[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lung-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lung-neoplasms":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,47,0,25,[9,47,81,121,154,196,222,243,270,289,315,342,368,393,424,453,480,503,532,550,562,599,630,653,682],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100053731","lung-bases-4-life-mobile-low-dose-computed-tomography-ldct-screening-ages-40-54-100053731",false,"NCT04577599","Lung B.A.S.E.S. 4 Life Mobile Low-dose Computed Tomography (LDCT) Screening: Ages 40-54","Lung B.A.S.E.S 4 Life Mobile Low-dose Computed Tomography (LDCT) Screening: Assessing Incidence and Stage of Lung Cancer Diagnosis in Subjects Ages 40-54 With a 30 Pack Year History or More Within North and South Carolina","Inclusion Criteria:\n\n* Subject must meet all the following applicable inclusion criteria to participate in this study:\n\n  1. Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n  2. Age 40-54 years at the time of consent.\n  3. A positive smoking history of greater\u002Fequal to 30 pack years and they are either currently smoking or have quit within the last 15 years.\n  4. Ability to read and understand the English and\u002For Spanish language.\n  5. Ability to understand and comply with study procedures for the entire length of the study.\n\nExclusion Criteria:\n\n* Subjects meeting any of the criteria below may not participate in the study:\n\n  1. Known diagnosis of lung cancer in the past 5 years.\n  2. Any known contraindication to having a low-dose CT Scan.\n  3. Known pregnancy.",true,"ALL","40 Years","54 Years",{"count":22,"type":23},1160,"ESTIMATED","INTERVENTIONAL",[26],"NA","Low-dose CT Screening has been shown in two large trials in the United States (NLST) and Europe (NELSON) to increase overall survival in subjects 55 years of age and older with a strong smoking history. Unfortunately, in both North Carolina (NC) and South Carolina (SC), subjects are found to have the above referenced smoking history prior to reaching the minimum age in these studies. This study is aimed at decreasing the minimum age of screening in a high-risk population.",[29,30],"Lung Neoplasms","Lung Cancer",[32,30,33],"Screening","Smoking","RECRUITING","2026-07-10",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":38},"2021-01-07",{"date":42,"type":23},"2028-10",{"name":44,"class":45},"Wake Forest University Health Sciences","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":58,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":68,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":4},"100644397","feasibility-and-preliminary-performance-of-an-ai-prototype-for-digital-rose-during-ebus-tbna-and-peripheral-tbna-a-prospective-pilot-study-ai-rose-feas-100644397","NCT07662967","Feasibility and Preliminary Performance of an AI Prototype for Digital ROSE During EBUS-TBNA and Peripheral TBNA: a Prospective Pilot Study (AI-ROSE-FEAS)","Preliminary Feasibility and Diagnostic Performance of an Investigational Artificial Intelligence Prototype for Digital Rapid On-Site Evaluation (ROSE) of Cytological Slides During Diagnostic Bronchoscopy With Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA) and Peripheral Transbronchial Needle Aspiration: a Prospective Monocentric Pilot Study (AI-ROSE-FEAS)","AI-ROSE-FEAS","Inclusion Criteria\n\n* Age ≥ 18 years.\n* Clinical indication for diagnostic bronchoscopy with EBUS-TBNA for mediastinal lymphadenopathy and\u002For TBNA on peripheral lung lesions, according to ACCP\u002FERS-ESTS guidelines and the Unit's diagnostic pathways.\n* The procedure will be performed in two-person mode with IP-ROSE performed as per the center's SOP.\n* Ability to provide written informed consent.\n* Willingness to undergo the required follow-up.\n\nExclusion Criteria\n\n* Absolute contraindications to bronchoscopy.\n* Known histological diagnosis of the target lesion (except re-staging).\n* Concomitant interventional procedures that alter the standard sequence.\n* Inability to provide written informed consent.\n* Any condition that, in the investigator's judgment, compromises patient safety or the reliability of the data.","18 Years",{"count":57,"type":23},65,"6 Months","OBSERVATIONAL","Rapid On-Site Evaluation (ROSE) of cytological slides obtained during EBUS-TBNA improves diagnostic yield by providing real-time adequacy assessment and preliminary diagnostic orientation after each needle pass. In centers without a dedicated cytopathologist, ROSE is performed by a second interventional pulmonologist acting as a dedicated ROSE operator (interventional pulmonologist-performed ROSE, IP-ROSE), a model associated with good but variable diagnostic performance compared to cytopathologist-performed ROSE.\n\nThis study evaluates the feasibility and preliminary diagnostic performance of an investigational artificial intelligence prototype for digital ROSE. The prototype, developed in-house by the Principal Investigator, analyzes microscopic images of Diff-Quik stained cytological slides acquired through a dedicated digital microscope, together with basic clinical data, via API calls to a multimodal AI model. It produces two outputs: sample adequacy (appropriate\u002Fnot appropriate) and malignancy suspicion (benign\u002Fmalignant), each with a confidence score. The AI output is recorded in the study database for research purposes only and is not shown to the operator in real time; it does not influence clinical decisions during the procedure.\n\nThe study is a prospective, monocentric, observational pilot study enrolling 65 adult patients undergoing EBUS-TBNA or peripheral TBNA with IP-ROSE at a single interventional pulmonology unit. The primary statistical unit is the individual ROSE slide, with an expected 130 to 160 evaluable slides. Co-primary endpoints are: (1) technical feasibility of the AI prototype, defined as the proportion of slides with valid AI output within 90 seconds; and (2) AI accuracy for sample adequacy assessment compared to the definitive cytopathological diagnosis, with an expected 95% confidence interval precision of ±5.5%. Secondary endpoints include AI accuracy for malignancy suspicion, agreement between the AI prototype and the IP-ROSE operator, and AI output latency.\n\nThe AI prototype is not a commercially approved or CE-marked medical device. It was developed internally by the Principal Investigator for research purposes and is evaluated exclusively within this study. Data from this pilot study will inform the design of a subsequent confirmatory non-inferiority trial, which will be the subject of separate registration and ethical approval.",[29,62,63,64,65,66,67],"Bronchoscopy","AI (Artificial Intelligence)","Mediastinal ( Chest) Masses","Mediastinal Lymphadenopathy","EBUS Guided Transbronchial Needle Aspiration","Lung Cancer (Diagnosis)",[69,70],"bronchoscopy","artificial intelligence","NOT_YET_RECRUITING","2026-06-17",{"date":74,"type":38},"2026-06-23",{"date":76,"type":23},"2026-07-01",{"date":78,"type":23},"2027-03",{"name":80,"class":45},"Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli",{"id":82,"slug":83,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":24,"phases":91,"briefSummary":93,"conditions":94,"keywords":102,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":46},"100584158","phase-1-anti-mesothelin-tnaivescm-hyp218-tnhyp218-car-t-cells-in-participants-with-mesothelin-expressing-solid-tumors-including-mesothelioma-100584158","NCT06885697","Anti-Mesothelin TNaive\u002FSCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma","Phase 1 Study With Dose Expansion of the Anti-Mesothelin TNaive\u002FSCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria. For this protocol, treatment initiation is defined as the first day of lymphodepleting chemotherapy.\n\n* Participant must have unresectable, locally advanced, or metastatic, or recurrent mesothelioma and other mesothelin expressing solid tumors. For participants with mesothelioma only those with epithelioid or biphasic histology (with \\>80% epithelioid component) will be eligible. The diagnosis will be confirmed by the Laboratory of Pathology, CCR, NCI.\n* Participant must have progressed on at least one FDA-approved systemic therapy considered standard of care for their tumor type. There is no limit on the number of prior treatment regimens. Note: Given the aggressive nature of pancreatic cancer, otherwise eligible individuals with this cancer type can undergo leukapheresis before or while they are getting their frontline treatment as long as they meet all other inclusion criteria. However, TNhYP218 CAR T cells will only be administered after progression on first line standard of care therapy.\n* Participant must have at least 1 measurable lesion by RECIST version 1.1.\n* Tumor must have MSLN positivity of 2+ to 3+ in \\>= 50% cancer cells by immunohistochemistry on freshly collected biopsy or archival tissue.\n* Age \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participants must have adequate organ and marrow function as defined below:\n\nSystem: Laboratory Value\n\nHematological\n\n* Hemoglobi: \\>=9 g\u002FdL(a)\n* absolute neutrophil count: \\>=1,500\u002FmcL\n* platelets: \\>=100,000\u002FmcL\n\nHepatic\n\n* total bilirubin: \\\u003C=2.5 X institutional ULN OR direct bilirubin ULN for participants with total bilirubin levels \\>1.5 X ULN\n* AST and ALT \\\u003C= 2.5 X institutional ULN (\\\u003C= 5 X ULN for participants with liver metastases)\n\nRenal\n\n* Creatinine OR: \\\u003C=1.5 X ULN OR\n* Calculated(b) creatinine clearance (GFR can also be used in place of creatinine or CrCl) \\>= 50 mL\u002Fmin for participant with creatinine levels \\> 1.5 X institutional ULN\n\nCoagulation\n\n* International normalized ratio (INR) OR prothrombin time (PT): \\\u003C=1.5 X ULN unless participant is receiving anticoagulant therapy if PT or aPTT is within therapeutic range of intended use of anticoagulants\n* Activated partial thromboplastin time (aPTT): \\\u003C=1.5 X ULN unless participant is receiving anticoagulant therapy if PT or aPTT is within therapeutic range of intended use of anticoagulants\n\nALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal.\n\n1. Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.\n2. Creatinine clearance (CrCl) should be calculated per institutional standard.\n\n   * Normal cardiac ejection fraction (\\>= 45% by echocardiogram) and no evidence of hemodynamically significant pericardial effusion as determined by an echocardiogram.\n   * Room air oxygen saturation of 90% or greater.\n   * Treatment-related toxicities from prior treatments must be resolved to \\\u003C= grade 2.\n   * Participants with CNS metastases, leptomeningeal disease or carcinomatous meningitis are eligible if they are asymptomatic, have completed their treatment for CNS disease and have recovered from the acute effects of radiation therapy or surgery prior to study entry. Participants must have radiographically stable CNS disease without associated edema at least three months prior to study entry. Additionally, participants have had to have discontinued corticosteroid treatment or non-prophylactic antiseizure medications for these metastases at least four weeks prior to study entry.\n   * Participants of child-bearing potential and participants who can father children must agree to use highly effective contraception or abstinence.\n   * Participants who are nursing or plan to nurse a child must agree to discontinue\u002Fpostpone nursing for the duration of study therapy and for 12 months after the administration of the cell product or for 4 months from the time no evidence of persistence\u002Fgene modified cells is documented in the participant s blood.\n   * Ability of participant to understand and the willingness to sign a written informed consent document.\n\n   EXCLUSION CRITERIA:\n\n   An individual who meets any of the following criteria will be excluded from participation in this study:\n   * Prior systemic therapy, an investigational therapy, radiation, and\u002For surgery within 14 days prior to leukapheresis and 21 days prior to lymphodepleting chemotherapy.\n   * Prior administration of anti-PD-1 or anti-PD-L1 antibodies or other agents that in the opinion of the PI can stimulate immune activity and interfere with an infusion of CAR-T cells within 8 weeks prior to treatment initiation.\n   * Participants with any form of primary immunodeficiency (e.g. severe combined immunodeficiency).\n   * Participants with active or history of autoimmune or immune mediated disease such as multiple sclerosis, lupus, inflammatory bowel disease, rheumatoid arthritis, or small vessel vasculitis. NOTE: Participants with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible.\n   * History of severe immediate hypersensitivity reaction to cyclophosphamide or fludarabine.\n   * Therapeutic doses of systemic corticosteroid therapy within 14 days prior to treatment initiation. Physiological doses of steroids (up to 5mg\u002Fday of prednisolone or equivalent) are allowed. Corticosteroid creams, ointments, and eye drops are allowed.\n   * Participants with lung fibrosis, inflammatory lung disease or evidence of pneumonitis on baseline imaging studies or medical history of these disorders.\n   * Participant has any other prior or concurrent malignancy with the following exceptions:\n\n     * Adequately treated basal cell or squamous cell carcinoma\n     * In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 12 months prior to initiation of study therapy.\n     * Treated non-melanoma skin cancer.\n     * Stage 0 or 1 melanoma completely resected at least 12 months prior to initiation of study therapy.\n     * Successfully treated organ-confined prostate cancer with no evidence of progressive disease based on PSA levels and are not on active therapy.\n     * A primary malignancy which has been completely resected and in complete remission for \\>= 5 years.\n   * Electrocardiogram showing a QTc interval \\> 450 msec in males and \\> 470 msec in females (\\> 80 msec for participants with bundle branch block). Either Fridericia s or Bazett s formula may be used to correct the QT interval.\n   * Participant has active infection with HIV, hepatitis B virus, HCV, or HTLV as defined below:\n\n     * Positive serology for HIV, HTLV-1, or HTLV-2.\n     * Active hepatitis B infection as demonstrated by test for hepatitis B surface antigen. Participants who are hepatitis B surface antigen negative but are hepatitis B core antibody positive must have undetectable hepatitis B DNA and receive prophylaxis against viral reactivation.\n     * Active hepatitis C infection as demonstrated by hepatitis C RNA test. Participants who are HCV antibody positive will be screened for HCV RNA by any reverse transcription PCR or branched DNA assay. If HCV antibody is positive, eligibility will be determined based on a negative screening RNA value.\n   * Participant is pregnant or intends to be pregnant during the required period of contraception for participants of childbearing potential.\n   * Participants who received live or attenuated vaccine or virus-based vaccine within 30 days before initiation of treatment initiation\n   * Participants with a history of seizure disorder unless due to now treated metastatic lesions.\n   * Ongoing uncontrolled intercurrent illness, including but not limited to ongoing or active infection, that would impact participant safety or limit compliance with study requirements.","120 Years",{"count":90,"type":23},100,[92],"PHASE1","Background:\n\nMesothelioma is an aggressive cancer that grows in the linings of the body; this can include the membranes that line the heart, lungs, and internal organs. Mesothelin (MSLN) is a protein that appears in high numbers in many tumors, including mesothelioma. Researchers are developing a new treatment that collects a person s own immune cells (T cells); the T cells are genetically modified to target and kill tumor cells with high levels of MSLN.\n\nObjective:\n\nTo test a new treatment (TNhYP218 CAR T cells) in people with solid tumors including mesothelioma.\n\nEligibility:\n\nPeople aged 18 and older with solid tumors including mesothelioma that returned or spread after standard treatment.\n\nDesign:\n\nParticipants will be screened. A small piece of tissue will be cut from a tumor (biopsy). The sample will be tested to see if it has enough MSLN.\n\nParticipants will undergo leukapheresis: Blood will be taken from their body through a vein. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different vein.\n\nParticipant s T cells will be modified in a lab to produce TNhYP218 CAR T cells.\n\nParticipants will enter the hospital. For 7 days, they will receive drugs to prepare their bodies for the study treatment.\n\nTNhYP218 CAR T cells will be administered into a vein. Participants will remain in the hospital for at least 7 more days.\n\nAfter discharge, participants will have follow-up visits for 5 years. These visits may include imaging scans, blood and heart tests, and a new biopsy.\n\nLong-term follow-up will continue another 10 years....",[95,96,97,98,99,29,100,101],"Mesothelioma","Neoplasms","Stomach Neoplasms","Pancreatic Neoplasms","Ovarian Neoplasms","Thymus Neoplasms","Colonic Neoplasms",[103,104,105,106,30,107,108,109,110,111],"Peritoneal Mesothelioma","Thymic Carcinoma","Colon Cancer","Gastric Cancer","Ovarian Cancer","Pancreatic Cancer","mesothelin expressing solid tumors","CAR T cell therapy","Gene Therapy","2026-06-16",{"date":72,"type":38},{"date":115,"type":38},"2025-07-08",{"date":117,"type":23},"2044-06-01",{"name":119,"class":120},"National Cancer Institute (NCI)","NIH",{"id":122,"slug":123,"hasResults":12,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":4,"enrollmentInfo":129,"targetDuration":131,"studyType":59,"phases":4,"briefSummary":132,"conditions":133,"keywords":136,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":46},"100641818","deep-learning-time-series-prediction-of-long-term-growth-patterns-of-pulmonary-ground-glass-nodules-using-serial-ct-100641818","NCT07647692","Deep Learning Time-Series Prediction of Long-Term Growth Patterns of Pulmonary Ground-Glass Nodules Using Serial CT","Development and Multi-Cohort Validation of a Deep Learning Spatiotemporal Model for Predicting Long-Term Progression of Pulmonary Ground-Glass Nodules Using Serial Thoracic CT","GGN-Trajectory","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Persistent pulmonary ground-glass nodule (pGGN or mGGN, 5-30 mm) on thin-slice chest CT (slice thickness ≤ 1.5 mm).\n* Baseline and follow-up thin-slice chest CTs of sufficient quality for 3D segmentation and registration.\n* Minimum interval between any two consecutive CTs \\> 1 month.\n* Complete baseline clinical data available (age, sex, smoking history, family history of malignancy, relevant comorbidities).\n\nCohort-specific inclusion\n\n* Group 1 (Development): surgical resection of the target GGN at PKUPH between Jan 2007 - Jun 2025, with ≥ 2 pre-operative thin-slice CTs available.\n* Group 2 (Surgical internal test): surgical resection at PKUPH between Jul 2025 - Jan 2026, with ≥ 2 pre-operative thin-slice CTs available.\n* Group 3 (Non-surgical internal test): non-operative management at PKUPH between Jan 2020 - Dec 2025, with ≥ 3 thin-slice CTs of the target GGN available.\n* Group 4 (Prospective external validation): prospective enrollment after model lock at participating centers, baseline CT plus ≥ 2 planned routine follow-up thin-slice CTs.\n\nExclusion Criteria:\n\n* Coexisting severe pulmonary disease that obscures evaluation of the target GGN (e.g., active pulmonary tuberculosis, severe interstitial lung disease).\n* Prior history of any other thoracic malignancy, or active extrathoracic malignancy under treatment within 5 years, that would confound interpretation of the target GGN.\n* CT image quality insufficient for registration and feature extraction (severe motion artifact, slice thickness \\> 1.5 mm at any required timepoint, or extensive metallic artifact projecting over the target GGN).\n* Pure solid nodule with no ground-glass component.\n* Target GGN already received treatment (resection, ablation, or radiotherapy) prior to the baseline CT used in this study.",{"count":130,"type":23},4750,"5 Years","Pulmonary ground-glass nodules (GGNs) are commonly found on chest CT scans. Some stay stable for years, while others slowly or rapidly turn into lung cancer. Doctors currently follow these nodules with repeated CT scans, but it is difficult to tell ahead of time which nodules will progress, how fast they will progress, and which ones can be safely monitored rather than immediately treated.\n\nThis observational study aims to develop and validate an artificial intelligence (AI) model that uses each patient's series of CT scans over time to predict the long-term growth behavior of a GGN. The research team will collect three retrospective single-center cohorts from Peking University People's Hospital (a development cohort and two internal test cohorts, one from surgically resected patients and one from non-operated patients followed by serial CT) as well as a prospective multi-center validation cohort enrolled after the AI model is locked.\n\nFor every patient, each GGN is automatically segmented in three dimensions on every CT scan. A deep learning model extracts imaging features at each timepoint and feeds the sequence of features, together with the actual times between scans, into a time-aware sequence model. The model is trained to predict (i) whether the nodule will show radiological progression at 1, 3, and 5 years after baseline, and (ii) which of four long-term growth patterns the nodule will follow: stable, slow progression, slow-then-rapid progression, or rapid progression. In patients who were ultimately resected, the histopathological diagnosis serves as a secondary reference standard.\n\nThis is an observational study. No experimental treatment is given. All CT scans and clinical visits are part of routine clinical care.",[134,29,135],"Pulmonary Nodules","Adenocarcinoma of Lung",[137,138,139,140,141,142,143,144],"Ground Glass Opacity","Ground-Glass Nodule","Longitudinal CT","Time-Series Analysis","Growth Trajectory","Volume Doubling Time","Deep Learning","Radiomics","2026-06-10",{"date":147,"type":38},"2026-06-15",{"date":149,"type":23},"2026-06-01",{"date":151,"type":23},"2031-06-01",{"name":153,"class":45},"Peking University People's Hospital",{"id":155,"slug":156,"hasResults":12,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":24,"phases":163,"briefSummary":165,"conditions":166,"keywords":175,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":190,"leadSponsor":192,"locationsCount":195},"100630545","phase-2-symbiotic-lung-10-a-study-to-learn-about-pf-08634404-alone-or-in-combination-in-early-stage-or-locally-advanced-nsclc-100630545","NCT07489066","Symbiotic-Lung-10: A Study to Learn About PF-08634404 Alone or in Combination in Early-stage or Locally Advanced NSCLC","AN INTERVENTIONAL, OPEN-LABEL, PHASE 2 STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY OR IN COMBINATION IN ADULT PARTICIPANTS WITH EARLY-STAGE RESECTABLE OR LOCALLY ADVANCED UNRESECTABLE NON-SMALL CELL LUNG CANCER","Inclusion Criteria:\n\n* 18 years of age or older at screening.\n* Have tumor tissue available, either paraffin block or slides from a core, excisional or fine needle biopsy\n* PD-L1 status available based on local testing results\n* Adequate organ function\n* Eastern Cooperative Oncology Group performance status (ECOG) score of 0 or 1\n* Part A only: Participants must have newly diagnosed, previously untreated, pathologically confirmed early-stage or LA (Stage II or IIIA\u002FB), squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) with disease that is considered resectable, as assessed by a multidisciplinary evaluation, which must include a thoracic surgeon who performs lung cancer surgery as a prominent part of his\u002Fher practice. The participant must be a candidate for neoadjuvant therapy followed by complete surgical resection.\n* Part B only: Participants must have pathologically confirmed early-stage or LA (Stage II or IIIA\u002FB), squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) and have undergone complete surgical resection. The participant must be considered a candidate for adjuvant therapy and must not have achieved pCR with SOC neoadjuvant chemo-immunotherapy.\n* Part C only: Participants must have pathologically confirmed LA, unresectable (Stage III) squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) and have received ≥ 60 Gy of radiation and ≥ 2 cycles of definitive, platinum-based concurrent chemotherapy and achieved SD or better per RECIST 1.1.\n\nExclusion Criteria:\n\n* Participants with known EGFR and ALK AGAs; documented negative results for EGFR and ALK AGAs are required for participants with non-squamous histology.\n* Participants with CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression.\n* Participants with clinically significant risk of hemorrhage or fistula are excluded.\n* Participants with any history of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.\n* Unresolved toxicities from prior anti-tumor therapy, that did not recover to NCI CTCAE v5.0 Grade 0 or 1.\n* Known to have a history of a severe allergy to any component of the study intervention, or a history of severe allergic reaction to chimeric or humanized antibody.\n* History of allogeneic organ \u002F hematopoietic stem cell transplantation.\n* Participants with any of the following respiratory conditions:\n\n  * Evidence of noninfectious or drug-induced interstitial lung disease (ILD) or pneumonitis\n  * Grade ≥3 pulmonary disease unrelated to underlying malignancy\n* History of uncontrolled comorbidities within 6 months prior to the first dose including uncontrolled cardiac and cerebrovascular conditions, hypertension, diabetes, significant vascular disease or arterial\u002Fsevere venous thromboembolic events.\n* Major surgery \\\u003C 4 weeks or minor surgery \\\u003C 3 days prior to first dose of study intervention.\n* History of severe bleeding tendency or coagulation dysfunction\n* History of esophageal varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose.\n* Participants with acute, chronic or symptomatic infections including participants positive for active HIV, hepatitis B virus (HBV), or Hepatitis C virus (HCV).\n* Participants with history of immunodeficiency\n* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior (in the past 5 years) or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.\n* Breastfeeding participants, participants of childbearing potential, and male participants who are unwilling to follow contraceptive measures.",{"count":162,"type":23},120,[164],"PHASE2","This study is being done to learn more about a new medicine called PF-08634404. The study team wants to understand how well it works when given alone or with chemotherapy. The study is for adults with early stage or locally advanced non-small cell lung cancer (NSCLC) that may or may not be removable with surgery.\n\nThe study is seeking participants who:\n\n* Are aged 18 years or older\n* Have either:\n\n  * Early-stage or locally advanced (Stage II or IIIA\u002FB) NSCLC and are a candidate for neoadjuvant therapy, followed by surgical removal of the tumor. Neoadjuvant therapy is a treatment given as a first step to shrink the tumor before surgery.\n  * Early-stage or locally advanced (Stage II or IIIA\u002FB) NSCLC and are a candidate for adjuvant therapy and did not achieve a pathological complete response (pCR) from approved treatment that was administered before surgery. Adjuvant therapy is an additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. pCR is defined as absence of viable tumor in all surgically removed samples.\n  * Locally advanced (Stage III) NSCLC that may not be removable with surgery, was treated with concurrent chemoradiotherapy (cCRT), and is a candidate for additional treatment, otherwise known as consolidation therapy. cCRT is chemotherapy and radiation given simultaneously.\n* Be in good physical condition and have healthy organs based on medical tests.\n* Do not have known actionable changes in DNA\n\nThe study has 3 parts and each participant will be assigned to one part by their doctor based on their disease diagnosis:\n\n* Part A will test PF-08634404 given with chemotherapy in the neoadjuvant setting, followed by surgery.\n* Part B will test PF-08634404 alone in adults who already were treated with neoadjuvant chemo-immunotherapy, underwent surgery, and did not achieve pCR per tumor tissue pathology analysis. Neoadjuvant chemo-immunotherapy refers to the combination of chemotherapy with immunotherapy per local standard-of-care, given before surgical removal of the tumor.\n* Part C will test PF-08634404 alone in adults with unresectable disease who received cCRT and did not have progressive disease. Progressive disease refers to a condition that grows, spreads, or worsens.\n\nAll treatments will be done at clinical study sites, where a trained medical team will monitor adults during and after each visit.",[167,168,169,29,170,171,172,173,174],"Carcinoma","Non-Small-Cell Lung","Lung Cancer (NSCLC)","Carcinoma, Non-Small-Cell Lung (NSCLC)","Lung Disease","Non-Small Cell Lung Cancer","Non-small Cell Lung Cancer, Non-squamous","Non-small Cell Lung Cancer, Squamous",[176,177,178,179,180,181,182,183,184,185],"early stage non small cell lung cancer","NSCLC","adjuvant NSCLC","locally advanced non small cell lung cancer","resectable NSCLC","unresectable NSCLC","neoadjuvant NSCLC","consolidation NSCLC","squamous NSCLC","non-squamous NSCLC","2026-06-04",{"date":188,"type":38},"2026-06-08",{"date":149,"type":23},{"date":191,"type":23},"2031-07-30",{"name":193,"class":194},"Pfizer","INDUSTRY",3,{"id":197,"slug":198,"hasResults":12,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":24,"phases":205,"briefSummary":206,"conditions":207,"keywords":213,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":221},"100629562","phase-2-symbiotic-lung-14-a-study-to-learn-about-the-study-medicine-called-pf08634404-in-combination-with-chemotherapy-in-adult-participants-with-transformed-small-cell-lung-cancer-100629562","NCT07476287","Symbiotic-Lung-14: A Study to Learn About the Study Medicine Called PF08634404 in Combination With Chemotherapy in Adult Participants With Transformed Small Cell Lung Cancer","A PHASE 2 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH PREVIOUSLY UNTREATED TRANSFORMED SMALL CELL LUNG CANCER","Inclusion Criteria:\n\n* Male or female participants aged ≥18 years at the time of informed consent.\n* Histologically or cytologically confirmed T-SCLC. Participant must have had a prior diagnosis of NSCLC with EGFR mutation which transformed to SCLC following the treatment with TKI(s).\n* Participants have not received systemic therapy for T-SCLC.\n* Have at least one measurable lesion as the target lesion based on RECIST v1.1.\n* Have sufficient tumor tissue from the diagnosis of transformed SCLC available.\n* Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Have a minimum life expectancy of \\>12 weeks.\n* Clinical laboratory values at screening within acceptable limits, as defined in the protocol, including: 1) Hematology, 2) Liver function and 3) Renal function.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Active or untreated CNS disease, including brain, brainstem, spinal cord, or meningeal metastases. Participants with definitively treated, clinically stable brain metastases may be eligible per protocol criteria. Participants with untreated asymptomatic brain metastases of longest diameter \\\u003C1 cm are permitted if all of the following criteria are met: absence of neurological symptoms, no need for corticosteroids, and brain metastasis has no evidence of edema or hemorrhagic features.\n* Leptomeningeal disease\n* Clinically significant risk of hemorrhage or fistula, including tumor necrosis\u002Fcavitation, invasion or compression of major blood vessels, airways, or critical organs, or risk of tracheoesophageal or pleuroesophageal fistula\n* History of another malignancy (other than NSCLC) within 3 years prior to first dose, except for malignancies with negligible risk of metastasis or death (eg, adequately treated carcinoma in situ, nonmelanoma skin cancer)\n* Unresolved toxicity from prior anti-tumor therapy that has not recovered to Grade ≤1 per NCI CTCAE v5.0 (except alopecia or irreversible toxicities deemed stable)\n* History of allogeneic organ or hematopoietic stem cell transplantation\n* Active autoimmune disease requiring systemic treatment within the past 2 years (Stable replacement therapy and selected low-risk autoimmune conditions are permitted per protocol)\n* Interstitial lung disease (ILD), pneumonitis, or significant pulmonary disease, including:\n\n  * Prior or current non-infectious pneumonitis requiring systemic therapy\n  * DLCO \\\u003C50% predicted\n  * Severe asthma, COPD, pulmonary embolism, or autoimmune lung involvement\n* Uncontrolled or clinically significant cardiovascular, cerebrovascular, metabolic, hepatic, or renal disease within 6 months prior to first dose\n* Baseline QTcF \\>480 msec\n* Major surgery or severe trauma within 4 weeks prior to first dose, or planned major surgery during the study\n* Clinically significant pleural effusion, pericardial effusion, or ascites requiring repeated drainage\n* History of significant bleeding disorders or recent major bleeding events\n* Clinically significant gastrointestinal conditions, including recent perforation, fistula, obstruction, or active bleeding\n* Active, uncontrolled, or symptomatic infection, including:\n\n  * Active TB\n  * Active hepatitis B or C\n  * Uncontrolled HIV infection\n* History of immunodeficiency\n* Severe hypersensitivity or allergic reactions to study intervention components or monoclonal antibodies\n* Psychiatric illness or medical condition, including recent suicidal ideation or behavior, that may increase risk or interfere with study participation\n* Prior anti-angiogenic therapy or other prohibited anti-tumor or immunomodulatory therapies per protocol-specified washout periods\n* Use of prohibited concomitant medications, including high-dose systemic corticosteroids, certain anticoagulants, or live vaccines within protocol-specified timeframes\n* Recent participation in another investigational study (within 30 days or 5 half-lives, whichever is longer)\n* Pregnant or breastfeeding participants, or unwillingness to comply with contraception requirements",{"count":204,"type":23},40,[164],"This study is being done to learn more about a new medicine called PF-08634404. The study team wants to understand how well PF-08634404 works when given alone or with chemotherapy . Chemotherapy is a type of cancer treatment that uses medicines to destroy cancer cells or stop them from growing. The study is for adults with Transformed Small Cell Lung Cancer (T-SCLC ). T SCLC is a rare lung cancer that happens when one type of lung cancer changes into a more aggressive type after treatment stops working.\n\nTo join the study, participants must meet the following conditions:\n\n* Are aged 18 years or older\n* Diagnosed with T-SCLC and have not received treatment for this type of lung cancer (a single cycle of chemotherapy may be permitted)\n* Prior diagnosis of epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer treated with tyrosine kinase inhibitors (TKIs)\n* Have healthy organs based on medical tests and are in good physical condition\n\nAfter joining the study, adults will be given chemotherapy in addition to the study medicine. After this combination treatment is finished, the study medicine will be continued alone. Adults will receive the treatment through IV infusions (medicine given directly into a vein). All treatments will be done at clinical study sites, where a trained medical team will monitor adults during and after each visit.",[208,209,210,29,211,212],"Small Cell Lung Cancer","Small Cell Lung Cancer ( SCLC )","Transformed Small Cell Lung Cancer","Carcinoma, Small Cell Lung","Small Cell Cancer Of The Lung",[210,208],"2026-06-03",{"date":186,"type":38},{"date":217,"type":23},"2026-05-15",{"date":219,"type":23},"2031-03-19",{"name":193,"class":194},12,{"id":223,"slug":224,"hasResults":12,"nctId":225,"briefTitle":226,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":24,"phases":230,"briefSummary":231,"conditions":232,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":4},"100643269","construction-and-feasibility-study-of-a-home-based-intelligent-symptom-management-program-for-lung-cancer-patients-receiving-combined-drug-therapy-based-on-symptom-journey-profiling-100643269","NCT07632703","Construction and Feasibility Study of a Home-Based Intelligent Symptom Management Program for Lung Cancer Patients Receiving Combined Drug Therapy Based on Symptom Journey Profiling","Inclusion Criteria:\n\n* Diagnosed with primary lung cancer confirmed by histology or cytology\n* First-time recipient of combination drug therapy, with an expected treatment course of at least 4 cycles; the combination regimen is not restricted\n* Aged 18 years or older\n* Able to use a smartphone\n* Eastern Cooperative Oncology Group performance status score of 2 or lower\n* Aware of their own diagnosis and medication regimen\n* Voluntarily agree to participate in this study\n\nExclusion Criteria:\n\n* History of mental illness or currently receiving mental health treatment\n* Diagnosis of malignancy in another organ site\n* Presence of cognitive impairment, indicated by 3 or more errors on the Short Portable Mental Status Questionnaire",{"count":229,"type":23},60,[26],"The goal of this clinical trial is to develop and evaluate a home-based intelligent symptom management program based on symptom journey profiles for patients with lung cancer receiving combination drug therapy. The program will be delivered through the \"Zhihu Feifang\" WeChat mini-program and is designed to help patients monitor symptoms, receive personalized symptom management recommendations, and obtain timely support during treatment intervals at home.\n\nThe study will assess the feasibility, acceptability, and preliminary effectiveness of this intelligent symptom management program.\n\nThe main research questions are as follows: (1) Is the intelligent symptom management program feasible and acceptable for patients with lung cancer receiving combination drug therapy? (2) Compared with usual care, can the program reduce symptom burden and improve symptom self-management ability? (3) Can the program improve quality of life and help patients identify and manage symptoms more promptly during treatment intervals? Researchers will compare the intelligent symptom management program with usual care to evaluate its preliminary effectiveness. Participants will be randomly assigned to either the intervention group or the usual care group.\n\nParticipants in the intervention group will: (1) Receive usual care plus the \"Zhihu Feifang\" WeChat mini-program intervention; (2) Use the mini-program during four consecutive treatment intervals, lasting approximately 4 months; (3) Complete regular symptom assessments through the mini-program; (4) Receive personalized symptom management education, coping strategies, and risk alerts based on their symptom severity and symptom changes; (5) Receive nurse monitoring and follow-up support when needed; (6) Complete questionnaires at baseline and at follow-up time points during the study; (7) Some participants may also take part in an interview after the intervention to share their experience and suggestions.\n\nParticipants in the usual care group will receive routine follow-up care, including health education, telephone follow-up, and medical visit guidance.",[29,233,234],"Symptom Management","mHealth Intervention","2026-06-02",{"date":188,"type":38},{"date":238,"type":23},"2026-05-25",{"date":240,"type":23},"2027-06-30",{"name":242,"class":45},"Feifei Huang",{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":250,"enrollmentInfo":251,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":253,"conditions":254,"keywords":255,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":269},"100603945","lung-roll-treatment-patterns-and-cost-of-illness-of-lung-cancer-in-canada-100603945","NCT07143110","LUNG-ROLL: Treatment Patterns and Cost of Illness of Lung Cancer in Canada","LUNG-ROLL","Inclusion Criteria:\n\n* Patients with lung cancer between January 1, 2018 and end of the Selection Period.\n* Patient is 18 years of age or older on diagnosis date.\n* Patient has at least 12 months of health insurance coverage prior to the diagnosis date.\n\nExclusion Criteria:\n\n* Diagnosed with any other cancer in the 5-year period prior to January 1, 2018.\n* Diagnosed with any other cancer concurrently (i.e., on the same date) as lung cancer diagnosis.\n* Invalid or incomplete records for key variables (e.g., missing year of diagnosis, missing cancer type).\n* Non-Ontario or non-Alberta resident on diagnosis date.","130 Years",{"count":252,"type":23},60000,"LUNG-ROLL is a retrospective cohort study that will describe the contemporary treatment patterns, prevalence and incidence, patient demographic and clinical characteristics, clinical outcomes, and healthcare resource use\u002Fcosts for patients with lung cancer in Canada (specifically, Alberta and Ontario) using administrative data.",[29],[29,168,256,257,258,259],"Small Cell Lung","Epidemiology","Treatment Patterns","Real-World","2026-05-20",{"date":262,"type":38},"2026-05-22",{"date":264,"type":38},"2025-08-20",{"date":266,"type":23},"2027-09-30",{"name":268,"class":194},"AstraZeneca",2,{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":12,"sex":18,"minAge":276,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":24,"phases":279,"briefSummary":280,"conditions":281,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":287,"leadSponsor":288,"locationsCount":4},"100638969","construction-and-preliminary-evaluation-of-dyadic-acceptance-and-commitment-therapy-for-couples-with-fear-of-lung-cancer-recurrence-100638969","NCT07588347","Construction and Preliminary Evaluation of Dyadic Acceptance and Commitment Therapy for Couples With Fear of Lung Cancer Recurrence","Inclusion Criteria\n\nPatients:\n\n* Diagnosis of primary lung cancer confirmed by pathological examination.\n* Age ≥ 22 years for men and ≥ 20 years for women (legal marriage age in China).\n* Have undergone lung cancer surgery and are scheduled to receive the first round of radiotherapy and\u002For chemotherapy treatment\n* Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF) score ≥ 13, indicating moderate-to-severe FCR.\n* Eastern Cooperative Oncology Group (ECOG) ≤2.\n* Aware of their diagnosis and willing to participate voluntarily.\n* Normal cognitive function (Montreal Cognitive Assessment \\[MoCA\\] score ≥ 26), alert and conscious, and able and willing to communicate their thoughts.\n\nSpouse Caregivers:\n\n* Identified by the patient as the primary caregiver, providing ≥ 50% of care in the past 2 weeks.\n* Legally married to the patient.\n* Age ≥ 22 years for men and ≥ 20 years for women.\n* Normal cognitive function (MoCA score ≥ 26), no diagnosed mental disorders, able to communicate effectively, and willing to share their thoughts.\n\nExclusion Criteria\n\nPatients:\n\n* Diagnosed mental disorders or currently receiving psychiatric treatment.\n* Presence of personality disorders, intellectual disability, memory disorders, brain injury, or neurological disease.\n* Concurrent malignant tumors in other organs.\n* Severe complications (e.g., chest pain and\u002For dyspnea due to pleural tumor invasion).\n* Spouse caregiver unwilling to participate.\n* History of upper limb fractures or surgery resulting in impaired hand function.\n* Participation in other similar psychological interventions.\n\nSpouse Caregivers:\n\n* Presence of serious comorbid conditions (e.g., respiratory failure, malignant tumors, or other critical illnesses).\n* Patient unwilling to participate.\n* Participation in other research studies.","20 Years",{"count":278,"type":23},72,[26],"The goal of this clinical trial is to develop a simple, scientific, effective, and culturally adapted dyadic Acceptance and Commitment Therapy (ACT) intervention program (the ADAPT program) targeting fear of cancer recurrence (FCR) among lung cancer patients and their spouse caregivers. The study will also evaluate the feasibility, acceptability, and preliminary effectiveness of the ADAPT program.\n\nThe main research questions are as follows:\n\n* Is the ADAPT intervention program feasible and acceptable for lung cancer patients and their spouse caregivers?\n* Compared with usual care, can the ADAPT intervention program preliminarily reduce FCR levels in both patients and their spouse caregivers? Can the program improve coping styles, illness perceptions, family functioning, and intimate relationships among both patients and their spouse caregivers? Can the program enhance psychological flexibility and quality of life (QOL) in both patients and their spouse caregivers? Researchers will compare the ADAPT intervention program with usual care to evaluate its preliminary effectiveness in reducing FCR among lung cancer patients and their spouse caregivers.\n\nParticipants will:\n\n* Receive the ADAPT intervention twice during each radiotherapy and\u002For chemotherapy cycle, for a total of three treatment cycles (approximately 3 months);\n* Complete questionnaires at baseline (before the intervention), immediately after the intervention, and one month post-intervention;\n* Report outcomes including FCR severity, FCR triggers, psychological flexibility, illness perception, dyadic coping, family functioning, intimacy, and quality of life (QOL).",[29,282,283],"Acceptance and Commitment Therapy","Spouses",{"date":285,"type":38},"2026-05-19",{"date":217,"type":23},{"date":240,"type":23},{"name":242,"class":45},{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":295,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":299,"conditions":300,"keywords":301,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":314},"100601335","denila-comprehensive-demographics-and-clinical-profile-of-nsclc-patients-analyzing-guideline-concordant-care-in-first-line-treatment-patterns-100601335","NCT07109154","DeniLA: Comprehensive Demographics and Clinical Profile of NSCLC Patients: Analyzing Guideline-Concordant Care in First-line Treatment Patterns","DeniLA: Comprehensive Demographics and Clinical Profile of NSCLC Patients: Analyzing Guideline-Concordant Care in First-line Treatment Patterns Observational Study (Prospective and Survey); Evaluation Patterns of Choice in First Line Treatment of Metastatic NSCLC","DeniLA","Inclusion Criteria:\n\n* Advanced (unresectable or metastatic) non-small cell lung carcinoma\n* First-line oncological treatment in one of the participating centers between 2025 and 2026 (between January 2025 and January 2026)\n* \\> 18 years old\n* Data available in electronic medical records.\n\nExclusion Criteria:\n\n* Localized disease amenable to local treatment\n* Non-epithelial histology\n* Small cell carcinoma\n* Neuroendocrine tumor\n* Patients with unresectable NSCLC who underwent treatment with the PACIFIC protocol and are being followed up.",{"count":298,"type":23},200,"This is a prospective, observational, multicenter study, in which clinical and demographic data will be extracted from medical records. Convenience sample, with an estimated inclusion of 200 patients treated in seven participating centers.\n\nEligible tumors for this project will be from patients with advanced (unresectable or metastatic) non-small cell lung carcinoma, who will start first-line oncological treatment in one of the participating centers between 2025 and 2026 (between January 2025 and January 2026). Patients must be over 18 years old and data must be available in electronic medical records.\n\nMedical records will be assessed to confirm patients' eligibility. Patients with localized disease amenable to local treatment, non-epithelial histology, small cell carcinoma and neuroendocrine tumor will not be eligible.\n\nA survey will be designed targeting thoracic and generalist medical oncologists, aiming to understand the factors guiding the choice of first-line treatment regimens and to compare these insights with real-world data. The survey will be directed to Brazil, with an estimated of 200 filled files.",[29],[302,303,304,305],"Advanced Non Small Cell Lung Câncer;","Driver mutations;","PD-L1 expression;","Real World Evidence","2026-05-12",{"date":308,"type":38},"2026-05-13",{"date":310,"type":38},"2025-11-25",{"date":312,"type":23},"2027-04-30",{"name":268,"class":194},7,{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":322,"enrollmentInfo":323,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":324,"conditions":325,"keywords":327,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":340,"locationsCount":46},"100626512","3d-virtual-resection-for-predicting-lung-function-in-vats-100626512","NCT07436598","3D Virtual Resection for Predicting Lung Function in VATS","Preoperative Three-Dimensional Virtual Resection Predicts Postoperative Pulmonary Function After Anatomical Resection : A Prospective Longitudinal Study","Inclusion Criteria:\n\n* Patients scheduled for video-assisted thoracoscopic (VATS) lobectomy or segmentectomy at National Taiwan University Hospital or NTU Cancer Center.\n* Age between 18 and 80 years.\n* Patients who have signed the informed consent form agreeing to provide imaging data for 3D modeling.\n\nExclusion Criteria:\n\n* Age younger than 18 or older than 80 years.\n* Patients not scheduled for VATS lobectomy or segmentectomy.\n* Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD).\n* Patients unable or unwilling to sign the informed consent form.\n* Vulnerable populations.","80 Years",{"count":229,"type":23},"This study aims to validate a novel preoperative assessment strategy using three-dimensional (3-D) computed tomography (CT) reconstruction and virtual resection simulation. The goal is to accurately predict postoperative pulmonary function in patients with non-small cell lung cancer (NSCLC) undergoing Video-Assisted Thoracoscopic Surgery (VATS) anatomical resection.\n\nAccurate prediction of postoperative lung function is crucial for patient safety. Traditional methods, such as segment counting, often lack precision because they assume all lung segments contribute equally to function, ignoring variations caused by tumors or emphysema. This study utilizes 3-D \"virtual resection\" to quantify the \"Planned Resected Ventilated Lung Volume Fraction\" (pRVLVF) before surgery.\n\nThe study will recruit 60 participants divided into two groups: those undergoing lobectomy (n=30) and those undergoing segmentectomy (n=30). Participants will undergo standard thin-slice CT scans and pulmonary function tests (PFT) before surgery. Postoperatively, lung function and recovery will be tracked at 3, 6, and 12 months to develop a dynamic prediction model and evaluate the compensatory capacity of the residual lung.",[326,30,29],"Non-small Cell Lung Cancer",[328,329,330,331,332,333,334],"Three-dimensional virtual resection","Pulmonary Function Prediction","Ventilated Lung Volume Fraction (VLVF)","VATS Anatomical Resection","Segmentectomy","Lobectomy","Postoperative Compensation Coefficient","2026-05-10",{"date":308,"type":38},{"date":338,"type":38},"2026-04-07",{"date":240,"type":23},{"name":341,"class":45},"National Taiwan University Hospital",{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":348,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":350,"enrollmentInfo":351,"targetDuration":4,"studyType":24,"phases":353,"briefSummary":354,"conditions":355,"keywords":357,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":365,"leadSponsor":366,"locationsCount":4},"100637058","apple-vision-pro-assisted-vascular-identification-in-lung-surgery-100637058","NCT07573748","Apple Vision Pro-Assisted Vascular Identification in Lung Surgery","Apple Vision Pro-Assisted Vascular Identification in Lung Surgery: A Prospective Interventional Study","AVP-Lung","Inclusion Criteria:\n\nPatients aged 18 years or older. Diagnosed with lung nodules or early-stage lung cancer requiring surgical resection (lobectomy or segmentectomy).\n\nScheduled for elective lung surgery at Huai'an Second People's Hospital. American Society of Anesthesiologists (ASA) Physical Status Classification I-III.\n\nAbility to understand and sign the informed consent form. Willingness to undergo surgery with the Apple Vision Pro navigation assistance.\n\nExclusion Criteria:\n\nPatients under 18 years of age. Pregnant or breastfeeding women. Patients with severe cardiopulmonary dysfunction (e.g., severe COPD, unstable angina, recent myocardial infarction) that would contraindicate surgery.\n\nParticipation in another interventional clinical trial within the past 30 days. Inability to cooperate with the surgical team or follow study procedures.","85 Years",{"count":352,"type":23},20,[26],"This study is testing whether a new mixed-reality head-mounted display (Apple Vision Pro) can help surgeons see blood vessels more clearly during lung surgery.\n\nDuring the operation, doctors usually need to identify and protect important blood vessels to avoid bleeding. In this study, surgeons will wear the Apple Vision Pro device, which shows 3D images of the lungs and blood vessels. This may help them find vessels more accurately and make surgery safer.\n\nParticipants scheduled for lung surgery at Huai'an Second People's Hospital will be invited to join. Before the operation, participants will have a CT scan. During surgery, doctors will use the device while performing the procedure.\n\nThe study does not change the standard surgical steps, and there are no extra risks for participants. The main goal is to see if this new technology makes surgery easier and safer.\n\nParticipation is voluntary, and all personal information will be kept confidential.",[29,356],"Mixed Reality",[29,358,359,360],"Mixed reality","Intraoperative Navigation","Three-Dimensional Imaging","2026-05-01",{"date":363,"type":38},"2026-05-07",{"date":361,"type":23},{"date":76,"type":23},{"name":367,"class":45},"The Second People's Hospital of Huai'an",{"id":369,"slug":370,"hasResults":12,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":4,"enrollmentInfo":375,"targetDuration":4,"studyType":24,"phases":377,"briefSummary":378,"conditions":379,"keywords":380,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":46},"100635159","phase-2-vebreltinib-plus-chemotherapy-as-first-line-treatment-for-met-overexpressing-nsclc-100635159","NCT07549061","Vebreltinib Plus Chemotherapy as First-line Treatment for MET-overexpressing NSCLC","A Phase II Study of Vebreltinib Combined With Platinum-Doublet Chemotherapy as First-Line Treatment for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Negative Driver Genes and MET Overexpression","Inclusion Criteria:\n\n1. Voluntarily sign a written informed consent form (ICF) to participate in the study; be willing and able to comply with study-related visits and procedures.\n2. Male or female subjects aged 18 years or older.\n3. Pathologically confirmed non-small cell lung cancer (NSCLC); outside hospital pathology reports are acceptable.\n4. Newly diagnosed metastatic NSCLC (clinical Stage IVA or IVB) or recurrent NSCLC (staged in accordance with the AJCC Cancer Staging Manual 9th edition), not eligible for curative-intent surgery or radiotherapy.\n5. Treatment-naïve advanced NSCLC not amenable to curative surgery or radiotherapy. For recurrent disease, prior adjuvant and neoadjuvant therapy (chemotherapy, radiotherapy, immunotherapy, biologic therapy, investigational agents), or definitive radiotherapy\u002Fchemoradiotherapy with or without immunotherapy, biologic therapy, or investigational agents is permitted if completed at least 12 months before disease recurrence.\n6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-2.\n7. Driver gene-negative status confirmed by tumor tissue or blood sample, including but not limited to negative EGFR mutation, negative ALK rearrangement, negative ROS1 rearrangement, negative KRAS G12C mutation, and negative MET exon 14 skipping mutation. MET amplification is permitted: FISH demonstrating GCN ≥ 4 or MET\u002FCEP7 ≥ 2, or positive result confirmed by NGS.\n8. MET protein overexpression defined as ≥50% of tumor cells staining at IHC 2++ or stronger. Local laboratory IHC results are acceptable.\n9. Estimated overall survival of at least 3 months.\n10. Laboratory values meeting the following requirements:\n\n    Absolute neutrophil count (ANC)≥1.5 × 10⁹\u002FL; Hemoglobin≥90 g\u002FL; Platelets≥75 × 10⁹\u002FL; Serum total bilirubin≤1.5×upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤3×ULN; for patients with liver metastases, AST and ALT≤5×ULN; Serum creatinine\\\u003C1.5 × ULN. Creatinine clearance (CrCl)\\>50 mL\u002Fmin, calculated using the Cockcroft-Gault formula\n11. Males with reproductive potential and females of childbearing potential must agree to use highly effective contraception from signing informed consent until 3 months after the last dose of study drug. For females of childbearing potential, a serum pregnancy test must be negative within ≤7 days before the first dose of study drug.\n\nExclusion Criteria:\n\n1. Spinal cord compression. Symptomatic or unstable brain metastases, unless the patient has completed curative treatment, is not receiving corticosteroid therapy, and has maintained a stable neurological status for at least 2 weeks after completion of curative treatment and steroid therapy. Patients with asymptomatic brain metastases may be included if the investigator determines there is no immediate indication for curative treatment.\n2. Meeting any of the following prior treatment history criteria:\n\n   Major surgery (e.g., intrathoracic, intra-abdominal, or intrapelvic surgery) within 4 weeks prior to enrollment, or failure to recover from side effects of such surgery. Thoracoscopic biopsy and mediastinoscopy are not considered major surgery, and patients may be enrolled 1 week after these procedures.\n\n   Treatment with traditional Chinese medicine (TCM) or Chinese patent medicine with anti-tumor indications within 1 week prior to the first dose of study drug.\n\n   Treatment with strong CYP3A4 inducers and\u002For strong inhibitors, and inability to discontinue such agents for at least 1 week prior to initiation of study treatment and during the study period.\n\n   Prior systemic anti-tumor therapy for advanced NSCLC, including chemotherapy, biologic therapy, immunotherapy, or any investigational agent, administered as non-curative surgery or radiotherapy. For recurrent disease, prior adjuvant and neoadjuvant therapy (chemotherapy, radiotherapy, immunotherapy, biologic therapy, investigational agents), or definitive radiotherapy\u002Fchemoradiotherapy with or without immunotherapy, biologic therapy, or investigational agents is permitted only if completed at least 12 months before disease recurrence.\n\n   Radiation therapy to more than 30% of bone marrow, or large-field radiation therapy within 4 weeks prior to the first dose of vebreltinib.\n\n   Patients with intracranial lesions requiring urgent local treatment for symptom relief are recommended for exclusion, at the discretion of the investigator.\n\n   Any severe or uncontrolled systemic disease, including but not limited to other severe medical or psychiatric disorders or laboratory abnormalities that, in the investigator's judgment, render the study drug inappropriate for the patient or impair compliance with the protocol.\n3. Meeting any of the following cardiac function or disease criteria:\n\n   Mean corrected QT interval (QTc) \\> 470 ms based on three routine ECG assessments performed at least 5 minutes apart (preferably completed within 1 hour) during the screening period at rest. Calculation shall be performed using the Fridericia formula (see Appendix 5 for details), with mean QTcF \\> 470 ms.\n\n   Any significant cardiac arrhythmia, such as complete left bundle branch block, second- or third-degree heart block, ventricular arrhythmia, drug-uncontrolled supraventricular or nodal arrhythmia, or other drug-uncontrolled cardiac arrhythmias.\n\n   Any risk factors for prolonged QTc interval, including chronic hypokalemia uncorrected by supplementation, congenital long QT syndrome, and concomitant use of QTc-prolonging medications.\n\n   Congestive heart failure of New York Heart Association (NYHA) Class ≥3. Unstable or uncontrolled diseases or conditions related to or affecting cardiac function (e.g., unstable angina pectoris, inadequately controlled hypertension defined as diastolic blood pressure \\> 100 mmHg and\u002For systolic blood pressure \\> 160 mmHg regardless of antihypertensive use; initiation or adjustment of antihypertensive agents prior to screening is permitted).\n4. Diagnosis of another active malignancy requiring treatment within the past 3 years, other than NSCLC. Excluded are completely resected basal cell and squamous cell skin cancer, and completely resected carcinoma in situ of any type.\n5. Presence of active infection, including but not limited to:\n\n   Chronic hepatitis B (hepatitis B surface antigen \\[HBsAg\\] positive with hepatitis B virus \\[HBV\\] DNA ≥ 500 IU\u002Fml), hepatitis C (positive anti-hepatitis C virus \\[HCV\\] antibody and positive HCV-RNA), human immunodeficiency virus (HIV) infection (positive HIV antibody), or syphilis infection.\n\n   Active tuberculosis. Active infection requiring systemic anti-infective therapy (e.g., pneumonia) within 2 weeks prior to the first dose of study drug.\n\n   History of interstitial lung disease (ILD), drug-induced ILD, or radiation pneumonitis requiring corticosteroid therapy; or current active interstitial lung abnormalities requiring medical therapy or other clinical intervention.\n\n   Active gastrointestinal disorders (e.g., ulcerative lesions, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome) or other conditions (e.g., inability to swallow study medication, prior major gastrointestinal surgery) that may significantly affect absorption, distribution, metabolism, or excretion of oral study drug.\n6. Known hypersensitivity to drugs of the same class as the study drug or to any of its excipients.\n7. Any concurrent medical condition that may increase the risk of toxicity.\n8. Pregnant or lactating females.\n9. Current participation in another clinical trial, or receipt of investigational product within 2 weeks prior to the first dose of study drug.\n10. Any other circumstances deemed by the investigator to render the patient ineligible for study participation, including evidence of severe or uncontrolled systemic disease such as active primary immunodeficiency disorders and allogeneic organ transplantation, which would make the patient unsuitable for enrollment or interfere with compliance with the study protocol.",{"count":376,"type":23},19,[164],"To explore the efficacy and safety of vebreltinib plus platinum-doublet chemotherapy as first-line therapy in patients with driver gene-negative, locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET overexpression.",[29],[177,381,382,383],"Vebreltinib","Met","Overexpression","2026-04-23",{"date":386,"type":38},"2026-04-29",{"date":388,"type":23},"2026-03-30",{"date":390,"type":23},"2028-12-30",{"name":392,"class":45},"Shanghai Chest Hospital",{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":12,"sex":18,"minAge":400,"maxAge":401,"enrollmentInfo":402,"targetDuration":4,"studyType":24,"phases":404,"briefSummary":405,"conditions":406,"keywords":410,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":46},"100632103","mdt-based-umbrella-decision-model-for-geriatric-lung-cancer-patients-100632103","NCT07509333","MDT-Based Umbrella Decision Model for Geriatric Lung Cancer Patients","Establishment and Validation of a Multidisciplinary Team (MDT)-Based Umbrella Decision-making and Treatment Model for Geriatric Lung Cancer Patients","Inclusion Criteria:\n\n1. Age 60 to 90 years.\n2. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC).\n3. Clinical stage I-IV (according to the 9th edition of the IASLC TNM staging system).\n4. ECOG Performance Status 0-2.\n5. Estimated life expectancy ≥ 3 months.\n6. Able to tolerate baseline examinations (including CT, MRI, pulmonary function tests) and at least one planned treatment modality (surgery, ablation, SBRT, etc.) as assessed by the investigator.\n7. Patients or their legal representatives provide written informed consent and commit to completing the full follow-up schedule (including questionnaires and functional assessments).\n8. Other conditions deemed suitable by the investigator.\n\nExclusion Criteria:\n\n1. History of other primary malignancies within the past 5 years (except non-melanoma skin cancer or carcinoma in situ of the cervix).\n2. Unclear pathological diagnosis (no definite histologic or cytologic evidence) or post-enrollment pathological review excludes lung cancer.\n3. Severe psychiatric disorders (e.g., Alzheimer's disease, schizophrenia) or cognitive impairment (MMSE score \\\u003C 20) that interferes with questionnaire completion or treatment decision-making communication.\n4. Contraindications to study-related examinations or treatments:\n\n   4.1Known contraindication to iodine-based contrast agents or MRI (e.g., incompatible metallic implants).\n\n   4.2Known severe allergy to any of the essential therapeutic agents (e.g., chemotherapy, targeted drugs) involved in the study.\n5. Severe organ dysfunction (e.g., Child-Pugh class C cirrhosis, end-stage renal disease without dialysis) that precludes tolerability of baseline examinations or any treatment.\n6. No fixed residential address or effective contact information, or family members refuse to assist with follow-up, leading to an estimated follow-up dropout risk \\> 50%.\n7. Concurrent participation in another interventional clinical trial for lung cancer (observational studies are allowed).\n8. Any other condition that, in the opinion of the investigator, makes the patient unsuitable for study participation.","60 Years","70 Years",{"count":403,"type":23},2000,[26],"This is a single-center, prospective, single-arm interventional study with historical control, designed to evaluate the clinical value of a multidisciplinary team (MDT)-based decision-making umbrella decision model in elderly patients with lung cancer. A total of 2,000 patients aged 60-90 years with newly diagnosed non-small cell or small cell lung cancer will be enrolled. Each patient will undergo comprehensive geriatric assessment and receive an individualized treatment plan formulated by an MDT comprising thoracic surgeons, geriatricians, oncologists, pulmonologists, rehabilitation therapists, and radiologists. Treatment options include surgery, ablation, stereotactic body radiotherapy (SBRT), neoadjuvant immunochemotherapy, targeted therapy, and best supportive care. The primary outcome is 3-year progression-free survival (PFS). Secondary outcomes include overall survival, objective response rate, quality of life (EORTC QLQ-LC43), incidence of adverse events (CTCAE v5.0), and healthcare economics. Historical controls (2014-2024) will be extracted from hospital records and matched using propensity score matching. The study aims to establish a standardized MDT pathway to improve treatment outcomes and reduce risks in the geriatric lung cancer population.",[29,407,408,409],"Carcinoma, Non-Small-Cell Lung","Small Cell Lung Carcinoma","Elderly",[411,409,412,413,414],"Lung cancer","Geriatric","Multidisciplinary team","Umbrella trial","2026-03-28",{"date":417,"type":38},"2026-04-03",{"date":419,"type":38},"2025-12-01",{"date":421,"type":23},"2030-10-31",{"name":423,"class":45},"West China Hospital",{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":430,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":4,"enrollmentInfo":432,"targetDuration":4,"studyType":24,"phases":433,"briefSummary":434,"conditions":435,"keywords":439,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":46},"100578334","phase-2-feasibility-of-fluorescence-imaging-with-bevacizumab-800cw-during-bronchoscopy-100578334","NCT06809946","Feasibility of Fluorescence Imaging With Bevacizumab-800CW During Bronchoscopy","Feasibility of Fluorescence Imaging With Bevacizumab-800CW During Bronchoscopy in Patients With a Pulmonary Lesion Considered to be Malignant - DEFLECT I","DEFLECT I","Inclusion Criteria:\n\n1. Signed informed consent prior to participation in the study.\n2. Age ≥ 18 years.\n3. Patient has at least one intrabronchial, near-to-airway located or peripheral pulmonary nodule - with or without pathological lymph nodes - which is considered malignant (independent of its primary origin).\n4. Patient is considered fit to undergo a diagnostic and\u002For therapeutic bronchoscopy (with or without addition of virtual navigation and\u002For endobronchial ultrasound; including propofol sedation or general anesthesia if either is indicated) to obtain tumor material according to standard care protocols.\n\nExclusion Criteria:\n\n1. History of infusion reactions to bevacizumab.\n2. Medical or psychiatric conditions that compromise the patient's ability to give informed consent.\n3. Pregnancy or breast feeding.",{"count":352,"type":23},[164],"In this feasibility study, bronchoscopy will be combined with fluorescence molecular imaging using the near-infrared fluorescence (NIRF) tracer bevacizumab-800CW for assessment of pulmonary lesions and\u002For lymph nodes considered to be malignant.",[29,436,437,438],"Pulmonary Neoplasms","Lymph Node Involvement","Pulmonary Nodule",[440,441,442,443,444],"Fluorescence molecular bronchoscopy","Bevacizumab-800CW","Near-infrared fluorescence imaging","Molecular imaging","Pulmonary nodule","2026-03-24",{"date":388,"type":38},{"date":448,"type":23},"2026-08-17",{"date":450,"type":23},"2028-08-17",{"name":452,"class":45},"University Medical Center Groningen",{"id":454,"slug":455,"hasResults":12,"nctId":456,"briefTitle":457,"officialTitle":457,"acronym":4,"eligibilityCriteria":458,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":350,"enrollmentInfo":459,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":460,"conditions":461,"keywords":465,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":46},"100615385","to-conduct-multi-omics-integrated-studies-in-peripheral-blood-such-as-fragment-omics-metabolomics-and-epigenetics-and-establish-non-invasive-dynamic-follow-up-monitoring-programs-during-perioperative-and-postoperative-periods-observational-study-100615385","NCT07291921","To Conduct Multi-omics Integrated Studies in Peripheral Blood, Such as Fragment Omics, Metabolomics and Epigenetics, and Establish Non-invasive Dynamic Follow-up Monitoring Programs During Perioperative and Postoperative Periods (Observational Study)","Inclusion Criteria:\n\n1. Signed written informed consent.\n2. Male or female, aged ≥ 18 and \\\u003C 85 years.\n3. Radical resection performed, pathologic stage IB-IIIA (8th TNM) non-small-cell lung cancer.\n4. Tumor tissue and blood samples obtainable at all protocol-specified time-points.\n5. No pure ground-glass nodule on imaging.\n6. Completed standard neoadjuvant immunotherapy combined with platinum-based chemotherapy.\n\nExclusion Criteria:\n\n1. Postoperative pathology shows other than NSCLC, including but not limited to benign lesions, small-cell carcinoma, metastasis, or indeterminate\u002Finadequate histology.\n2. Insufficient or poor-quality blood or tissue samples.\n3. Pure ground-glass nodule on imaging.\n4. History of any malignancy within the past 5 years.\n5. Contraindication to surgery preventing radical resection.\n6. Non-radical (R2) resection.\n7. Pathologic stage IIIB-N3, IIIC, or IV on paraffin sections.\n8. Refusal or withdrawal of informed consent.\n9. Any condition deemed unsuitable by the investigator (e.g., perioperative blood transfusion, severe psychiatric disorder precluding follow-up).",{"count":90,"type":23},"This project aims to innovatively integrate multi-omics data, including plasma metabolomics, radiomics, and cfDNA multi-level information, combined with survival data (e.g., RFS), to establish a novel multidimensional approach for noninvasive postoperative recurrence monitoring in lung cancer using artificial intelligence algorithms. The goal is to develop a new noninvasive recurrence monitoring system for lung cancer.",[29,462,463,464],"Neoadjuvant Therapy","Immunotherapy","Minimal Residual Disease",[177,466,467,468,469,470,471],"Neoadjuvant immunotherapy","Perioperative monitoring","Liquid biopsy","MRD","Minimal residual disease","Multiple omics","2026-02-27",{"date":474,"type":38},"2026-03-03",{"date":476,"type":38},"2025-05-08",{"date":478,"type":23},"2027-10-31",{"name":153,"class":45},{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":350,"enrollmentInfo":487,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":489,"conditions":490,"keywords":491,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":46},"100177207","molecular-analysis-of-oncogenes-and-resistance-mechanisms-in-lung-cancer-100177207","NCT01580982","Molecular Analysis of Oncogenes and Resistance Mechanisms in Lung Cancer","Molecular Analysis of Oncogenes and Resistance Mechanisms in Lung and Other Thoracic Cancers","Inclusion Criteria:\n\n1. Patients undergoing investigation or treatment for thoracic cancers with oncogene-targeted therapies\n2. Aged 18 years or older\n3. Either a) have suspected tumor progression or other condition that dictates a standard-of-care palliative, therapeutic, or diagnostic intervention including but not limited to procedures such as bronchoscopic biopsy, computed tomography (CT) or ultra-sound (US)-guided biopsy, thoracentesis, video assisted thoracoscopic (VATS) pleurodesis, lobectomy, adrenalectomy or pleural catheter placement, providing tumor specimen appropriate molecular analysis or b) have previously had biopsy\u002Fsurgical intervention with tumor tissue at University of Colorado or an outside institution available for medullar analysis.\n4. Patients must have the ability to understand and willingness to sign an informed consent document.\n\nExclusion Criteria:\n\n\\-",{"count":488,"type":23},500,"The mechanisms of sensitivity and resistance to oncogene-targeted therapy can be determined from tumor tissue or tumor cell lines derived from available archival samples and\u002For from standard-of-care re-biopsy upon suspected tumor progression.",[29],[492,493],"Oncogenes","Lung and Other Thoracic Cancers","2026-02-13",{"date":496,"type":38},"2026-02-18",{"date":498,"type":38},"2012-01-23",{"date":500,"type":23},"2029-01-30",{"name":502,"class":45},"University of Colorado, Denver",{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":509,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":322,"enrollmentInfo":511,"targetDuration":4,"studyType":24,"phases":513,"briefSummary":514,"conditions":515,"keywords":517,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":46},"100623341","non-intubated-versus-intubated-anesthesia-for-thoracoscopic-sublobar-resection-100623341","NCT07395375","Non-intubated Versus Intubated Anesthesia for Thoracoscopic Sublobar Resection","A Multicenter, Randomized, Controlled Trial of Non-Intubated Spontaneous Breathing Anesthesia Versus Intubated Mechanical Ventilation Anesthesia in Thoracoscopic Sublobar Resection: A Stratified Analysis Study Focusing on Safety and Recovery Quality","NIVA-TSLR","Inclusion Criteria:\n\n1. Aged 18 to 80 years (inclusive).\n2. Scheduled for elective, uniportal or single utility port video-assisted thoracoscopic sublobar resection (wedge resection or simple anatomical segmentectomy).\n3. Preoperative CT diagnosis of a peripheral pulmonary nodule meeting: maximum diameter ≤ 2.0 cm and outer edge ≤ 2.0 cm from the visceral pleura.\n4. American Society of Anesthesiologists (ASA) physical status I or II.\n5. Preoperative pulmonary function: FEV1% ≥ 60% of predicted.\n6. Preoperative arterial blood gas analysis (room air): PaO₂ ≥ 80 mmHg and PaCO₂ ≤ 45 mmHg.\n7. Body Mass Index (BMI) between 18.0 and 28.0 kg\u002Fm².\n8. Able to understand the study and provide written informed consent.\n\nExclusion Criteria:\n\n1. Cardiovascular: NYHA class ≥ III, unstable angina, acute myocardial infarction within 3 months, or severe arrhythmia requiring medication.\n2. Respiratory: Severe COPD (GOLD 3 or 4), symptomatic interstitial lung disease, resting SpO₂ \\\u003C 92% on room air, or severe pulmonary hypertension (estimated systolic PAP \\> 50 mmHg).\n3. Airway Risk: Modified Mallampati score ≥ 3, mouth opening \\\u003C 3 cm, or other predictors of difficult airway management.\n4. Radiological: Preoperative CT suggesting extensive pleural adhesion, moderate or large pleural effusion, or mediastinal lymph nodes \\> 1.5 cm short axis.\n5. Contraindications to Regional Anesthesia: Infection\u002Ftumor at the block site, patient refusal, or allergy to local anesthetics.\n6. Coagulopathy: Platelet count \\\u003C 100×10⁹\u002FL, INR \\> 1.5, or use of anticoagulants that cannot be safely discontinued perioperatively.\n7. Other: Severe hepatic or renal dysfunction, previous ipsilateral thoracic surgery, pregnancy or lactation, active psychiatric or cognitive disorders, or participation in another conflicting clinical trial.",{"count":512,"type":23},1600,[26],"This is a large clinical study that compares two different types of anesthesia for patients undergoing a specific kind of minimally invasive lung surgery (thoracoscopic sublobar resection) to remove small, early-stage lung nodules.\n\nThe study aims to find out if a newer anesthesia method, known as \"non-intubated anesthesia\" (where patients breathe on their own with the help of a laryngeal mask airway and nerve blocks for pain control), is as safe as the traditional \"intubated anesthesia\" (which uses a breathing tube and a machine to breathe for the patient).\n\nThe main goals of the study are, in order:\n\n1. Safety First: To confirm that the non-intubated method does not lead to more lung complications within 30 days after surgery compared to the traditional method.\n2. Effectiveness: If it is proven safe, the study will then check if patients receiving the non-intubated anesthesia have a better quality of recovery in the first 24 hours after surgery (e.g., less pain, fewer side effects like a sore throat, and a faster return to normal activities).\n\nApproximately 1600 patients from multiple hospitals will be randomly assigned (like flipping a coin) to receive one of the two anesthesia methods. Neither the patients nor the surgeons will be told which group the patient is in when assessing the main outcomes after surgery, to ensure the results are fair and unbiased.\n\nThe results of this study will provide high-quality evidence to help doctors and patients choose the best and most comfortable anesthesia option for this type of lung surgery.",[134,29,516],"Thoracic Surgery",[518,519,520,521,522],"Non-intubated Thoracic Surgery","Lung Sublobar Resection","Video-Assisted Thoracoscopic Surgery","Enhanced Recovery After Surgery","Randomized Controlled Trial","2026-02-06",{"date":525,"type":38},"2026-02-09",{"date":527,"type":23},"2026-03-01",{"date":529,"type":23},"2027-08-01",{"name":531,"class":45},"The First Affiliated Hospital of Guangzhou Medical University",{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":536,"acronym":4,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":350,"enrollmentInfo":538,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":539,"conditions":540,"keywords":541,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":46},"100177561","specimen-banking-from-patients-with-lung-cancer-100177561","NCT01585675","Specimen Banking From Patients With Lung Cancer","Inclusion Criteria:\n\n1. Subjects who are undergoing further testing for the diagnosis or treatment of lung cancer.\n2. Oral and written informed consent\n\nExclusion Criteria:\n\n1\\. Any individual who does not give oral and written consent for participation",{"count":403,"type":23},"The primary objective of the protocol is to develop a comprehensive specimen banking program from patients with lung cancer for future translation research, which will enable the investigators to detect lung cancer earlier, develop better therapies and explore screening and prevention strategies.",[29],[30],"2026-01-27",{"date":544,"type":38},"2026-01-29",{"date":546,"type":38},"2005-11-03",{"date":548,"type":23},"2035-07-01",{"name":502,"class":45},{"id":551,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":552,"targetDuration":4,"studyType":24,"phases":553,"briefSummary":27,"conditions":554,"keywords":555,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":557,"startDateStruct":559,"completionDateStruct":560,"leadSponsor":561,"locationsCount":46},"100406836",{"count":22,"type":23},[26],[29,30],[32,30,33],"2026-01-16",{"date":558,"type":38},"2026-01-21",{"date":40,"type":38},{"date":42,"type":23},{"name":44,"class":45},{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":567,"acronym":4,"eligibilityCriteria":568,"healthyVolunteers":17,"sex":18,"minAge":569,"maxAge":570,"enrollmentInfo":571,"targetDuration":4,"studyType":24,"phases":573,"briefSummary":574,"conditions":575,"keywords":579,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":591,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":597,"locationsCount":46},"100620522","liquid-biopsy-based-pre-screening-to-streamline-ldct-lung-cancer-screening-in-high-risk-individuals-100620522","NCT07358715","Liquid Biopsy-Based Pre-Screening to Streamline LDCT Lung Cancer Screening in High-Risk Individuals","A Multimodal Liquid Biopsy-Based Assay as a Pre-Screening Test Before Low Dose CT Thorax (LDCT) to Streamline Lung Cancer Screening in High-Risk Individuals","Inclusion Criteria\n\nHigh-Risk Individuals (n = 100)\n\n* No prior history of lung cancer\n* Meets one of the following high-risk definitions:\n\n  * Current or former smoker (quit within the past 15 years), aged 55-74 years, with a smoking history of ≥30 pack-years; OR\n  * Never-smoker aged 55-75 years with a first-degree family history of lung cancer\n* Able and willing to provide written informed consent\n\nEarly-Stage Lung Cancer Patients (n = 20)\n\n* Aged ≥21 years\n* Histologically or clinically confirmed stage I-II lung cancer\n* Treatment-naïve (no prior surgery, chemotherapy, radiotherapy, or immunotherapy for lung cancer)\n* Able and willing to provide written informed consent\n\nAdvanced-Stage Lung Cancer Patients (n = 20)\n\n* Aged ≥21 years\n* Histologically or clinically confirmed stage III-IV lung cancer\n* Treatment-naïve (no prior systemic or local therapy for lung cancer)\n* Able and willing to provide written informed consent\n\nExclusion Criteria\n\nApplicable to All Participants\n\n* Pregnant or breastfeeding women\n* Inability or unwillingness to comply with study procedures\n\nHigh-Risk Individuals Only\n\n* Known allergy or contraindication to CT contrast agents\n* Prior low-dose CT (LDCT), CT thorax, or PET-CT performed within 12 months prior to enrollment\n\nLung Cancer Cohorts Only\n\n• Receipt of any prior cancer-directed treatment for lung cancer","21 Years","75 Years",{"count":572,"type":23},140,[26],"This study evaluates the feasibility and cost-effectiveness of using a blood-based liquid biopsy assay as a pre-screening tool before low-dose CT (LDCT) for lung cancer screening. By identifying individuals unlikely to have lung cancer, this approach aims to reduce unnecessary LDCT scans, radiation exposure, and healthcare costs, while improving early detection, particularly among high-risk individuals including never-smokers with a family history of lung cancer.",[30,29,576,577,578],"Early Lung Cancer Detection","Cancer Screening","High-Risk Populations",[468,580,581,582,583,584,585,586,587,588,589],"DNA methylation","Exosomes","Blood-based screening","Low-dose CT","LDCT","Lung cancer screening","Early cancer detection","High-risk individuals","Never-smokers","Multimodal assay","2026-01-13",{"date":592,"type":38},"2026-01-22",{"date":594,"type":38},"2024-11-01",{"date":596,"type":23},"2028-12-31",{"name":598,"class":45},"National University Hospital, Singapore",{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":603,"acronym":4,"eligibilityCriteria":604,"healthyVolunteers":12,"sex":18,"minAge":605,"maxAge":4,"enrollmentInfo":606,"targetDuration":607,"studyType":59,"phases":4,"briefSummary":608,"conditions":609,"keywords":611,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":621,"lastUpdatePostDateStruct":622,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":628,"locationsCount":46},"100618444","association-of-bal-fluid-t-cell-immune-activity-with-tumor-pd-l1-expression-and-its-prognostic-value-a-prospective-observational-study-100618444","NCT07331701","Association of BAL Fluid T-Cell Immune Activity With Tumor PD-L1 Expression and Its Prognostic Value: A Prospective Observational Study","Inclusion Criteria:\n\n* Adults aged 19 years or older\n* Patients with suspected or histologically confirmed stage IV lung cancer based on clinical and radiologic findings\n* Scheduled to undergo clinically indicated bronchoscopy with bronchoalveolar lavage as part of routine clinical care\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Receipt of treatment for acute lower respiratory tract infection (including pneumonia or fungal infection) within 4 weeks prior to bronchoscopy\n* History of solid organ transplantation or hematopoietic stem cell transplantation\n* Current use of systemic immunosuppressive therapy\n* Current or planned use of biologic immunomodulatory agents\n* Known autoimmune disease requiring systemic immunosuppressive treatment\n* Pregnant women\n* Patients with recurrent stage IV lung cancer after prior definitive therapy","19 Years",{"count":229,"type":23},"2 Years","This prospective observational study aims to evaluate whether immune profiles of T-cell subsets in bronchoalveolar lavage fluid can complement tumor PD-L1 expression, assessed by immunohistochemistry in tumor tissue specimens, in predicting clinical outcomes in patients with advanced lung cancer. Although tumor PD-L1 expression measured on tissue biopsies is widely used to guide immunotherapy decisions, its predictive value is limited by spatial heterogeneity and sampling variability. By analyzing activated, exhausted, and regulatory T-cell populations in bronchoalveolar lavage fluid and examining their association with tissue-based tumor PD-L1 expression, this study seeks to determine whether combining local immune biomarkers with PD-L1 expression improves the prediction of treatment response and survival in patients receiving standard-of-care systemic therapy.",[29,610],"Tumor Immune Microenvironment",[612,613,614,615,616,610,617,618,619,620],"Bronchoalveolar Lavage Fluid","Tumor-Infiltrating T Lymphocytes","Programmed Cell Death 1 Ligand 1","Immune Checkpoint Inhibitors","Flow Cytometry","Treatment Response","Progression-Free Survival","Overall Survival","Predictive Biomarkers","2025-12-29",{"date":623,"type":38},"2026-01-12",{"date":625,"type":23},"2026-01",{"date":627,"type":23},"2027-12-31",{"name":629,"class":45},"Seoul National University Hospital",{"id":631,"slug":632,"hasResults":12,"nctId":633,"briefTitle":634,"officialTitle":635,"acronym":4,"eligibilityCriteria":636,"healthyVolunteers":17,"sex":18,"minAge":55,"maxAge":4,"enrollmentInfo":637,"targetDuration":4,"studyType":24,"phases":639,"briefSummary":640,"conditions":641,"keywords":642,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":644,"lastUpdatePostDateStruct":645,"startDateStruct":647,"completionDateStruct":649,"leadSponsor":651,"locationsCount":269},"100476996","telescope--telehealth-shared-decision-making-coaching-100476996","NCT05491213","TELESCOPE- TELEhealth Shared Decision-making COaching","TELEhealth Shared Decision-making COaching for Lung Cancer Screening in Primary carE (TELESCOPE)","Inclusion Criteria:\n\n\\- Inclusion Criteria Cluster Randomized Trial\n\nEligibility of patients for the cluster randomized trial will follow United States Preventive Services Task Force criteria for lung cancer screening. Specifically, patients must:\n\n* Be 50 to 77 years of age\n* Be a current or former smoker having quit within the past 15 years\n* Have at least a 20 pack-year smoking history\n* Be scheduled for a non-acute care visit at one of the study sites. Interviews (N=50)\n\nParticipants completing the semi-structured interviews will be:\n\n* A practicing primary care clinician or a clinic director (n=20), nursing director, or clinic practice administrator (n=20) at one of the participating sites or a TELESCOPE study patient navigator (n=7) and nurse navigator (n = 3)\n* Age 18 or older\n* Fluent in English Online surveys (N=130)\n\nProviders completing online PRISM construct surveys will be:\n\n* A practicing primary care provider at one of the participating sites or a TELESCOPE study navigator\n* Age 18 or older\n* Fluent in English\n\nExclusion Criteria:\n\n\\- Cluster Randomized Trial\n\nExcluded will be patients who:\n\n* Do not speak English\n* Have a history lung cancer\n* Were screened for lung cancer within the past 12 months\n* Have health conditions that make them poor candidates for curative treatment as determined by the primary care provider\n* Are unable to provide informed consent Interviews (N=50)\n\nProviders\u002Fadministrators will be excluded if they:\n\n* Are unable to provide informed consent Online surveys (N=130)\n* Are unable to provide informed consent\n* Women who are pregnant. English proficiency is required for the completion of surveys, and the intervention will be conducted in English.",{"count":638,"type":23},594,[26],"Hypothesis 1a: The investigators anticipate that navigator decision coaching, compared to enhanced usual care (EUC) will result in higher quality SDM for lung cancer screening (LCS )(primary outcome), greater knowledge of lung cancer screening benefits and harms, and lower decisional conflict.\n\nHypothesis 1b: Compared to enhanced usual care (EUC), we expect that TELESCOPE will result in more screening discussions, increased initial for lung cancer screening (LCS) with low-dose CT scan (LDCT) uptake among interested participants, increased adherence to repeat LCS and diagnostic testing, and increased smoking cessation referrals for current smokers.\n\nHypothesis 2: The investigators expect that a \"booster\" coaching session will increase adherence to repeat lung cancer screening (LCS).",[29],[585,643],"Shared decision making","2025-12-02",{"date":646,"type":38},"2025-12-09",{"date":648,"type":38},"2023-02-14",{"date":650,"type":23},"2027-01-31",{"name":652,"class":45},"Rutgers, The State University of New Jersey",{"id":654,"slug":655,"hasResults":12,"nctId":656,"briefTitle":657,"officialTitle":658,"acronym":4,"eligibilityCriteria":659,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":570,"enrollmentInfo":660,"targetDuration":4,"studyType":24,"phases":662,"briefSummary":663,"conditions":664,"keywords":668,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":673,"lastUpdatePostDateStruct":674,"startDateStruct":676,"completionDateStruct":678,"leadSponsor":680,"locationsCount":46},"100574393","phase-2-post-line-treatment-with-teniposide-for-c-myc-driven-extensive-stage-small-cell-lung-cancer-100574393","NCT06758700","Post-line Treatment With Teniposide for c-Myc-driven Extensive-stage Small Cell Lung Cancer","Phase II Clinical Study to Evaluate the Efficacy and Safety of Teniposide as a Post-Line Therapy for c-Myc-Driven Extensive-Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n1. extensive stage small cell lung cancer\n2. Progression after receiving at least one chemotherapy drug treatment in the past;\n3. ECOG score 0-1\n4. c-Myc-driven\n5. Expected survival period ≥3 months\n6. Age: 18-75 years old;\n7. The informed consent form complies with the ICH-GCP principles.\n\nExclusion Criteria:\n\n1. No measurable lesions\n2. Other severe and persistent diseases or organ system dysfunction;\n3. Women planning pregnancy or men planning family planning;\n4. Women who are pregnant or breastfeeding;\n5. Those who cannot follow the research protocol provided by the investigator.",{"count":661,"type":23},15,[164],"The study is being conducted to investigate the efficacy and safety of teniposide in patients with extensive-stage small cell lung cancer who have failed standard treatment and with high expression of the c-Myc-driven FBXW2\u002FMYC gene. Based on the results, the study will explore the correlation between the expression of FBXW2\u002FMYC and the efficacy of teniposide.",[665,666,29,667],"Extensive-stage Small Cell Lung Cancer (ES-SCLC)","Thoracic Neoplasms","Lung Diseases",[669,670,671,672],"c-Myc","SCLC","Phase II","Post-line","2025-11-30",{"date":675,"type":38},"2025-12-05",{"date":677,"type":38},"2025-02-07",{"date":679,"type":23},"2026-12-31",{"name":681,"class":45},"Shanghai Pulmonary Hospital, Shanghai, China",{"id":683,"slug":684,"hasResults":12,"nctId":685,"briefTitle":686,"officialTitle":686,"acronym":687,"eligibilityCriteria":688,"healthyVolunteers":17,"sex":18,"minAge":689,"maxAge":690,"enrollmentInfo":691,"targetDuration":4,"studyType":24,"phases":693,"briefSummary":694,"conditions":695,"keywords":696,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":702,"lastUpdatePostDateStruct":703,"startDateStruct":704,"completionDateStruct":706,"leadSponsor":707,"locationsCount":46},"100605682","telehealth-shared-decision-making-coaching-for-lung-cancer-screening-in-primary-care-telescope-for-hispanics-100605682","NCT07165691","TELEhealth Shared Decision-making COaching for Lung Cancer Screening in Primary Care (TELESCOPE) for Hispanics","TELESCOPE-H","Inclusion Criteria:\n\nAim 1 (Cultural Adaptation):\n\nTo be eligible, patients must:\n\n1. Identify as Hispanic and\u002For Latino(a)\n2. Able to read and speak in English or Spanish\n3. Be 50 to 77 years of age\n4. Be a current or former smoker\n5. Have at least a 20-pack-year smoking history\n\nAims 2-3 (Pilot Randomized Controlled Trial)\n\nTo be eligible, patients must:\n\n* Identify as Hispanic or Latino(a)\n* Able to speak and read in English or Spanish\n* Be 50 to 77 years of age\n* Be a current or former smoker having quit within the past 15 years\n* Have at least a 20 pack-year smoking history\n* Be scheduled for a non-acute care visit at one of the study sites.\n* Not coughing up blood in the last two weeks\n\nInterviews\n\nProviders completing the semi-structured interviews will be:\n\n* A practicing primary care clinician or a clinic director (n=20), nursing director, or clinic practice administrator at one of the participating sites, or a TELESCOPE study patient navigator and nurse navigator\n* Age 18 or older\n* Fluent in English\n\nOnline surveys\n\nProviders completing online PRISM construct surveys will be:\n\n* A practicing primary care provider at one of the participating sites or a TELESCOPE study navigator\n* Age 18 or older\n* Fluent in English\n\nExclusion Criteria:\n\nFor the cluster randomized trial, excluded will be patients who:\n\n* Do not speak English\n* Are not Hispanic or Latino(a)\n* Have a history of lung cancer\n* Had a CT scan in the past 12 months\n* Has been coughing up blood in the last two weeks\n* Have health conditions that make them poor candidates for curative treatment as determined by the primary care provider,\n* Are unable to provide informed consent Interviews\n\nProviders\u002Fadministrators will be excluded if they:\n\n* Are unable to provide informed consent Online surveys\n* Are unable to provide informed consent\n* Women who are pregnant.","50 Years","77 Years",{"count":692,"type":23},91,[26],"Aim 1: Culturally adapt the TELESCOPE intervention for Hispanics. Using iterative qualitative feedback from a study-specific Community Advisory Board, focus groups, and interviews with community members, the investigators will culturally adapt the TELESCOPE intervention for Hispanics at high risk for lung cancer.\n\nAim 2: Assess the feasibility, acceptability, and implementation potential of the culturally adapted TELESCOPE intervention delivered by bilingual patient navigators for Hispanics. Hypothesis 1: The investigators expect a recruitment rate of ≥60%, ≥90% of Hispanic participants will complete the 1-week follow-up assessments, ≥80% of the key intervention components will be delivered with 80% fidelity by the patient navigators, and ≥90% of participants and clinicians will agree or completely agree that the intervention was feasible and acceptable.\n\nAim 3: Explore the impact of a culturally adapted TELESCOPE intervention delivered by bilingual patient navigators vs enhanced usual care (EUC) on the initial uptake of low-dose computed tomography (LDCT) and quality of the shared decision-making (SDM) process. Hypothesis 2: The investigators expect that an adapted TELESCOPE intervention will result in higher uptake of LDCT and higher SDM quality for lung cancer screening (LCS) compared to EUC.",[29],[697,698,699,666,700,96,667,701,29],"lung cancer screening","shared decision making","Respiratory Tract Neoplasms","Neoplasms by Site","Respiratory Tract Diseases","2025-11-24",{"date":644,"type":38},{"date":705,"type":38},"2025-09-11",{"date":240,"type":23},{"name":652,"class":45}]