[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"egfr-activating-mutation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:egfr-activating-mutation":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,43,73,102,126,156,182,205,232,259,281,303],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100054099","phase-2-first-line-therapy-with-egfr-tki-combined-with-trastuzumab-rezetecan-for-advanced-nsclc-harboring-egfr-mutations-concomitant-with-her2-alterations-100054099",false,"NCT07699952","First-line Therapy With EGFR-TKI Combined With Trastuzumab Rezetecan for Advanced NSCLC Harboring EGFR Mutations Concomitant With HER2 Alterations","Inclusion Criteria:\n\n1. Aged 18-75 years, male or female without restriction;\n2. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1; Estimated survival time ≥ 3 months;\n3. Histologically or cytologically confirmed unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC);\n4. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1);\n5. No prior systemic anti-tumor therapy before enrollment (oral EGFR-TKI administered within 2 weeks prior to screening is permitted);\n6. Confirmed EGFR mutations via genetic testing, including Exon 19 deletion or L858R point mutation;\n7. Presence of HER2 alterations, any of the following subtypes is acceptable: confirmed HER2 mutations or amplification by genetic testing; HER2 low expression or overexpression by immunohistochemistry (IHC 1+\u002F2+\u002F3+);\n8. Adequate laboratory parameters. No blood product transfusion or hematopoietic growth factor support administered within 14 days prior to the first study drug dose to correct lab abnormalities.\n9. Female subjects of childbearing potential must have a negative serum pregnancy test within 3 days before the initial study drug administration. 10. They must agree to use a medically approved highly effective contraceptive method (e.g., intrauterine device, oral contraceptives, condoms) throughout the study and for 180 days after the last dose of study drug. Male subjects with female partners of childbearing potential must be surgically sterilized or agree to effective contraception during the study and for 180 days after the last study drug administration.\n\n11\\. Voluntarily participate in this trial, sign written informed consent, demonstrate good treatment compliance, and agree to complete all scheduled visits and study-related procedures.\n\n12\\. Estimated survival time ≥ 3 months.\n\nExclusion Criteria:\n\n1. Histologically confirmed tumor containing small cell lung cancer components.\n2. Medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid intervention, or any clinical evidence of active ILD.\n3. Symptomatic or actively progressive central nervous system (CNS) metastases or leptomeningeal metastases confirmed by CT\u002FMRI during screening and prior to radiological assessment.\n\n   Asymptomatic patients with stable CNS lesions who have received local therapy may be enrolled only if all of the following criteria are simultaneously met:\n\n   Fewer than 5 brain metastatic lesions; At least one measurable lesion per RECIST v1.1 exists outside the CNS; No history of intracranial or spinal hemorrhage; No neurosurgical resection within 28 days prior to the first study treatment dose, no whole-brain radiotherapy within 14 days, and no stereotactic radiotherapy within 7 days; Imaging confirms lesion stability for at least 4 weeks before enrollment, and systemic steroid therapy has been discontinued for more than 2 weeks (equivalent to ≤10 mg prednisone per day or equivalent steroids); Metastases do not involve the midbrain, pons, medulla oblongata, or spinal cord.\n4. Subjects requiring systemic corticosteroids or other immunosuppressive agents within 14 days before the first study drug administration. 5. Nasal\u002Finhaled corticosteroids or physiological doses of systemic steroids (i.e., ≤10 mg prednisolone per day or equivalent physiological doses of other corticosteroids) are excluded from this restriction.\n\n6\\. Received systemic anti-tumor vaccines, anti-tumor traditional Chinese herbal medicines, or immunomodulatory drugs (including thymopeptides, interferons, interleukins, excluding local administration for pleural effusion control) within 4 weeks prior to the first dose.\n\n7\\. Prior anti-HER2 therapy or anticipated need for any other anti-tumor treatment during the study.\n\n8\\. History of other malignant tumors within 5 years before enrollment, except for in situ carcinomas that have achieved complete remission after treatment and require no additional therapy during the trial.\n\n9\\. Received live attenuated vaccines within 4 weeks before the first dose or planned to receive such vaccines during the study.\n\n10\\. Currently receiving treatment in another interventional clinical trial, or administered any other investigational product\u002Fdevice within 4 weeks before the first study dose.\n\n11\\. Complicated with severe infection, localized infection within 4 weeks prior to the first dose (including but not limited to infectious complications requiring hospitalization or ≥2 weeks of intravenous antibiotics, bacteremia, severe pneumonia, etc.), or any active infectious disease.\n\n12\\. History of active tuberculosis infection within 1 year before the first dose.\n\nDiagnosis of any active, known or suspected autoimmune disease, or past medical history of autoimmune disease. Subjects with stable disease not requiring systemic immunosuppressants are eligible for enrollment.\n\nHBsAg positive with HBV DNA above the upper limit of normal (1000 copies\u002FmL or 500 IU\u002FmL); HCV positivity indicating acute or chronic HCV infection via HCV RNA or HCV antibody testing; active hepatitis B or C; known HIV positivity or AIDS diagnosis.\n\n13\\. Received major surgery within 4 weeks before the first dose; invasive minor procedures (catheter placement, biopsy, bronchoscopy) within 7 days before the first dose; non-thoracic radiotherapy \\>30 Gy within 4 weeks before the first dose; thoracic radiotherapy \\>30 Gy within 24 weeks before the first dose; or palliative radiotherapy \\\u003C30 Gy within 2 weeks before the first dose.\n\n14\\. Have not fully recovered from toxicities and\u002For complications induced by any prior interventions before the first dose (i.e., residual toxicity \\> Grade 1 or not returned to baseline; fatigue and alopecia are exempted).\n\n15\\. Grade ≥2 myocardial ischemia or myocardial infarction; uncontrolled arrhythmia (QTc interval ≥450 ms for males, ≥470 ms for females); New York Heart Association (NYHA) Class III-IV cardiac insufficiency; or left ventricular ejection fraction (LVEF) \\\u003C50% on echocardiography.\n\n16\\. History of severe bleeding events, arterial\u002Fvenous thrombosis, or pulmonary embolism.\n\n17\\. Patients at risk of gastrointestinal perforation. 18. History of allogeneic solid organ transplantation or allogeneic hematopoietic stem cell transplantation.\n\n19\\. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage.\n\n20\\. Known allergy, hypersensitivity or intolerance to the study drug or its excipients.\n\n21\\. Diagnosed with psychiatric disorders or substance abuse; female patients who are pregnant, breastfeeding, or planning pregnancy during the trial.\n\n22\\. Any medical condition that, in the Investigator's judgment, may harm the subject or prevent the subject from complying with study requirements and procedures.","ALL","18 Years","75 Years",{"count":19,"type":20},35,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","To explore the efficacy and safety of first-line EGFR-TKI combined with Trastuzumab Rezetecan in advanced NSCLC patients harboring EGFR mutations with concomitant HER2 genomic alterations or HER2 protein expression (1+\u002F2+\u002F3+)",[26,27,28],"Lung Cancer (NSCLC)","EGFR Activating Mutation","HER2",[30],"EGFR；HER2；TKI;ADC","NOT_YET_RECRUITING","2026-07-07",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":20},"2026-07-09",{"date":39,"type":20},"2029-03",{"name":41,"class":42},"Yongsheng Wang","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100643728","phase-2-egfr-tkis-plus-pd-1-in-egfr-mutant-advanced-nsclc-100643728","NCT07637448","EGFR-TKIs Plus PD-1 in EGFR-Mutant Advanced NSCLC","A Clinical Study Evaluating the Preliminary Antitumor Activity and Safety of EGFR-TKIs Combined With PD-1 Monoclonal Antibody as First-Line Therapy in Patients With EGFR-Mutant Advanced Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Patients with histologically or cytologically confirmed, previously untreated EGFR-mutant (19del\u002FL858R) locally advanced or metastatic (stage IIIB\u002FIIIC or IV) non-small cell lung cancer (NSCLC), according to the 9th edition of the TNM staging system for lung cancer jointly issued by the International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC);\n2. Male or female patients aged ≥ 18 years;\n3. Patients who are willing to receive third-generation EGFR-TKI targeted therapy, followed by maintenance therapy with a PD-1 antibody during the stable phase of the disease (defined as no further tumor shrinkage for at least two consecutive assessments based on RECIST v1.1 criteria);\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n5. At least one measurable or non-measurable but evaluable lesion according to RECIST version 1.1;\n6. Adequate organ function;\n7. Female or male patients of childbearing potential must agree to use highly effective contraceptive measures throughout the study period;\n8. Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study requirements as specified in the visit schedule.\n\nExclusion Criteria:\n\n1. Patients who are ineligible for standard anti-tumor therapy according to routine clinical practice;\n2. Prior treatment with anti-PD-1\u002FPD-L1 immunotherapy;\n3. Concurrent enrollment in another clinical study;\n4. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n5. Receipt of systemic corticosteroids or other immunosuppressive therapy within 2 weeks prior to the first dose of study drug;\n6. Receipt of any live vaccine within 4 weeks prior to the first dose of study drug, or planned receipt of live vaccine during the study period;\n7. Presence of brainstem, leptomeningeal, spinal cord metastasis, or spinal cord compression;\n8. Presence of uncontrolled concomitant diseases, including but not limited to decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, etc.;\n9. History of severe gastrointestinal ulcer, gastrointestinal perforation, fistula or obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose, or other gastrointestinal diseases that, in the investigator's opinion, may predispose to bleeding or perforation;\n10. Presence of severe uncontrolled cardiovascular disease;\n11. Interstitial lung disease (ILD) (including pulmonary fibrosis or radiation pneumonitis) requiring corticosteroid therapy, or current ILD\u002Fnon-infectious pneumonitis;\n12. Concomitant pulmonary disease resulting in clinically severe impairment of respiratory function;\n13. Chronic autoimmune disease or inflammatory disease requiring systemic therapy or receiving systemic therapy within 2 years prior to the first dose;\n14. Active or history of documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea), intestinal obstruction, or extensive bowel resection;\n15. Diagnosis of Gilbert's syndrome;\n16. Severe infection within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia;\n17. Known active pulmonary tuberculosis;\n18. Known active syphilis infection;\n19. Known history of immunodeficiency, or positive test for human immunodeficiency virus (HIV) antibody;\n20. Presence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection;\n21. Known allergy to any component of any study drug, history of severe allergic reactions (e.g., anaphylactic shock), history of severe hypersensitivity to other monoclonal antibodies or recombinant protein-based substances, or history of severe infusion reactions;\n22. Women who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study period;\n23. Any disease, medical condition, organ system dysfunction, or social circumstance (including but not limited to psychiatric illness, substance\u002Falcohol abuse, history of drug abuse, etc.) that, in the investigator's opinion, may interfere with the subject's ability to provide informed consent, adversely affect the subject's cooperation and participation in the study, or confound the interpretation of study results.",{"count":51,"type":20},32,[23],"This study is an open-label, multicenter, single-arm clinical study.",[55,27,56],"Lung Cancer Non-Small Cell Cancer (NSCLC)","PD-1 Antibody",[58,59,60,61],"Non-Small Cell Cancer (NSCLC)","EGFR-Mutant","EGFR-TKIs","PD-1 Monoclonal Antibody","RECRUITING","2026-06-04",{"date":65,"type":35},"2026-06-09",{"date":67,"type":35},"2026-05-21",{"date":69,"type":20},"2030-03-01",{"name":71,"class":42},"Nanfang Hospital, Southern Medical University",1,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":83,"conditions":84,"keywords":88,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":72},"100619772","pulsatile-high-dose-furmonertinib-in-egfr-mutant-nsclc-with-leptomeningeal-metastasis-100619772","NCT07348965","Pulsatile High-dose Furmonertinib in EGFR-mutant NSCLC With Leptomeningeal Metastasis","Inclusion Criteria:\n\n1. Patients with non-small cell lung cancer (NSCLC) confirmed by histopathological or cytopathological examination\n2. Patients with EGFR exon 19 deletion or exon 21 L858R mutation\n3. Patients with leptomeningeal metastasis (LMD) confirmed by positive cerebrospinal fluid (CSF) cytology (within 28 days prior to the first dose administration) and with at least 1 LMD lesion that can be repeatedly evaluated by magnetic resonance imaging (MRI)\n4. Patients with disease progression after first-line tyrosine kinase inhibitor (TKI) treatment\n5. Aged ≥18 years and ≤85 years, with no gender restrictions.\n6. Sufficient organ function, defined as: absolute neutrophil count ≥ 1.5×10⁹\u002FL, platelet count ≥ 75×10⁹\u002FL, hemoglobin ≥ 90g\u002FL total bilirubin ≤ 1.5×upper limit of normal (ULN) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN (for patients with liver metastasis, total bilirubin can be relaxed to ≤ 3×ULN, and ALT\u002FAST can be relaxed to ≤ 5×ULN) serum creatinine ≤ 1.5×ULN or creatinine clearance ≥ 50 mL\u002Fmin (calculated by the Cockcroft-Gault formula)\n7. For patients enrolled in the pharmacokinetic study: no prior treatment with furmonertinib (either in combination or as monotherapy)\n8. Patients who have signed the informed consent form, are willing to receive treatment under this protocol, can adhere to medication administration, and have good compliance.\n\nExclusion Criteria:\n\n1. Unable to complete the baseline assessment form\n2. Complicated with severe or uncontrolled systemic diseases, including active infection, electrolyte disturbance, bleeding tendency, etc.\n3. Pregnant or lactating women, or those with planned pregnancy during the study or within 6 months after the study ends\n4. Presence of central nervous system complications requiring emergency neurosurgical intervention\n5. Suffering from other malignant tumors or having a history of other malignant tumors\n6. Complicated with severe brain diseases or mental illnesses that affect the patient's ability to report symptoms by themselves\n7. Individuals without legal capacity, or those for whom medical or ethical reasons affect the continuation of the study\n8. Other circumstances deemed unsuitable for participation in this study by the researcher.\n9. Patients with a severe allergic diathesis, especially those who have experienced severe drug allergies or other serious adverse reactions during previous treatment with tyrosine kinase inhibitors (TKIs).",{"count":80,"type":20},42,[82],"NA","The goal of this clinical trial is to clarify the efficacy and safety of the high-dose alternate-day furmonertinib in NSCLC with leptomeningeal metastasis. It will also explore the mechanism by which the high-dose alternate-day administration regimen enhances efficacy from a pharmacokinetic perspective, and investigate the impact of co-occurring mutations on the efficacy and prognosis of furmonertinib in the treatment of EGFR-mutant NSCLC with leptomeningeal metastasis. The main questions it aims to answer are:\n\nDoes the high-dose alternate-day administration regimen have definite efficacy? Does the high-dose alternate-day administration regimen have favorable safety? Does the high-dose alternate-day administration regimen improve efficacy by increasing the cerebrospinal fluid (CSF) concentration and CSF penetration rate of the drug? Which co-occurring mutations may affect the efficacy and prognosis of patients with EGFR-mutant NSCLC and leptomeningeal metastasis? Participants will enter Cohort A (320mg qod po) or Cohort B (160mg qd po) to receive furmonertinib based on their own willingness and the clinician's decision, until disease, progression or uncontrollable adverse reactions occur. All patients in Cohort A will undergo efficacy and safety evaluation, with some also participating in pharmacokinetic study; patients in Cohort B will only undergo pharmacokinetic study.\n\nEfficacy and safety evaluation will be conducted through imaging examinations, neurological function assessment scales, quality of life self-assessment scales, and adverse event records. Pharmacokinetic study will be carried out by detecting the plasma concentrations and CSF concentrations of furmonertinib and its active metabolites, and calculating the CSF penetration rate for evaluation.",[85,86,87,27],"NSCLC (Advanced Non-small Cell Lung Cancer)","Leptomeningeal Metastasis","Furmonertinib",[89,90,91,92],"NSCLC","furmonertinib","leptomeningeal metastasis","cerebrospinal fluid","2026-03-31",{"date":95,"type":35},"2026-04-02",{"date":97,"type":35},"2026-03-01",{"date":99,"type":20},"2028-12-31",{"name":101,"class":42},"Guangzhou University of Traditional Chinese Medicine",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":112,"phases":4,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":72},"100615076","prediction-of-targeted-therapy-efficacy-in-egfr-mutant-lung-cancer-patients-using-ai-based-multimodal-data-100615076","NCT07287904","Prediction of Targeted Therapy Efficacy in EGFR-mutant Lung Cancer Patients Using AI-based Multimodal Data","A Retrospective Analysis Study on Predicting the Efficacy of Targeted Therapy in Lung Cancer Patients With EGFR Mutations Based on AI-driven Multimodal Data","Inclusion Criteria:\n\n1. Age 18-80 years, undergoing radical surgery for lung cancer (R0 resection);\n2. Postoperative pathological stage IB-IIIA, pathology confirmed as adenocarcinoma;\n3. EGFR gene testing positive, EGFR 19del\u002FL858R mutation;\n4. Receiving postoperative EGFR-TKI targeted adjuvant therapy;\n5. Complete and clear preoperative imaging data, genetic testing report, and pathology report available.\n\nExclusion Criteria:\n\n1. Patients negative for EGFR;\n2. Incomplete surgical resection (R1, R2);\n3. Did not receive EGFR-TKI targeted therapy after surgery;\n4. Recurrent or advanced stage patients;\n5. Incomplete preoperative or postoperative data;\n6. Patients who died within 30 days post-surgery.","80 Years",{"count":111,"type":20},1000,"OBSERVATIONAL","The main purpose of this study is to explore the value of multimodal imaging information and models in predicting the prognosis of EGFR-positive non-small cell lung cancer patients undergoing targeted therapy, providing a basis for selecting suitable populations for precise tumor treatment and corresponding therapy. We retrospectively analyzed patient case data, extracted preoperative CT images, H\\&E-stained whole-slide digital pathology images, and pre- or postoperative genetic testing reports to extract radiomic features of tumor and peritumoral regions. These features were combined with multidimensional pathological features and gene expression distribution characteristics to construct a multimodal radiopathogenomic model, offering more precise prognostic evaluation for lung cancer patients receiving targeted therapy.",[26,27,115,116],"Adenocarcinoma Lung","Postoperative Adjuvant Therapy","2025-12-16",{"date":119,"type":35},"2025-12-17",{"date":121,"type":20},"2025-12-25",{"date":123,"type":20},"2027-08",{"name":125,"class":42},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":21,"phases":136,"briefSummary":137,"conditions":138,"keywords":141,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":72},"100606988","phase-2-high-dose-firmonertinib-plus-bevacizumab-as-neoadjuvant-therapy-for-resectable-egfrm-stage-ii-iiib-nsclc-100606988","NCT07182708","High-Dose Firmonertinib Plus Bevacizumab as Neoadjuvant Therapy for Resectable EGFRm Stage II-IIIB NSCLC","High-dose Firmonertinib Combined With Bevacizumab as Neoadjuvant Therapy in Stage II-IIIB, Resectable, EGFR-mutated Non-small Cell Lung Cancer Patients: A Single-arm, Multi-center, Open-label Phase II Clinical Study","HOFIBREN","Inclusion Criteria:\n\n1. Male or female, aged ≥18 years.\n2. Histologically\u002Fcytologically confirmed primary non-small cell lung cancer within 60 days prior to the study.\n3. Stage II-IIIB disease evaluated by endobronchial ultrasound guided tranbronchial needle aspiration(EBUS-TBNA), mediastinoscopy, or Positron Emission Tomography\u002FComputed Tomography (PET\u002FCT), with lesions planned for radical resection after neoadjuvant therapy.\n4. EGFR mutation-positive confirmed by local laboratory testing of tissue or blood samples.\n5. Presence of at least one measurable lesion, with a baseline Computed Tomography (CT) scan showing the longest diameter ≥10 mm (except for lymph nodes, which must have a short axis ≥15 mm), and suitable for accurate repeated measurements.\n6. ECOG performance status score of 0-1, with no deterioration within 2 weeks prior to the first dose administration.\n7. Female patients should adopt fully effective contraceptive measures, must not be breastfeeding, and have a negative pregnancy test before the first administration of the study drug; or female patients must meet the following criteria at screening to confirm the absence of reproductive potential:\n8. Postmenopausal, defined as age greater than 50 years and amenorrhea for at least 12 months after cessation of all exogenous hormonal therapies.\n9. For women under 50 years of age, they are considered postmenopausal if they have not had a menstrual period for 12 months or more after stopping exogenous hormone therapy, and their luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are within the postmenopausal range.\n10. Documented irreversible sterilization procedures, including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, excluding tubal ligation.\n11. Male patients should be willing to use barrier contraception, i.e., condoms.\n\nExclusion Criteria:\n\n1. Presence of small cell lung cancer or mixed pathological types of NSCLC. EGFR exon 20 insertion mutation detected by genetic testing.\n2. Exposure to any other antitumor therapy prior to enrollment, including perioperative radiotherapy.\n3. The patient is in pregnancy or lactation.\n4. History of other malignant tumors, or currently combined with other malignant tumors (except for malignancies that have undergone radical surgery with no recurrence within 5 years post-operation, such as cervical carcinoma in situ, basal cell carcinoma of the skin, and papillary thyroid carcinoma, etc.).\n5. Presence of severe or uncontrolled systemic diseases requiring treatment, which the investigator deems unsuitable for trial participation, including hypertension, diabetes mellitus, chronic heart failure (New York Heart Association, NYHA Class III-IV), unstable angina, myocardial infarction within the past year, etc.\n6. Severe gastrointestinal dysfunction, diseases, or clinical conditions that may affect the intake, transport, or absorption of the study drug, such as inability to take oral medications, uncontrollable nausea and vomiting, extensive gastrointestinal resection history, etc.\n7. Any of the following laboratory tests indicate insufficient bone marrow reserve or organ reserve function.\n\n   * Absolute neutrophil count \\\u003C1.5×10\\^9\u002FL\n   * Platelet count \\\u003C100×10\\^9\u002FL\n   * Hemoglobin \\\u003C90 g\u002FL\n   * Alanine aminotransferase (ALT) \\>2.5×upper limit of normal (ULN)\n   * Aspartate aminotransferase (AST) \\>2.5×ULN\n   * Total bilirubin \\>1.5×ULN or \\>3×ULN in cases of Gilbert's syndrome (unconjugated hyperbilirubinemia)\n8. Known or suspected allergy to almonertinib mesylate, bevacizumab, or any other component of their formulations, or patients with other contraindications.\n9. If the patient cannot comply with the study procedures, restrictions, and requirements, or if the investigator deems the patient ineligible or unsuitable for participation in the study for any other reason.\n10. Patients currently or previously enrolled in any other anti-tumor clinical studies.",{"count":135,"type":20},62,[23],"This is a Phase II, single-arm, open-label, multicenter clinical study aimed at evaluating the efficacy and safety of Firmonertinib 160 mg combined with Bevacizumab as neoadjuvant therapy in patients with resectable stage II-IIIB Epidermal Growth Factor Receptor(EGFR)-mutated non-small cell lung cancer.",[139,27,140],"NSCLC (Non-small Cell Lung Cancer)","Resectable Lung Non-Small Cell Carcinoma",[142,143,144,89,145,146],"High-dose Firmonertinib","Bevacizumab","Neoadjuvant therapy","EGFR-mutated","Single-arm study","2025-09-12",{"date":149,"type":35},"2025-09-19",{"date":151,"type":20},"2025-10-01",{"date":153,"type":20},"2030-06-30",{"name":155,"class":42},"Peking University Cancer Hospital & Institute",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":21,"phases":165,"briefSummary":166,"conditions":167,"keywords":169,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":72},"100459080","csf-analysis-in-egfr-mutant-non-small-cell-lung-cancer-with-leptomeningeal-disease-100459080","NCT05257967","CSF Analysis in EGFR Mutant Non-Small Cell Lung Cancer With Leptomeningeal Disease","CSF Liquid Biopsy Based Characterization of Leptomeningeal Disease in EGFR Mutant Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Subject age is greater than or equal to 18 years at the time of signature of informed consent.\n* Histologically or cytologically confirmed metastatic EGFR mutant NSCLC.\n* Leptomeningeal disease based on brain MRI or CSF cytology.\n* ECOG 0-3.\n* Life expectancy of at least 8 weeks.\n* Adequate hematologic and end organ function for testing.\n* Ability to give informed consent for the study procedures defined in this protocol.\n\nExclusion Criteria:\n\n* Inability to undergo a lumbar puncture due to thrombocytopenia, bleeding disorders, as well as inability to cooperate or consent to procedure.\n* Subjects who are otherwise felt by the treating clinician to be unfit to proceed with this protocol.\n* MRI spine demonstrating spinal leptomeningeal disease preventing a safe lumbar puncture.",{"count":164,"type":20},10,[82],"Leptomeningeal disease is malignant seeding of the leptomeninges and presents with a variety of symptoms frequently impacting quality of life. With improvement in treatment options, rates of leptomeningeal disease are increasing and currently found in up to 9% of EGFR mutant NSCLC.\n\nSystemic therapy may be more effective if it can target the correct molecular aberration. The molecular characterization of central nervous system disease may differ from disease outside of the central nervous system. The aim of this pilot trial is to evaluate for molecular differences between cerebral spinal fluid (CSF) and blood circulating tumor DNA (ctDNA) through the use of ddPCR and BC Cancer NGS panel molecular testing.",[27,86,168],"Non Small Cell Lung Cancer",[170,171,172],"non-small cell lung cancer","EGFR","leptomeningeal disease","2025-02-08",{"date":175,"type":35},"2025-02-11",{"date":177,"type":35},"2022-07-18",{"date":179,"type":20},"2026-12-31",{"name":181,"class":42},"British Columbia Cancer Agency",{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":109,"enrollmentInfo":189,"targetDuration":4,"studyType":21,"phases":191,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":72},"100512158","phase-2-ty-9591-in-the-patients-with-egfr-mutations-in-advanced-nsclc-with-brain-metastases-100512158","NCT05948813","TY-9591 in the Patients With EGFR Mutations in Advanced NSCLC With Brain Metastases","A Phase II Study of TY-9591 Tablets in Patients With EGFR-Mutated Non-small Cell Lung Cancer With Brain Metastases","Inclusion Criteria:\n\n1. Male or female aged ≥18 years and \\\u003C80 years.\n2. Patients diagnosed with NSCLC by histology or cytology, with brain metastases.\n3. Presence of an activating EGFR-sensitive mutations (including exon 19 deletions, L858R, the above mentioned mutations alone or co-existed with other EGFR-mutated sites).\n4. No prior systemic antitumor therapy for locally advanced or metastatic NSCLC.\n5. Stable brain metastases that do not require immediate or planned local treatment for it during the study period.\n6. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.\n7. The ECOG score is 0-1, and there is no deterioration 2 weeks before the study, and the expected survival is not less than 3 months.\n8. Adequate bone marrow reserve function, and no liver, kidney and coagulation dysfunction.\n9. Male patients and female patients of reproductive age should take adequate contraceptive measures from signing informed consent to 3 months after the last study drug treatment; Women of childbearing age have negative pregnancy test results within 7 days of the first dose.\n10. Patients having recovered from all grade ≤ 1 toxicities related to previous anticancer therapies (CTCAE v 5.0) except for alopecia, platinum-therapy-related neuropathy (where ≤2 is allowed) before first dose of study treatment.\n11. Patients can understand and voluntarily sign the informed consent form.\n12. Patient able to comply with study requirements.\n\nExclusion Criteria:\n\n1. Any of the following treatment:\n\n   1. Previous treatment with EGFR inhibitor;\n   2. Previous treatment with Systematic antitumor therapy (including targeted therapy, biotherapy and immunodrug therapy, etc.)；\n   3. Previous treatment with standard chemotherapy with 28 days before the first dose of the study drug, and traditional Chinese medicine antitumor therapy within 7 days before the first dose of the study drug;\n   4. Previous whole brain radiation therapy (WBRT); Receiving radiation to more than 30% of the bone marrow or with a wide field of radiation that had to be completed within 28 days of the first dose of study treatment; Radiotherapy with a limited field of radiation within 7 days of the first dose of study treatment or palliative radiation therapy for bone metastasis;\n   5. Uncontrollable or poorly controlled pleural, abdominal and pericardial effusion;\n   6. Uncontrollable cancerous pain; Anesthetic painkillers did not reach a stable dose at the time of enrollment;\n   7. Major surgery within 28 days of the first dose of study treatment;\n   8. Patients currently receiving (or at least within 14 days prior to receiving the first dose )medications or herbal supplements known to be potent inhibitors or inducers of cytochrome P450 isoenzyme (CYP)3A4;\n   9. Patients who are receiving and need to continue receiving medications during the study that are known to prolong the QTc interval or may cause tachycardia;\n   10. Participants in other clinical trials (other than non-interventional clinical trials) within 28 days prior to the first administration of the investigational drug.\n2. Patients with primary malignant brain tumors and unstable brain metastases.\n3. Patients who have had or have a history of other malignancies within the past 5 years (except cured basal cell or squamous cell carcinoma of the skin, papillary carcinoma of the thyroid gland, carcinoma in situ of the cervix, and ductal carcinoma in situ of the breast).\n4. The patient had symptoms of spinal cord compression caused by the tumor.\n5. Clinically severe gastrointestinal dysfunction may affect the ingestion, transport or absorption of the study drugs.\n6. Cardiac function and disease are consistent with the following:\n\n   1. Corrected QT interval(QTc)\\> 470 milliseconds from 3 electrocardiograms (ECGs);\n   2. Any clinically important abnormalities in rhythm;\n   3. Any factors that increase the risk of QTc prolongation;\n   4. Left ventricular ejection fraction (LVEF) \\\u003C50%.\n7. Active human immunodeficiency virus (HIV), syphilis, hepatitis c virus (HCV) or hepatitis b virus (HBV) infection, with the exception of asymptomatic chronic hepatitis b or hepatitis c carriers.\n8. Previous history of interstitial lung disease(ILD) or drug-induced ILD or radiation pneumonitis require steroid treatment, or any evidence of clinically active ILD diseases.\n9. Previous allogeneic bone marrow transplant.\n10. Pregnant or lactating women.\n11. Any other disease or medical condition that is unstable or may affect the safety or study compliance.\n12. Hypersensitivity to TY-9591 or similar compounds or excipients.",{"count":190,"type":20},420,[23],"This study is to evaluate the efficacy and safety of TY-9591 in first-line treatment of patients with EGFR-sensitive mutation-positive non-small cell lung cancer with brain metastases compared to Osimertinib.",[89,27,194],"Brain Metastases","2024-11-18",{"date":197,"type":35},"2024-11-21",{"date":199,"type":35},"2023-08-17",{"date":201,"type":20},"2027-12-30",{"name":203,"class":204},"TYK Medicines, Inc","INDUSTRY",{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":212,"targetDuration":4,"studyType":21,"phases":213,"briefSummary":214,"conditions":215,"keywords":219,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":230,"locationsCount":72},"100544042","phase-2-osimertinib-plus-dalpiciclib-in-patients-with-egfr-mutant-cdk46-pathway-aberrant-advanced-non-small-cell-lung-cancer-following-acquired-resistance-to-third-generation-egfr-tki-a-phase-ii-trial-100544042","NCT06363734","Osimertinib Plus Dalpiciclib in Patients With EGFR-mutant, CDK4\u002F6 Pathway Aberrant, Advanced Non-small Cell Lung Cancer Following Acquired Resistance to Third-generation EGFR TKI: a Phase II Trial","Osimertinib Plus Dalpiciclib in Patients With EGFR-mutant, CDK4\u002F6 Pathway Aberrant, Advanced Non-small Cell Lung Cancer Following Acquired Resistance on Third-generation EGFR TKI： a Single-arm Phase II Trial","Inclusion Criteria:\n\n* ECOG performance status 0 to 2 with a minimum life expectancy of 12 weeks\n* Advanced non-small cell lung cancer with EGFR-sensitive mutation\n* Confirmed medical history of acquired resistance to third-generation EGFR TKI\n* Concurrent CDK4\u002F6 pathway gene dysfunctional aberrations\n* Evaluable or measurable disease as defined by RECIST, Version 1.1\n* At least one prior line of systemic chemotherapy\n* Adequate organ function\n\nExclusion Criteria:\n\n* Prior treatment with any CDK4\u002F6 inhibitor\n* Active uncontrolled\u002Funstable CNS metastases, carcinomatous meningitis, or leptomeningeal disease\n* Unresolved toxicities from any prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2 prior platinum therapy related neuropathy.\n* active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy (eg, ulcerative disease, uncontrolled nausea, vomiting, diarrhoea Grade ≥2, malabsorption syndrome or previous significant bowel resection).\n* Unstable angina pectoris, Congestive heart failure, Acute myocardial infarction, Stroke or transient ischemic attack or other uncontrolled cardiovascular disease currently or within the last 6 months, Mean resting correct QT interval (QTcF) \\>470 msec for women and \\>450 msec for men at Screening, obtained from 3 ECGs using the screening clinic ECG machine derived QTcF value.\n* Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered ≤28 days or limited field radiation for palliation ≤7 days prior to starting study drug or has not recovered from side effects of such therapy.\n* Major surgical procedures ≤28 days of beginning study drug or minor surgical procedures ≤7 days\n* Evidence of severe or uncontrolled systemic diseases, including renal transplant, active bleeding diatheses or uncontrolled hypertension\n* Active hepatitis B or C or known serious active infection e.g. tuberculosis or human immunodeficiency virus. Viral testing is not required for assessment of eligibility for the study.\n* Known serious active infection including, but not limited to, tuberculosis, or human immunodeficiency virus (positive human immunodeficiency virus 1\u002F2 antibodies).\n* Presence of other active cancers, or history of treatment for invasive cancer, within the last 5 years.\n* Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 2 weeks prior to start of study treatment.\n* Past medical history of interstitial lung disease(ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.\n* History of liver cirrhosis of any origin and clinical stage; or history of other serious liver disease or chronic disease with relevant liver involvement, with or without normal LFTs,\n* Any cytotoxic chemotherapy, investigational agents or other anticancer drugs for the treatment of advanced NSCLC from a previous treatment regimen or clinical study within 14 days prior to the first dose of study treatment with the exception of monotherapy osimertinib which may continue uninterrupted during screening.\n* Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers or inhibitors of CYP3A4 within 3 weeks of the first dose of study treatment\n* Participation in another clinical study with a cytotoxic, investigational product (IP), or other anticancer drug for the treatment of advanced NSCLC if received IP from that study within 14 days of the first dose of study treatment.\n* Known hypersensitivity to the active or inactive excipients of osimertinib or dalpiciclib or drugs with a similar chemical structure or class.",{"count":51,"type":20},[23],"This study is a prospective, single-arm, phase II trial. It is aimed to evaluate the efficacy and safety of the combination of osimertinib and dalpiciclib in patients with EGFR-mutant, CDK4\u002F6 pathway aberrant, advanced NSCLC following acquired resistance to third-generation EGFR TKI.",[216,27,217,218],"Non-small Cell Lung Cancer","Cell Cycle Deregulation","EGFR-TKI Resistant Mutation",[89,220,221,222,223],"EGFR activating mutations","Third-generation EGFR-TKI","Cell cycle signaling pathway aberrations","CDK4\u002F6 inhibitors","2024-04-14",{"date":226,"type":35},"2024-04-16",{"date":228,"type":35},"2024-04-09",{"date":179,"type":20},{"name":231,"class":42},"Tianjin Medical University Cancer Institute and Hospital",{"id":233,"slug":234,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":21,"phases":241,"briefSummary":242,"conditions":243,"keywords":246,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":258},"100520171","a-prospective-cohort-study-to-evaluate-molecular-prognostic-factors-and-resistance-mechanisms-to-osimertinib-in-adjuvant-treatment-of-completely-resected-pib-iiia-non-small-cell-lung-carcinoma-with-common-egfr-mutations-l858r-and-del19-100520171","NCT06053099","A Prospective Cohort Study to Evaluate Molecular pRognostic Factors and Resistance Mechanisms to Osimertinib in Adjuvant Treatment of Completely Resected pIB-IIIA Non-small Cell Lung Carcinoma With Common EGFR Mutations (L858R and Del19)","ROSIE","Inclusion Criteria:\n\n1. Signed Informed consent.\n2. Age ≥ 18 years.\n3. Pre-surgical disease evaluation including brain MRI\u002FCT-scan and total body PET-FDG CT-scan prior to surgery.\n4. Histologically complete anatomical resection (R0) of stage pIB-IIIA (pTNM 8th edition) NSCLC.\n5. Presence of a common EGFR mutation (Del19 or L858R).\n6. Archival tumour tissue FFPE blocks from surgery available for centrally molecular analyses.\n7. Patient eligible to receive osimertinib adjuvant therapy in a 3-year intent to treat decision; patients could receive if necessary adjuvant chemotherapy before starting osimertinib treatment.\n8. Patient who is capable, according to the investigator, of complying with the study's requirements and restrictions.\n9. Patient followed in the institution on a regular basis (every 3 to 6 months) according to standard recommendations.\n10. Estimated life expectancy \\> 3 years.\n11. Woman patients who are of childbearing potential are eligible:\n\n    * They must have a negative pregnancy test before the first dose of osimertinib.\n    * They must agree to use effective methods of contraception throughout the course of treatment and should be maintained for 2 months after the end of treatment.\n12. Male subjects who are sexually active with a woman of childbearing potential are eligible if an efficacious contraception method should be used during the treatment and during the 4 months following the last dose.\n\nExclusion Criteria:\n\n1. History of cancer, except for the following situations:\n\n   Patients with history of cancer for more than 3 years are eligible if they have been treated and considered cured. Patients with history of in situ carcinoma of the cervix or non-melanoma skin carcinoma are eligible.\n2. Neoadjuvant anti-cancer treatment (osimertinib and\u002For chemotherapy or other anti-cancer treatment).\n3. Incompletely resected NSCLC (R1 or R2).\n4. Any medical condition that would, according to the investigator's judgment, prevent the patient's participation in the clinical study.\n5. Active infection (e.g. patients receiving treatment for infection) including hepatitis C virus (HCV) and human immunodeficiency virus (HIV), or active uncontrolled hepatitis B infection except for the situations described in APPENDIX I. Screening for chronic conditions is not required.",{"count":240,"type":20},300,[82],"IFCT-2202 ROSIE study aims to incorporate a broad-panel centralized NGS testing at baseline in all patients with completely resected NSCLC with common EGFR mutation after confirmation of an optimal preoperative extension assessment and with a centralized review of the quality of the surgical excision. Furthermore, the IFCT-2202 ROSIE study also aims to study the molecular events associated with relapse on, or after osimertinib exposure, that should result in the opportunity to accede to optimal treatment in case of metastatic relapse.",[168,27,244,245],"EGFR DEL19","EGFR L858R",[247,89,248],"IFCT","Adjuvant Osimertinib","2024-03-06",{"date":251,"type":35},"2024-03-08",{"date":253,"type":35},"2024-01-22",{"date":255,"type":20},"2031-10",{"name":257,"class":42},"Intergroupe Francophone de Cancerologie Thoracique",36,{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":109,"enrollmentInfo":266,"targetDuration":4,"studyType":21,"phases":268,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":280},"100468664","phase-3-phase-iii-study-of-ty-9591-in-patients-with-locally-advanced-or-metastatic-non-small-cell-lung-cancer-fleteo-100468664","NCT05382728","Phase III Study of TY-9591 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLETEO)","A Phase III, Randomised, Double-blind, Multi-center Study to Assess the Efficacy and Safety of TY-9591 Tablets Versus Osimertinib as First Line Treatment in Patients With EGFR-sensitive Mutation, Locally Advanced or Metastatic Non Small Cell Lung Cancer.","Inclusion Criteria:\n\n1. Male or female aged ≥18 years and \\\u003C80 years.\n2. Locally advanced or metastatic NSCLC diagnosed by histology or cytology.\n3. Presence of an activating EGFR-sensitive mutations (including exon 19 deletions, L858R, the above mentioned mutations alone or co-existed with other EGFR-mutated sites).\n4. No prior systemic antitumor therapy for locally advanced or metastatic NSCLC.\n5. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.\n6. The ECOG score is 0-1, and there is no deterioration 2 weeks before the study, and the expected survival is not less than 3 months.\n7. Adequate bone marrow reserve function, and no liver, kidney and coagulation dysfunction.\n8. Male patients and female patients of reproductive age should take adequate contraceptive measures from signing informed consent to 3 months after the last study drug treatment; Women of childbearing age have negative pregnancy test results within 7 days of the first dose.\n9. Patients having recovered from all grade ≤ 1 toxicities related to previous anticancer therapies (CTCAE v 5.0) except for alopecia, platinum-therapy-related neuropathy (where ≤2 is allowed) before first dose of study treatment.\n10. Patients can understand and voluntarily sign the informed consent form.\n11. Patient able to comply with study requirements.\n\nExclusion Criteria:\n\n1. Any of the following treatment:\n\n   1. Previous treatment with EGFR inhibitor;\n   2. Previous treatment with Systematic antitumor therapy (including targeted therapy, biotherapy and immunodrug therapy, etc.)；\n   3. Previous treatment with standard chemotherapy with 28 days before the first dose of the study drug, and traditional Chinese medicine antitumor therapy within 7 days before the first dose of the study drug;\n   4. Receiving radiation to more than 30% of the bone marrow or with a wide field of radiation that had to be completed within 28 days of the first dose of study treatment; Radiotherapy with a limited field of radiation within 7 days of the first dose of study treatment or palliative radiation therapy for bone metastasis;\n   5. Uncontrollable or poorly controlled pleural and abdominal effusion;\n   6. Major surgery within 28 days of the first dose of study treatment;\n   7. Patients currently receiving (or at least within 14 days prior to receiving the first dose )medications or herbal supplements known to be potent inhibitors or inducers of cytochrome P450 isoenzyme (CYP)3A4;\n   8. Patients who are receiving and need to continue receiving medications during the study that are known to prolong the QTc interval or may cause tachycardia;\n   9. Participants in other clinical trials (other than non-interventional clinical trials) within 28 days prior to the first administration of the investigational drug.\n2. Pathologically confirmed squamous cell carcinoma or squamous cell component predominance in NSCLC.\n3. Symptomatic brain metastases or leptomeningeal metastases.\n4. Patients have spinal cord compression caused by tumor.\n5. Clinically severe gastrointestinal dysfunction may affect the ingestion, transport or absorption of the study drugs.\n6. Cardiac function and disease are consistent with the following:\n\n   1. Corrected QT interval(QTc)≥ 470 milliseconds from 3 times of electrocardiograms (ECGs);\n   2. Any clinically important abnormalities in rhythm;\n   3. Any factors that increase the risk of QTc prolongation;\n   4. Left ventricular ejection fraction (LVEF) \\\u003C50%.\n7. Active human immunodeficiency virus (HIV), syphilis, hepatitis c virus (HCV) or hepatitis b virus (HBV) infection, with the exception of asymptomatic chronic hepatitis b or hepatitis c carriers.\n8. Previous history of interstitial lung disease(ILD), drug-induced ILD or radiation pneumonitis require steroid treatment, or any evidence of clinically active ILD diseases.\n9. Previous allogeneic bone marrow transplant.\n10. Pregnant or lactating women.\n11. Any other disease or medical condition that is unstable or may affect the safety or study compliance.\n12. Hypersensitivity to investigational drug or similar compounds or excipients.",{"count":267,"type":20},680,[269],"PHASE3","To assess the efficacy and safety of TY-9591 versus Osimertinib in patients with locally advanced or Metastatic Non Small Cell Lung Cancer.",[89,27],"2024-01-28",{"date":274,"type":35},"2024-01-30",{"date":276,"type":35},"2022-06-08",{"date":278,"type":20},"2027-12",{"name":203,"class":204},2,{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":288,"targetDuration":4,"studyType":21,"phases":290,"briefSummary":291,"conditions":292,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":72},"100498302","phase-3-early-or-delayed-intervention-of-brain-radiotherapy-combined-with-almonertinib-in-egfr-mutated-nsclc-with-brain-metastases-100498302","NCT05768490","Early or Delayed Intervention of Brain Radiotherapy Combined With Almonertinib in EGFR Mutated NSCLC With Brain Metastases","A Prospective, Multicenter, Randomized, Controlled Clinical Study of Early or Delayed Intervention of Brain Radiotherapy Combined With Almonertinib in EGFR Mutated NSCLC With Brain Metastases","Inclusion Criteria:\n\n* Patients with histologically or cytologically confirmed non-small cell lung cancer;\n* Initial diagnosis of intracranial oligometastases (no treatment after brain metastases) was defined as brain parenchymal metastases confirmed by MRI, the number of intracranial parenchymal metastases was less than 5, and the lesions were 3mm away from the optic nerve and brainstem; There must be at least one measurable lesion with a diameter of 5mm or more in the brain.\n* EGFR sensitivity mutation (exon19del or exon21 L858R);\n* Anti-EGFR-targeting drugs and other TKI drugs have not been used in the past;\n* Age 18-75;\n\nInclusion criteria:\n\n* A history (past or concurrent) of malignancies in other sites, excluding curable non-melanoma skin cancer and cervical carcinoma in situ;\n* The subjects had received brain radiotherapy before enrollment;\n* Patients whose lung lesions were surgically evaluated as resectable were not included if there was no metastasis in other parts of the body;\n* Received EGFR inhibitors (including small molecule or monoclonal antibody therapy) or systematic anti-tumor therapy before treatment;\n* Prior patients with interstitial lung disease, drug-induced interstitial disease, radiation pneumonia requiring hormone therapy, or any clinically proven active interstitial lung disease with idiopathic pulmonary fibrosis found on CT scan at baseline;\n* Pregnant and lactating patients;\n* MRI contraindicated patients;\n* Patients who cannot receive oral administration, need intravenous high-energy nutrition, have undergone previous surgery that interferes with absorption, or have active digestive tract ulcers;\n* The researchers judged that brain radiotherapy could not be received because of other head and facial diseases;\n* Any unstable systemic disease (including active infection, poorly controlled hypertension, unstable angina, congestive heart failure, liver, kidney or metabolic disease).",{"count":289,"type":20},232,[269],"This is a prospective, multicenter, randomized, controlled clinical study of NSCLC patients with intracranial oligo-metastatic EGFR-sensitive mutations treated with EGFR-TKI Almonertinib , according to the implementation time of brain radiotherapy. Patients were randomly divided into two groups, experimental group (early intervention group of brain radiotherapy) : the brain radiotherapy started within 1 month of TKI treatment, the brain radiotherapy here specifically refers to stereotactic radiotherapy; Control group (brain radiotherapy late intervention group) : Brain radiotherapy was given within 3 months after brain progression during TKI treatment. The differences in OS,iPFS, PFS, iORR, safety, neurocognitive function and quality of life between the two groups were compared.",[194,293,27],"Radiotherapy","2023-03-13",{"date":296,"type":35},"2023-03-14",{"date":298,"type":20},"2023-03-15",{"date":300,"type":20},"2029-12-31",{"name":302,"class":42},"Sun Yat-sen University",{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":309,"targetDuration":4,"studyType":21,"phases":311,"briefSummary":312,"conditions":313,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":4},"100499045","phase-2-safety-and-efficacy-of-aumolertinib-combined-with-anlotinib-as-1st-line-treatment-in-advanced-lung-cancer-egfr-mutation-with-tp53-co-mutation-100499045","NCT05778149","Safety and Efficacy of Aumolertinib Combined With Anlotinib as 1st Line Treatment in Advanced Lung Cancer EGFR Mutation With TP53 Co-Mutation","Inclusion Criteria:\n\n1. Locally advanced or metastatic NSCLC EGFR sensitive mutations (19del and L858R) and TP53 co-mutation;\n2. Age 18-85 years, male or female;\n3. Have not received systematic treatment; If the subject has received adjuvant therapy after completing radical treatment for early gastric cancer and the subject has relapsed disease, ensure that the end of adjuvant therapy is more than 6 months from the first dose of the study and that various toxicities due to the adjuvant therapy have recovered;\n4. ECOG 0-1, The expected survival is more than 6 months;\n5. At least one assessable lesion (RECIST 1.1 );\n6. If the main organs function normally, they meet the following standards:\n\n   1. Absolute value of neutrophils (ANC) ≥ 1.5 × 10 \\^ 9 \u002FL;\n   2. platelet count ≥ 100 × 10 \\^ 9 \u002FL\n   3. hemoglobin ≥ 90g \u002FL;\n   4. white blood cell ≥ 3.0 × 10\\^9\\\\\u002FL；\n   5. Liver function: total bilirubin\\\u003C1.5 times the upper limit of normal value, aspartate aminotransferase (AST \u002FSGOT), alanine aminotransferase (ALT \u002FSGPT) and alkaline phosphatase (ALP) ≤ 2.5 times the upper limit of normal value; In case of liver metastasis, AST and ALT ≤ 5.0 times the upper limit of normal value; In case of liver metastasis and\u002For bone metastasis, ALP ≤ 5.0 times the upper limit of normal value.\n   6. Renal function: serum creatinine (Scr) ≤ 1.5 times the upper limit of normal value; Urine routine test: urine protein\\\u003C2 (+); If the urine protein at baseline is ≥ 2 (+), the 24-hour urine protein quantity must be ≤ 1.0g;\n   7. Coagulation function: international normalized ratio (INR) ≤ 1.5, and activated partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal value;\n\nExclusion Criteria:\n\n1. Squamous cell carcinoma (including adenosquamous carcinoma and undifferentiated carcinoma); Small cell lung cancer (including small cell and non-small cell mixed lung cancer); Patients who have received systemic therapy in the past (allow to receive adjuvant or neoadjuvant therapy in the past);\n2. Patients with symptomatic brain metastasis at the beginning of treatment (patients with brain metastasis who have received treatment in the past are eligible if asymptomatic brain metastasis lasts for at least 4 weeks when receiving stable dose of drug treatment);\n3. . Patients who participated in the intervention tumor clinical trial during the first-line treatment or within the last 30 days before the first-line treatment;\n4. History of tracheoesophageal fistula, gastrointestinal perforation or gastrointestinal fistula and intra-abdominal abscess within 6 months before treatment;\n5. Suffer from serious cardio-cerebrovascular disease;\n6. Subjects who received chest radiotherapy in the lung field within the first 4 weeks, or who have not recovered from radiotherapy-related toxicity. Subjects who received radiotherapy or did not recover from radiotherapy-related toxicity within 2 weeks before randomization for all other anatomical sites;\n7. Major surgical treatment was performed within 4 weeks before treatment or planned during the trial period (the researcher judged that there was bleeding risk or wound healing complications);\n8. . Have bleeding tendency, high bleeding risk or coagulation dysfunction, including thrombotic disease within 6 months before randomization and\u002For hemoptysis history within 3 months before randomization (single cough bleeding ≥ 2.5mL)\n9. Subjects with high suspicion of idiopathic pulmonary fibrosis, organic pneumonia, drug-related pneumonia, idiopathic pneumonia or active pneumonia on chest CT scan during screening period;\n10. Imaging examination showed that there was evidence of tumor invasion into large vessels, and the tumor had completely approached, surrounded or invaded the lumen of large vessels (such as pulmonary artery or superior vena cava);\n11. Subjects with hypertension (systolic blood pressure\\>160mmHg or diastolic blood pressure\\>100mmHg) that are still poorly controlled after treatment with two or more antihypertensive drugs in the screening period, and who have a history of hypertensive crisis or hypertensive brain disease in the past;\n12. Those with unhealed wounds, active digestive ulcer, fractures (excluding old healed fractures);\n13. Known or suspected to be allergic to aumolertinib and Anlotinib and\u002For other components of their preparations;\n14. Pregnant or lactating women;\n15. Women or male subjects of childbearing age who are unwilling to take effective contraceptive measures during the study period or within 6 months after the last administration of the study drug\n16. In addition to the above conditions, the researcher believes that there are other conditions that are not suitable for selection",{"count":310,"type":20},47,[23],"The goal of this open, single-arm, exploratory phase II clinical study is to exploratory safety and efficacy in 1st line treatment in advanced lung cancer EGFR mutation with TP53 co-mutation. 47 patients are scheduled to be enrolled. Treatment regimen is aumolertinib 110mg p.o QD and Anlotinib 12mg oral for 2 weeks, three weeks a cycle, until disease progression or intolerable adverse reactions or death.",[314,315,316,89,27],"Aumolertinib","Anlotinib","TP53","2023-03-08",{"date":319,"type":35},"2023-03-21",{"date":321,"type":20},"2023-03-31",{"date":323,"type":20},"2027-03-31",{"name":231,"class":42}]