[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Li-kun Chen\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":96},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"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":4},"100608088","phase-2-sacituzumab-tirumotecan-sac-tmt-plus-bevacizumab-in-3rd-generation-egfr-tki-treated-advanced-egfr-mutant-nonsquamous-nsclc-with-brain-metastasis-100608088",false,"NCT07197008","Sacituzumab Tirumotecan (Sac-TMT) Plus Bevacizumab in 3rd Generation EGFR-TKI Treated Advanced EGFR-mutant Nonsquamous NSCLC With Brain Metastasis","Sacituzumab Tirumotecan (Sac-TMT) Plus Bevacizumab in 3rd Generation EGFR-TKI Treated Advanced EGFR-mutant Nonsquamous NSCLC With Brain Metastasis: a Single-arm, Phase II Study（TOP BRAIN）","Inclusion Criteria:\n\n1. Age ≥ 18 and ≤80 when signing the informed consent form, regardless of gender;\n2. Histologically or cytologically confirmed nonsquamous NSCLC with EGFR-sensitive mutation (exon 19 deletion or exon 21 L858R mutation).\n3. Progression on or after 3rd-generation EGFR-TKI (change to the third-generation EGFR-TKIs after receiving 1st or 2nd generations of TKI, or to use the third-generation TKI in the first line are all allowed).\n4. Brain parenchymal metastases confirmed by cranial MRI, including asymptomatic BM or those with symptoms controlled after local treatment and\u002For dehydration therapy, should maintain a clinically stable state (no longer requiring glucocorticoids or anticonvulsants) for at least 2 weeks before the first dose.\n5. According to mRECIST 1.1, the subject must have at least one accurately measurable intracranial target lesion that has not been previously treated with local therapies such as radiation therapy or surgery. Brain metastatic lesions with a diameter of ≥ 5 mm are permitted to be designated as target lesions.\n6. ECOG PS 0-1.\n7. Estimated life expectancy of 12 weeks or more.\n8. Adequate organ function.\n9. Female subjects of childbearing potential and male subjects whose partners are of childbearing potential must agree to use effective medical contraceptive measures from the time of signing the informed consent form until 6 months after the last dose.\n10. The subject voluntarily participates in this study, signs the informed consent form, and is able to comply with the study visits and related procedures as specified in the protocol.\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed tumor with components of small cell lung cancer, neuroendocrine carcinoma, carcinosarcoma, or squamous cell carcinoma;\n2. Patients with spinal cord compression or those assessed by the investigator as having extensive meningeal metastasis;\n3. Previous whole-brain radiotherapy for brain metastases;\n4. Subjects who have previously received chemotherapy, TROP2-targeted therapy, or any drug therapy containing topoisomerase I inhibitors, including antibody-drug conjugate (ADC) therapy (including in the context of adjuvant or neoadjuvant therapy);\n5. Tumor invading or surrounding important surrounding organs and blood vessels (such as the heart, esophagus, superior vena cava, etc.), or with obvious necrosis, cavitation, or at risk of developing esophagotracheal fistula or esophagopleural fistula;\n6. A history of bleeding tendency or coagulation disorder and\u002For clinically significant bleeding symptoms or risks within 4 weeks before the first dose;\n7. Use of aspirin (\\> 325 mg\u002Fday) or treatment with dipyridamole or clopidogrel within 2 weeks before the first dose;\n8. Use of full-dose oral or intravenous anticoagulants or thrombolytics within 2 weeks before the first dose;\n9. Biopsy or other minor surgeries (excluding placement of vascular access devices) within 7 days before the first dose;\n10. Presence of non-healing wounds or untreated fractures (excluding old fractures and other fractures that do not require treatment);\n11. History of other malignant tumors within 3 years before the first dose (except tumors cured by local treatment, such as cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in situ, etc.);\n12. Presence of any of the following cardiovascular and cerebrovascular diseases or risk factors:\n\n    1. Myocardial infarction, unstable angina pectoris, acute or persistent myocardial ischemia, grade 3 or 4 heart failure (according to the New York Heart Association (NYHA) classification), symptomatic or poorly controlled severe arrhythmia, cerebrovascular accident, transient ischemic attack, or other severe cardiovascular and cerebrovascular diseases within 6 months before the first dose;\n    2. Previous history of myocardial diseases such as myocarditis, primary cardiomyopathy, or specific cardiomyopathy;\n    3. Any deep vein thrombosis within 3 months before the first dose (subjects with stable condition after treatment with low-molecular-weight heparin or drugs with similar effects for ≥ 2 weeks are permitted to enroll), peripheral arterial thromboembolic events, pulmonary embolism, or other severe thromboembolic events;\n    4. Presence of major vascular diseases that may be life-threatening or require surgery within 6 months before the first dose, such as aortic aneurysm or aortic dissecting aneurysm;\n13. Uncontrolled systemic diseases as judged by the investigator:\n14. History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid treatment, current ILD or non-infectious pneumonia, or suspected ILD or non-infectious pneumonia at screening that cannot be excluded by imaging examinations;\n15. Documented history of severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or severe corneal diseases that may impede\u002Fdelay corneal healing;\n16. Clinically severe lung damage caused by concurrent pulmonary diseases, including but not limited to any underlying lung diseases (such as severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease within 3 months before the first dose) or any autoimmune, connective tissue, or inflammatory diseases that may involve the lungs (i.e., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or previous pneumonectomy;\n17. Subjects with active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcer, gastrointestinal perforation, abdominal abscess, or acute gastrointestinal bleeding;\n18. Proteinuria, evidenced by protein \\> 1.0 gram in urine test strip or 24-hour urine collection. All patients with protein ≥ 2+ in baseline urine test strip analysis must undergo 24-hour urine collection, and the protein in 24 hours must be proven to be ≤ 1 g;\n19. Toxicity from previous anti-tumor treatment has not recovered to ≤ grade 1 (assessed based on NCI CTCAE v5.0) or the level specified in the inclusion\u002Fexclusion criteria","ALL","18 Years","80 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a prospective, single-center, phase 2 clinical study to explore the efficacy and safety of Sac-TMT in combination with bevacizumab for patients with EGFR-mutated nonsquamous NSCLC with brain metastases. The study will enroll 50 EGFR-sensitive mutation(19del\u002F21L858R) nonsquamous NSCLC patients who progressed on or after 3rd generation EGFR-TKI with brain metastases.",[27],"Lung Cancer",[29,30,31],"brain metastases","EGFR mutated","Sacituzumab tirumotecan","NOT_YET_RECRUITING","2025-09-20",{"date":35,"type":36},"2025-09-29","ACTUAL",{"date":38,"type":21},"2025-10-01",{"date":40,"type":21},"2028-12-30",{"name":42,"class":43},"Li-kun Chen","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100572099","phase-2-evaluation-of-the-efficacy-and-safety-of-furmonertinib-combined-with-bevacizumab-as-first-line-treatment-for-egfr-positive-non-small-cell-lung-cancer-with-brain-metastases-a-single-arm-open-label-prospective-phase-ii-clinical-study-100572099","NCT06728865","Evaluation of the Efficacy and Safety of Furmonertinib Combined with Bevacizumab As First-Line Treatment for EGFR-Positive Non-Small Cell Lung Cancer with Brain Metastases: a Single-Arm, Open-Label, Prospective Phase II Clinical Study","Better Brain","Inclusion Criteria:\n\n1. Aged 18-75 years. ECOG performance status (PS) score of 0-2. Expected survival time of ≥3 months.\n2. Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC).\n3. Baseline evaluation confirming the presence of EGFR-sensitizing mutations (19del\u002FL858R) via first- or second-generation sequencing. Test samples can include archived tumor tissue or fresh tumor tissue collected during screening. If unavailable, pleural effusion, cerebrospinal fluid, or blood samples may be used for testing.\n4. Asymptomatic brain metastases or those with controlled intracranial hypertension symptoms following dehydration treatment. Continued medication to maintain stable symptoms at enrollment or during the study is allowed.\n5. For patients with parenchymal or leptomeningeal brain metastases, MRI must confirm at least one brain lesion with a diameter ≥5 mm.\n6. No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC. Patients who underwent radical surgery, chemoradiotherapy, or adjuvant therapy (chemotherapy or radiotherapy) for early-stage NSCLC may be included if their disease recurred or metastasized after treatment, provided the interval from the last treatment to initial tumor recurrence exceeds 6 months.\n7. Normal function of major organs, with the following criteria: Hematology (without transfusion or hematopoietic stimulating factors within 14 days): Hemoglobin (HB) ≥ 90 g\u002FL. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL. Platelets (PLT) ≥ 80 × 10⁹\u002FL. Biochemistry: Total bilirubin (TBIL) \\\u003C 1.5 × upper limit of normal (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C 2.5 × ULN (if liver metastases are present, ALT and AST \\\u003C 5 × ULN). Creatinine (Cr) ≤ 1.25 × ULN or creatinine clearance rate (CCr) ≥ 45 mL\u002Fmin (using the Cockcroft-Gault formula). Proteinuria \\\u003C 2+ (if baseline proteinuria ≥ 2+, a 24-hour urine protein quantification ≤ 1 g is required). International normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN. Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%) as assessed by Doppler ultrasound.\n8. Women of childbearing potential must agree to use effective contraception (e.g., intrauterine devices, oral contraceptives, or condoms) during the study and for 6 months after its completion. Negative serum or urine pregnancy test within 7 days prior to enrollment and non-lactating status are required. Male participants must agree to use contraception during the study and for 6 months afterward.\n9. Participants must voluntarily consent to participate in the study, sign an informed consent form, and demonstrate good compliance.\n\nExclusion Criteria:\n\n1. Active Bleeding with Brain and\u002For Leptomeningeal Metastases\n2. Includes therapies with agents such as bevacizumab, endurance, or anlotinib.\n3. ≥ Grade 2 toxicity (NCI-CTCAE v4.03) related to prior treatments not resolved at the start of study treatment (excluding alopecia and Grade 2 neurotoxicity caused by platinum agents).\n4. Includes uncontrolled nausea\u002Fvomiting, inability to swallow, gastrointestinal resection, chronic diarrhea, or intestinal obstruction\n5. Prior whole-brain radiotherapy (WBRT). Radiotherapy involving \\>30% of bone marrow or extensive radiation within 4 weeks before the first dose (palliative radiotherapy for non-brain metastases, such as bone metastases, is exempt).\n6. Poorly controlled hypertension (defined as blood pressure ≥160\u002F100 mmHg despite optimal antihypertensive therapy). Cardiac criteria, including: QTcF ≥ 470 msec (average of three ECGs, corrected using Fredericia's formula) at rest. Clinically significant arrhythmias, conduction abnormalities, or ECG changes (e.g., complete left bundle branch block, third-degree AV block, second-degree AV block, PR interval ≥250 msec). Factors increasing risk of QT prolongation or arrhythmias, such as NYHA Class III-IV heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age, or use of QT-prolonging medications. Active or uncontrolled severe infections. Liver disease, including cirrhosis, decompensated liver disease, or chronic active hepatitis. Poorly controlled diabetes (fasting blood glucose \\>10 mmol\u002FL). Urinalysis showing ≥2+ proteinuria, confirmed by 24-hour urine protein quantification \\>1.0 g.\n7. Presence of unhealed wounds or fractures.\n8. NCI-CTCAE \\> Grade 1 pulmonary bleeding within 4 weeks before enrollment. NCI-CTCAE \\> Grade 2 bleeding at other sites within 4 weeks before enrollment. Bleeding tendencies (e.g., active gastrointestinal ulcers) or patients on thrombolytic or anticoagulant therapy (e.g., warfarin, heparin, or similar agents).\n9. History of arterial\u002Fvenous thrombosis within 12 months before enrollment, including stroke (e.g., transient ischemic attack, cerebral hemorrhage, or infarction), deep vein thrombosis, or pulmonary embolism.\n10. Clinically significant hemoptysis (\\>50 mL\u002Fday) within 3 months before enrollment. Severe bleeding symptoms or conditions such as gastrointestinal bleeding, bleeding gastric ulcers, stool occult blood ≥2+, or vasculitis.\n11. History of interstitial lung disease, drug-induced interstitial lung disease, steroid-requiring radiation pneumonitis, or clinically active interstitial lung disease.\n12. History of substance abuse or uncontrolled psychiatric disorders.\n13. Poorly controlled pleural or ascitic effusions despite symptomatic treatment, causing Grade ≥2 respiratory syndrome (≥CTCAE Grade 2).\n14. Known active infections, including: Active hepatitis B (HBsAg positive and HBV-DNA ≥ 2 × 10³ IU\u002FmL during screening). Hepatitis C (HCV-Ab positive and HCV-RNA positive during screening). Active tuberculosis (evidence of active infection within 1 year). Syphilis (both specific and non-specific antibodies positive). HIV infection (HIV antibody positive). Active infections are not routinely screened unless clinically indicated.\n15. Severe diseases or conditions deemed to pose risks to patient safety or impede study completion.\n16. Severe diseases or conditions deemed to pose risks to patient safety or impede study completion.\n17. Prior allogeneic bone marrow transplantation.\n18. Prior allogeneic bone marrow transplantation. 19)Any other condition deemed unsuitable for the study by the investigator. 20)Major surgery within 28 days before the first dose (defined as surgeries requiring at least 3 weeks of recovery before study treatment).","15 Years","75 Years",{"count":54,"type":21},70,[24],"This study evaluates the safety and efficacy of Befotertinib combined with Bevacizumab as a first-line treatment for patients with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC) accompanied by brain or leptomeningeal metastases. It is a single-arm, open-label, prospective Phase II clinical trial aiming to explore the potential benefits of this combination therapy in improving intracranial progression-free survival (iPFS) and overall survival (OS). Patients will receive Befotertinib daily and Bevacizumab every three weeks until disease progression, intolerable toxicity, or withdrawal of consent. The study seeks to address the unmet need for effective treatments in this challenging patient population.",[58,59,60,61,62],"Non-small Cell Lung Cancer (NSCLC)","EGFR Mutation-Positive Lung Cancer","Brain Metastases","Leptomeningeal Metastases","Intracranial Tumor Progression","RECRUITING","2024-12-08",{"date":66,"type":36},"2024-12-11",{"date":68,"type":36},"2024-09-04",{"date":70,"type":21},"2028-02-01",{"name":42,"class":43},1,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":72},"100572098","phase-2-efficacy-and-safety-of-vorolanib-monotherapy-as-third-line-or-later-treatment-for-advanced-non-small-cell-lung-cancer-patients-a-single-arm-prospective-open-label-phase-ii-clinical-study-100572098","NCT06728852","Efficacy and Safety of Vorolanib Monotherapy As Third-line or Later Treatment for Advanced Non-small Cell Lung Cancer Patients: a Single-arm, Prospective, Open-label Phase II Clinical Study","Vigor","Inclusion Criteria:\n\n1. Sign the informed consent\n2. Pathologically or cytologically diagnosed with metastatic\u002Frelapsed advanced NSCLC, with measurable lesions (according to RECIST 1.1)\n3. Previously received at least two systemic therapies, allowing for third-line or higher chemotherapy or unable to tolerate chemotherapy\n4. Patients with negative results for driver gene testing or patients with positive results who have already received relevant targeted drugs or systemic anti-tumor treatments and are either resistant or unable to tolerate them\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. Expected survival time ≥ 3 months\n6. Normal major organ function: renal function with creatinine clearance rate ≥ 60 mL\u002Fmin; liver function with bilirubin ≤ 1.5× upper limit of normal (ULN), ALT\u002FAST ≤ 2.5× ULN (for patients with documented liver metastasis, AST and ALT levels ≤ 5× ULN)\n7. Good hematological function, defined as an absolute neutrophil count (ANC) ≥ 1.5×10\\^9\u002FL, platelet count ≥ 100×10\\^9\u002FL, hemoglobin ≥ 90g\u002FL (without blood transfusion or erythropoietin \\[EPO\\] dependency within the last 7 days)\n8. Good coagulation function, defined as an international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5× ULN; if the subject is on anticoagulation therapy, PT should be within the intended therapeutic range of the anticoagulant\n9. Female patients of childbearing potential must agree to use contraception (e.g., intrauterine device, contraceptives, or condoms) during the study and for 6 months after the study ends; must not be breastfeeding and must have a negative serum or urine pregnancy test within 7 days before enrollment. Male patients must agree to use contraception during the study and for 6 months after the study ends\n10. Patients with well-controlled pleural or peritoneal effusions that do not cause grade 2 or higher respiratory syndrome (≥ CTCAE grade 2) can be included\n11. Patients without clinical symptoms of intracranial hypertension caused by brain metastases or with brain metastasis symptoms that are stable after prior treatment (radiation therapy or surgery) of brain or meningeal metastasis (usually requiring more than 4 weeks post-radiation therapy)\n\nExclusion Criteria:\n\n1. Previously failed treatment with multi-target anti-angiogenic drugs, such as anlotinib, cabozantinib, apatinib, lenvatinib, etc. The use of bevacizumab is allowed, but the last administration must be more than 3 weeks before enrollment\n2. Small cell lung cancer (including small cell carcinoma, non-small cell lung cancer mixed with other types of tumors)\n3. Testing positive for driver genes but not treated with TKIs\n4. Tumor invasion of large blood vessels, central squamous cell carcinoma of the lung with cavitation, or non-small cell lung cancer with hemoptysis (\\>5ml\u002Fday), or where the tumor is likely to invade important blood vessels and cause fatal bleeding during the subsequent study period\n5. Accompanied by other types of malignant tumors within the past 5 years or currently\n6. Planning to receive systemic anti-tumor therapy within 4 weeks before enrollment or during the study period, including cytotoxic therapy, signal transduction inhibitors, and immunotherapy (or mitomycin C within 6 weeks before receiving experimental drug therapy); received extended-field radiation therapy (EF-RT) within 4 weeks before enrollment or limited-field radiation therapy within 2 weeks before enrollment with evaluation of lesions recommended\n7. Unremitting toxic reactions caused by previous treatment, CTCAE grade \\>1, excluding hair loss\n8. Various factors affecting oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea, bowel obstruction)\n9. Pleural effusion or ascites leading to respiratory syndrome (≥CTCAE grade 2)\n10. Symptoms of brain metastasis not controlled and treated within 2 months\n11. Presence of any severe or uncontrolled disease\n12. Major surgery, open biopsy, or significant traumatic injury within 28 days before enrollment\n13. Bleeding diathesis or history of significant bleeding, regardless of severity; any wound, ulcer, or fracture that has not healed following a bleeding or bleeding event (≥CTCAE grade 3)\n14. Arterial\u002Fvenous thrombosis within 6 months, such as cerebrovascular accident (including transient ischemic attack), venous thrombosis, pulmonary embolism\n15. History of substance abuse that cannot be quit or diagnosed with psychiatric disorders\n16. Participated in other clinical trials of anti-tumor drugs within 4 weeks\n17. Diagnosed with diseases that severely jeopardize patient safety or affect the completion of this study\n18. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1\u002F2 antibody positive); untreated active hepatitis B; active HCV infection (HCV antibody positive and HCV-RNA levels above detection limit)","70 Years",{"count":82,"type":21},32,[24],"This study evaluates the efficacy and safety of Vorolanib as monotherapy for advanced non-small cell lung cancer (NSCLC) patients receiving third-line or higher treatments. It is a single-center, single-arm, prospective Phase II clinical trial. Thirty-two patients who have undergone at least two lines of systemic therapy and exhibited progression or recurrence will receive 300 mg of Vorolanib daily until disease progression, intolerable toxicity, withdrawal of consent, or death. The primary endpoint is the 6-month progression-free survival (PFS) rate. Secondary endpoints include PFS, objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety. This research aims to expand the clinical applications of Vorolanib in NSCLC, providing a basis for further investigation.",[86,87,88,89],"Advanced Non-small Cell Lung Cancer (NSCLC)","Recurrent or Metastatic Lung Cancer","Third-line and Beyond Therapy","Angiogenesis Inhibition in Oncology",{"date":66,"type":36},{"date":92,"type":21},"2024-12-01",{"date":94,"type":21},"2026-12-01",{"name":42,"class":43},""]