Creatinine ≤ 1.5 x upper limit of normal (ULN)\n   5. Calc. Creatinine Clearance ≥ 30 mL\u002Fmin\n   6. Total Bilirubin ≤ 2.0 mg\u002FdL\n   7. AST \u002F ALT ≤ 3.0 x upper limit of normal (ULN) or 5.0 x ULN if known liver metastases\n   8. Serum albumin ≥ 3.0 g\u002FdL Negative urine or serum pregnancy test ≤ 7 days of NBTXR3 injection in all females of child-bearing potential.\n\nExclusion Criteria:\n\n1. Unable to undergo NBTXR3 injection via bronchoscopic or CT-guided approach\n2. Unable to undergo radiation therapy for any reason\n3. Female patients who are pregnant or breastfeeding.\n4. Women of child-bearing potential and their male partners who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period. Acceptable methods of contraception are those that, alone or in combination, result in a failure rate of \\\u003C 1% per year when used consistently and correctly.\n5. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.\n6. At screening, past medical history of:\n\n   1. Interstitial lung disease\n   2. Drug related pneumonitis\n   3. Radiation therapy to lung or other intrathoracic organs (e.g. prior breast radiation okay)\n7. Has received any approved or investigational anti-neoplastic or immunotherapy agent within 4 weeks prior to NBTXR3 injection\n8. Receipt of more than 1 line of systemic therapy prior to RT\n9. Use of concurrent systemic therapy (chemotherapy, immunotherapy, targeted therapy) or patient participation on another therapeutic clinical trial.\n10. Known contraindication to iodine-based or gadolinium-based IV contrast.\n11. Active malignancy, in addition to locoregional recurrent NSCLC, with the exception of definitively treated and relapse free within 1 year from diagnosis of non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or patients with another primary malignancy who are definitely treated and relapse free with at least 2 years elapsed since the diagnosis of the other primary malignancy.\n12. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, recent severe pulmonary infection, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia, or psychiatric illness that would limit compliance with treatment.\n13. Known active, uncontrolled (high viral load) HIV or hepatitis B or hepatitis C infection\n14. Cognitively impaired subjects",{"count":145,"type":21},40,[24,99],"This is a single institution, single arm phase I\u002FII study of NBTXR3 with radiation therapy for stage I-III advanced non-small cell lung cancer patients who are not candidates for chemotherapy or surgical resection.",[126],"2026-03-31",{"date":151,"type":38},"2026-04-06",{"date":153,"type":38},"2026-03-27",{"date":155,"type":21},"2030-08-30",{"name":157,"class":113},"M.D. Anderson Cancer Center",{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":22,"phases":167,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":86},"100605620","rapart-in-locally-advanced-non-small-cell-lung-cancer-patients-100605620","NCT07164885","RAPART in Locally Advanced Non-small Cell Lung Cancer Patients","Phase II\u002FIII Randomized Clinical Trial of Radiosensitivity-Assisted Personalized Adaptive RadioTherapy (RAPART) in Locally Advanced Non-small Cell Lung Cancer Patients","Inclusion Criteria:\n\n* Adult research participants, aged over 18 years old;\n* Non small cell lung cancer that requires pathological confirmation;\n* All stage 3 unresectable non-small cell lung cancer, including stage correction after MDT and stage downgrading after treatment (4 → 3), and stage upregulation due to disease progression (2 → 3);\n* ECOG physical condition is 0-2;\n* In addition to study participants who have not received any treatment, study participants who have undergone surgery, chemotherapy, immunotherapy, and targeted therapy are also eligible for enrollment.\n\nExclusion Criteria:\n\n* Prisoners who are not convenient for close clinical follow-up;\n* Study participants with contraindications to radiation therapy.",{"count":166,"type":21},911,[168],"NA","This is a Phase II\u002FIII randomized clinical trial of Radiosensitivity-Assisted Personalized Adaptive Radiotherapy Technology (RAPART) in locally advanced non-small cell lung cancer patients. The main objective is to test the overall improvement of overall survival (OS), progression free survival (PFS), and local progression free survival (LPFS) of unresectable stage III NSCLC under standard and non-standard mixed treatment conditions compared to conventional 60Gy radiotherapy.",[171],"Locally Advanced Non-small Cell Lung Cancer","2025-12-01",{"date":174,"type":38},"2025-12-02",{"date":176,"type":38},"2025-02-17",{"date":178,"type":21},"2027-12-30",{"name":180,"class":113},"Capital Medical University",{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":95,"enrollmentInfo":188,"targetDuration":4,"studyType":22,"phases":190,"briefSummary":192,"conditions":193,"keywords":194,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":208},"100596991","phase-3-hypofractionated-versus-conventional-chemoradiotherapy-followed-by-consolidative-immunotherapy-in-locally-advanced-nsclc-100596991","NCT07052669","Hypofractionated Versus Conventional Chemoradiotherapy Followed by Consolidative Immunotherapy in Locally Advanced NSCLC","Hypofractionated Chemoradiotherapy Followed by Consolidative Immunotherapy Versus Conventional Fractionated Chemoradiotherapy Followed by Consolidative Immunotherapy in Locally Advanced Non-small Cell Lung Cancer: A Randomized, Phase III Controlled Study","Inclusion Criteria:\n\n* Signed and Dated Informed Consent: Written informed consent must be provided prior to any study procedures, with the consent form signed and dated by the participant.\n* Age Range: Male or female patients aged 18 to 75 years.\n* Diagnosis: Patients must have locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC), with histological or cytological confirmation of the diagnosis.\n* Previous Treatment: Treatment-naïve or previously treated with induction chemotherapy ± immunotherapy.\n* Tumor Sample Requirement: Tumor tissue samples must be provided, and they should be sufficient for analysis. The samples must be unstained and archived.\n* Driver gene testing: EGFR wild-type, ALK rearrangement-negative.\n* Life Expectancy: Patients must have an expected survival of at least 12 weeks.\n* Performance Status (PS): The patient's WHO Performance Status (PS) must be 0 or 1.\n* Pregnancy Testing: Postmenopausal women, or women who have had a negative urine or serum pregnancy test within 14 days before the study medication (HCG sensitivity ≥ 25 IU\u002FL or equivalent).\n* Breastfeeding: Women must not be breastfeeding.\n* Women of childbearing potential (WOCBP) must agree to use contraception during the study treatment period and for 5 months after the last dose of the investigational drug (i.e., 30 days \\[ovulation cycle\\] + approximately 5 half-lives of the study drug).\n* Men who have sexual relations with WOCBP must agree to use contraception during the study treatment period and for 7 months after the last dose of the investigational drug (i.e., 90 days \\[sperm renewal cycle\\] + approximately 5 half-lives of the study drug).\n* Males with no sperm production are exempt from contraception requirements. WOCBP who are not sexually active are exempt from contraception but must still undergo pregnancy testing as outlined above.\n* Organ and Bone Marrow Function: The following laboratory parameters must be met:\n\nForced expiratory volume in 1 second (FEV1) ≥ 800 mL Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL Platelets ≥ 100 × 10⁹\u002FL Hemoglobin ≥ 9.0 g\u002FdL Calculated creatinine clearance using the Cockcroft-Gault formula ≥ 50 mL\u002Fmin Serum bilirubin ≤ 1.5 × upper limit of normal (ULN) AST and ALT ≤ 2.5 × ULN\n\nExclusion Criteria:\n\n* Patients meeting any of the following criteria should not be enrolled in the study:\n* Concurrent participation in another clinical trial, except for observational (non-interventional) studies.\n* Histological subtype of mixed small-cell and non-small-cell lung cancer. Use of immunosuppressive drugs within 28 days before treatment, except for intranasal or inhaled corticosteroids at physiological doses or systemic corticosteroids ≤10 mg\u002Fday of prednisone or equivalent.\n* Major surgery within 4 weeks prior to enrollment (excluding procedures for vascular access).\n* History or active autoimmune diseases within the past two years.\n* Active or a history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).\n* History of primary immunodeficiency.\n* History of organ transplantation requiring immunosuppressive therapy.\n* Average corrected QT interval (QTc) ≥470 ms calculated from three ECG cycles using the Bazett formula.\n* Uncontrolled comorbidities, including but not limited to: Persistent or active infections. Symptomatic congestive heart failure. Poorly controlled hypertension. Unstable angina. Cardiac arrhythmias. Active peptic ulcer disease or gastritis. Active bleeding disorders. Hepatitis C or HIV infection. HBsAg-positive patients with HBV DNA \\>500 IU\u002FmL. Mental or social conditions that may limit adherence to study requirements or compromise the ability to provide informed consent.\n* Known history of tuberculosis.\n* Receipt of a live attenuated vaccine within 30 days before study initiation or planned during the study period.\n* History of another primary malignancy within the past 5 years, except for adequately treated basal or squamous cell carcinoma of the skin or in situ cervical cancer.\n* Pregnancy, breastfeeding, or not using effective contraception (for men and women of reproductive potential).\n\nPatients in the experimental group should not proceed to concurrent chemoradiotherapy if any of the following criteria are met:\n\n* Presence of distant metastases.\n* Locoregional progression making definitive concurrent chemoradiotherapy unfeasible due to normal tissue dose constraints (assessed by the radiation oncologist).\n* WHO performance status score of 2-4.\n* Impaired organ or bone marrow function, including:\n\nForced expiratory volume in 1 second (FEV1) \\\u003C800 mL. Absolute neutrophil count (ANC) \\\u003C1.5 × 10⁹\u002FL. Platelets \\\u003C100 × 10⁹\u002FL. Hemoglobin \\\u003C9.0 g\u002FdL. Creatinine clearance (Cockcroft-Gault formula) \\\u003C50 mL\u002Fmin. Serum bilirubin \\>1.5 × upper limit of normal (ULN). AST and ALT \\>2.5 × ULN.\n\n\\- Patient withdrawal from the study.\n\nPatients should not proceed to consolidation immunotherapy if any of the following criteria are met:\n\n* Disease progression during concurrent chemoradiotherapy.\n* Use of immunosuppressive drugs within 28 days before the first dose of tislelizumab, except for physiological doses of intranasal or inhaled corticosteroids or systemic corticosteroids ≤10 mg\u002Fday of prednisone or equivalent. Use of corticosteroids to manage chemoradiotherapy-related toxicity is permitted.\n* Persistent unresolved CTCAE grade \\>2 toxicities from prior chemoradiotherapy.\n* Grade ≥2 pneumonitis resulting from prior chemoradiotherapy.\n* Any prior grade ≥3 immune-related adverse event (irAE) or unresolved irAE \\> grade 1.",{"count":189,"type":21},311,[191],"PHASE3","Consolidative immunotherapy following concurrent chemoradiotherapy, based on the PACIFIC trial, has become the standard treatment for locally advanced non-small cell lung cancer (LANSCLC). Radiotherapy strategies for maximizing efficacy and local control require further investigation. This phase III, randomized controlled clinical trial is to investigate the efficacy and safety of hypofractionated chemoradiotherapy followed by consolidative immunotherapy versus conventional fractionated chemoradiotherapy followed by consolidative immunotherapy in LANSCLC patients.",[27],[195,196,197,198],"Hypofractionated radiotherapy","Conventionally fractionated radiotherapy","Concurrent Chemoradiotherapy","Consolidative immunotherapy","2025-07-19",{"date":201,"type":38},"2025-07-23",{"date":203,"type":38},"2025-07-01",{"date":205,"type":21},"2029-06-30",{"name":207,"class":113},"Sun Yat-sen University",3,{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":95,"enrollmentInfo":216,"targetDuration":4,"studyType":22,"phases":218,"briefSummary":219,"conditions":220,"keywords":222,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":86},"100572548","phase-3-neoadjuvant-immunotherapy-plus-chemotherapy-followed-by-concurrent-chemoradiotherapy-and-consolidative-immunotherapy-for-locally-advanced-non-small-cell-lung-cancer-100572548","NCT06734702","Neoadjuvant Immunotherapy Plus Chemotherapy Followed by Concurrent Chemoradiotherapy and Consolidative Immunotherapy for Locally Advanced Non-small Cell Lung Cancer","Neoadjuvant Immunotherapy Plus Chemotherapy Followed by Concurrent Chemoradiotherapy and Consolidative Immunotherapy Compared With Concurrent Chemoradiotherapy and Consolidative Immunotherapy in Locally Advanced Non-small Cell Lung Cancer: A Randomized, Phase III Controlled Study","Inclusion Criteria:\n\n* Signed and Dated Informed Consent: Written informed consent must be provided prior to any study procedures, with the consent form signed and dated by the participant.\n* Age Range: Male or female patients aged 18 to 75 years.\n* Diagnosis: Patients must have locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC), with histological or cytological confirmation of the diagnosis.\n* Previous Treatment: Patients must not have received prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy.\n* Tumor Sample Requirement: Tumor tissue samples must be provided, and they should be sufficient for analysis. The samples must be unstained and archived.\n* Life Expectancy: Patients must have an expected survival of at least 12 weeks.\n* Performance Status (PS): The patient's WHO Performance Status (PS) must be 0 or 1.\n* Pregnancy Testing: Postmenopausal women, or women who have had a negative urine or serum pregnancy test within 14 days before the study medication (HCG sensitivity ≥ 25 IU\u002FL or equivalent).\n* Breastfeeding: Women must not be breastfeeding.\n* Women of childbearing potential (WOCBP) must agree to use contraception during the study treatment period and for 5 months after the last dose of the investigational drug (i.e., 30 days \\[ovulation cycle\\] + approximately 5 half-lives of the study drug).\n* Men who have sexual relations with WOCBP must agree to use contraception during the study treatment period and for 7 months after the last dose of the investigational drug (i.e., 90 days \\[sperm renewal cycle\\] + approximately 5 half-lives of the study drug).\n* Males with no sperm production are exempt from contraception requirements. WOCBP who are not sexually active are exempt from contraception but must still undergo pregnancy testing as outlined above.\n* Organ and Bone Marrow Function: The following laboratory parameters must be met:\n\nForced expiratory volume in 1 second (FEV1) ≥ 800 mL Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL Platelets ≥ 100 × 10⁹\u002FL Hemoglobin ≥ 9.0 g\u002FdL Calculated creatinine clearance using the Cockcroft-Gault formula ≥ 50 mL\u002Fmin Serum bilirubin ≤ 1.5 × upper limit of normal (ULN) AST and ALT ≤ 2.5 × ULN\n\nExclusion Criteria:\n\n* Patients meeting any of the following criteria should not be enrolled in the study:\n* Concurrent participation in another clinical trial, except for observational (non-interventional) studies.\n* Histological subtype of mixed small-cell and non-small-cell lung cancer. Use of immunosuppressive drugs within 28 days before treatment, except for intranasal or inhaled corticosteroids at physiological doses or systemic corticosteroids ≤10 mg\u002Fday of prednisone or equivalent.\n* Prior treatment with anti-PD-1 or anti-PD-L1 antibodies.\n* Major surgery within 4 weeks prior to enrollment (excluding procedures for vascular access).\n* History or active autoimmune diseases within the past two years.\n* Active or a history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).\n* History of primary immunodeficiency.\n* History of organ transplantation requiring immunosuppressive therapy.\n* Average corrected QT interval (QTc) ≥470 ms calculated from three ECG cycles using the Bazett formula.\n* Uncontrolled comorbidities, including but not limited to: Persistent or active infections. Symptomatic congestive heart failure. Poorly controlled hypertension. Unstable angina. Cardiac arrhythmias. Active peptic ulcer disease or gastritis. Active bleeding disorders. Hepatitis C or HIV infection. HBsAg-positive patients with HBV DNA \\>500 IU\u002FmL. Mental or social conditions that may limit adherence to study requirements or compromise the ability to provide informed consent.\n* Known history of tuberculosis.\n* Receipt of a live attenuated vaccine within 30 days before study initiation or planned during the study period.\n* History of another primary malignancy within the past 5 years, except for adequately treated basal or squamous cell carcinoma of the skin or in situ cervical cancer.\n* Pregnancy, breastfeeding, or not using effective contraception (for men and women of reproductive potential).\n\nPatients in the experimental group should not proceed to concurrent chemoradiotherapy if any of the following criteria are met:\n\n* Presence of distant metastases.\n* Locoregional progression making definitive concurrent chemoradiotherapy unfeasible due to normal tissue dose constraints (assessed by the radiation oncologist).\n* WHO performance status score of 2-4.\n* Impaired organ or bone marrow function, including:\n\nForced expiratory volume in 1 second (FEV1) \\\u003C800 mL. Absolute neutrophil count (ANC) \\\u003C1.5 × 10⁹\u002FL. Platelets \\\u003C100 × 10⁹\u002FL. Hemoglobin \\\u003C9.0 g\u002FdL. Creatinine clearance (Cockcroft-Gault formula) \\\u003C50 mL\u002Fmin. Serum bilirubin \\>1.5 × upper limit of normal (ULN). AST and ALT \\>2.5 × ULN.\n\n\\- Patient withdrawal from the study.\n\nPatients should not proceed to consolidation immunotherapy if any of the following criteria are met:\n\n* Disease progression during concurrent chemoradiotherapy.\n* Use of immunosuppressive drugs within 28 days before the first dose of tislelizumab, except for physiological doses of intranasal or inhaled corticosteroids or systemic corticosteroids ≤10 mg\u002Fday of prednisone or equivalent. Use of corticosteroids to manage chemoradiotherapy-related toxicity is permitted.\n* Persistent unresolved CTCAE grade \\>2 toxicities from prior chemoradiotherapy.\n* Grade ≥2 pneumonitis resulting from prior chemoradiotherapy.\n* Any prior grade ≥3 immune-related adverse event (irAE) or unresolved irAE \\> grade 1.",{"count":217,"type":21},497,[191],"Consolidative immunotherapy following concurrent chemoradiotherapy, based on the PACIFIC trial, has become the standard treatment for locally advanced non-small cell lung cancer (LANSCLC), leading to a 5-year survival rate of over 40%. The optimal timing of radiotherapy combined with immunotherapy still requires further exploration. This phase III, randomized controlled clinical trial is to investigate the efficacy and safety of neoadjuvant immuno-chemotherapy followed by concurrent chemoradiotherapy and consolidative immunotherapy, compared with concurrent chemoradiotherapy and consolidative immunotherapy in LANSCLC patients.",[221,197,74,27],"Neoadjuvant Therapy",[223,197,74,27],"Neoadjuvant therapy",{"date":225,"type":38},"2025-07-24",{"date":227,"type":38},"2024-11-30",{"date":229,"type":21},"2028-11-29",{"name":207,"class":113},{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":22,"phases":240,"briefSummary":241,"conditions":242,"keywords":245,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":86},"100595840","phase-2-radiotherapy-plus-anlotinib-in-la-nsclc-intolerable-to-ccrt-100595840","NCT07037680","Radiotherapy Plus Anlotinib in LA-NSCLC Intolerable to cCRT","Efficiency and Safety of Radiotherapy Combined With Anlotinib in Locally Advanced Non-small Cell Lung Cancer Patients Intolerable to Concurrent Chemoradiotherapy: A Phase II Single-arm Trial","Patients with histologically or cytologically confirmed negative EGFR (including EGFR exon 19 deletion or L858R mutations) or ALK\u002FROS1-mutated locally advanced unresectable NSCLC were screened.\n\nInclusion Criteria:\n\n1. ≥18 years old with no restrictions on sex;\n2. Peripheral tumor, or central lung cancer with non-squamous tissue or a mixed tissue with less than 50% squamous carcinoma;\n3. Eastern cooperative oncology group (ECOG) score ≤2 was required;\n4. Received systemic chemotherapy or combined chemotherapy and immumitherapy for ≥ 4 weeks without progression;\n5. .No cavity inside the tumor, and located ≥ 1 cm of the main pulmonary artery trunk;\n6. No symptoms of hemoptysis;\n7. Adequate hepatic and renal functions with a negative urine protein;\n8. Expected survival of more than 6 months.\n\nExclusion Criteria:\n\n1. currently receiving treatment for malignancies at other sites, except for curable non-melanoma skin cancer and cervical carcinoma in situ;\n2. previous malignancy within five years;\n3. thoracic radiotherapy history, hemoptysis, myocardial infarction or cerebrovascular accident within three months;\n4. uncontrolled or active pulmonary inflammation;\n5. participated in other clinical trials;\n6. Pregnant women.",{"count":239,"type":21},44,[99],"Concurrent chemoradiotherapy (cCRT) is the standard treatment for patients with negative epidermal growth factor receptor (EGFR)-mutated unresectable locally advanced non-small cell lung cancer (LA-NSCLC). However, parts of patients only receive sequential chemoradiotherapy (sCRT) due to various reasons. This phase II study aimed to improve the outcomes of patients receiving sCRT by combining anti-angiogenesis therapy (Anlotinib) during radiotherapy course.We hypothesize that the combination of radiotherapy with anlotinib could improve the 2-year PFS rate from 35% with sCRT to 50. The accrual target was 44 patients.",[27,243,244],"Thoracic Radiotherapy","Safety",[246,247,248,249,250],"thoracic radiotherapy","non-small cell lung carcinoma","locally advanced","safety","Anlotinib","2025-07-03",{"date":253,"type":38},"2025-07-09",{"date":255,"type":38},"2024-01-01",{"date":257,"type":21},"2026-06-30",{"name":259,"class":113},"JIANYANG WANG",{"id":261,"slug":262,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":22,"phases":269,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":86},"100580488","phase-2-neoadjuvant-chemotherapy-combined-with-bispecific-antibody-versus-monoclonal-antibody-in-locally-advanced-nsclc-100580488","NCT06837948","Neoadjuvant Chemotherapy Combined With Bispecific Antibody Versus Monoclonal Antibody in Locally Advanced NSCLC","Neoadjuvant Chemotherapy Combined With Bispecific Antibody Versus Monoclonal Antibody in Locally Advanced Non-Small Cell Lung Cancer: A Multicenter, Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n1. The patient shall sign the Informed Consent Form.\n2. Aged 18 ≥ years.\n3. Histological or cytological diagnosis of NSCLC by needle biopsy, and stage II-III confirmed by imageological examinations (CT, PET-CT or EBUS)，and have not previously received anti-tumor treatment.\n4. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.\n5. Life expectancy is at least 12 weeks.\n6. At least 1 measurable lesion according to RECIST 1.1.\n7. Patients with good function of other main organs (liver, kidney, blood system, etc.)\n8. Patients with lung function can tolerate surgery;\n9. Without systematic metastasis (including M1a, M1b and M1c);\n10. Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of toripalimab (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.\n11. Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of toripalimab (whichever is later).\n\nExclusion Criteria:\n\n1. Patients with lung adenocarcinoma with confirmed EGFR mutations or ALK rearrangements;\n2. Histological evidence of small cell components;\n3. Patients with other malignant tumors within five years prior to the start of this trial;\n4. Having received any systemic anti-cancer treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment, and experimental treatment, etc.;\n5. Concomitant unstable systemic diseases, including active infections, uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg), unstable angina, angina that started within the last 3 months, congestive heart failure (≥New York Heart Association \\[NYHA\\] Class II), myocardial infarction (within 6 months prior to enrollment), severe arrhythmias requiring drug treatment, liver, kidney, or metabolic diseases;\n6. Active, known, or suspected autoimmune diseases, or autoimmune paraneoplastic syndromes requiring systemic treatment;\n7. Allergy to the trial drug;\n8. Currently diagnosed with interstitial lung disease;\n9. Concomitant HIV infection or active hepatitis;\n10. Pregnant or lactating women;\n11. Patients with neurological or psychiatric disorders who are unable to cooperate;\n12. Concurrently participating in another therapeutic clinical study;\n13. Other situations deemed unsuitable for enrollment by the investigator.",{"count":268,"type":21},160,[99],"Surgical intervention remains the primary treatment option for early-stage lung cancer. With the proven efficacy of immunotherapy in the treatment of advanced non-small cell lung cancer (NSCLC), neoadjuvant immunotherapy has increasingly become a focal point of research. Blocking vascular endothelial growth factor (VEGF) not only inhibits the proliferation of vascular endothelial cells and the formation of new blood vessels but also improves the tumor microenvironment and enhances the infiltration of cytotoxic T lymphocytes within it. Simultaneously targeting the VEGF and PD-L1 pathways can create a synergistic anti-cancer effect. PM8002 injection is a bispecific antibody drug that targets both PD-L1 and VEGF, functioning as a dual-action agent that combines immune suppression and anti-angiogenesis. In patients with locally advanced stage II-III NSCLC, neoadjuvant therapy that concurrently targets PD-L1\u002FVEGF in combination with chemotherapy can improve pathological response rates, provided that the safety of the drug combination is maintained. This approach offers additional benefits to patients, prolongs event-free survival (EFS), and improves prognosis.",[27],"2025-02-19",{"date":274,"type":38},"2025-02-20",{"date":276,"type":21},"2025-02-18",{"date":278,"type":21},"2031-12-01",{"name":280,"class":113},"Shanghai Pulmonary Hospital, Shanghai, China",{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":22,"phases":290,"briefSummary":291,"conditions":292,"keywords":300,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":86},"100574161","phase-2-neoadjuvant-befotertinib-combined-bevacizumab-or-platinum-based-double-chemotherapy-for-resectable-locally-advanced-egfr-mutation-positive-non-small-cell-lung-cancer-100574161","NCT06755684","Neoadjuvant Befotertinib Combined Bevacizumab or Platinum-based Double Chemotherapy for Resectable Locally-advanced EGFR Mutation-positive Non-Small Cell Lung Cancer","Neoadjuvant Befotertinib Combined Bevacizumab or Platinum-based Double Chemotherapy for Resectable Locally-advanced EGFR Mutation-positive Non-Small Cell Lung Cancer: a Single-center, Randomized Controlled Trial","Inclusion Criteria:\n\n* NSCLC patient with EGFR sensitive mutation as confirmed by needle biopsy;\n* At stage II-IIIA (TNM Staging, Version 8) as identified by chest CT, PET-CT or\u002Fand EBUS;\n* No systemic metastasis (confirmed by head MRI, whole body bone scan, PET-CT, liver and adrenal CT, etc.);\n* With the feasibility to receive radical surgery ;\n* Good lung function that could tolerate surgical treatment;\n* Aged 18-75 years;\n* At least one measurable tumor foci (the longest diameter measured by CT shall be \\> 10 mm);\n* Other major organs shall function well (liver, kidney, blood system, etc.):\n* ECOG PS score shall be 0-1;\n* The child-bearing female must undergo pregnancy test within 7 days before starting the treatment and the result shall be negative. Reliable contraceptive measures, such as intrauterine device, contraceptive pill and condom, shall be adopted during the trial and within 30 days after completion of the trial. The child-bearing male shall use condom for contraception during the trial and within 30 days after completion of the trial;\n* The patient shall sign the Informed Consent Form.\n\nExclusion Criteria:\n\n* The patient has undergone any systemic anti-cancer treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment, etc.;\n* The patient suffers from any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris that starts to attack within the last 3 months, congestive heart failure \\[≥ Grade II specified by New York Heart Association (NYHA)\\], cardiac infarction (6 months before enrollment), severe arrhythmia and liver, kidney or metabolic diseases that requires drug treatment;\n* The patient is a carrier of HIV;\n* The patient has had or is currently suffering from interstitial lung disease;\n* The patient had undergone other major systemic operations or suffered from severe trauma within 3 months before the trial;\n* The patient is allergic to befotertinib or its any excipients;\n* The patient is allergic to bevacizumab or its any excipients;\n* The patient is allergic to platinum-based double chemotherapy or its any excipients;\n* The female patient is in pregnancy or lactation period;\n* There are any conditions under which the investigator considers the patient is not suitable to be enrolled.",{"count":289,"type":21},60,[99],"This study targeted patients with resectable stage II-IIIA non-small cell lung cancer with EGFR mutation",[293,294,27,295,296,297,298,299],"EGFR","Non-Small Cell Lung Cancer","Pemetrexed","Carboplatin","Bevacizumab","Antineoplastic Agents","Tyrosine Kinase Inhibitor",[301,302,303,297,304],"EGFR-TKI","NSCLC","Chemotherapy","Locally advanced non-small cell lung cancer","2025-01-03",{"date":307,"type":38},"2025-01-06",{"date":309,"type":38},"2024-11-07",{"date":311,"type":21},"2028-12-31",{"name":313,"class":113},"Peng Zhang",{"id":315,"slug":316,"hasResults":11,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":320,"eligibilityCriteria":321,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":324,"phases":4,"briefSummary":325,"conditions":326,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":86},"100465349","patients-whole-process-follow-up-managementhope-1-100465349","NCT05339568","Patient's Whole Process Follow-up Management(HOPE-1)","A Multicenter, Randomized, Open, Parallel Grouping, Investigator-initiated Study Evaluating the Long-term Benefit of Patients With Locally Advanced\u002FMetastatic Non-small Cell Lung Cancer Followed up Using a Patient-wide Management Platform","HOPE-1","Inclusion Criteria:\n\n1. Fully understand the research and voluntarily sign the informed consent form (ICF)\n2. Male or female subjects who are over 18 years old (inclusive) at the time of signing the informed consent form.\n3. The subject is diagnosed pathologically or cytologically with non-small cell lung cancer(NSCLC).\n4. According to the 8th edition of the American Joint Committee on Cancer \\[AJCC\\], it is classified as stage IIB, stage III, stage IV NSCLC.\n5. Not suitable for radical treatment or refuse surgery.\n6. The life expectancy is not less than 3 months.\n7. Be able to use a smartphone.\n\nExclusion Criteria:\n\n1. Patients with mental illness.\n2. Presence of any other malignant tumor.\n3. Patients who are expected to undergo radical surgery.\n4. Currently participating in clinical trials.\n5. Subjects who judged by the investigator to be unsuitable to participate in the trial.",{"count":323,"type":21},1268,"OBSERVATIONAL","Our project is going to explore whether management and follow-up of locally advanced\u002Fmetastatic patients using the patient process management platform can prolong patient survival and improve patient quality of life.",[27,327],"Metastatic NSCLC","2022-09-05",{"date":330,"type":38},"2022-09-08",{"date":332,"type":38},"2022-05-22",{"date":334,"type":21},"2030-08-20",{"name":336,"class":113},"Qianfoshan Hospital",{"id":338,"slug":339,"hasResults":11,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":343,"eligibilityCriteria":344,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":345,"targetDuration":4,"studyType":22,"phases":347,"briefSummary":348,"conditions":349,"keywords":350,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":4},"100374305","phase-2-pembrolizumab--platinum-doublets-without-radiation-for-programmed-death-ligand-1-pd-l1-50-locally-advanced-nsclc-100374305","NCT04153734","Pembrolizumab + Platinum Doublets Without Radiation for Programmed Death-ligand 1 (PD-L1) ≥50% Locally Advanced NSCLC","Pembrolizumab + Platinum Doublets Without Radiation for Patients With PD-L1 ≥50% Locally Advanced Non-small Cell Lung Cancer: a Multicenter Prospective Single Arm Phase II Study","Evolution","Inclusion Criteria:\n\n1. Histologically confirmed NSCLC\n2. PD-L1 Total Proportion Score (TPS) ≥50%\n3. Locally advanced NSCLC (unresectable stage III with indication of curative CRT based on Tumour, Node and Metastasis (TNM) classification of Union for International Cancer Control (UICC) version 8)\n4. Treatment naïve for primary disease\n5. Have at least measurable disease based on RECIST 1.1.\n6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n7. Have adequate organ function as defined in the following:\n\n   Adequate Organ Function and Laboratory Values\n\n   Hematological:\n\n   Absolute neutrophil count (ANC) ≥1500\u002FμL Platelets ≥100 000\u002FμL Hemoglobin ≥9.0 g\u002FdL or ≥5.6 mmol\u002FL (a)\n\n   Renal:\n\n   Creatinine OR Measured or calculated (b) creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × Upper Limit of Normal (ULN) OR ≥45 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN\n\n   Hepatic:\n\n   Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN Aspartate aminotransferase (AST) (SGOT) and Alanine transaminase (ALT) (SGPT) ≤2.5 × ULN\n\n   Coagulation:\n\n   International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n\n   Thyroid functions:\n\n   Thyroid-Stimulating Hormone (TSH) Within institutional ULN (If TSH is not within ULN at baseline, the participant may still be eligible if T3 and free T4 are within ULN.)\n   1. Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.\n   2. Creatinine clearance (CrCl) should be calculated per institutional standard.\n8. Male\u002Ffemale participants who are at least 20 years of age on the day of signing informed consent\n9. Male participants:\n\n   A male participant must agree to use a contraception as detailed in of this protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.\n\n   Female participants:\n\n   A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) as defined in OR b.) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.\n10. The participant is discussed in a conference including radiation oncologists.\n11. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n\nExclusion Criteria:\n\n1. A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., Cytotoxic T Lymphocyte-associated Antigen 4 (CTLA-4), OX-40, CD137).\n3. Has received any prior systemic anti-cancer therapy. Note: If participant received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting study treatment.\n4. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n5. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.\n\n   Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.\n6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n7. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n8. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n9. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n10. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n11. Has an active infection requiring systemic therapy.\n12. Has a history of tissue\u002Forgan transplantation.\n13. Has a known history of Human Immunodeficiency Virus (HIV).\n14. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (HCV) (defined as HCV RNA is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n15. Has a known history of active Tuberculosis (TB).\n16. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n17. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n18. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.",{"count":346,"type":21},21,[99],"This is a phase II, multicenter, single-arm, non-blind study. To 21 patients with PD-L1 ≥50% locally advanced non-small cell lung cancer, the combination of Pembrolizumab and platinum-doublets will be intravenously administered without radiotherapy to evaluate the efficacy and safety of combination therapy with Pembrolizumab and platinum-doublets.",[171],[351,352,353,354,355,356],"Pembrolizumab","Platinum doublets","Non-small cell lung cancer","Without radiation","Locally advanced","PD-L1 ≥50%","2019-11-05",{"date":359,"type":38},"2019-11-06",{"date":361,"type":21},"2019-12-01",{"date":363,"type":21},"2023-11-30",{"name":365,"class":113},"Kobe Minimally Invasive Cancer Center"]