[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"egfr-exon-21-mutation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:egfr-exon-21-mutation":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,54,81],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":34,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100636247","observational-multicenter-study-in-patients-receiving-chemotherapy-and-amivantamab-for-metastatic-non-small-cell-lung-cancer-100636247",false,"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","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","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.",[25,26,27,28,29,30,31,32,33],"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","EGFR Exon 19 Deletion Mutation","EGFR Exon 21 Mutation",[35,36,37,38,39,40,29],"Lung Cancer","Non Small Cell lung cancer","Metastatic lung cancer","EGFR Exon 20","EGFR Exon 19","EGFR Exon 21","RECRUITING","2026-04-24",{"date":44,"type":45},"2026-05-01","ACTUAL",{"date":47,"type":45},"2025-11-19",{"date":49,"type":21},"2027-11-19",{"name":51,"class":52},"GFPC Investigation","OTHER",16,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100527042","phase-2-a-prospective-study-of-pembrolizumab-combining-chemotherapy-in-advanced-nsclc-patients-with-egfr-exon-21-point-mutation-100527042","NCT06142617","A Prospective Study of Pembrolizumab Combining Chemotherapy in Advanced NSCLC Patients With EGFR Exon 21 Point Mutation.","A Phase II Study of Pembrolizumab Plus Platinum and Pemetrexed as First Line Therapy in Advanced Non-squamous Non-small Cell Lung Cancer Patients With EGFR Exon 21 Point Mutation and Programmed Cell Death Ligand 1 Expression","Inclusion Criteria:\n\n1. Male or female, ≥18 years old\n2. Primary non-squamous non-small cell lung cancer(NSCLC) with stage IV (AJCC stage,8th Edition) confirmed by cytology or histology\n3. Patients who have not used any anti-tumor therapy drugs such as targeted drugs, chemotherapy or immunotherapy and patients after surgery are acceptable\n4. EGFR exon 21 point mutation confirmed by gene test of tissue or blood and PD-L1 (22C3) TPS≥1% confirmed by immunohistochemical method\n5. At least one evaluable focus judged according to RECIST 1.1 standard\n6. Eastern Cooperative Oncology Group performance score (PS) 0 or 1\n7. Adequate blood function: absolute neutrophil count (ANC) ≥ 2 × 109 \u002F L, platelet count ≥ 100 × 109 \u002F L and hemoglobin 110 ≥ 9 g \u002F dl. Adequate renal function: serum creatinine ≤ upper limit of normal value. Adequate liver function: total bilirubin ≤ upper limit of normal value(ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ upper limit of normal value (ULN); alkaline phosphatase ≤ upper limit of normal value (ULN)\n8. Life expectancy is not less than 6 months\n9. Male participants: Male participants must take effective contraception and do not donate sperm during the study and 180 days at least after the last dose\n10. Female participants can not be pregnant, breastfeeding, and meet at least one of the following conditions:\n\n    1. non-fertile women or\n    2. agree to use effective contraception during treatment and 180 days at least after the last dose\n    3. Fertile women must perform a serum or urine pregnancy test within 72 hours before the first dose and the results must be negative (minimum sensitivity 25 IU\u002FL or human chorionic gonadotropin (HCG) equivalent unit)\n11. Sign the informed consent form (the informed consent form needs to be approved by the independent ethics committee, and the informed consent of the patient should be obtained before starting any substantive trial procedure)\n\nExclusion Criteria:\n\n1. patients who have active autoimmune disease which needs systemic treatment like disease relievers, corticosteroids, or immunosuppressants) in the last 2 years e. Alternative therapies ( such as thyroxine, insulin, and physiologic corticosteroid replacement therapy of adrenal or pituitary function insufficiency) are permitted)\n2. History of pneumonia (non-infectious)\u002Finterstitial lung disease which require s steroid treatment or a current pneumonia\u002Finterstitial lung disease\n3. Previously diagnosed immunodeficiency diseases, such as immunoglobulin deficiency, aplastic anemia\n4. Known history of human immunodeficiency virus (HIV) infection\n5. Patients who have hepatitis B (defined as hepatitis B virus (HBV) DNA \\> 1000 copy number) and hepatitis C virus (HCV) (defined as HCV RNA (+) infection\n6. Known history of active tuberculosis infection\n7. Patients who received live or attenuated vaccine within 30 days prior to the first study intervention and inactivated vaccines are allowed.\n8. Patients who have other known malignancies within the past 1 year and needs treatment. Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that has undergone potentially curative treatment, and bladder carcinoma in situ are not included.\n9. Patients who have symptomatic central nervous system metastases and\u002For meningitis\n10. History of hypersensitivity ( ≥ Level 3) to pembrolizumab\u002Fpemetrexed\u002Fplatinum\u002Fosimertinib and\u002For any of its excipients\n11. Active infection that requires systemic treatment\n12. Any medical condition that the investigator believes might do harm to the patient or not in the best interest of the patients such as poorly controlled diabetes, infection requiring treatment by injection, liver failure, mental illness or any disease, treatment, laboratory abnormality that might confuse the results or interfere with the participation of patients throughout the study.\n13. Patients with mental illness or substance abuse which are confirmed to interfere with compliance with test requirements\n14. Planed or currently pregnant or lactation during the study (from beginning of the screening visit to 180 days after the last dose of the experimental drug)\n15. Patients who have undergone allogeneic tissue\u002Fsolid organ transplantation\n16. Patients who could not accept regular follow-up\n17. Patients who are participating in or have used other investigational drugs or investigational equipment",{"count":62,"type":21},37,"INTERVENTIONAL",[65],"PHASE2","A phase II, single-arm, open-label study evaluating efficacy, safety and feasibility of combined chemotherapy and pembrolizumab as first line therapy and Osimertinib as second line therapy in advanced non squamous NSCLC adult patients with epidermal growth factor receptor (EGFR) exon 21 point mutation and programmed cell death receptor ligand 1 (PD-L1) positive.",[68,69,33],"Non Small Cell Lung Cancer","Immune Checkpoint Inhibitor","NOT_YET_RECRUITING","2023-11-16",{"date":73,"type":45},"2023-11-21",{"date":75,"type":21},"2023-12-01",{"date":77,"type":21},"2028-06-30",{"name":79,"class":52},"Peking Union Medical College Hospital",1,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":63,"phases":92,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":80},"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":91,"type":21},35,[93],"NA","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).",[96,68,97,33,98],"EGF-R Positive Non-Small Cell Lung Cancer","EGFR Exon 19 Deletion","EGFR G719X","2023-08-16",{"date":101,"type":45},"2023-08-21",{"date":103,"type":21},"2023-11",{"date":105,"type":21},"2028-11",{"name":107,"class":52},"Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo"]