[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lung-neoplasm-malignant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lung-neoplasm-malignant":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,44,66,107,139,163,191,217,250],{"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":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100576716","phase-2-pembrolizumab-mk-3475-plus-investigational-agents-in-resectable-non-small-cell-lung-cancer-nsclc-mk-3475-01ekeymaker-u01-100576716",false,"NCT06788912","Pembrolizumab (MK-3475) Plus Investigational Agents in Resectable Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E\u002FKEYMAKER-U01)","KEYMAKER-U01 Substudy 01E: A Phase 2 Umbrella Study With Rolling Arms of Investigational Agents With or Without Chemotherapy in Combination With Pembrolizumab in Treatment of Participants With Newly Diagnosed Resectable Stages II-IIIB (N2) Non-small Cell Lung Cancer (NSCLC)","The main inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Has previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC)\n* Able to undergo protocol therapy, including necessary surgery\n* Confirmation that epidermal growth factor receptor (EGFR) -directed therapy is not indicated as primary therapy\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1 as assessed within 10 days before initiation of study intervention.\n* Is able to provide archival or newly obtained core\u002Fexcisional biopsy of the primary lung tumor or lymph node metastasis.\n\nExclusion Criteria:\n\n* Has one of the following tumor locations\u002Ftypes: NSCLC involving the superior sulcus, large-cell neuro-endocrine cancer, mixed tumors containing small cell and non-small cell elements, or sarcomatoid tumor.\n* Has Grade ≥2 peripheral neuropathy.\n* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing.\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention\n* Received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids.\n* 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 intervention.\n* Known additional malignancy that is progressing or has required active treatment within the past 5 years.\n* Severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n* Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid) is allowed.\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Active infection requiring systemic therapy.\n* Hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive) or Hepatitis C virus (defined as detectable hepatitis C virus (HCV) ribonucleic acid (RNA) \\[qualitative\\]) infection.\n* Known history of human immunodeficiency virus (HIV) infection.\n* History of allogeneic tissue\u002Fsolid organ transplant.","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The main goals are after treatment given before surgery, to measure the number of people who have no signs of cancer cells in tumors and lymph nodes removed during surgery; and to learn about whether the cancer gets smaller or goes away by measuring the number of people with a certain number of living cancer cells in the tumor removed during surgery.",[26],"Lung Neoplasm Malignant",[28,29,30],"Programmed Cell Death-1 (PD1, PD-1)","Programmed Cell Death 1 Ligand 1(PDL1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)","RECRUITING","2026-06-25",{"date":34,"type":35},"2026-06-26","ACTUAL",{"date":37,"type":35},"2025-03-20",{"date":39,"type":20},"2032-02-06",{"name":41,"class":42},"Merck Sharp & Dohme LLC","INDUSTRY",38,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100614942","phase-1-a-clinical-study-of-mk-1084-with-other-treatments-for-non-small-cell-lung-cancer-mk-3475-01f-100614942","NCT07286149","A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F)","KEYMAKER-U01 Substudy 01F: A Phase 1b\u002F2 Umbrella Study With Rolling Arms of Investigational Agents for Previously Treated Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically or cytologically confirmed diagnosis of advanced or metastatic non-squamous non-small cell lung cancer (NSCLC)\n* Has tumor tissue or circulating tumor deoxyribonucleic acid (ctDNA) that demonstrates the presence of Kirsten rat sarcoma viral oncogene (KRAS) mutation of glycine to cysteine at codon 12 (G12C) mutations\n* Has documented disease progression after receiving 1-2 prior lines of programmed cell death protein 1 (PD-1)\u002Fprogrammed death-ligand 1 (PD-L1) therapy and platinum-based chemotherapy\n* Provides archival tumor tissue sample of a tumor lesion not previously irradiated\n* Has provided tissue prior to treatment allocation\u002Frandomization from a newly obtained biopsy of a tumor lesion not previously irradiated\n* Participants with human immunodeficiency virus (HIV) infection must have well-controlled HIV on antiretroviral therapy (ART) per protocol\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease\n* Has evidence of any leptomeningeal disease\n* Has uncontrolled or significant cardiovascular disorder or cerebrovascular disease prior to allocation\u002Frandomization\n* Has one or more of the following ophthalmological conditions: a) Clinically significant corneal disease b) history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has received previous treatment with an agent targeting KRAS\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has history of (noninfectious) pneumonitis\u002F interstitial lung disease (ILD) that required steroids or has current pneumonitis\u002FILD\n* Has an active infection requiring systemic therapy\n* Have not adequately recovered from major surgery or have ongoing surgical complications",{"count":52,"type":20},190,[54,23],"PHASE1","Researchers want to learn if MK-1084, the study medicine, can treat advanced or metastatic non-squamous NSCLC. MK-1084 is a targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread. The goals of this study are to learn:\n\n* About the safety of MK-1084 and if people tolerate it when taken with other treatments\n* How many people have the cancer respond (get smaller or go away) to the treatments",[26],"2026-06-16",{"date":59,"type":35},"2026-06-18",{"date":61,"type":35},"2026-04-30",{"date":63,"type":20},"2032-04-13",{"name":41,"class":42},24,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":78,"conditions":79,"keywords":91,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":106},"100634739","enhanced-copd-management-in-suspected-lung-cancer-patients-100634739","NCT07543601","Enhanced COPD Management in Suspected Lung Cancer Patients","Enhanced COPD Management in Suspected Lung Cancer Patients - Improving Outcomes Through Timely Intervention","ECHELON","Inclusion Criteria:\n\n* Undergoing diagnostic evaluation for suspected lung cancer\n* Spirometry showing obstructive airflow limitation (FEV₁\u002FFVC \\\u003C 75 % or FEV₁ \\\u003C 80 %, and no reversibility) at the first outpatient visit at the lung cancer evaluation\n\nExclusion Criteria:\n\n* Presence of significant comorbidities that may interfere with diagnostic procedures or spirometry\n* Pregnant or breastfeeding women",{"count":75,"type":20},280,[77],"NA","Identifying and treating COPD in patients undergoing lung cancer evaluation is crucial. Early intervention could lead to better management of both diseases, improving health status, reducing healthcare costs, and potentially increasing survival rates.\n\nThis study aims to assess the impact of early diagnosis and optimal treatment of COPD on clinical outcomes in patients under evaluation for lung cancer. The study will combine information through an open-label RCT at the Lung Cancer Investigation Unit at Lillebaelt Hospital Vejle.\n\nThe findings could inform clinical practice by emphasizing the importance of integrated care approaches for patients with coexisting COPD and lung cancer, ultimately leading to better health outcomes.",[80,81,26,82,83,84,85,86,87,88,89,90],"COPD (Chronic Obstructive Pulmonary Disease)","Lung Cancer (Diagnosis)","Lung Carcinoma","Pulmonary Neoplasms","Pulmonary Neoplasm","Pulmonary Cancers","Pulmonary Cancer","Pulmonary Carcinoma","COPD","COPD - Chronic Obstructive Pulmonary Disease","Airflow Obstruction, Chronic",[92,93,94,95],"Invesigation","Evaluation","Diagnostic Work-up","Diagnostic Pathway","2026-04-15",{"date":98,"type":35},"2026-04-22",{"date":100,"type":35},"2026-03-06",{"date":102,"type":20},"2027-06-30",{"name":104,"class":105},"Ditte Krag-Hansen","OTHER",1,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":21,"phases":117,"briefSummary":118,"conditions":119,"keywords":123,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":138},"100522234","confocal-laser-endomicroscopy-verification-100522234","NCT06079970","Confocal Laser Endomicroscopy VERification","Bronchoscopy With and Without Needle-based Confocal Laser Endomicroscopy for Peripheral Lung Nodule Diagnosis: Protocol for a Multicenter Randomized Controlled Trial (CLEVER Trial)","CLEVER","Inclusion Criteria:\n\n1. ≥18 years of age\n2. Suspected malignant peripheral lung lesion with an indication for a bronchoscopic diagnostic work-up as determined by the attending physician or tumor board. Peripheral pulmonary lesions are defined as lesions located beyond the visible segmental bronchi, not detectable by regular flexible bronchoscopy\n3. Bronchus sign on pre-procedural CT or estimated confidence for successful navigation to the nodule resulting in a r-EBUS signal\n4. Solid part of the lesion must be ≧10 mm\n5. Largest dimension of lesion size on CT ≦30 mm (long-axis)\n6. Ability to understand and willingness to sign a written informed consent\n\nExclusion Criteria:\n\n1. Inability or non-willingness to provide informed consent\n2. Endobronchial visible malignancy on bronchoscopic inspection\n3. Target lesion within reach of the linear EBUS scope\n4. Failure to comply with the study protocol\n5. Known allergy or risk factors for an allergic reaction to fluorescein\n6. Pregnancy or breastfeeding\n7. Hemodynamic instability\n8. Refractory hypoxemia\n9. Therapeutic anticoagulant use that cannot be withheld for an appropriate interval before the procedure\n10. Unable to tolerate general anesthesia according to the anesthesiologist\n11. Undergoing chemotherapy as several chemotherapies have fluorescent properties at the same wavelength (e.g., doxorubicin)",{"count":116,"type":20},208,[77],"The goal of this multi-center randomized clinical trial is to evaluate the added value of needle based confocal laser endomicroscopy (nCLE)-imaging to regular diagnostic bronchoscopic peripheral lung lesion analysis on the diagnostic yield in patients with peripheral pulmonary nodules suspect for malignancy.\n\nThe main question\\[s\\] it aims to answer are:\n\nTo determine if the addition of nCLE-imaging to conventional diagnostic bronchoscopic peripheral lung lesion analysis results in an improved diagnostic yield (defined as the proportion of patients in whom the bronchoscopic procedure results in a definitive diagnosis out of the total number of patients that have received the diagnostic bronchoscopic procedure).\n\nParticipants will undergo diagnostic bronchoscopy either with or without the addition of nCLE imaging before each TBNA. Based on the feedback of the CLE images on (in)correct placement of the needle, the needle might be repositioned before sampling. Comparison between the diagnostic yield of these groups will be done including subgroup analysis.",[120,26,121,122],"Lung Cancer","Carcinoma, Non-Small-Cell Lung","Neoplasm of Lung",[124,125,126,127,128],"Confocal Microscopy","Bronchoscopy","Confocal laser endomicroscopy","CLE","Fluoroscopy","2026-04-01",{"date":131,"type":35},"2026-04-07",{"date":133,"type":35},"2023-10-18",{"date":135,"type":20},"2026-12-31",{"name":137,"class":105},"Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)",5,{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":21,"phases":148,"briefSummary":149,"conditions":150,"keywords":151,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":106},"100549942","benefit-of-spectral-information-in-patients-suspected-for-lung-cancer-100549942","NCT06440616","Benefit of Spectral Information in Patients Suspected for Lung Cancer","Benefit of Spectral Information Provided by Photon Counting CT in Patients Suspected for Lung Cancer","Inclusion Criteria:\n\n* Patients suspected of lung cancer refered to Copenhagen University Hospital as per the guidelines from the danish national health authorities from either the general practitioner or from the department of pulmonology.\n* Informed consent\n\nExclusion Criteria:\n\n* Patients who cannot tolerate intravenous iodinated contrast\n* Already verified lung cancer from another institution\n* Comorbidities that exclude the patient from receiving treatment\n* Lack of reference standard in the form of either histology or follow-up\n* Known extrapulmonary malignancy\n* Technical limitations within the scans\u002Freconstructions\n* other\n\nPr. the 29th of September included 433 participants.",{"count":147,"type":20},1000,[77],"Purpose The aim of the study is to investigate the utilization of photon counting CT (PCCT) and the spectral information provided to determine the impact of spectral information on follow-up examinations.\n\nAs secondary aims we will compare conventional CT, CT + 18Flouro-deoxy-glucose (18F-FDG) positron emission tomography (PET) and PCCT + 18F-FDG PET for the tumor-node-metastasis (TNM) staging of lung cancer patients.\n\nPCCT with and without spectral information to assess the need for additional work-up,TNM classification, and sensitivity\u002Fspecificity for malignant lesions. Patients will be randomized for reading with or without spectral information available within a clinical setting. The clinical readings are performed as a structured reports of all significant findings. Including both malignant and benign findings. Furthermore, in case additional follow-up\u002Fwork-up is needed based on the guidelines on incidental findings by the American College of Radiology (ACR), this will be reported as well. If lesions suspicious of pulmonary malignancy is present, a provisional TNM classification is provided based on the scan findings.\n\nAfter 3 months, the patient record is reviewed where additional examinations that can be attributed to the PCCT scan are recorded. The financial impact is calculated by a health economist based on the findings. PET\u002FCT, conventional CT and PCCT combined with PET will be assessed retrospectively for comparison. Endpoints are number of supplementary examinations and cost savings. Sensitivity and specificity for any malignant finding. The T, N and M stages are assessed separately as diagnostic measures by the McNemar's test with a reference standard from the Danish Lung cancer register. The number of malignant lesions will be determined by reviewing the patient records incl. pathology assessment if available 12 months after inclusion of the last patient.",[26],[152,153],"Computed tomography","Spectral CT","2026-03-18",{"date":156,"type":35},"2026-03-20",{"date":158,"type":35},"2024-05-24",{"date":160,"type":20},"2027-06-01",{"name":162,"class":105},"Copenhagen University Hospital at Herlev",{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":171,"enrollmentInfo":172,"targetDuration":4,"studyType":21,"phases":174,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":106},"100598408","phase-2-intestinal-low-dose-radiotherapy-combined-with-immunotherapy-in-immune-resistant-metastatic-malignant-solid-tumors-100598408","NCT07071103","Intestinal Low Dose Radiotherapy Combined With Immunotherapy in Immune-resistant Metastatic Malignant Solid Tumors","Efficacy and Safety of Combining Intestinal Low Dose Radiotherapy and PD-1\u002FPD-L1 Inhibitors for Metastatic Malignant Solid Tumors After Acquired Resistance to Anti-PD1\u002FPD-L1 Treatment","ILDR-02","Inclusion Criteria:\n\n* Age ≥18 years, ≤80 years, regardless of gender.\n* ECOG level 0-2.\n* Expected life span\\>3 months.\n* At least one accessible and measurable lesion should be selected as the target lesion for observation according to RECIST criteria.\n* Patients with metastatic solid tumors (of any histology) without standard therapy options, who have previously received immunotherapy, immunotherapy combined with chemotherapy, or immunotherapy combined with anti-angiogenesis treatment and have shown disease progression.\n* Patients should not be considered eligible for surgical treatment.\n* Patients with brain metastases that are assessed as clinically stable after treatment through repeated CT and\u002For MRI scans are eligible.\n* Patients have complete clinical and pathological information.\n* Patients should not be borthered by any psychological, family, social or geographical conditions that may hinder compliance with the research protocol.\n* Patients should be able to understand the informed consent form, voluntarily participate, and sign the informed consent form.\n* Other indicators accord with the general inclusion criteria for clinical trials.\n\nExclusion Criteria:\n\n* Patients with contraindications to radiation therapy and immunotherapy.\n* Previous occurrence of unacceptable immune related toxic side effects (immune myocarditis, pneumonia, etc.).\n* Patients who were assessed as hyperprogressive disease (HPD).\n* Patients who have received pelvic and abdominal radiation therapy within 6 months prior to enrollment.\n* The adverse reactions from prior treatment have not yet recovered to a CTCAE5.0 rating of ≤ 1 (excluding toxicity that has been determined to be risk-free, such as fatigue or hair loss).\n* Patients with active uncontrolled systemic bacterial, viral, or fungal infections despite optimal treatment.\n* Significant liver or kidney dysfunction (i.e., laboratory values \\>3 times the upper limit of normal).\n* Active hepatitis B, hepatitis C, HIV, or syphilis.\n* Brain disorders, symptomatic central nervous system (CNS) or meningeal metastases, or impaired cognitive function.\n* Hypersensitivity to any drug included in the trial.\n* Drug and\u002For alcohol abuse.\n* Pregnant or breastfeeding women.\n* Concurrent participation in another therapeutic clinical trial.\n* Poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within ≤14 days after intervention).\n* Major surgery within 30 days.\n* Use of antibiotics, antifungals, antivirals, antiparasitics, or probiotics within 4 weeks before enrollment.","80 Years",{"count":173,"type":20},48,[23],"Preclinical and clinical evidence suggests that intestinal low-dose radiotherapy (ILDR) may enhance antitumor immune responses by modulating the gut microenvironment, thereby improving the efficacy of immune checkpoint inhibitors (ICBs) in refractory solid tumors. Based on these findings, the investigators initiate a multicohort phase II clinical trial to evaluate the clinical benefit and safety of ILDR combined with PD-1\u002FPD-L1 monoclonal antibody therapy in patients with metastatic solid tumors resistant to prior ICB treatment.\n\nIn this study, patients are stratified into three parallel cohorts by tumor type (lung cancer, esophageal cancer, and other solid tumors), with 16 patients per cohort (48 in total, including subjects enrolled from the ILDR-01 study). Eligible participants includes patients with advanced metastatic solid tumors progressing after monotherapy or combination ICB treatment, meeting criteria of ECOG performance status 0-2, life expectancy ≥3 months, and have at least one measurable lesion. Exclusion criteria encompasses prior pelvic radiotherapy, ongoing infections, major organ dysfunction, or concurrent antitumor therapies.\n\nThe primary endpoints includes objective response rate (ORR), disease control rate (DCR), progression-free survival after ILDR (PFS2), and the incidence of abscopal effects. Secondary endpoints includes overall survival (OS), treatment safety, α\u002Fβ diversity changes in gut microbiota, peripheral blood immune cell subset dynamics, and tumor immune microenvironment remodeling characteristics. All patients receives a 1 Gy jejunoileal radiotherapy followed by PD-1\u002FPD-L1 monoclonal antibody administration (in accordance to prior protocols or guidelines) within 24 hours, with maintenance therapy up to 2 years. Therapeutic efficacy is assessed via RECIST v1.1, while therapeutic toxicity is assessed according to CTCAE v5.0.\n\nPaired pre- and post-treatment samples (including wumor tissue, stool, peripheral blood etc.) are collected for metagenomic sequencing, metabolomic analysis, and multi-omics integrative modeling to systematically elucidate the regulation mechanism of gut microbiota-metabolite-immune axis mediated by ILDR. This approach aims to provide theoretical foundations for optimizing treatment strategies in immunotherapy-resistant tumors and identify biomarkers that potentially associated with therapeutic efficacy.",[177,178,179,180,26,181],"Radiotherapy","Metastatic Solid Cancers","Immune Checkpoint Blockade","Esophageal Neoplasms Malignant","Drug Resistance","2025-11-17",{"date":184,"type":35},"2025-11-20",{"date":186,"type":35},"2025-09-26",{"date":188,"type":20},"2028-01-01",{"name":190,"class":105},"Chuangzhen Chen",{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":198,"enrollmentInfo":199,"targetDuration":4,"studyType":21,"phases":201,"briefSummary":202,"conditions":203,"keywords":204,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":106},"100437209","preoperative-sintilimab-combined-with-bevacizumab-and-chemotherapy-for-resectable-non-small-cell-lung-cancer-100437209","NCT04973293","Preoperative Sintilimab Combined With Bevacizumab and Chemotherapy for Resectable Non-Small Cell Lung Cancer","The Safety and Feasibility of Preoperative Sintilimab Combined With Bevacizumab and Chemotherapy for Locally Advanced Resectable Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed, previously untreated and surgically resectable non-small cell lung cancer (stage II-IIIA, patients with squamous cell carcinoma or EGFR mutation should not be included);\n2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;\n3. Satisfactory preoperative laboratory testing and adequate pulmonary function for surgery;\n4. Patients approve and sign the informed consent.\n\nExclusion Criteria:\n\n1. Pancoast tumor, squamous cell carcinoma, large-cell carcinoma and sarcomatoid carcinoma;\n2. Patients with active autoimmune disease or history of autoimmune disease;\n3. Patients who have a condition requiring systemic treatment with either prednisone or other immunosuppressive medications;\n4. Patients with a history of symptomatic interstitial lung disease;\n5. History of allergy to study drug components;\n6. Women must not be pregnant or breast-feeding;\n7. Men with female partners that are not willing to use contraception;\n8. Patients who have received prior chemotherapy, anti-angiogenesis therapy and immunotherapy for this malignancy or for any other past malignancy;\n9. Patients who have received prior treatment for non-small cell lung cancer;\n10. Any mental or psychological condition which would not permit the patient to complete the study or understand the patient information;\n11. Patients who have major hemoptysis within the past 4 weeks, tumor has invasion or is close to great vessels;\n12. Patients with high risk of major bleeding;\n13. Patients who have arterial thrombotic events, esophageal varices, peptic ulcers, wounds or bone fractures;\n14. Patients who have prior malignancies;\n15. HIV, HBV, HCV infection or active pulmonary tuberculosis;\n16. Underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events.","75 Years",{"count":200,"type":20},20,[77],"Neoadjuvant chemotherapy followed by surgery has been recommended as the standard treatment for locally advanced and resectable non-small cell lung cancer (NSCLC). However, its efficacy remains to be improved. Drugs targeting PD-1\u002FPD-L1 pathway have been proven to be effective for late-stage NSCLC, and anti-angiogenesis agents targeting VEGF (bevacizumab) has also been used for the first line treatment of advanced or metastatic NSCLC. Therefore, we conduct this single-arm clinical trial, which aims to investigate the safety and feasibility of neoadjuvant sintilimab combined with bevacizumab and chemotherapy followed by surgery in treating locally advanced and resectable NSCLC.",[26],[205,206,207],"Non-small cell lung cancer","Neoadjuvant therapy","Immunotherapy","2024-11-16",{"date":210,"type":35},"2024-11-19",{"date":212,"type":35},"2022-10-01",{"date":214,"type":20},"2025-12-31",{"name":216,"class":105},"Ruijin Hospital",{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":224,"targetDuration":226,"studyType":227,"phases":4,"briefSummary":228,"conditions":229,"keywords":230,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":249},"100514129","mondrian-multi-omics-integrative-modelling-for-stereotactic-body-radiotherapy-in-early-stage-non-small-cell-lung-cancer-100514129","NCT05974475","MONDRIAN: Multi-omics Integrative Modelling for Stereotactic Body Radiotherapy in Early-stage Non-small Cell Lung Cancer","MONDRIAN","Inclusion Criteria:\n\n* Histologically proven NSCLC; all histologies will be considered eligible (e.g. squamous, adenocarcinoma, large cell carcinoma);\n* American Joint Committee on Cancer Tumor Node Metastasis (AJCC TNM) classification (8th Edition) clinical stage I-II;\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1;\n* No absolute contraindications to either surgery (e.g. severe comorbidities) or SBRT (e.g. active connective diseases, severe pulmonary fibrosis);\n* Ability and willingness to sign a written informed consent for treatment and study participation.\n\nExclusion Criteria:\n\n* Prior diagnosis of invasive cancer (within 3 years before the diagnosis of ES-NSCLC);\n* Mental diseases or psychiatric disorders preventing the acquisition of a valid informed consent.",{"count":225,"type":20},270,"24 Months","OBSERVATIONAL","Stereotactic Body Radiotherapy (SBRT) is a form of high-precision radiotherapy playing a major role in patients diagnosed with early-stage non-small cell lung cancer (NSLCL), especially when surgery cannot be performed. It is a non-invasive, well-tolerated treatment, with an excellent ability to control disease recurrence. However, in some patients, disease response is suboptimal: understanding why this happens may open doors to more aggressive approaches, such as the combination with systemic therapies.\n\nHence, the goal of this observational trial is to understand which clinical, imaging, and biological factors are associated with response to SBRT through the development of complex models. In other words, the main question it aims to answer is: \"Will this patient respond to radiation treatment based on the characteristics of their disease?\".\n\nParticipants will be treated according to the best clinical practice standards, in agreement with international, national, and internal guidelines.\n\nResearchers will compare data collected from patients treated with SBRT with those collected from a similar group of patients, who will be treated with surgery, to see which factors are actual predictors of response to SBRT, or rather are indicators of more or less aggressive disease behavior.",[26],[231,232,233,234,235,236,237,238,239],"Early stage non-small cell lung cancer","Stereotactic body radiotherapy (SBRT)","Radiosensitivity","Radioresistance","Multi-omics","Radiomics","Genomics","Proteomics","Outcome modeling","2024-09-20",{"date":242,"type":35},"2024-09-23",{"date":244,"type":35},"2023-09-11",{"date":246,"type":20},"2028-09",{"name":248,"class":105},"European Institute of Oncology",2,{"id":251,"slug":252,"hasResults":11,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":257,"enrollmentInfo":258,"targetDuration":4,"studyType":21,"phases":260,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":264,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":269,"leadSponsor":271,"locationsCount":106},"100556865","broadband-collaborative-pulse-ablation-instrument-treating-malignant-pulmonary-nodules-100556865","NCT06530667","Broadband Collaborative Pulse Ablation Instrument Treating Malignant Pulmonary Nodules","A Prospective Clinic Study to Evaluate the Effectiveness Safety and Feasibility of the Broadband Collaborative Pulse Ablation Instrument in Treating Malignant Pulmonary Nodules","Inclusion Criteria:\n\n1. Age: between 18 and 70 years old with no gender limitation;\n2. Malignant pulmonary nodules diagnosed by cytology and\u002For histopathology, or the number of tumors ≤3. The pulmonary nodules were oligometastatic and the primary lesions were stable, with no uncontrolled metastasis to other sites;\n3. Surgery is not available or the patient refuses surgical treatment;\n4. Nodules' Maximum diameter≤2cm;\n5. ECOG score≤2;\n6. Patients understood the trial procedure and voluntarily signed informed consent.\n\nExclusion Criteria:\n\n1. An electronic device is implanted near the target area or an implanted pacemaker or defibrillator is present in the body;\n2. Coagulation dysfunction with severe bleeding tendency and short-term correction (prothrombin time \\>18s, prothrombin activity \\\u003C40%, platelet \\\u003C80×109 \u002FL);\n3. Patient who can not stop taking Antiplatelet and anticoagulant drugs 5 days before surgery;\n4. Severe pulmonary fibrosis and pulmonary hypertension;\n5. Patients with poor control of pleural effusion;\n6. Patients with serious insufficiency of Liver, kidney, heart, lung, and brain function;\n7. Patients with Severe anemia, dehydration, and severe disturbance of nutrient metabolism, which cannot be corrected or improved in the short term;\n8. Patients with severe systemic infection, high fever (\\>38.5℃);\n9. Pregnant and lactating women and those planning to become pregnant within one year;\n10. Participants in clinical trials of any drugs and\u002For medical devices within 3 months before enrollment;\n11. Any other factors that the investigator considers inappropriate for inclusion or that may affect the subject's participation in the study.","70 Years",{"count":259,"type":20},3,[77],"Effectiveness safety and feasibility of the broadband collaborative pulse ablation instrument in treating malignant pulmonary nodules",[26,263],"Secondary Lung Cancer","NOT_YET_RECRUITING","2024-07-26",{"date":267,"type":35},"2024-07-31",{"date":267,"type":20},{"date":270,"type":20},"2025-07-31",{"name":272,"class":105},"Shanghai Zhongshan Hospital"]