[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"egfr-g719x\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:egfr-g719x":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"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":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100555889","phase-2-befotertinib-and-icotinib-for-nsclc-with-uncommon-egfr-mutations-100555889",false,"NCT06517953","Befotertinib and Icotinib for NSCLC With Uncommon EGFR Mutations","A Phase II Study to Assess Befotertinib and Icotinib as First-Line Treatment in Patients With Locally Advanced or Metastatic NSCLC and Uncommon EGFR Mutation(IcomBine, GASTO-10114)","IcomBine","Inclusion Criteria:\n\n1. 18 years of age or older.\n2. Pathologically confirmed adenocarcinoma of the lung, with locally advanced or metastatic disease and not amenable to curative surgery or radiotherapy (stage IIIB, IIIC or IV disease based on the eighth edition of the American Joint Committee on Cancer (AJCC) TNM classification). Patients with mixed histology are eligible if adenocarcinoma is the predominant histology.\n3. Patients must be treatment-naive for locally advanced or metastatic NSCLC systemic antitumor therapy. Prior adjuvant and neo-adjuvant therapy (except for EGFR-TKIs) is permitted if have been completed at least 6 months prior to initiation of disease progression.\n4. Tissue or blood samples are confirmed by the central laboratory or research center as rare EGFR mutations, including exon 18 G719X, S768I in exon 20 and at least one of the L861Q mutations in exon 21;\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n6. Predicted survival ≥ 3 months.\n7. At least 1 measurable tumor lesion without radiotherapy as per RECIST v1.1.\n8. Agree to use effective contraception during the study period and for at least 3 months after completion of the study treatment.\n9. Provision of informed consent prior to any study procedure.\n\nExclusion Criteria:\n\n1. Combined with other malignancy(except for clinically cured in situ cervix carcinoma, basal cell or squamous epithelial skin cancer,thyroid papillary carcinoma).\n2. Prior treatment with any EGFR-TKIs.\n3. Prior treatment with any systemic antitumor therapy for locally advanced or metastatic NSCLC.\n4. Previous traditional chinese medicine with an antitumor indication within 2 weeks before the first dose of study drug.\n5. Previous major surgery within 4 weeks before the first dose of study drug,or planing to have major surgery during study.\n6. Symptoms or signs worsened within 2 weeks before the first dose of study drug.\n7. Any unresolved toxicities from prior treatment greater than NCI CTCAE v4.03 grade 2 or higher.\n8. Spinal cord compression,symptomatic or unstable central nervous system (CNS) metastases that require the use of steroids .Patients who have a stable CNS status for at least 4 weeks before treatment will be allowed to join the study.\n9. Any clinical evidence of serious or uncontrolled systemic disease,including uncontrolled hypertension after drug treatment,active bleeding diatheses, previous or present thrombus,uncontrolled cardiovascular and cerebrovascular diseases.\n10. Active infection including hepatitis B,hepatitis C,syphilis and human immunodeficiency virus (HIV).\n11. Mean resting corrected QT interval (QTcF) ≥450 msec,obtained from 3 ECGs or any clinically important abnormalities in rhythm,conduction, morphology of resting ECG or left ventricular ejection fraction (LVEF) ≤ 50%,etc.\n12. Previous history of interstitial lung disease(ILD),drug-induced interstitial lung disease,history of radiation-induced pneumonia requiring hormone therapy,or clinical evidence of active interstitial lung disease.\n13. Any instance that affects the patient's ability to swallow drug or oral malabsorption.\n14. Occur any laboratory indicator abnormalities as follow：\n\n    * absolute neutrophil count(ANC)\\\u003C1,500\u002FmcL\n    * platelets\\\u003C100,000\u002FmcL\n    * hemoglobin\\\u003C9.0 g\u002FdL\n    * AST\u002FALT\\>2.5 times the upper limit of normal (ULN)or \\>5 times the ULN in the presence of liver metastases\n    * total bilirubin(TBIL)\\>1.5 times the ULN if no liver metastases or \\> 3 times the ULN in the presence of liver metastases\n    * serum creatinine(SCr) \\>1.5 times the ULN or creatinine clearance ≥50 mL\u002Fmin.\n15. Patients with a known allergy or delayed hypersensitivity reaction to the any component of study drugs or their excipients.\n16. Within 1 week before the first dose of study drug currently receiving or need concomitant medications known to be potent inhibitors or inducers of CYP3A, CYP2D6,CYPC8 and CYP2C19,sensitive substrate of CYP3A and CYP2C9.\n17. Within 1 week before the first dose of study drug ongoing use of warfarin.\n18. Previous therapeutic clinical trial within 4 weeks before the first dose of study drug.","ALL","18 Years",{"count":20,"type":21},23,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This research study aims to explore the combination of two targeted drugs as first-line treatment for Non-Small Cell Lung Cancer (NSCLC) with uncommon EGFR mutation.",[27,28,29,30],"Non-small Cell Lung Cancer Metastatic","EGFR G719X","EGFR L861Q","EGFR S768I","RECRUITING","2024-07-23",{"date":34,"type":35},"2024-07-25","ACTUAL",{"date":37,"type":35},"2024-07-17",{"date":39,"type":21},"2027-12-24",{"name":41,"class":42},"Sun Yat-sen University","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":43},"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":54,"type":21},35,[56],"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).",[59,60,61,62,28],"EGF-R Positive Non-Small Cell Lung Cancer","Non Small Cell Lung Cancer","EGFR Exon 19 Deletion","EGFR Exon 21 Mutation","NOT_YET_RECRUITING","2023-08-16",{"date":66,"type":35},"2023-08-21",{"date":68,"type":21},"2023-11",{"date":70,"type":21},"2028-11",{"name":72,"class":42},"Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo"]