[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lung-cancer---non-small-cell\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lung-cancer---non-small-cell":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,45,80,105,132,163,188,211],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100609563","the-impact-of-exercise-on-the-tumor-microenvironment-in-patients-with-lung-cancer-100609563",false,"NCT07216209","The Impact of Exercise on the Tumor Microenvironment in Patients With Lung Cancer","Exercise and the Lung Cancer Tumor Microenvironment","Inclusion Criteria:\n\n* lung cancer\n* low risk for submaximal exercise testing in accordance with the risk stratification guidelines published by the American Heart Association and the American College of Sports Medicine (AHA\u002FACSM criteria).\n\nExclusion Criteria:\n\n* younger than 18 years of age\n* select a condition on the ACSM-AHA pre-exercise screening questionnaire indicating that physician approval is required prior to exercise\n* body mass index of \\>30 kg\u002Fm2\n* waist girth of \\>102cm for men and \\>88cm for women\n* have chronic\u002Fdebilitating arthritis\n* have been bedridden in the past three months\n* have common illness (i.e. colds) within the past 6-weeks\n* HIV\n* hepatitis\n* history of stroke\n* major affective disorder\n* autoimmune disease\n* pregnancy or are breast-feeding\n* history of severe anaphylactic reaction to an allergen\n* present with more than one of the following CVD risk factors: family history of myocardial infarction, coronary revascularization, or sudden death before 55 years of age in father or other male first-degree relative or before 65 years of age in mother or other female first-degree relative",true,"ALL","18 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"NA","There is increased interest and knowledge about the lung cancer tumor microenvironment (TME). Investigators hypothesize that patients with better baseline physiologic health will have better post-operative outcomes and that strenuous exercise will alter the TME and genetic make-up of the tumor, improving the tumor immune response. Investigators aim to identify the peri-operative and clinical outcomes that differ based on pre-operative VO2max, HRV and resting heart rate following resection of early-stage lung cancer. The physiologic states that are individual and measurable with wearable devices include but are not limited to VO2max, heart rate variability (HRV), and average resting heart rate. Investgators hypothesize that a patient's pre-operative physiologic function with higher VO2max, HRV and lower resting heart rate will be associated with improved peri-operative and post-operative outcomes. Second, investigators will compare alterations in TME based on targeted pre-operative exercise (60-80% of their VO2 max for 75min\u002Fweek x2 weeks) compared to normal activity adults following resection of early-stage lung cancer. Investigators hypothesize that strenuous exercise in the pre-operative period will impact the TME by increasing levels of cytokines.",[27],"Lung Cancer - Non Small Cell",[29,30,31],"exercise","tumor microenvironment","lung cancer","RECRUITING","2026-04-16",{"date":35,"type":36},"2026-04-21","ACTUAL",{"date":38,"type":36},"2026-01-13",{"date":40,"type":21},"2030-01-15",{"name":42,"class":43},"University of Arizona","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":63,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100624096","phase-2-ivonescimab-alone-and-with-carboplatinpemetrexed-for-nsclc-100624096","NCT07405190","Ivonescimab Alone And With Carboplatin\u002FPemetrexed For NSCLC","A Phase II Study of Ivonescimab as Monotherapy or in Combination With Platinum\u002FPemetrexed Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Harboring Actionable Genomic Alterations (AGAs)","Inclusion Criteria:\n\n* Histologically or cytologically confirmed advanced or metastatic non-squamous NSCLC not amenable to curative resection or radiation.\n* AGA requirements as follows:\n\nIvonescimab monotherapy: Tumor harboring classical EGFR sensitizing mutation (i.e., L858R, exon 19 deletion), or ALK, ROS1, RET, or NTRK1-3 fusion, per local testing. Note: The number of patients with EGFR mutation-positive NSCLC enrolled will be capped at maximum of 10 (in order to ensure the assessment of non-EGFR disease subsets). Ivonescimab plus carboplatin\u002Fpemetrexed: Tumor harboring ALK, ROS1, RET, or NTRK1-3 fusion, per local testing.\n\n* Prior therapy requirements as follows:\n\n  a. Prior genotype-specific standard-of-care targeted therapy must have included at least one genotype-appropriate TKI(s) specified below: i. EGFR sensitizing mutation: a third-generation EGFR TKI such as osimertinib or lazertinib ii. ALK fusion: a third- or fourth-generation ALK TKI such as lorlatinib or neladalkib (NVL-655) iii. ROS1 fusion: crizotinib, entrectinib, repotrectinib, or taletrectinib iv. RET fusion: selpercatinib or pralsetinib v. NTRK1-3 fusion: entrectinib, larotrectinib, or repotrectinib Ivonescimab monotherapy: Must have received platinum\u002Fpemetrexed chemotherapy. No limitations on the number of prior lines of systemic therapy including the number of lines of chemotherapy or TKI(s). Ivonescimab plus carboplatin\u002Fpemetrexed: May not have received any prior chemotherapy. No limitations on the number of prior TKI(s).\n* At least 1 measurable lesion as assessed by investigator per the RECIST v1.1 criteria for both cohorts.\n* Participants must be willing to undergo the mandatory pre-treatment and post-progression tissue biopsies. If archival pre-treatment tissue is available from within 6 months of study enrollment, with no new intervening systemic therapy since the biopsy, a repeat pre-treatment biopsy may be omitted upon discussion with the principal investigator. On-treatment tissue biopsy (obtained within 7 days prior to Cycle 2 Day 1) will be mandatory for patients in Cohort 1 and optional for patients in Cohort 2. In select cases, if medically deemed unsafe\u002Fnot feasible, exception may be granted upon discussion with the principal investigator.\n* Clinically asymptomatic treated or untreated brain metastases are allowed if they have not required increasing doses of steroids within 2 weeks prior to study entry for CNS symptoms.\n* Age ≥18 years old.\n* ECOG performance status of 0 or 1.\n* Adequate Organ Function:\n\n  a. Hematology (no blood transfusions or growth factor therapy used within 7 days of the screening CBC): i. Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL ii. Platelet count ≥ 100 × 109\u002FL iii. Hemoglobin ≥ 9.0 g\u002FdL b. Kidneys: i. Creatinine clearance (CrCl) ≥ 50 mL\u002Fmin using the Cockcroft-Gault formula (Cohorts 1 and 2) or estimated glomerular filtration rate (eGFR) value ≥ 60 mL\u002Fmin (for Cohort 1) or ≥30 mL\u002Fmin (for Cohort 2) using the Cockcroft-Gault formula or estimated glomerular filtration rate (eGFR) ii. Urine protein \\\u003C 2+ or 24 hour urine protein quantification \\\u003C 1.0 g c. Liver: i. Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); for patients with liver metastases or confirmed\u002Fsuspected Gilbert syndrome, TBIL ≤3 × ULN ii. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)\n  * 2.5 × ULN; for patients with liver metastases, AST and ALT ≤ 5 × ULN d. Coagulation: prothrombin time (PT) or international normalized ratio (INR)\n  * 1.5 x ULN, and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated to coagulopathy). This applies only to patients who are not on therapeutic anti-coagulation. Patients receiving therapeutic anti-coagulation should be on a stable dose for at least one month prior to study enrollment.\n* Female patients of childbearing age must have negative serum pregnancy test results before first ivonescimab drug dose or per region-specific guidance documented in the informed consent and a negative urine pregnancy test on the day of first dose prior to dosing.\n* Female patient of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 90 days after the last dose of the ivonescimab and until 6 months after the last doses of carboplatin and pemetrexed.\n* Unsterilized male patients having sex with a female partner of childbearing potential, or a pregnant or breastfeeding partner must agree to use barrier contraception (male condom) for the duration of the treatment period until 90 days after the last dose of ivonescimab and until 90 days after the last doses of carboplatin and pemetrexed. Male patients with female partners of childbearing potential must have the female partner agree to use at least 1 form of highly effective contraception for the duration of the treatment period until 90 days after the last dose of ivonescimab and until 90 days after the last doses of carboplatin and pemetrexed.\n\nExclusion Criteria:\n\n* Participants previously treated with immune checkpoint inhibitors or other T cell immune-modulating antibodies, including anti-CTLA-4, anti-PD-1 and\u002For anti-PD-L1 agents.\n* Major surgical procedures or serious trauma within 4 weeks prior to first ivonescimab dose or plans for major surgical procedures within 4 weeks after the first ivonescimab dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to first ivonescimab dose.\n* History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to first ivonescimab dose, including but not limited to:\n\n  1. Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots). Note: transient hemoptysis associated with diagnostic bronchoscopy is allowed.\n  2. Nasal bleeding\u002Fepistaxis (bloody nasal discharge is allowed)\n  3. Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to first ivonescimab dose is not allowed; stability of anti-coagulation dosing will be defined by remaining on the same dose for at least one month prior to study enrollment.\n  4. The use of full-dose anticoagulants is permitted as long as the international normalized ratio (INR) or activated partial thromboplastin time (aPTT) is within therapeutic limits according to the medical standard of the enrolling institution.\n* Poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy.\n* Active autoimmune or lung disease requiring systemic therapy (eg, with disease modifying drugs, prednisone \\>10 mg daily or equivalent, immunosuppressant therapy) within 2 years prior to first ivonescimab dose; however, the following will be allowed:\n\n  1. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is permitted.\n  2. Intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections is permitted.\n* History of major diseases before first ivonescimab dose, specifically:\n\n  1. Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥ grade 2) or unstable vascular disease (eg, aortic aneurysm at risk of rupture, Moyamoya disease) that required hospitalization within 6 months prior to first ivonescimab dose, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia)\n  2. History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months before first ivonescimab dose\n  3. History of any grade arterial thromboembolic event, Grade 3 and above venous thromboembolic event, as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 6.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to first ivonescimab dose\n  4. Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before first ivonescimab dose\n  5. History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to first ivonescimab dose\n* Imaging during the screening period shows that the patient has:\n\n  1. Radiologically documented evidence of major blood vessel invasion (central pulmonary artery, central pulmonary veins, aorta, brachiocephalic artery, common carotid artery, subclavian artery, superior vena cava) or tumor invading organs (heart, trachea, esophagus, central bronchi \\[not including segmental bronchi\\]) or if there is a risk of esophagotracheal or esophagopleural fistula in the opinion of the investigator.\n  2. Radiographic evidence of major blood vessel encasement with narrowing of the vessel or intratumor lung cavitation or necrosis that the investigator determines will pose a significantly increased risk of bleeding.\n* Symptomatic CNS metastases, CNS metastases with hemorrhagic features, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to first ivonescimab dose, potential need for CNS radiation within the first cycle, or leptomeningeal disease.\n\nNote: Patients must have stopped corticosteroids or be on physiologic corticosteroid replacement therapy (prednisone ≤ 10 mg daily or equivalent).\n\n* Live vaccine or live attenuated vaccine within 4 weeks prior to planned first ivonescimab dose, or if scheduled to receive a live vaccine or live attenuated vaccine during the study period. Inactivated vaccines are permitted.\n* Severe infection within 4 weeks prior to first ivonescimab dose, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection (as determined by the investigator) requiring systemic anti-infective therapy within 2 weeks prior to first ivonescimab dose (excluding antiviral therapy for hepatitis B or C)\n* Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 6\n* Uncontrolled pleural effusions, pericardial effusions, or ascites that is clinically symptomatic Note: Patients managed with indwelling catheters (eg, PleurX) are allowed.\n* Any evidence of current ILD or pneumonitis or a prior history of ILD or non-infectious pneumonitis requiring systemic corticosteroids\n* Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)\n* Known history of human immunodeficiency virus (HIV) whose viral load is not controlled.\n* Current use of systemic corticosteroids (\\>10 mg daily prednisone or equivalent)\n* Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation\n* Patients with active hepatitis B are required to have stable or declining levels of hepatitis B DNA by polymerase chain reaction (PCR) on appropriate anti-viral therapy with acceptable tolerability for one month prior to first ivonescimab dose. All patients with active hepatitis C (hepatitis C virus \\[HCV\\] antibody positive with HCV RNA levels above the lower limit of detection) are excluded.\n* Known allergy to any component of any study drug; known history of severe hypersensitivity to other monoclonal antibodies\n* History or current evidence of any condition (medical \\[including adverse events from prior anticancer therapy, disorders secondary to tumor\\], surgical or psychiatric \\[including substance abuse\\]), or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, might lead to higher medical risk and\u002For is not in the best interest of the patient to participate, in the opinion of the treating investigator\n* Patient is breastfeeding or plans to breastfeed during the study",{"count":53,"type":21},46,[55],"PHASE2","The goal of this clinical trial is to assess the efficacy of ivonescimab monotherapy in patients with advanced non-small cell lung cancer harboring actionable genomic alterations who have received prior targeted therapies and chemotherapy. This clinical trial also aims to assess the efficacy of ivonescimab plus carboplatin\u002Fpemetrexed chemotherapy in patients with advanced non-small cell lung cancer harboring actionable genomic alterations other than epidermal growth factor receptor mutations who have received prior targeted therapies but no chemotherapy. The main questions it aims to answer are:\n\n* Will ivonescimab alone or together with carboplatin\u002Fpemetrexed chemotherapy shrink tumors in the clinical trial's patients?\n* Will ivonescimab alone or together with carboplatin\u002Fpemetrexed chemotherapy effectively influence if the patients' cancer grows, how long the treatment takes to start working, how long the treatment keeps working after it first starts to help, how long the treatment keeps the cancer from getting worse, and overall survival of patients?\n* How many patients receiving ivonescimab alone or together with carboplatin\u002Fpemetrexed chemotherapy will experience treatment-emergent, treatment-related, immune-related, and especially interesting side effects? Patients receiving ivonescimab alone will receive an intravenous infusion of ivonescimab every 3 weeks for up to 24 months. Patients receiving ivonescimab together with carboplatin\u002Fpemetrexed chemotherapy will receive separate intravenous infusions of ivonescimab, pemetrexed, and carboplatin every 3 weeks for 4 cycles (each cycle is 21 days). These patients will continue to receive infusions of ivonescimab and pemetrexed every 3 weeks for up to 24 total months.",[58,59,60,27,61,62],"Lung Cancer (NSCLC)","Lung Cancer Non-Small Cell Cancer (NSCLC)","Lung Cancer (Non-Small Cell)","Lung Cancer Non Small Cell","Genomic Alterations",[64,65,31,66,67,68],"NSCLC","AGAs","non-small cell","chemotherapy","ivonescimab","NOT_YET_RECRUITING","2026-02-05",{"date":72,"type":36},"2026-02-12",{"date":74,"type":21},"2026-08-04",{"date":76,"type":21},"2029-03-01",{"name":78,"class":43},"Massachusetts General Hospital",3,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":102,"locationsCount":4},"100583143","expanded-access-protocol-for-the-use-of-sl-28-in-the-treatment-of-advanced-solid-tumors-100583143","NCT06872489","Expanded Access Protocol for the Use of SL-28 in the Treatment of Advanced Solid Tumors","Inclusion Criteria:\n\n* Subjects with locally advanced or metastatic solid tumor confirmed by histopathology;\n* Having at least one evaluable or measurable lesion according to the solid tumor response Evaluation Criteria (RECIST 1.1);\n* For patients with relapsed\u002Frefractory neuroblastoma with original diagnosis based on tumor histopathology, Karnofsky or Lansky performance status of ≥ 50%;\n* ECOG Performance Status from 0 or 3;\n* The expected survival time is more than 12 weeks;\n* 2 to 65+ old, gender is not limited;\n* The subjects gave informed consent to the study before participating in, and voluntarily signed informed consent;\n* Be able to comply with trial and follow-up procedures;\n* Adequate bone marrow and organ function;\n* Patients who have progressed, recurrent or refractory disease after first-line treatment (failure to obtain complete or partial remission after recent treatment);\n* Fertile women must agree to abstain from sex (abstaining from heterosexual intercourse)or use a highly effective method of contraception for at least one week from the time they sign an informed consent form until the last dose of the study drug.\n* The blood HCG test must be negative within 7 days before the start of the study treatment, and must be non-lactating;\n* For male patients whose partner is a woman of reproductive age, they must agree to abstain from sex for at least one week from signing the informed consent until the last dose of the study drug, or to use a highly effective method of contraception.\n* Immunotherapy: At least 42 days after completing any type of immunotherapy, including immune checkpoint;\n* Radiation therapy: 60 days should have elapsed in the case of completing radiation.\n* Cytokine therapy (e.g. G-CSF, GM-CSF, IL-6, IL-2): must be discontinued a minimum of 7 days prior to SL-28 therapy.\n\nExclusion Criteria:\n\n* Untreated or active primary central nervous system (CNS) tumor or metastasis;\n* Patients diagnosed of having primary and secondary immunodeficiencies;\n* Patients with disease of any major organ system that would compromise their ability to withstand therapy.\n* Arterial\u002Fvenous thrombosis events that occurred in the 12 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;\n* Known allergy to any of the agents or their ingredients used in this study;\n* Patients who are on hemodialysis;\n* Pregnant or breast-feeding women; fertility patients who are unwilling or unable to take effective contraceptive measures;\n* Patients with untreated positive blood cultures or progressive infections.","2 Years","EXPANDED_ACCESS","This is an Expanded Access Program (EAP) that will give the participants access to the drug SL-28 before it is approved by the FDA. Participants in this study will have Advanced Solid Tumors who failed to respond to standard therapy (chemotherapy, immunotherapy) or developed progressive disease at any phase of standard therapy.\n\nResearchers think the SL-28 will be effective because SL-28 has a direct activity against different types of tumors.\n\nSL-28 is a cell-based therapy, based on leukocytes isolated from healthy donors and are activated through the proprietary process. After quality assessment (sterility, viable cell count, purity, and absence of infectious diseases), they are stored at -80°C until use. Upon need, the SL-28 is thawed, followed by checking their viability, count, and sterility. Adult and older adult patients aged 18 to 65+ who meet the eligibility criteria will be included in the study. Patients receive SL-28 IV once daily on days 1-5 and 8-12. Based on the patient's response, the need for additional injections will be evaluated. If improvements in the patient's condition are confirmed by MRI, further injections can continue on a rate 5 days a week.",[90,91,92,93,94,59,27,95,96,97],"Neuroblastoma in Children","Neuroblastoma, Recurrent, Refractory","Advanced Cancer","Advanced Malignant Neoplasm","Prostate Cancer Patients With Bone Metastasis","Gastrointestinal Cancers","Head and Neck Cancer","Pancreatic Cancer","AVAILABLE","2025-07-17",{"date":101,"type":36},"2025-07-23",{"name":103,"class":104},"Second Life Therapeutics","INDUSTRY",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":119,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":44},"100587315","phase-2-neoadjuvant-nivolumab-plus-ipilimumab-in-resectable-nsclc-galaxy-3-100587315","NCT06926790","Neoadjuvant Nivolumab Plus Ipilimumab in Resectable NSCLC (GALAXY 3)","Neoadjuvant Nivolumab Plus Ipilimumab in Resectable Non-small Cell Lung Cancer","GALAXY 3","Inclusion Criteria:\n\n1. Informed consent must be signed.\n2. At least 18 years of age.\n3. Histologically or cytologically confirmed non-small cell lung cancer (without EGFR, ALK mutation).\n4. Have measurable and clinical stage II-IIIA with no known PD-L1 expression or PD-L1 ≤ 1%.\n5. disease eligible for surgery.\n6. No previous systematic therapy or radiotherapy.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n8. At least one measurable lesion.\n9. No major organ dysfunction, including liver, kidney, and cardiac function.\n\nExclusion Criteria:\n\n1. Patients with active autoimmune disease or history of autoimmune disease.\n2. Patients have received other treatment for non-small cell lung cancer or for any other malignancy.\n3. History of allergy to study drug components.\n4. Pregnant or breast-feeding.\n5. Any mental or psychological condition that would prevent the patient from completing the study or understanding the patient information.\n6. Patients who have other malignancies.\n7. History of major surgery or serious injury within the past 3 months.\n8. HIV, HBV, HCV infection or active pulmonary tuberculosis.\n9. Vaccination within 4 weeks prior to the start of the study.\n10. Presence of underlying medical conditions that, in the investigator's judgment, could increase the risk associated with study drug administration or interfere with the assessment of toxicity and adverse events.","80 Years",{"count":115,"type":21},69,[55],"Neoadjuvant immunotherapy followed by surgery has emerged as the standard treatment for locally advanced and resectable non-small cell lung cancer (NSCLC). However, conventional chemotherapy components may increase treatment-related toxicity, particularly in elderly populations. Additionally, the efficacy of preoperative immunochemotherapy for patients with PD-L1 expression \\\u003C1% remains to be improved. Emerging evidence has demonstrated that the combination of nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4) provides superior responses in the treatment of advanced NSCLC. However, the safety and efficacy of this strategy in the neoadjuvant setting remain controversial. Therefore, this single-arm clinical trial aims to evaluate the safety and feasibility of neoadjuvant nivolumab plus ipilimumab followed by surgery in treating locally advanced and resectable NSCLC.",[27],[31,120,121,122],"nivolumab plus ipilimumab","neoadjuvant treatment","non-small cell lung cancer","2025-04-17",{"date":125,"type":36},"2025-04-22",{"date":127,"type":36},"2025-02-17",{"date":129,"type":21},"2030-10-31",{"name":131,"class":43},"The First Affiliated Hospital of Guangzhou Medical University",{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":142,"conditions":143,"keywords":147,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":44},"100584448","liquid-biopsy-assay-of-ebus-tbna-supernatant-fluid-for-diagnosing-lung-cancer-100584448","NCT06889467","Liquid Biopsy Assay of EBUS-TBNA Supernatant Fluid for Diagnosing Lung Cancer","Validation of Liquid Biopsy Assay of EBUS-TBNA Supernatant Fluid for Diagnosing Lung Cancer: A Feasibility Study","Inclusion Criteria:\n\n* adult (age ≥18 years) patients with high suspicion for NSCLC with thoracic lymph nodes involvement (per clinical judgement and imaging studies), planned for an EBUS-TBNA procedure\n* Subjects with negative EBUS-TBNA results (no evidence of lymph node involvement by tumor according to histology) who will require surgical resection of the thoracic lymph nodes will comprise the final study group\n\nExclusion Criteria:\n\n1. Subjects unable or not willing to provide informed consent for study participation.\n2. Subjects in whom NSCLC will ultimately be ruled out.\n3. Subjects who will not require surgical resection of thoracic lymph nodes, or who will not undergo such procedure in our Medical Center for any reason",{"count":140,"type":21},10,"OBSERVATIONAL","Background and aim: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is the gold standard of lung cancer staging, yet up to 15% of procedures produce inadequate samples for definite diagnosis or staging. In such cases, more invasive surgical procedures are usually considered. Fluid collected during EBUS-TBNA is centrifuged to produce a pellet for cell block histopathological examination , while the supernatant is usually discarded. It has been demonstrated that this supernatant can provide material for next generation sequencing (NGS) mutation analysis using liquid biopsy (LB) technics when the procedure yielded positive results (tumor cells were demonstrated in the aspirate).\n\nWe wish to assess whether LB NGS of the supernatant may provide data regarding lymph nodes involvement in non-small cell lung cancer (NSCLC) in cases with a negative EBUS-TBNA evaluation (no tumor cell identified in the aspirate).\n\nMethods: A prospective feasibility study which will recruit participants with high suspicion for thoracic lymph nodes involvement in NSCLC who will be subjected to EBUS-TBNA. The final study group will comprise of 10 subjects with a negative EBUS-TBNA evaluation (no tumor cell detected) who will require surgical resection of the thoracic lymph nodes.\n\nEBUS-TBNA collected fluid will be centrifuged and separated. Cellular pellets will undergo cytological and histopathological evaluation, including tissue NGS, as usual. Cell-free DNA will be extracted from the supernatant and will undergo separate LB NGS targeted to genes frequently mutated in NSCLC. We will assess the concordance between the positivity of supernatant NGS and surgical lymph nodes staging, and the concordance between supernatant NGS and blood NGS.\n\nExpected results: We expect high concordance between surgical lymph nodes staging and supernatant NGS, that is, genetic mutations would be identified by the supernatant NGS in subjects with lymph nodes involvement by tumor, and not in those without it.\n\nImportance to Medicine: NSCLC is the leading cause of cancer mortality. Improving the effectiveness of EBUS-TBNA may reduce the need for additional invasive procedures, increase accuracy and reduce turnaround time of specimens.",[144,145,58,27,146],"Non Small Cell Lung Cancer","Non Small Cell Lung Cancer (NSCLC)","Pulmonary Nodule",[148,149,150,151,152,31,153,64],"Endobronchial ultrasound","Endobronchial ultrasound transcbronchial needle aspiration","EBUS","EBUS-TBNA","staging","non small cell lung cancer","2025-03-22",{"date":156,"type":36},"2025-03-26",{"date":158,"type":36},"2025-01-20",{"date":160,"type":21},"2025-12-31",{"name":162,"class":43},"Barzilai Medical Center",{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":16,"sex":170,"minAge":18,"maxAge":171,"enrollmentInfo":172,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":174,"conditions":175,"keywords":177,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":186,"locationsCount":44},"100566767","utilizing-long-read-sequencing-to-investigate-the-egfr-landscape-of-egfr-positive-lung-cancer-patients-100566767","NCT06659458","Utilizing Long-read Sequencing to Investigate the EGFR Landscape of EGFR Positive Lung Cancer Patients","EGFR Lung Canc","Inclusion Criteria:\n\n* 18-100 years old\n* Biologically born female\n* Diagnosed with EGFR positive lung cancer (Arm 1-Cancer group)\n* No cancer diagnosis (Arm 2-health control)\n\nExclusion Criteria:\n\n* less than 18 years of age\n* Biologically born male\n* Incarcerated at the time of participation","FEMALE","100 Years",{"count":173,"type":21},20,"EGFR gene mutations are some of the most commonly occurring mutations in non-small cell lung cancer. Investigators have developed a DNA instability model that estimates a risk score to assess the likelihood of an individual acquiring a cancer-linked mutation. The aim of this study is to collect blood from both those diagnosed with EGFR positive lung cancer and healthy individuals, evaluate their gene sequence surrounding the EGFR landscape and use the cancer positive and healthy sequences to validate the risk assessment model, which may one day be used to provide insight on susceptibility of getting EGFR positive lung cancer or potentially other cancer types.",[27,176],"EGFR Exon 19 Deletion Mutation",[178,179],"Lung cancer","EGFR gene","2025-03-17",{"date":182,"type":36},"2025-03-20",{"date":184,"type":36},"2025-01-01",{"date":160,"type":21},{"name":187,"class":43},"Our Lady of the Lake Hospital",{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":22,"phases":197,"briefSummary":198,"conditions":199,"keywords":200,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":44},"100576528","standard-care-with-or-without-early-palliative-care-provided-by-palliative-care-specialist-in-advanced-non-small-cell-lung-cancer-patients-100576528","NCT06786468","Standard Care With or Without Early Palliative Care Provided by Palliative Care Specialist in Advanced Non-small Cell Lung Cancer Patients","Randomized Controlled Trial of Standard Care With or Without Early Palliative Care Provided by Palliative Care Specialist in Advanced Non-small Cell Lung Cancer Patients","Inclusion Criteria:\n\n* Age at least 18 years old\n* Pathologically confirmed advanced non-small cell lung cancer\n* Plan to receive systemic treatment for lung cancer within three weeks\n* ECOG performance status 0-2 with estimated life expectancy \\> 24 weeks\n* Having at least 4 scores according to Edmonton Symptom Assessment System (ESAS)\n* Able to complete the questionnaires\n\nExclusion Criteria:\n\n* Had received systemic treatment for advanced lung cancer before",{"count":196,"type":21},104,[24],"Early palliative care has been shown to improve the survival of advanced lung cancer patients. However, most of the clinical studies were performed in the era when systemic treatment options for this disease were limited. Currently, many effective treatment options are available, including targeted therapy and immunotherapy. These novel agents improve the treatment outcomes while having less toxicity compared to conventional chemotherapy. Moreover, medical oncologists are now trained to provide palliative care for patients. This study was designed to demonstrate whether early palliative care provided by the palliative care specialist still improves the quality of life or survival of advanced lung cancer patients compared to standard care provided by the medical oncologist.",[27,58],[201,202,31],"early palliative care","palliative care",{"date":204,"type":36},"2025-01-22",{"date":206,"type":36},"2024-04-02",{"date":208,"type":21},"2027-04",{"name":210,"class":43},"Mahidol University",{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":217,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":17,"minAge":219,"maxAge":220,"enrollmentInfo":221,"targetDuration":4,"studyType":22,"phases":223,"briefSummary":224,"conditions":225,"keywords":227,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":44},"100568322","transbroncheal-novel-pdt-peripheral-lung-tumor-ablation-with-5-ala-100568322","NCT06679712","Transbroncheal Novel PDT Peripheral Lung Tumor Ablation With 5-ALA","Development of 5-Aminolevulinic Acid (5-ALA) Based Novel Tranbroncheal Photodynamic Ablation for Peripheral Lung Malignant Tumors","5ALA-TBPDT","Inclusion Criteria:\n\n* Patients with a pathological diagnosis of malignant lung tumors (including primary lung cancer and metastatic lung cancer) in advanced or terminal stages.\n* Patients for whom first- or second-line standard treatments (surgery, radiation therapy, or chemotherapy\u002Fimmunotherapy\u002Ftargeted therapy) have failed or who are unsuitable for standard treatments.\n* Tumor size of less than or equal to 3 cm, clearly visible and assessable on chest CT scans.\n* Patients whose tumors are inoperable or for whom surgery is not suitable.\n* Patients in good physical condition with an ECOG (Eastern Cooperative - -Oncology Group) performance status score of 0 to 2.\n* Patients capable of providing informed consent and willing to undergo regular follow-up during the trial.\n\nExclusion Criteria:\n\n* Diagnosis of small cell lung cancer or non-solid malignancy.\n* Tumor located in the central part of the lung.\n* Previous radiation therapy to the area intended for treatment.\n* Abnormal blood chemistry values.\n* Chemotherapy within the past 4 weeks.\n* Tumor invasion into major blood vessels.\n* Allergy to porphyrins, porphyrin-related metabolites, Lipiodol, or iodine-based contrast agents.\n* Plans to undergo curative surgery for lung tumors within the next 90 days.\n* Patients with ophthalmologic diseases who may require a slit-lamp eye examination within the next 30 days.\n* Mental illness that prevents the patient from undergoing bronchoscopy.\n* Pregnant or planning to become pregnant, breastfeeding, or planning to breastfeed within 6 months after the procedure.\n* Photodynamic therapy within the past month.\n* Severe kidney or liver disease with abnormal renal or hepatic function.\n* Plans to participate in another cancer treatment clinical trial within 3 months post-procedure.\n* Patients with AIDS.\n* Patients deemed unsuitable for the trial by the principal investigator or safety monitoring committee due to severe illness.","20 Years","75 Years",{"count":222,"type":21},6,[24],"Photodynamic therapy (PDT) involves the use of special light-sensitive drugs that are selectively absorbed by cancer cells. When exposed to a specific wavelength of light, these drugs are activated within the tumor cells, triggering a free radical reaction that destroys the cancer cells. Currently, PDT is used in the treatment of early-stage lung cancer in the central airways or for advanced tumors causing airway obstruction. With advancements in medical technology, electromagnetic navigation bronchoscopy (EMB) can now be employed in a hybrid operating room (Hybrid OR) under radiological guidance to direct photodynamic therapy fibers to the tumor site for light therapy.\n\nOur research team previously proposed a novel light transmission method, using Sodium Porfimer as the photosensitizer. In the Hybrid OR, electromagnetic navigation bronchoscopy was utilized to infuse Lipiodol into the bronchial tree, enhancing the illumination range through the optical fiber effect. Energy of 630 nm at 200 J\u002Fcm (400 mW\u002F500 seconds) delivered through a 3 cm cylindrical laser fiber was deemed safe, with no significant acute complications observed. However, due to the low light dosage, the therapeutic outcome was suboptimal, although one case demonstrated tumor necrosis with no apparent damage to the surrounding lung tissue. A second-phase pilot clinical trial aimed at improving light energy and treatment coverage through a multi-session, multi-angle light exposure model is also proved this method is feasible and safe.\n\nIn addition to Sodium Porfimer, other photosensitizers are approved for clinical use in photodynamic diagnosis and therapy. For example, 5-Aminolevulinic Acid (5-ALA) has been approved for the treatment of brain cancer surgery. Similar to Sodium Porfimer, 5-ALA is a precursor of heme, and in certain cells (such as cancer cells and reticuloendothelial tissues) where there is a deficiency of the enzyme ferrochelatase, administering large amounts of 5-ALA or Sodium Porfimer leads to the accumulation of Protoporphyrin IX (PpIX). PpIX is a photosensitizer, and when exposed to a specific wavelength of light, it generates oxygen free radicals that destroy cancer cells, thereby producing the therapeutic effect of PDT.\n\nWe propose this clinical trial to explore the use of 5-ALA as a substitute for Sodium Porfimer in the novel PDT treatment of peripheral lung tumors. Compared to Sodium Porfimer, 5-ALA has the same therapeutic mechanism but a shorter half-life. It can be taken orally 2-4 hours before treatment, requires only one day of light protection post-procedure, and is more cost-effective. 5-ALA (Gliolan) has also been approved by the FDA for photodynamic diagnosis and treatment of brain cancer, and clinical trials in other cancers have demonstrated its safety and feasibility.\n\nThis phase 0 pilot clinical study plans to recruit six patients with peripheral malignant lung tumors (tumor diameter ≤ 30 mm). 5-ALA (Gliolan) will be used as the photosensitizer, and in the hybrid operating room, electromagnetic navigation bronchoscopy will guide a catheter to the tumor site. Lipiodol (iodized poppy seed oil) will be infused to coat the tumor, enhancing the light exposure range. The first three subjects will undergo a single-session light exposure to assess the feasibility and safety of the procedure. The remaining three subjects will receive multi-session, multi-angle light exposure to further verify the safety and effectiveness of the treatment. The findings from these subjects will serve as a reference for light energy parameters for future phase I clinical trials.",[27,226],"Lung Metastases From Any Primary",[228,229,230],"Photodynamic therapy","Peripheral lung cancer","Transbroncheal Ablation","2024-11-06",{"date":233,"type":36},"2024-11-07",{"date":235,"type":21},"2024-12-01",{"date":237,"type":21},"2026-12-31",{"name":239,"class":240},"Taoyuan General Hospital","OTHER_GOV"]