[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"egfr-exon-19-deletion-mutation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:egfr-exon-19-deletion-mutation":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,88],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100647348","phase-2-befotertinib-plus-chemotherapy-with-an-mrd-guided-adaptive-strategy-for-treatment-escalation-and-response-optimization-in-egfr-mutated-nsclc-patients-100647348",false,"NCT07709585","Befotertinib Plus Chemotherapy With an MRD-guided Adaptive Strategy for Treatment Escalation and Response Optimization in EGFR-mutated NSCLC Patients","BE-MASTER","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed stage IIIB-IV non-small cell lung cancer (NSCLC).\n2. Age ≥18 years, any gender.\n3. Confirmed EGFR exon 19 deletion or exon 21 (L858R) substitution mutation by central laboratory or site-validated testing assay.\n4. No prior systemic anti-tumor therapy.\n5. ECOG performance status 0-2.\n6. Expected survival ≥12 weeks.\n7. Able to swallow oral study medication.\n8. At least one measurable lesion per RECIST 1.1 criteria.\n9. Adequate organ function as defined below:\n\n   1. Absolute neutrophil count ≥1.5 × 10\\^9\u002FL;\n   2. Platelet count ≥100 × 10\\^9\u002FL;\n   3. Hemoglobin ≥9 g\u002FdL (transfusion allowed);\n   4. Total bilirubin ≤1.5 × ULN;\n   5. ALT\u002FAST ≤2.5 × ULN (≤5 × ULN if liver metastasis);\n   6. Serum creatinine ≤1.5 × ULN, or creatinine clearance ≥45 mL\u002Fmin by Cockcroft-Gault formula if creatinine \\>1.5 × ULN.\n10. Fertile men and women agree to effective contraception during study treatment and for specified time after last dose.\n\nExclusion Criteria:\n\n1. Receiving other systemic anti-tumor therapy, or plan to combine other systemic anti-cancer agents during study.\n2. Participated in another investigational drug trial within 4 weeks prior to first study drug; major surgery within 4 weeks; unhealed wound, active ulcer or fracture; radiotherapy within 2 weeks without recovery.\n3. Severe cardiovascular disease: QTcF ≥450 ms or clinically significant ECG abnormality; uncontrolled hypertension (SBP\\>160 mmHg or DBP\\>100 mmHg); congestive heart failure, cardiomyopathy, arrhythmia requiring intervention, unstable angina, myocardial infarction, stroke or TIA within 6 months prior to treatment.\n4. Uncontrolled active infection including active HBV, HCV, HIV, active syphilis infection judged by investigator. Stable infection without safety risk is permitted.\n5. History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroids, or active interstitial lung disease.\n6. Active hemorrhage, clinically significant hemoptysis, high thromboembolic risk or prior severe thromboembolic events unsuitable for study treatment.\n7. Renal dysfunction with creatinine clearance \\\u003C45 mL\u002Fmin; prior intolerable toxicity to pemetrexed; severe hypersensitivity to pemetrexed or its excipients.\n8. Positive serum pregnancy test within 7 days before treatment, pregnant or breastfeeding women; fertile subjects refusing contraception during study and 3 months after last dose.\n9. Known severe hypersensitivity to befotertinib, cisplatin, carboplatin or their excipients.\n10. Any other medical, metabolic, physical or lab abnormality that may compromise subject safety or interfere with study results per investigator judgment.","ALL","18 Years",{"count":19,"type":20},124,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a multicenter, phase II exploratory clinical trial in untreated patients with EGFR-mutant non-small cell lung cancer (stages IIIB-IV) .All participants will receive oral befotertinib monotherapy for 3 weeks first, then serial minimal residual disease (MRD\u002FMRD) testing is performed to adjust subsequent treatment. Patients with positive MRD will receive 4 cycles of pemetrexed plus platinum chemotherapy; patients with negative MRD will continue single-agent befotertinib. After induction, maintenance therapy will be given according to follow-up MRD results. The primary goal is to evaluate progression-free survival guided by dynamic MRD monitoring, and secondary endpoints include objective response rate, disease control rate, safety and MRD clearance rate.",[26,27,28,29],"Advanced Non-small Cell Lung Cancer (NSCLC)","EGFR Exon 19 Deletion Mutation","EGFR Exon 21 Mutation","EGFR Exon 21 L858R Mutation",[31,32,33,34,35,36],"EGFR sensitive mutation","Minimal Residual Disease","MRD dynamic monitoring","Befotinib","Advanced Non-small Cell Lung Cancer","Targeted therapy plus chemotherapy","NOT_YET_RECRUITING","2026-07-12",{"date":40,"type":41},"2026-07-16","ACTUAL",{"date":43,"type":20},"2026-07-05",{"date":45,"type":20},"2030-07-31",{"name":47,"class":48},"Guangzhou University of Traditional Chinese Medicine","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":70,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":87},"100636247","observational-multicenter-study-in-patients-receiving-chemotherapy-and-amivantamab-for-metastatic-non-small-cell-lung-cancer-100636247","NCT07563205","Observational Multicenter Study in Patients Receiving Chemotherapy and Amivantamab for Metastatic Non-small Cell Lung Cancer","Observational Multicenter Study in Patients Receiving Chemotherapy and Amivantamab for Metastatic Non-small Cell Lung Cancer as Part of an Early Access Program","OMAE","Inclusion Criteria:\n\n* Patient over 18 years old\n* Cohort A: Patient with metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion treated with amivantamab-platimum based chemotherapy via an early access program in first line setting.\n* Cohort B: Patient with metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 19 or 21 treated with amivantamab-platimum based chemotherapy post osimertinib (with or without chemotherapy) via an early access program.\n* Patient covered by the French National Health Insurance system or by an approved third-party payer\n* Patient who does not object to the collection of their personal data for research purposes (an information sheet will be provided to all living participants; for deceased participants, documented non-opposition in the medical record is not required)\n\nExclusion Criteria:\n\n* Patient placed under legal guardianship or subject to a protective legal measure\n* Patient who explicitly refuses the collection or use of their personal data for research purposes\n* Patient not enrolled, managed, or followed at the investigating site by a qualified site investigator",{"count":59,"type":20},100,"OBSERVATIONAL","The purpose of this observational study is to understand how well a treatment combining chemotherapy and amivantamab works in real life, and how safe it is, in adults with metastatic non-small cell lung cancer (NSCLC) who have certain EGFR gene mutations.\n\nThe study includes two groups of people:\n\n* Group A: people with an EGFR exon 20 insertion who receive amivantamab together with platinum-based chemotherapy as their first treatment, through an early access program.\n* Group B: people with an EGFR exon 19 or exon 21 mutation who receive amivantamab with platinum-based chemotherapy after having been treated with osimertinib (with or without chemotherapy), also through an early access program.\n\nThe main question the study wants to answer is:\n\nHow long can the combination of amivantamab and chemotherapy keep the cancer from coming back or getting worse in these two groups of people?\n\nPeople already receiving amivantamab and chemotherapy for NSCLC through an early access program may be included. They will continue to be followed by their usual oncologist as part of their normal medical care. The study will simply collect their medical information from March 21, 2024 to October 21, 2025.\n\nNo extra tests or procedures are required. This is an observational study, carried out by the GFPC and partner centers in France.",[63,64,65,66,67,68,69,27,28],"Non-Small Cell Lung Cancer","Non Small Cell Lung Cancer Metastatic","Non Small Cell Lung Cancer NSCLC","Non Small Cell Lung Carcinoma","NSCLC","EGFR","EGFR Exon 20 Insertion Mutation",[71,72,73,74,75,76,67],"Lung Cancer","Non Small Cell lung cancer","Metastatic lung cancer","EGFR Exon 20","EGFR Exon 19","EGFR Exon 21","RECRUITING","2026-04-24",{"date":80,"type":41},"2026-05-01",{"date":82,"type":41},"2025-11-19",{"date":84,"type":20},"2027-11-19",{"name":86,"class":48},"GFPC Investigation",16,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":95,"sex":96,"minAge":17,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":49},"100566767","utilizing-long-read-sequencing-to-investigate-the-egfr-landscape-of-egfr-positive-lung-cancer-patients-100566767","NCT06659458","Utilizing Long-read Sequencing to Investigate the EGFR Landscape of EGFR Positive Lung Cancer Patients","EGFR Lung Canc","Inclusion Criteria:\n\n* 18-100 years old\n* Biologically born female\n* Diagnosed with EGFR positive lung cancer (Arm 1-Cancer group)\n* No cancer diagnosis (Arm 2-health control)\n\nExclusion Criteria:\n\n* less than 18 years of age\n* Biologically born male\n* Incarcerated at the time of participation",true,"FEMALE","100 Years",{"count":99,"type":20},20,"EGFR gene mutations are some of the most commonly occurring mutations in non-small cell lung cancer. Investigators have developed a DNA instability model that estimates a risk score to assess the likelihood of an individual acquiring a cancer-linked mutation. The aim of this study is to collect blood from both those diagnosed with EGFR positive lung cancer and healthy individuals, evaluate their gene sequence surrounding the EGFR landscape and use the cancer positive and healthy sequences to validate the risk assessment model, which may one day be used to provide insight on susceptibility of getting EGFR positive lung cancer or potentially other cancer types.",[102,27],"Lung Cancer - Non Small Cell",[104,105],"Lung cancer","EGFR gene","2025-03-17",{"date":108,"type":41},"2025-03-20",{"date":110,"type":41},"2025-01-01",{"date":112,"type":20},"2025-12-31",{"name":114,"class":48},"Our Lady of the Lake Hospital"]