[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"egfr-sensitive-mutation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:egfr-sensitive-mutation":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"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":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100519302","phase-3-adjuvant-befotertinib-in-stage-ib-iiib-non-small-cell-lung-cancer-with-positive-egfr-sensitive-mutations-100519302",false,"NCT06041776","Adjuvant Befotertinib in Stage IB-IIIB Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations","A Multicenter, Randomized, Controlled, Double Blind, Double Simulated, Phase III Clinical Study of Befotertinib vs Icotinib for Postoperative Adjuvant Treatment of IB-IIIB (T3N2M0) Stage Non Small Cell Lung Cancer With Positive EGFR Sensitive Mutations","Inclusion Criteria:\n\n1. Willingness to sign informed consent prior to any study specific procedures, and ability to with scheduled visits, treatment plans, laboratory tests, and other study procedures.\n2. Male or female, aged at least 18 years.\n3. Histologically confirmed primary NSCLC, and mainly non-squamous cell carcinoma (including mixed type carcinoma mainly composed of adenocarcinoma components).\n4. Absence of brain metastasis.\n5. Complete resection of histologically confirmed Stage IB, II, IIIA or IIIB(T3N2M0) according to the TNM staging system for lung cancer (AJCC\u002FUICC 8th edition), with negative margins.\n6. Confirmation by the central laboratory that the tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R).\n7. Patients who fully recover from surgery during randomization (any surgery must achieve complete postoperative wound healing) and should receive adjuvant treatment within 4-10 weeks after surgery.\n8. ECOG-PS score of 0 or 1 and did not deteriorate 2 weeks before the first administration of the investigational drug, with a minimum expected survival greater than 12 weeks.\n9. Female subjects with fertility need to have a negative serum pregnancy test during screening.\n10. Female subjects who have possibility of becoming pregnant, as well as male subjects whose partners are women of childbearing age, must use a highly effective contraceptive method (such as oral contraceptives, intrauterine devices, abstinence or barrier contraception combined with spermicides) throughout the study and continue to use contraception for 3 months after the end of treatment.\n\nExclusion Criteria:\n\n1. There are unresectable or metastatic diseases, pathological reports showing positive surgical margins under the microscope or extranodal invasion, or lesions left after surgery, or suspicious lesions determined by imaging after surgery. Subjects receiving only wedge resection.\n2. Upper lung groove cancer.\n3. Patient with complete resection of the right lung with NSCLC.\n4. Malignancies other than NSCLC within 5 years prior to first dosage, except for malignant tumors that can be cured after treatment (including but not limited to fully treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or breast ductal carcinoma in situ treated with radical surgery).\n5. Received systematic anti-tumor therapy, including chemotherapy, radiotherapy or targeted therapy (including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitors), immunotherapy, investigational therapy, etc., before being enrolled in this study.\n6. Within 3 weeks prior to the first administration of the investigational drug, the patient underwent major surgery (including primary tumor surgery, craniotomy, thoracotomy, or laparotomy, excluding vascular pathway establishment procedures).\n7. Within 14 days prior to first dose of the investigational drug, Traditional Chinese medicine with anti-tumor indications have been received.\n8. After the start of the study, any form of systemic or local anti-tumor treatment (including maintenance therapy with another drug, radiotherapy, and\u002For surgical resection) is still required.\n9. Clinically significant cardiovascular diseases, including:\n\n   1. QTcF interval \\>450 ms (men) or \\>470 ms (women), symptomatic bradycardia (\\\u003C45 beats \u002Fmin), or other significant ECG abnormalities as determined by the investigator (e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval \\>250 msec).\n   2. Echocardiography showed LVEF \\\u003C50%.\n   3. Hypertension was clinically uncontrollable (e.g., blood pressure \\>160\u002F100 mmHg; Except that isolated elevated readings that were determined by the investigators to be clinically insignificant or controllable hypertension.)\n\n   Within 6 months before the first medication, there were the following situations:\n   1. Congestive heart failure (New York Heart Association rating III or IV).\n   2. Arrhythmias or conduction abnormalities that require medication treatment. Note: Patients with drug-controlled atrial fibrillation\u002Fflutter, as well as those with pacemaker- controlled arrhythmia, can be selected.\n   3. Severe\u002Funstable angina, coronary artery\u002Fperipheral bypass grafting, or myocardial infarction (Note: Severe angina is classified as Grade III or IV by the Canadian Society of Cardiology).\n   4. Cerebrovascular accidents or transient ischemic attacks, transient myocardial ischemia.\n10. Previous history of concomitant interstitial lung disease (ILD), drug-induced ILD, radiation pneumonia requiring hormone therapy, or clinical evidence of concomitant active interstitial lung disease.\n11. Patients who have a history of thrombosis or are currently present with thrombosis or have a potential risk of thrombosis assessed by the investigator.\n12. Any clinical evidence of a serious active infection, or any serious concomitant disease that may affect the subject's acceptance of investigational drugs, such as active bleeding predisposition, active hepatitis B, hepatitis C, or tuberculosis, syphilis, or HIV antibody positive.\n13. There are serious gastrointestinal functional abnormalities in clinical practice that may affect drug intake, transportation, or absorption, such as inability to take medication orally, uncontrollable nausea or vomiting, history of extensive gastrointestinal resection, untreated recurrent diarrhea, atrophic gastritis, untreated stomach diseases requiring long-term use of proton pump inhibitors, gastrointestinal obstruction, active diverticulitis, Crohn's disease, ulcerative colitis, etc.\n14. Abnormal laboratory parameters.\n15. Known hypersensitivity to the befotertinib, icotinib or their inactive excipients.\n16. Within one week before the first administration of the investigational drug, it is currently in use or needs to be combined with CYP3A strong inhibitors or inducers during the study period.\n17. Patients who are still using warfarin within 7 days prior to initial dosing (low molecular weight heparin sodium is allowed).\n18. Participating in clinical research and receiving treatment with the study drug or research device, or participating in clinical research and receiving treatment with the study drug or research device within 4 weeks before the first administration, or planning to participate in any other clinical trial during this study period.\n19. Inoculate with a live vaccine within 180 days before the first medication.\n20. Researchers believe that it may affect protocol compliance or affect the signing of informed consent forms by participants (such as a history of mental illness or drug abuse, alcoholism or other addiction), or any other clinically significant disease or condition that is not suitable for participation in this clinical trial (such as laboratory abnormal results, clinically active diverticulitis, abdominal abscess).","ALL","18 Years",{"count":19,"type":20},570,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This multicenter, randomized, controlled, double-blind, double-simulated, Phase III study is designed to evaluate the efficacy and safety of Befotertinib compared with Icotinib as adjuvant treatment in EGFR-sensitive mutation-positive stage IB-IIIB (T3N2M0) non-small cell lung cancer after surgical resection.",[26,27,28],"Non-Small Cell Lung Cancer","EGFR Sensitive Mutation","Adjuvant Therapy","RECRUITING","2023-09-20",{"date":32,"type":33},"2023-09-22","ACTUAL",{"date":35,"type":33},"2023-03-28",{"date":37,"type":20},"2029-11-30",{"name":39,"class":40},"Betta Pharmaceuticals Co., Ltd.","INDUSTRY",3,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":4},"100519804","phase-3-a-single-center-single-arm-clinical-study-on-the-treatment-of-advanced-non-small-cell-lung-cancer-with-positive-egfr-sensitive-mutations-and-failed-egfr-tkis-with-the-combination-of-enrotinib-and-paclitaxel-monoclonal-antibody-100519804","NCT06048315","A Single Center, Single Arm Clinical Study on the Treatment of Advanced Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations and Failed EGFR TKIs With the Combination of Enrotinib and Paclitaxel Monoclonal Antibody","A Single Center, Single Arm Clinical Study on the Treatment of Advanced Non-small Cell","Inclusion Criteria:\n\n* Volunteer to participate in clinical research, aged 18-75 years old, regardless of gender, and sign a written informed consent form.\n* According to the International Association for the Study of Lung Cancer and the Joint Committee on the American Classification of Cancer, 8th edition TNM staging of lung cancer, locally advanced or metastatic (IIIB, IIIC, IV) NSCLC patients who are confirmed by histology or cytology to be inoperable and unable to undergo radical synchronous radiotherapy and chemotherapy.\n* NSCLC patients who have tested positive for EGFR gene sensitive mutations through driver gene testing and have not undergone systematic treatment after EGFR TKI treatment failure.\n* Newly treated patients who have not received systemic radiotherapy and chemotherapy in the past, or patients who have relapsed after more than 6 months of follow-up after adjuvant chemotherapy after surgery.\n* At least one evaluable lesion judged according to RECIST criteria.\n* Men or women aged 18 years ≤ 75 years old.\n* ECOG PS 0 or 1.\n* The expected survival period is ≥ 12 weeks.\n* Adequate blood function: Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL and platelet count ≥ 90 × 109\u002FL and hemoglobin ≥ 9 g\u002FdL.\n* Adequate liver function: Serum bilirubin ≤ 1.5 times the upper limit of normal value (ULN); AST and ALT ≤ 2.5 times the upper limit of normal value (ULN); Alkaline phosphatase ≤ 5 times the upper limit of normal value (ULN).\n* Adequate renal function: serum creatinine ≤ upper limit of normal (ULN) or calculated creatinine clearance rate ≥ 60 mL\u002Fmin.\n* Women of childbearing age must have negative pregnancy test results within 28 days prior to enrollment in the study (unless amenorrhea has occurred for 24 months). If the pregnancy test is more than 7 days after the first administration, a urine pregnancy test is required for validation (within 7 days before the first administration).\n* If there is a risk of conception, all patients (whether male or female) are required to use contraceptive measures with an annual failure rate of less than 1% throughout the entire treatment period until 120 days after the last study drug administration.\n\nExclusion Criteria:\n\n* Known hypersensitivity to any component contained in the formulation of arotinib or piazepril monoclonal antibody;\n* Individuals who are intolerant to the treatment of investigational drugs or are known to be allergic to any investigational drug or its excipients.\n* Pregnant or lactating women, or female patients with fertility who have not taken contraceptive measures;\n* Existing severe acute infections that have not been controlled; Those who may have purulent or chronic infections, and the wound persists without healing;\n* Individuals with previously severe heart disease, including congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina, myocardial infarction, severe heart valve disease, and refractory hypertension;\n* Those who suffer from uncontrollable neurological, mental disorders or mental disorders, have poor compliance, and are unable to cooperate and describe treatment responses; Patients with primary brain tumors or central nervous system metastases whose condition has not been controlled and who have obvious intracranial hypertension or neuropsychiatric symptoms;\n* Have coagulation dysfunction or bleeding tendency, or have a history of thrombotic or hemorrhagic diseases;\n* Those undergoing anticoagulation or thrombolysis treatment;\n* There are unhealed wounds, ulcers, or fractures;\n* Currently participating in interventional clinical research treatment, or receiving other research drugs or using research instruments within 4 weeks before the first administration;\n* Has undergone major surgical treatment (excluding surgery for biopsy purposes) within 4 weeks prior to the first study drug administration, or is expected to undergo major surgery during the study period;\n* Pulmonary interstitial fibrosis with respiratory failure;\n* Patients with chronic obstructive pulmonary disease and respiratory failure;\n* Based on chest imaging examination, sputum examination, and clinical examination, it is determined that there is active pulmonary tuberculosis (TB) infection;\n* Patients with active, known or suspected autoimmune diseases. Patients with hypothyroidism who only require hormone replacement therapy can be selected;\n* Patients who require systemic corticosteroids (with a dose equivalent to\\>10 mg prednisone\u002Fday) or other immunosuppressive drugs within the 14 days prior to enrollment. Patients who use inhaled or topical corticosteroids, as well as patients with adrenal corticosteroid replacement therapy doses equivalent to\\>10 mg prednisone\u002Fday, may participate in the study if there is no active autoimmune disease;\n* Previously received PD-1 or PD-L1 antibody treatment for any reason;\n* Suffering from other primary malignant tumors before the start of the study;\n* Other situations where the researcher believes that patients are not suitable to participate in this trial.","75 Years",{"count":51,"type":20},52,[23],"Lung cancer is the second most common malignancy and mortality rate in the world. In the United States and Europe, approximately 10% to 15% of NSCLC patients have epidermal growth factor receptor (EGFR)-sensitive mutations, with higher mutation rates of 30% to 40% in Asia, and objective response rates (ORRs) of 76% to 80% with EGFR Tyrosine Kinase Inhibitor (TKI)-targeted therapy. However, resistance mechanisms such as EGFR, MET, PIK3CA and BRAF gene alterations occur with the development of resistance to EGFR-TKI therapy; Median Progression Free Survival (mPFS) for only 2.8-3.2 months; The median overall survival (mOS) is only 7.5-10.6 months. Due to the variety of mechanisms of resistance to EGFR-TKIs and the limited efficacy of chemotherapy, it is necessary to provide salvage treatment for advanced non-small cell lung cancer that is positive for EGFR-sensitive mutations and has failed EGFR TKIs.\n\nAnlotinib is a novel multi-target tyrosine kinase inhibitor (TKI) used to inhibit tumor angiogenesis and proliferative signaling. The main targets of anlotinib include tyrosine kinase vascular endothelial growth factor receptor 1-3 (VEGFr1-3), fibroblast growth factor receptor 1-4 (Fibroblast Growth Factor Receptor 1-4), platelet-β derived growth factor receptor α and β, and stem cell factor receptor. Anlotinib is rapidly absorbed through the intestine, has high bioavailability, a half-life of 5 days, and is convenient for oral administration, which is conducive to improving patient dependence. IN MAY 2018, THE CHINA FOOD AND DRUG ADMINISTRATION APPROVED ANLOTINIB FOR MARKETING, ENTERED THE MEDICAL INSURANCE CATALOG IN OCTOBER OF THE SAME YEAR, AND WAS RECOMMENDED BY THE CHINESE SOCIETY OF CLINICAL ONCOLOGY (CSCO) FOR THE THIRD-LINE TREATMENT OF LUNG CANCER IN 2019.\n\nPenpulimab is a humanized immunoglobulin G1 monoclonal antibody (IgG1), which is a class 1 new drug jointly developed by Zhongshan Akeso Biopharmaceutical Co., Ltd. and Chia Tai Tianqing Pharmaceutical Group Co., Ltd., which can specifically bind to PD-1 molecules on the surface of T lymphocytes, thereby blocking the PD-1\u002FPD-L1 pathway that leads to tumor immune tolerance, and reactivating the anti-tumor activity of T lymphocytes to achieve the purpose of treating tumors. A number of preclinical in vitro trials have verified the effect of PEAMPLIMAB in blocking PD-1 pathway, and the results of preclinical pharmacodynamics, animal pharmacokinetics and toxicology have shown that PEAMPLIMAB has good stability, reduced host cell protein residues, and can effectively bind to antigens, and eliminate Fc-mediated effector function, with higher safety.\n\nAK105-201 is a multicenter, double-blind, randomized controlled, phase III clinical trial evaluating the efficacy and safety of pianpulimab combined with carboplatin + paclitaxel in the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer, the primary endpoint of the study was PFS, and the secondary endpoint was OS, and the results showed that the mPFS group of pianpulimab and the control group were 7.6m and 4.2m, respectively, and the HR was 0.44, reducing the risk of disease progression by 56%. In the 2022 CSCO guidelines for the diagnosis and treatment of non-small cell lung cancer, peamplimab combined with platinum-containing chemotherapy is recommended as the first-line treatment for stage IV driver-free squamous cell carcinoma Grade II. In advanced patients with EGFR TKIs resistance, pemetrexed chemotherapy has a good efficacy, with a median PFS of 2.83 months and a response rate of 22%. The AK105-203 study is a multicenter phase II clinical study led by Professors Jiao Shun and Bai Li of the Chinese PLA General Hospital of the People's Liberation Army of Anlotinib combined with péamplimab in the first-line treatment of hepatocellular carcinoma, with a median follow-up of 23 months and mPFS of 8.8 months.\n\nTherefore, based on the results of the current study on immunosuppressants and antiangiogenic drugs for the treatment of NSCLC, and the current research status in patients with advanced NSCLC who are positive for EGFR-sensitive mutations and have failed EGFR TKIs, we expect to conduct an exploratory clinical study of PD-1 antibody (péamplimab) combined with anlotinib in patients with advanced NSCLC who are positive for EGFR-sensitive mutations and have failed EGFR TKIs, with the aim of evaluating the safety of this combination, It was further investigated whether this combination could further improve the survival benefit of patients with advanced NSCLC.",[55,56,27,57,58],"Lung Cancer","TKI Resistance","Anlotinib","Pianzumab","NOT_YET_RECRUITING","2023-09-15",{"date":62,"type":33},"2023-09-21",{"date":64,"type":20},"2023-09",{"date":66,"type":20},"2026-09",{"name":68,"class":69},"Degan Lu","OTHER"]