[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"egf-r-positive-non-small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:egf-r-positive-non-small-cell-lung-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,42,70,94,120,144],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100558897","early-phase-1-csf-ctc-capture-guided-egfr-tki-and-bevacizumab-combination-therapy-in-egfr-mutant-advanced-nsclc-100558897",false,"NCT06557096","CSF CTC-Capture-Guided EGFR-TKI and Bevacizumab Combination Therapy in EGFR-Mutant Advanced NSCLC","Open-label, Single-Arm, Multicenter Clinical Study of EGFR-TKIs Sequentially Combined With Bevacizumab for the Treatment of EGFR-Mutant Advanced Non-Small Cell Lung Cancer, Based on Early Warning by CSF CTC Capture Technology","Inclusion Criteria:\n\n* 1.The subjects voluntarily joined this study and signed the informed consent form, showing good compliance and cooperation with follow-up.\n\n  2.Ages between 18 years old (inclusive) and 75 years old (inclusive). 3.ECOG score: 0-2 points. 4.Expected survival of no less than 3 months. 5.According to the RECIST 1.1 criteria, the patient has at least one extracranial target lesion.\n\n  6.Diagnosed with non-small cell lung cancer based on histology or cytology. 7.No leptomeningeal metastasis (EANO criteria). 8.The tumor tissue samples or blood samples are confirmed to have EGFR-sensitive mutations (including exon 19 deletions or L858R).\n\n  9.Have not received systemic anti-tumor treatment, and are planned to receive first-line monotherapy with osimertinib, aumolertinib, or furmonertinib.\n\n  10.The main organ functions are normal, that is, they meet the following criteria:\n  1. The standard for routine blood test should meet: HB≥90 g\u002FL; ANC≥1.5×10\\^9\u002FL; PLT≥80×10\\^9\u002FL.\n  2. The biochemical examination should meet the following standards: TBIL\\\u003C1.5×ULN; ALT and AST\\\u003C2.5×ULN; serum Cr≤1.25×ULN or endogenous creatinine clearance \\> 45 ml\u002Fmin (Cockcroft-Gault formula). 11.Women of childbearing age must have taken reliable contraceptive measures and have undergone a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result, and must be willing to use appropriate methods of contraception during the trial period and for 8 weeks after the last administration of the trial medication. For men, they must agree to use appropriate methods of contraception during the trial period and for 8 weeks after the last administration of the trial medication or have undergone surgical sterilization.\n\nExclusion Criteria:\n\n1. Subjects have received any of the following treatments:\n\n   1. Previously used any EGFR tyrosine kinase inhibitors;\n   2. Previously received any chemotherapy for lung cancer;\n   3. Previously received any radiotherapy for lung cancer (except for palliative radiotherapy for bone metastases);\n   4. Within 4 weeks before the first administration of the study medication, the subject had undergone major surgery;\n   5. Within 7 days before the first administration of the study medication, used strong inhibitors or inducers of CYP3A4.\n2. Subjects with concurrent other malignant tumors, except for basal cell carcinoma of the skin and in situ cancer.\n3. Subjects have uncontrollable malignant pleural effusion and pericardial effusion.\n4. Subjects who are allergic to contrast agents used in CT and MRI or who cannot tolerate MRI examinations.\n5. As judged by the investigator, there are any serious or poorly controlled systemic diseases, such as poorly controlled hypertension, active bleeding diathesis, or active infection.\n6. Clinically severe gastrointestinal dysfunction that may affect the intake, transport, or absorption of medication, such as the inability to take oral medication, uncontrollable nausea or vomiting, a history of extensive gastrointestinal resection, untreated recurrent diarrhea, atrophic gastritis, gastric diseases requiring long-term use of proton pump inhibitors that have not been cured, Crohn's disease, ulcerative colitis, etc.\n7. Hepatic encephalopathy, hepatorenal syndrome, or liver cirrhosis.\n8. Meet any of the following cardiac examination results:\n\n   1. The average value of the corrected QT interval (QTcF) derived from three electrocardiograms (ECG) at rest using the Fridericia formula is \\> 470 msec;\n   2. Resting ECG indicates conduction or ECG morphological abnormalities (such as complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, and PR interval \\> 250 msec, etc.);\n   3. There are any factors that increase the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication of unexplained sudden death in direct relatives under 40 years old or prolonged QT interval;\n   4. The left ventricular ejection fraction (LVEF) is \\\u003C 50%.\n9. Insufficient bone marrow reserve or organ function, meeting any of the following laboratory limits:\n\n   1. Absolute neutrophil count \\\u003C1.5×10\\^9\u002FL;\n   2. Platelet count \\\u003C100×10\\^9\u002FL;\n   3. Hemoglobin \\\u003C90 g\u002FL (\\\u003C9 g\u002FdL);\n   4. If there is no clear liver metastasis, alanine aminotransferase (ALT) \\> 3 times the upper limit of normal (ULN); if there is liver metastasis, ALT \\> 5×ULN;\n   5. If there is no clear liver metastasis, aspartate aminotransferase (AST) \\> 3×ULN; if there is liver metastasis, AST \\> 5×ULN;\n   6. If there is no clear liver metastasis, total bilirubin \\> 1.5×ULN; or with Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastasis, total bilirubin \\> 3×ULN;\n   7. Creatinine \\> 1.5×ULN and creatinine clearance \\\u003C50 mL\u002Fmin (calculated by the Cockcroft-Gault formula); creatinine clearance is only required to be confirmed if creatinine \\> 1.5×ULN;\n   8. Serum albumin (ALB) \\\u003C28 g\u002FL.\n10. Active fungal, bacterial, and\u002For viral infections requiring systemic treatment.\n11. Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period.\n12. History of interstitial lung disease, drug-induced interstitial lung disease, history of radiation pneumonitis requiring steroid treatment, or any evidence of clinically active interstitial lung disease.\n13. Subjects judged by the investigator to be likely non-compliant with the study procedures and requirements, such as those with a clear history of neurological or psychiatric disorders, or currently suffering from psychiatric disorders.\n14. Subjects judged by the investigator to have any conditions that may endanger the subject's safety or interfere with the study assessment.","ALL","18 Years","75 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","clinical trial The goal of this clinical trial is to learn whether the treatment of advanced non-small cell lung cancer with EGFR-TKIs, when combined with bevacizumab in the presence of positive circulating tumor cells in the cerebrospinal fluid, has better therapeutic efficacy. The main questions it aims to answer are:1.When EGFR-TKIs are sequentially combined with bevacizumab along with EGFR-TKIs for first-line treatment of advanced non-small cell lung cancer, how long can the participants survive? 2.What medical problems do participants have when using EGFR-TKIs sequentially combined with bevacizumab in conjunction with EGFR-TKIs.\n\nParticipants will:\n\nReceive EGFR-TKIs treatment for a duration of 3 months, and upon a positive cerebrospinal fluid tumor cell status, subsequently receive bevacizumab combined with EGFR-TKIs treatment until disease progression.\n\nVisit the clinic for check-ups and tests every two weeks, and have follow-up visits every six weeks after the treatment ends.\n\nKeep a record of their symptoms and disease progression.",[27,28,29],"Non Small Cell Lung Cancer","Circulating Tumor Cell","EGF-R Positive Non-Small Cell Lung Cancer","NOT_YET_RECRUITING","2024-08-13",{"date":33,"type":34},"2024-08-16","ACTUAL",{"date":36,"type":21},"2024-08-20",{"date":38,"type":21},"2028-07-31",{"name":40,"class":41},"Second Affiliated Hospital of Nanchang University","OTHER",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100524502","phase-1-the-efficacy-and-safety-of-lmv-12-combined-with-osimertinib-in-nsclc-100524502","NCT06109558","The Efficacy and Safety of LMV-12 Combined With Osimertinib in NSCLC","A Prospective Clinical Research of Efficacy and Safety of LMV-12(HE003) Combined With Osimertini in the Treatment of Advanced Non-small Cell Lung Cancer That Has Previously Failed From EGFR Inhibitor Therapy","PROFILE","Inclusion Criteria:\n\n* Eligible subjects selected for this study must meet all of the following criteria:\n\n  1. Sign written informed consent before implementing any trial-related procedures;\n  2. Age ≥18 years old;\n  3. No limit on the gender;\n  4. Histological or cytological confirmed advanced or metastatic non-small cell lung cancer, ineligible for radical surgery, relapse after failure of previous treatment with first-line (including first, second, and third generation)EGFR inhibitors.\n\n     Cohort A：MET amplification,(by FISH, NGS or IHC) Cohort B：RET fusion.\n  5. Laboratory tests for organ function levels must meet the following requirements:\n\n     1. Absolute neutrophil count ≥ 1.5 × 109\u002FL;\n     2. Platelet count ≥ 100 × 109\u002FL;\n     3. Hemoglobin ≥ 9 g\u002FdL;\n     4. Bilirubin ≤1.5 times ULN; e) AST and ALT ≤2.5 times ULN (total bilirubin ≤3 times the upper limit of normal and AST and ALT ≤5 times the upper limit of normal are permitted if hepatic metastases are present);\n\n     f) Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 mL\u002Fmin (according to the Cockcroft-Gault formula);\n  6. For premenopausal women of childbearing potential a pregnancy test must be performed within 7 days prior to initiation of treatment, a serum pregnancy test must be negative, and they must be non-lactating; all enrolled patients (whether male or female) should use adequate barrier contraception throughout the treatment period and for 3 months after completion of treatment.\n\nExclusion Criteria:\n\n1. Subjects treated with CYP isozyme inducers or inhibitors (see Appendix 4 for details) within 3 weeks prior to enrollment;\n2. Pregnant or lactating women;\n3. History of immunodeficiency or other acquired, congenital immunodeficiency diseases;\n4. Patients with prior bone marrow transplantation or prior solid organ transplantation;\n5. Patients with a combination of gastrointestinal perforation, gastrointestinal fistula, or non-gastrointestinal fistula;\n6. Prior history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy, or any evidence of clinically active interstitial lung disease.\n7. Hepatitis B, hepatitis C, or human immunodeficiency virus (HIV-positive). Hepatitis B is eligible for this study at \\\u003C500 IU\u002FmL (or 2500 cps\u002FmL) by quantitative HBV-DNA testing, and hepatitis C (HCV) antibody-positive patients are eligible for this study only if the polymerase chain reaction shows HCV RNA negativity;\n8. Fulfillment of any of the following cardiac criteria: (i) Bazetts' mean corrected QT interval (QTc) derived from electrocardiogram (ECG) examination at rest \\>470 msec (women) or \\>450 msec (men) (in the case of the 1st abnormality, retested once within 48 h and calculated by averaging the results of the 2 times); and (ii) a wide variety of clinically significant rhythmic, conduction, and resting ECG morphologic Abnormalities, such as complete left bundle branch block, grade III conduction block, grade II conduction block, PR interval \\>250 msec; (iii) Myocardial ischemia or myocardial infarction of grade I or higher, or congestive heart failure of grade ≥2 (New York Heart Association (NYHA) classification); (iv) Factors that may increase the risk of prolongation of QTc or the risk of arrhythmic events, such as coronary artery disease, heart failure hypokalemia, congenital long QT syndrome, family history of a first-degree relative with long QT syndrome or sudden unexplained death before the age of 40, and ongoing use of any medication known to prolong the QT interval;",{"count":51,"type":21},120,[53,54],"PHASE1","PHASE2","This is an open-label, single-arm, dose-escalation, multicenter phase I\u002FII clinical trial. The primary endpoints of this study were to evaluated the safety, tolerability, pharmacokinetic profile and preliminary efficacy of HE003 in combination with osimertinib in patients with advanced solid tumors who have failed previous standard therapy. The secondary endpoints of this study were to evaluated the efficacy HE003 in combination with osimertinib in patients with advanced solid tumors who have failed previous standard therapy.",[27,57,58,29],"RET Gene Mutation","MET Amplification","RECRUITING","2024-05-28",{"date":62,"type":34},"2024-05-30",{"date":64,"type":34},"2023-12-31",{"date":66,"type":21},"2027-07-30",{"name":68,"class":41},"Hunan Province Tumor Hospital",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":80,"conditions":81,"keywords":82,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":4},"100538189","the-feasibility-of-dynamic-liquid-biopsy-monitoring-during-neoadjuvant-treatment-for-egfr-mutated-nsclc-100538189","NCT06287593","The Feasibility of Dynamic Liquid Biopsy Monitoring During Neoadjuvant Treatment for EGFR-mutated NSCLC","Inclusion Criteria:\n\n1. Patients should voluntarily join this study and sign the informed consent form\n2. Patients diagnosed with resectable stage II-IIIB (T1-4N0-2M0, excluding T4 with invasion of vital structures and bulky or infiltrative N2) NSCLC\n3. Patients with EGFR 19del or L858R mutations.\n4. Age from 18 to 75 years old, both male and female\n5. ECOG score 0-1\n6. According to the RECIST v1.1 , patients should have at least one measurable lesion\n7. For suspicious mediastinal lymph nodes (including pathological enlargement or PET-CT indicating malignancy, etc.), further sampling is required for pathological diagnosis by EUBS, thoracoscopy, or mediastinoscopy\n8. According clinical evaluation, the lung function of patients (such as FVC, FEV1, TLC, FRC, DLco, etc.) should be sufficient for pneumonectomy\n9. The function of important organs should meet the following requirements: absolute count of neutrophils ≥ 1.5 × 109\u002FL# Platelets\n\n   ≥ 100 × 109\u002FL# Hemoglobin ≥ 90g\u002FL; Serum albumin ≥ 35g\u002FL; Thyroid hormone (TSH) ≤ 1 × ULN# Serum bilirubin ≤ 1.5 × ULN# ALT and AST ≤ 3 × ULN# International standardized ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ 1.5 × ULN# Serum creatinine ≤ 1.5 × ULN\n10. Female patients at childbearing age are required to use contraceptive measures; for male patients whose partners are women at childbearing age, effective methods of contraception should be used during the trial period\n\nExclusion Criteria:\n\n1. Patients with other primary malignancies within the past 3 years (excluding cured skin basal cell carcinoma and cervical carcinoma in situ)\n2. Patients with active hepatitis B\u002FC\n3. Patients with any active autoimmune diseases or a history of autoimmune diseases\n4. Patients who are using immunosuppressive agents or require systemic hormone therapy\n5. Patients with hypertension but without good control even through antihypertensive medication treatment ; patients with clinical symptoms or diseases related to unsatisfying cardiac function\n6. Patients with abnormal coagulation function (INR\\>2.0, PT\\>16s)\n7. Arterial\u002Fvenous thrombotic events occurred before screening within 6 months\n8. Patients with active infection\n9. Patients with congenital or acquired immune dysfunction (such as HIV infection)\n10. According to the judgment of the researchers, patients have other factors that may affect the results of the research or cause the research to be terminated",{"count":77,"type":21},300,[79],"NA","This study aimed to assess the value of dynamic ctDNA monitoring in guiding the development of personalized neoadjuvant treatment strategies for EGFR-mutated NSCLC patients.",[29],[83,84],"EGFR positive resectable NSCLC","ctDNA","2024-04-23",{"date":87,"type":34},"2024-04-24",{"date":89,"type":21},"2024-04-15",{"date":91,"type":21},"2027-12-31",{"name":93,"class":41},"Zhejiang University",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":69},"100516013","study-to-evaluate-sbrt-for-egfr-mutant-nsclc-patients-receiving-osimertinib-cultro-100516013","NCT05998993","Study to Evaluate SBRT for EGFR Mutant NSCLC Patients Receiving Osimertinib (CULTRO)","Phase II Study to Evaluate the Efficacy and Safety of SBRT as an Adjunctive Intervention for Oligoresidual Disease in EGFR Mutant NSCLC With First-Line Osimertinib Treatment","CULTRO","Inclusion Criteria:\n\n* Be older than 18 years of age.\n* Be capable of giving informed consent to participate in the study.\n* Have histological confirmation compatible with EGFR mutant non-small cell lung cancer (NSCLC) and metastatic disease (with or without histological confirmation of metastatic lesions).\n* Have confirmation of the presence of common EGFR mutations (exon 19 deletion, L858R\u002Fexon 21, or G719X) through any locally and internationally accepted standard tests.\n* Have received at least 12 weeks of Osimertinib treatment (with or without the addition of chemotherapy based on FLAURA2 study results after discussion with the investigative team).\n* Have a partial response defined by RECIST 1.1 criteria.\n* Have a maximum of 5 residual tumor lesions in up to 2 organs suitable for treatment with Stereotactic Ablative Radiotherapy (SABR).\n* Have the following imaging and clinical tests within 4 weeks before study entry:\n* Contrast-enhanced brain MRI.\n* Chest\u002Fabdomen\u002Fpelvis CT scan, with or without bone scan (at the investigator's discretion) if PET-CT was not performed.\n* 18-FDG PET-CT.\n* Spinal MRI for patients with vertebral or paravertebral metastases.\n* Electrocardiogram (EKG) and transthoracic echocardiogram.\n* Complete blood count and standard blood chemistry.\n* Negative pregnancy test for fertile women within 4 weeks prior to starting radiotherapy.\n* Liquid biopsy for assessment of tumor allelic fraction (baseline).\n* ECOG performance status 0-2.\n* All sites of oligoresidual disease must be safely treatable according to the following criteria:\n* All brain lesions must be treatable with SRS.\n* The maximum size for extracranial lesions will be up to 6 cm, with exceptions for bone metastases which may include lesions larger than 6 cm at the discretion of the investigative medical team (e.g., ribs, scapula, or pelvis).\n* Life expectancy \\>6 months.\n* Not eligible for surgical treatment.\n* Osimertinib treatment must be suspended 48 hours before the start of ablative therapy and cannot be initiated within 48 hours of receiving the last fraction. In patients receiving SBRT for central lung lesions, the suspension time for Osimertinib may be extended up to 5 days before and after ablative therapy.\n* Patients may have previously received treatments such as radiofrequency or microwave ablation for oligoresidual lesions, but imaging must demonstrate that the lesion persists and is treatable with SABR.\n* Metastatic tumor lesions that received initial treatment with radiosurgery cannot be included for SABR treatment.\n* If initial treatment was conventional radiotherapy, SABR could be considered if safe to administer. In this case, the ablative therapy must be discussed by the investigative team.\n* The eligibility and prognosis criteria will be reviewed by the multidisciplinary thoracic tumor board at CTIC Centro de Tratamiento e Investigación Sobre Cáncer Luis Carlos Sarmiento Angulo.\n\nExclusion Criteria:\n\n* Severe comorbidities contraindicating radiation therapy.\n* Bone metastases in the femur with a high risk of fracture.\n* Complete response to Osimertinib treatment (no oligoresidual disease for ablative treatment).\n* Inability to treat all oligoresidual lesions with ablative intent.\n* History of pneumonitis or functionally limiting interstitial lung disease. It may be considered limiting if the patient is unable to perform DLCO maneuvers or if adjusted DLCO is less than 35% of predicted, PaO2 at Bogotá altitude with FiO2 21% is less than or equal to 50 mmHg.\n* Clinical or radiological evidence of symptomatic spinal cord compression.\n* Dominant brain metastatic disease requiring surgical management (e.g., imminent herniation or hydrocephalus).\n* Candidate for a clinical trial with an experimental drug.\n* Inability to receive Osimertinib with minimal adherence.\n* Oligoresidual involvement in peritoneum, pleura, or bone marrow (non-measurable disease).\n* Leptomeningeal involvement (presumed based on imaging findings or confirmed by cerebrospinal fluid cytology).\n* Pregnant or breastfeeding women.","99 Years",{"count":104,"type":21},35,[79],"Phase II Study to Evaluate the Impact of SBRT (Stereotactic Body Radiation Therapy) and\u002For SRS (Stereotactic Radiosurgery) on Oligoresidual Disease in EGFR Mutation Patients Treated with Osimertinib as First-Line Systemic Intervention. All candidates must exhibit a partial response after 12 weeks of treatment with the third-generation tyrosine kinase inhibitor (alone or in combination with chemotherapy) and a maximum of five (5) residual lesions in a maximum of two (2) organs. The primary outcome will be progression-free survival (PFS), and secondary outcomes will include overall survival (OS), proportion of patients without progression at months 12 and 36, safety, and overall response rate (ORR). Additionally, an exploratory analysis will be conducted on the prognostic value of liquid biopsy (supplementary information), considering baseline presence of mutations (determined by Next Generation Sequencing tests) and reduction or negativization of allelic fraction (AF).",[29,27,108,109,110],"EGFR Exon 19 Deletion","EGFR Exon 21 Mutation","EGFR G719X","2023-08-16",{"date":113,"type":34},"2023-08-21",{"date":115,"type":21},"2023-11",{"date":117,"type":21},"2028-11",{"name":119,"class":41},"Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo",{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":127,"targetDuration":4,"studyType":22,"phases":129,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":69},"100449477","phase-2-neoadjuvant-icotinib-with-chemotherapy-for-epidermal-growth-factor-receptoregfr-mutated-resectable-lung-adenocarcinoma-100449477","NCT05132985","Neoadjuvant Icotinib With Chemotherapy for Epidermal Growth Factor Receptor(EGFR)-Mutated Resectable Lung Adenocarcinoma","Neoadjuvant Icotinib With Chemotherapy for Resectable Stage II-IIIB N2 EGFR Mutation-positive Lung Adenocarcinoma: A Phase II Study","Key Inclusion Criteria:\n\n* Written informed consent\n* Male or female, aged ≥18 years and ≤75 years\n* Histologically or cytologically documented lung adenocarcinoma with completely resectable disease (Stage II-IIIB N2, according to the 8th edition of the IASLC Staging Manual in Thoracic Oncology)\n* Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by an MDT evaluation\n* A tumor which harbors either Ex19del or L858R EGFR-TKI-sensitizing mutations, either alone\n* ECOG PS 0\u002F1 at enrollment, with no deterioration over the previous 2 weeks prior to baseline or day of first dosing\n* Adequate organ and marrow function as defined by:\n\n  * Hemoglobin: ≥9.0 g\u002FdL\n  * Absolute neutrophil count: ≥1.5 × 109\u002Fl\n  * Platelet count: ≥100 × 109\u002Fl\n  * Serum bilirubin: ≤1.5 ULN\n  * ALT and AST: ≤2.5 × ULN\n  * Creatinine clearance: ≥60 ml\u002Fmin\n* Life expectancy of 6 months prior to randomization\n\nExclusion Criteria:\n\n* Prior treatment with systemic anti-cancer treatment for NSCLC, EGFR-TKI treatment or pre-operative radiotherapy\n* EGFR-TKI-sensitizing mutations with T790M\n* Mixed small cell and non-small-cell lung cancer histology\n* T4 tumors infiltrating the aorta, esophagus and\u002For heart\n* Bulky N2 disease\n* Candidates for segmentectomies or wedge resections only\n* Medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment or any evidence of clinically active ILD\n* Severe or uncontrolled systemic diseases\u002Factive infections, history of allogeneic organ transplantation, history of primary immunodeficiency, history of another primary malignancy",{"count":128,"type":21},45,[54],"Icotinib is a first-generation inhibitor of EGFR-tyrosine kinase inhibitor in patients with non-small-cell lung cancer (NSCLC). Here we will evaluate neoadjuvant Icotinib with chemotherapy prior to surgery, in patients with resectable stage II-IIIB N2 EGFR mutation-positive NSCLC. The primary endpoint is centrally assessed major pathological response at the time of resection. Secondary endpoints include pathological complete response, objective response rate, R0 resection rate at the time of resection, disease-free survival, and overall survival. Safety and tolerability will also be assessed.",[132,29],"NSCLC",[134],"NSCLC, EGFR, Icotinib","2021-11-28",{"date":137,"type":34},"2021-12-10",{"date":139,"type":21},"2022-01-01",{"date":141,"type":21},"2028-01-01",{"name":143,"class":41},"Liaoning Cancer Hospital & Institute",{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":151,"enrollmentInfo":152,"targetDuration":4,"studyType":22,"phases":154,"briefSummary":155,"conditions":156,"keywords":160,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":69},"100441846","a-study-to-evaluate-the-efficacy-of-osimertinib-with-early-intervention-srs-treatment-compared-to-the-continuation-of-osimertinib-alone-in-patients-with-egfr-mutated-nsclc-and-asymptomatic-brain-metastases-100441846","NCT05033691","A Study to Evaluate the Efficacy of Osimertinib With Early Intervention SRS Treatment Compared to the Continuation of Osimertinib Alone, in Patients With EGFR Mutated NSCLC and Asymptomatic Brain Metastases","A Multi-center, Open-label, Randomized, Two-arm Study, to Evaluate the Efficacy of Osimertinib With Early Intervention SRS Treatment Compared to the Continuation of Osimertinib Alone, in Patients With EGFR Mutated NSCLC and Asymptomatic Brain Metastases.","Inclusion Criteria:\n\n1. Newly diagnosed metastatic NSCLC, not amenable to curative surgery or curative radiotherapy.\n2. Documented EGFR mutation (at any time since the initial diagnosis of NSCLC) known to be sensitive to Osimertinib - These include exon 19 del; L858R (exon 21); G719X (exon 18); L861G (exon 21); S768I (exon 20) and T790M (exon 20) NOTE: Mutation analysis is to be done as per local practice.\n3. An MRI showing brain metastases. At randomization, number of brain lesions is under 20. Patients with over 20 brain lesions at randomization MRI will be suitable for whole brain radiation, and will not be randomized.\n4. Brain metastases are asymptomatic or with minor symptoms (ECOG≤2) at study randomization.\n5. ECOG performance status ≤2 and a minimum life expectancy of at least 6 months\n6. Must be eligible and receive Osimertinib as their anti EGFR TKI at time of randomization.\n7. Must be eligible for SRS treatment at time of randomization.\n8. Provided written informed consent.\n9. Be male or female and at least 18 years of age on the day of signing informed consent.\n10. Female patients:\n\n    1. Willing to use adequate contraceptive measures until 6 weeks after the final dose of study treatment\n    2. Not breast feeding\n    3. Have a negative pregnancy test prior to the start of dosing if of childbearing potential or have evidence of non-childbearing potential by fulfilling one of the following criteria at screening:\n    4. Post-menopausal, defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments ii. Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with Luteinizing Hormone (LH) and Follicle-Stimulating Hormone (FSH) levels in the post-menopausal range for the institution iii. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation\n11. Male patients who are willing to use barrier contraception (i.e. condoms) until 4 months after the final dose of study treatment.\n\nExclusion Criteria:\n\n* a. Prior treatment with:\n\n  1. Anti EGFR TKI treatment.\n  2. Checkpoint inhibitors immunotherapy for metastatic NSCLC.\n  3. Whole brain radiation (WBRT) and\u002For Stereotactic Radiosurgery (SRS).\n  4. Medications or herbal supplements known to be potent inducers of CYP3A4 and are unable to stop use within the recommended wash out period prior to receiving the first dose of Osimertinib.\n  5. An investigational drug within five half-lives of the compound.\n  6. Any other cytotoxic chemotherapy, investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of entry to the study.\n\n     b. Systemic progression under Osimertinib treatment between screen and randomization systemic scan, per RECIST1.1.\n\n     c. Spinal cord compression unless asymptomatic and stable. d. Leptomeningeal disease. e. Moderate or severe symptomatic brain metastases defined as per Radiation Therapy Oncology Group acute morbidity grade 3 to 4.\n\n     NOTE: Grade 3 refers to neurological findings requiring hospitalization for initial management. Grade 4 refers to serious neurological impairment including paralysis, coma or seizures more than three times per week despite medication and requires hospitalization.\n\n     f. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.\n\n     g. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of Osimertinib.\n\n     h. Involvement in the planning and conduct of the study i. Judgement by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.","120 Years",{"count":153,"type":21},162,[79],"This study involves patients with EGFR-mutated NSCLC and asymptomatic brain metastases. This is an open-label, randomized study, comparing the continuation of Osimertinib treatment alone to Osimertinib treatment combined with early intervention stereotactic radiosurgery (SRS). The current first line of care for EGFR-mutated NSCLC is administration of Osimertinib, a small molecule that penetrates the blood brain barrier (BBB) well and controls majority, but not all, of the brain metastases. We hypothesize that relatively early intervention with SRS to brain metastases that are still visualized by MRI 2 months-post initiation of Osimertinib treatment, LUNG- will improve long term brain control, cognitive abilities and potentially overall survival. Patients with EGFR-mutated NSCLC and asymptomatic brain metastases will be treated with Osimertinib for 2 months. Brain MRI scans will be collected pre-Osimertinib and 2 months after treatment start. Patients with asymptomatic brain metastases present after 2 months of Osimertinib will be randomized into one of two study arms. Arm A patients will be treated with SRS while continuing Osimertinib, while arm B patients will continue with Osimertinib alone. Patients will be assessed based on brain and whole body progression by RECIST. Patients will also be assessed for CNS-PFS and body-PFS, cognitive function, Quality of life and overall survival status via routine follow-up tests.",[132,157,29,158,159],"EGFR Gene Mutation","Non-small Cell Lung Cancer","Brain Metastases",[161,162,157,29,163,159,164,165,166,167],"nsclc","non-small cell lung cancer","EGFR","osimertinib","tagrisso","SRS","stereotactic radiosurgery","2021-08-30",{"date":170,"type":34},"2021-09-05",{"date":172,"type":34},"2021-03-09",{"date":174,"type":21},"2026-12-31",{"name":176,"class":41},"Hadassah Medical Organization"]