[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"egfr-mutation-positive-advanced-non-small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:egfr-mutation-positive-advanced-non-small-cell-lung-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100575704","phase-2-orient-31-regimen-in-combination-with-sbrt-for-egfr-mutant-metastatic-nsclc-after-first-line-third-generation-egfr-tkis-100575704",false,"NCT06775743","ORIENT-31 Regimen in Combination With SBRT for EGFR-mutant Metastatic NSCLC After First-line Third-generation EGFR-TKIs","ORIENT-31 Regimen (Sintilimab Plus Bevacizumab Plus Platinum-doublet Chemotherapy) in Combination With Stereotactic Radiotherapy in EGFR-mutant Metastatic Non-small Cell Lung Cancer After First-line Third-generation EGFR Tyrosine Kinase Inhibitors (ORBIT Study)","Inclusion Criteria:\n\n* ECOG performance status score of 0-1;\n* Histologically or cytologically confirmed stage IV primary non-small cell lung cancer;\n* EGFR-sensitive mutations (L858R, 19del);\n* Resistance to first-line treatment with third-generation EGFR-TKIs;\n* At least one measurable lesion;\n* Patients with brain metastases may be included, but they must be asymptomatic neurologically and have stable lesions without the need for systemic corticosteroid treatment;\n* Men and women of reproductive age agree to contraception during the trial (surgical sterilization or oral contraceptives\u002Fintrauterine device + condoms);\n* Life expectancy ≥ 3 months;\n* Within one week before enrollment, organ function levels must meet the following criteria:\n\n  1. Bone marrow function: Hemoglobin ≥ 80 g\u002FL, white blood cell count ≥ 4.0 × 10\\^9\u002FL or neutrophil count ≥ 1.5 × 10\\^9\u002FL, platelet count ≥ 100 × 10\\^9\u002FL;\n  2. Liver: Serum total bilirubin level ≤ 1.5 times the upper limit of normal, and when serum total bilirubin level \\> 1.5 times the upper limit of normal, direct bilirubin level must be ≤ the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal;\n  3. Kidney: Serum creatinine level \\\u003C 1.5 times the upper limit of normal or creatinine clearance rate ≥ 50 ml\u002Fmin, blood urea nitrogen ≤ 200 mg\u002FL; serum albumin ≥ 30 g\u002FL;\n* Patients must have the capacity to understand and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Patients with severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granulomatosis), etc.\n* Symptomatic interstitial lung disease or active infectious\u002Fnon-infectious pneumonia.\n* Patients with risk factors for intestinal perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer, or other known risk factors for intestinal perforation.\n* History of other malignant tumors.\n* Patients with active infections, heart failure, myocardial infarction within the past 6 months, unstable angina, or unstable arrhythmias.\n* Physical examination or clinical laboratory findings that the investigator believes may interfere with the results or increase the risk of treatment complications, or other uncontrollable diseases.\n* Patients whom the investigator believes currently have lesions requiring palliative radiation therapy.\n* Mixed with small cell lung cancer components.\n* Nursing or pregnant women.\n* Congenital or acquired immunodeficiency diseases including human immunodeficiency virus (HIV), or history of organ transplantation or allogeneic stem cell transplantation.\n* Known hepatitis B virus (HBV), hepatitis C virus (HCV), or active tuberculosis infection.\n* Patients who have received cancer vaccines or received other vaccines within 4 weeks before starting treatment (Note: Seasonal influenza vaccines are often inactivated vaccines and are allowed, while intranasal preparations are usually live attenuated vaccines and are not allowed).\n* Patients who are concurrently using other immunotherapies, chemotherapy drugs, drugs from other clinical trials, or require long-term corticosteroid treatment are not eligible for enrollment.\n* Patients with psychiatric disorders, substance abuse, or social issues that affect compliance are not eligible for enrollment after physician review.\n* Patients who are allergic to or contraindicated for PD-1 monoclonal antibodies, VEGF monoclonal antibodies, or chemotherapy drugs.\n\nWithdrawl criteria:\n\n* Incorrectly enrolled participants. Those who have not yet received treatment in this study should be immediately withdrawn, and their information will not be included in the study analysis. If treatment has already begun, the investigator should assess the participant's benefit-risk profile and then decide whether to withdraw. If withdrawal is necessary, the participant should exit the study after completing treatment and follow-up and will not be included in the efficacy analysis of this study, but must be included in the safety analysis.\n* Participants who experience the following during the pre-treatment evaluation phase: new systemic diseases or worsening of existing systemic diseases that meet exclusion criteria; voluntary withdrawal, loss to follow-up, or death; poor compliance.\n* Participants whom the investigator deems necessary to exclude. The investigator must report the reason for exclusion to the principal investigator and obtain consent. Those who have not yet received treatment in this study should be immediately withdrawn, and their information will not be included in the study analysis. If treatment has already begun, the participant should exit the study after completing treatment and follow-up and will not be included in the efficacy analysis of this study, but must be included in the safety analysis.\n* Participants may request to withdraw from the clinical trial at any time during the trial process.\n* Participants who experience serious adverse events during the trial, and whom the investigator deems should stop participating in the trial.\n* Participants whose condition worsens during the trial, potentially threatening their life, or who develop other conditions that affect trial observations.\n* Participants who are lost to follow-up or die during the treatment phase.\n* Participants who use chemotherapy, traditional Chinese medicine, other immunotherapy drugs, radiotherapy sensitizers, or other agents that affect efficacy and toxicity evaluation during the trial period.\n* Participants in whom serious deviations occur during the implementation of the clinical trial protocol, making it difficult to evaluate the drug's effect; those with poor compliance.\n\nExit criteria:\n\n* Wrong enrollees who did not meet the inclusion criteria;\n* Serious protocol violations.","ALL","18 Years",{"count":19,"type":20},53,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The goal of this prospective study is to explore the safety and preliminary efficacy of stereotactic body radiotherapy (SBRT) combined with ORIENT-31 regimen (Sintilimab plus bevacizumab plus platinum-doublet chemotherapy) for advanced epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) patients who failed first-line third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) treatment. Participants will first receive the standard four-drug combination therapy: PD-1 antibody + vascular endothelial growth factor (VEGF) antibody + platinum + pemetrexed. The efficacy will be evaluated every two courses. According to the efficacy evaluation results, personalized SBRT was be administered.",[26,27],"NSCLC (Advanced Non-small Cell Lung Cancer)","EGFR Mutation Positive Advanced Non Small Cell Lung Cancer","RECRUITING","2026-03-08",{"date":31,"type":32},"2026-03-11","ACTUAL",{"date":34,"type":32},"2025-01-15",{"date":36,"type":20},"2027-06",{"name":38,"class":39},"Fudan University","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100564654","phase-1-a-study-to-assess-the-efficacy-and-safety-of-wsd0922-fu-in-patients-with-egfrm-advanced-non-small-cell-lung-cancer-100564654","NCT06631989","A Study to Assess the Efficacy and Safety of WSD0922-FU in Patients With EGFRm+ Advanced Non-small Cell Lung Cancer","A Phase I\u002FII Multicenter, Open Label, Single-arm Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of WSD0922-FU in the Treatment of Advanced Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Age 18-75 years old (including the threshold value), gender is not limited;\n* Locally advanced or metastatic NSCLC confirmed by pathology;\n* Patients who have been genetically tested to carry EGFR sensitive mutations;\n* Blood samples must be provided for testing and must be taken during or after disease progression following the last EGFR TKI inhibitor treatment;\n* Must have a minimum life expectancy of \\>= 3 months;\n* At least one measurable tumor lesion according to RECIST version 1.1; Previous radiotherapy-treated lesions cannot be used as target lesions unless imaging studies show clear progression of the lesions.\n* Physical Status (ECOG PS) score was 0-1;\n* Have full organ function;\n* Eligible patients (male and female) who are fertile must agree to use a reliable contraceptive method ;\n* Subjects are required to give informed consent to this study before the experiment and sign a written informed consent voluntarily.\n\nExclusion Criteria:\n\n* Received chemotherapy, radiotherapy, biological therapy, targeted therapy, endocrine therapy, immunotherapy, or other anti-tumor drug treatments within 4 weeks before the first administration of the study drug.\n* Have previously received more than one EGFR-TKI inhibitor;\n* Received other unlisted clinical study drugs or treatments within 4 weeks before the first administration.\n* Received major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks before the first administration, or require elective surgery during the trial period.\n* Used strong CYP3A4 inhibitors or strong CYP3A4 inducers within 7 days before the first use of the study drug.\n* Known active brain metastasis or progression evidence.\n* Other primary malignant tumors within 2 years before the first administration of the study drug.\n* Adverse reactions from previous anti-tumor treatments have not recovered to NCI-CTCAE v5.0 grade ≤1 (except for toxicities judged by the researcher to have no safety risks, such as hair loss, grade 2 peripheral neurotoxicity, and stable thyroid function after hormone replacement therapy).\n* Skin\u002Fpressure ulcers, chronic leg ulcers, known active gastric ulcers, or non-healing wounds.\n* History of severe allergies, or allergies to any active or inactive ingredients of the study drug;\n* Severe infections requiring intravenous antibiotic infusion or hospitalization at the time of screening; or uncontrollable active infections within 4 weeks before administration;\n* Known active or suspected autoimmune diseases; or known active ocular diseases (such as active wet age-related macular degeneration, diabetic retinopathy with macular edema);\n* Human immunodeficiency virus (HIV) (HIV1\u002F2 antibody) positive, syphilis spirochete antibody positive .\n* Patients with interstitial lung disease.\n* History of severe cardiovascular diseases.\n* Unable to orally swallow medication, or there is a condition that significantly affects gastrointestinal absorption as judged by the researcher;\n* Clinical intervention is required for pleural effusion, ascites (excluding subjects who do not need drainage and have been stable for more than 2 weeks after drainage).\n* Known alcohol or drug dependence.\n* Mental disorders or poor compliance;\n* Pregnant or lactating women;\n* The investigator believes that the subject has other reasons that make them unsuitable for participating in this clinical study.","75 Years",{"count":50,"type":20},100,[52,23],"PHASE1","This study is a multicenter, open label, single-arm phase I\u002FII clinical trial of WSD0922-FU for patients with locally advanced or metastatic non-small cell lung cancer whose disease has progressed with thrid-generation EGFR-TKI .",[55],"EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer",[57,58,59,60],"NSCLC","EGFR","C797S","BM","2025-08-22",{"date":63,"type":32},"2025-08-29",{"date":65,"type":32},"2024-09-04",{"date":67,"type":20},"2027-12-31",{"name":69,"class":70},"Wayshine Biopharm, Inc.","INDUSTRY",12,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":4},"100591630","phase-2-a-clinical-study-on-the-efficacy-and-safety-of-the-combination-of-limertinib-and-bevacizumab-versus-limertinib-as-first-line-treatment-for-nsclc-100591630","NCT06982924","A Clinical Study on the Efficacy and Safety of the Combination of Limertinib and Bevacizumab Versus Limertinib as First-line Treatment for NSCLC.","A Prospective, Controlled Phase II Clinical Study on the Efficacy and Safety of the Combination of Limertinib and Bevacizumab Versus Limertinib Monotherapy as First - Line Treatment for Locally Advanced or Recurrent Metastatic Non - Squamous NSCLC With EGFR Mutations and High PD-L1 Expression.","LIBRA","Inclusion Criteria:\n\n1. Signed written informed consent prior to any study - related procedures.\n2. Age ≥ 18 years.\n3. Histologically or cytologically confirmed non - squamous non - small cell lung cancer (NSCLC).\n4. Patients with locally advanced (IIIB - IIIC), metastatic, or recurrent (Stage IV) disease, as staged according to the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer (AJCC) 9th edition TNM staging for lung cancer, who are not candidates for surgical or radiation therapy.\n5. Confirmed EGFR - sensitive mutations (Ex19del, L858R) in tumor histology or cytology or in hematology.\n6. PD - L1 expression with a Combined Positive Score (CPS) ≥ 25%.\n7. ECOG performance status score of 0 - 1.\n8. No prior treatment with anti - angiogenic inhibitors or EGFR - TKIs.\n9. At least one radiologically measurable lesion, as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Lesions within a previously irradiated field may be considered measurable if progression has been confirmed.\n10. Asymptomatic or symptomatic - stable brain metastases after local treatment are allowed, provided that the following conditions are met: - Measurable disease outside the central nervous system (CNS). - No CNS symptoms or worsening of symptoms within the past 2 weeks. - No need for glucocorticoid treatment, or glucocorticoid treatment discontinued within 7 days prior to the first dose, or stable and reduced glucocorticoid dose to ≤ 10 mg\u002Fday prednisone (or equivalent) within 7 days prior to the first dose.\n11. Expected survival time \\> 3 months.\n12. Adequate organ function, with the following laboratory values met by subjects: - Absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL without the use of granulocyte - colony stimulating factor (G - CSF) within the past 14 days. - Platelets ≥ 100×10⁹\u002FL without blood transfusion within the past 14 days. - Hemoglobin \\> 9 g\u002FdL without blood transfusion or use of erythropoiesis - stimulating agents within the past 14 days. - Total bilirubin ≤ 1.5× the upper limit of normal (ULN). - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN (for subjects with liver metastases, ALT or AST ≤ 5×ULN is allowed). - Serum creatinine ≤ 1.5×ULN and creatinine clearance (calculated using the Cockcroft - Gault formula) ≥ 60 ml\u002Fmin. - Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5×ULN. - Normal thyroid function, defined as thyroid - stimulating hormone (TSH) within the normal range. Subjects may also be included if their baseline TSH is outside the normal range but their total T3 (or free T3) and free T4 are within the normal range. - Cardiac enzyme profile within the normal range (isolated laboratory abnormalities deemed not clinically significant by the investigator are also allowed).\n13. For women of childbearing age, a negative urine or serum pregnancy test must be conducted within 3 days prior to the first dose of the study drug (Day 1 of Cycle 1). If the urine pregnancy test result is inconclusive, a blood pregnancy test is required. Non - childbearing - age women are defined as those who have been post - menopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy.\n14. All subjects (regardless of gender) with the potential for conception must use contraceptive measures with a failure rate of less than 1% throughout the entire treatment period and until 120 days (or 180 days) after the last dose of the study drug.\n\nExclusion Criteria:\n\n1. Pathologically diagnosed with small cell lung cancer (SCLC), including lung cancer with a mixture of SCLC and NSCLC.\n2. Patients who have received any EGFR - TKI treatment or anti - angiogenic therapy.\n3. Received the following treatments: - Systemic anti - tumor treatment such as chemotherapy, targeted therapy, or immunotherapy (including traditional Chinese medicine for anti - tumor purposes) within 3 weeks prior to treatment. - Any investigational drug treatment within 4 weeks prior to treatment. - High - dose immunosuppressive drugs (systemic glucocorticoids exceeding 10 mg\u002Fday prednisone or equivalent doses) within 4 weeks prior to treatment. - Attenuated live vaccines within 4 weeks prior to treatment (or planned to receive attenuated live vaccines during the study period). - Major surgery (such as open - cavity, open - chest, or laparotomy) within 4 weeks prior to treatment, or unresolved surgical wounds, ulcers, or fractures.\n4. Clinically uncontrollable pleural effusion\u002Fperitoneal effusion (subjects who do not require drainage of effusion or whose effusion does not significantly increase after stopping drainage for 3 days are eligible for inclusion).\n5. Subjects who received chest radiotherapy with a dose greater than 30Gy within 6 months prior to treatment, or palliative radiotherapy with a dose of 30Gy or less within 7 days prior to treatment (palliative radiotherapy for bone lesions or intracranial lesions is allowed).\n6. Active autoimmune diseases that required systemic treatment (such as disease - modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose of study drug. Replacement therapies (such as thyroid hormone, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatment.\n7. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.\n8. Known allergy to the active ingredients or excipients of the study drugs bevacizumab and lerotinib.\n9. Not fully recovered from the toxicity and\u002For complications caused by any intervention prior to the start of treatment (i.e., ≤ grade 1 or returned to baseline, excluding fatigue or hair loss).\n10. Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1\u002F2 antibodies).\n11. Untreated active hepatitis B (defined as positive for HBsAg and HBV - DNA copies greater than the upper limit of normal in the laboratory of the research center). Note: Subjects with hepatitis B who meet the following criteria are also eligible for inclusion: - HBV viral load \\\u003C 1000 copies\u002Fml (200 IU\u002Fml) prior to the first dose of study drug, and subjects should receive anti - HBV treatment throughout the study drug treatment period to prevent viral reactivation. - For subjects with positive anti - HBc, negative HBsAg, negative anti - HBs, and negative HBV viral load, preventive anti - HBV treatment is not required, but close monitoring for viral reactivation is necessary.\n12. Subjects with active HCV infection (positive for HCV antibodies and HCV - RNA levels above the lower limit of detection).\n13. Received live vaccines within 30 days prior to the first dose of study drug (Day 1 of Cycle 1). Note: It is allowed to receive injectable inactivated virus vaccines for seasonal influenza within 30 days prior to the first dose of study drug 2: however, intranasal attenuated live influenza vaccines are not allowed. 14. Pregnant or lactating women.\n\n15\\. Any severe or uncontrolled systemic disease, such as: - Significant and symptomatic abnormalities in rhythm, conduction, or morphology on resting electrocardiogram that are difficult to control, such as complete left bundle branch block, second - degree or higher cardiac conduction block, ventricular arrhythmias, or atrial fibrillation. - Unstable angina, congestive heart failure, chronic heart failure with a New York Heart Association (NYHA) classification of ≥ Grade 2. - Myocardial infarction within 6 months prior to enrollment. - Poorly controlled blood pressure (systolic blood pressure \\> 140 mmHg, diastolic blood pressure \\> 90 mmHg). - History of non - infectious pneumonia that required glucocorticoid treatment within 1 year prior to the first dose of study drug, or current clinically active interstitial lung disease. - Active pulmonary tuberculosis. - Active or uncontrolled infections that require systemic treatment. - Clinically active diverticulitis, intra - abdominal abscess, or gastrointestinal obstruction. - Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis. - Poorly controlled diabetes (fasting blood glucose (FBG) \\> 10 mmol\u002FL). - Urine routine test indicating proteinuria ≥ ++, and confirmed 24 - hour urine protein quantification \\> 1.0 g. - Subjects with mental disorders who are unable to cooperate with treatment.\n\n16\\. Any medical history or evidence of disease, treatment, or laboratory test abnormalities that may interfere with the study results or prevent the subject from fully participating in the study, or other situations deemed by the investigator as unsuitable for inclusion. The investigator considers there are other potential risks that make the subject unsuitable for participation in this study.",{"count":81,"type":20},136,[23],"A prospective, controlled Phase II clinical study on the efficacy and safety of the combination of limertinib and bevacizumab versus limertinib monotherapy as first - line treatment for locally advanced or recurrent metastatic non - squamous NSCLC with EGFR mutations and high PD-L1 expression.",[27,85],"PD-L1 Positive","NOT_YET_RECRUITING","2025-05-13",{"date":89,"type":32},"2025-05-21",{"date":91,"type":20},"2025-06-30",{"date":93,"type":20},"2028-12-30",{"name":95,"class":39},"Shanghai Chest Hospital"]