[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lung-neoplasms-non-small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lung-neoplasms-non-small-cell-lung-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,75],{"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":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100649897","phase-3-osimertinib-with-or-without-primary-lung-tumor-resection-for-egfr-mutant-oligometastatic-non-small-cell-lung-cancer-100649897",false,"NCT07738172","Osimertinib With or Without Primary Lung Tumor Resection for EGFR-Mutant Oligometastatic Non-Small Cell Lung Cancer","A Multicenter, Randomized Controlled Phase III Clinical Trial of Primary Tumor Resection in Patients With Oligometastatic EGFR-Mutant Non-Small Cell Lung Cancer After EGFR-Targeted Therapy","PTR-2","This study consists of 2 screening phases:\n\nPart 1 screening (before osimertinib induction):\n\nPatients must meet the baseline eligibility criteria, including stage IV NSCLC, EGFR sensitizing mutation (exon 19 deletion or L858R), resectable dominant primary lung lesion, and adequate performance status and organ function.\n\nPart 2 screening (after 12 weeks of protocol-defined osimertinib induction and before randomization):\n\nPatients must complete 12 weeks of osimertinib 80 mg once daily and undergo restaging evaluation. Only patients with partial response (PR) or stable disease (SD) by RECIST 1.1, and who remain suitable for thoracic surgery, will proceed to randomization.\n\nDisease distribution must satisfy all of the following: no more than 3 involved organs, one dominant pulmonary primary lesion, the maximal diameter of the dominant primary lung lesion greater than any individual distant metastatic lesion, and a total number of distant metastatic lesions fewer or equal than 10. Pleural or peritoneal metastasis confined to a single cavity and amenable to treatment may be considered a single metastatic lesion.\n\nInclusion criteria for screening part 1\n\n1. Histologically or cytologically confirmed NSCLC.\n2. Age ≥18 years.\n3. AJCC 8th edition stage IV NSCLC.\n4. EGFR sensitizing mutation limited to exon 19 deletion or exon 21 L858R.\n5. WHO performance status 0-1. Patients with brain metastases must be conscious; patients with bone metastases must not have irreversible severe events such as severe pathological fracture.\n6. Disease distribution meeting all of the following criteria:\n\n   1. no more than 3 involved organs;\n   2. one dominant pulmonary primary lesion;\n   3. the maximal diameter of the dominant pulmonary primary lesion is greater than any single distant metastatic lesion;\n   4. total number of distant metastatic lesions fewer or equal to 10.\n7. The primary lung tumor is considered resectable by the investigator and thoracic surgeon, with surgery intended for maximal regional control.\n8. The patient is able to take oral medication and is expected to receive first-line osimertinib induction therapy.\n9. Major organ function and pulmonary reserve are adequate to tolerate the planned surgery.\n10. After 12 weeks of protocol-defined osimertinib induction, the patient must have PR or SD by RECIST 1.1 and remain eligible for randomization.\n\nInclusion Criteria for Screening Part 2\n\nSubjects may proceed to randomization only if all of the following criteria are met:\n\n1. The subject has received first-line protocol-defined osimertinib induction according to the study protocol, consisting of osimertinib once daily (QD) for 12 weeks, and has completed the pre-randomization evaluation.\n2. Restaging imaging has been completed after 12 weeks of induction therapy, and the response is assessed as partial response (PR) or stable disease (SD) according to RECIST version 1.1. In addition, the maximal diameter of the target primary lung tumor before surgery must be greater than the sum of the maximal diameters of the metastatic tumors. PET-CT before surgery or before randomization is recommended to evaluate for newly developed extrathoracic metastases, bone metastases, or mediastinal lymph node involvement. If PET-CT is not performed, the preoperative or pre-randomization imaging assessment should include contrast-enhanced CT scans of the chest and abdomen, including the liver and adrenal glands; brain imaging should be completed with contrast-enhanced CT or MRI. Pleural or peritoneal metastasis confined to a single cavity (for example, unilateral pleural disease) and amenable to treatment may be considered a single metastatic lesion.\n\nIf either of the following conditions is present on restaging imaging:\n\n1. the sum of the longest diameters (SLD) of the primary lung tumor after treatment falls within the range of less than 30% decrease and less than 20% increase (that is, -30% \\\u003C SLD change \\\u003C +20%); or\n2. the total number of distant metastatic lesions is 6 to 10, then the treatment response of the other distant target metastatic lesions must additionally meet an SLD reduction of at least 30% in order for the subject to remain eligible for randomization.\n\n   4\\. Estimated life expectancy is greater than 3 months, as judged by the investigator.\n\n   5\\. The subject remains suitable for primary lung tumor resection, as assessed by the investigator and thoracic surgeon, and has no major comorbidity that would increase surgical risk to an unacceptable level.\n\n   Exclusion criteria Subjects meeting any of the following criteria will be excluded from this study. If any of these conditions are identified only after completion of the 12-week induction phase, the subject will not proceed to randomization.\n   1. Pathology other than non-small cell lung cancer (NSCLC), or failure to meet the EGFR mutation criteria specified in this study.\n   2. EGFR mutation other than exon 19 deletion or exon 21 L858R.\n   3. Involvement of more than 3 organs by tumor lesions.\n   4. Total number of distant metastatic lesions greater than 10.\n   5. No clearly dominant primary pulmonary lesion, or the maximal diameter of the dominant primary pulmonary lesion is not greater than any individual distant metastatic lesion.\n   6. Diffuse pleural or peritoneal carcinomatosis that cannot be clearly localized and treated with local definitive therapy.\n   7. Progressive disease (PD) on imaging evaluation after 12 weeks of protocol-defined osimertinib induction.\n   8. Judged by the investigator or thoracic surgeon to be no longer suitable for thoracic surgery after induction therapy.\n   9. Any systemic therapy other than the protocol-defined osimertinib induction for the current stage IV NSCLC.\n   10. Any prior EGFR-TKI, chemotherapy, immunotherapy, or other systemic anticancer therapy for the current stage IV NSCLC, except for the protocol-defined osimertinib induction.\n   11. Pregnant, breastfeeding, or planning pregnancy during the study period.\n   12. Any condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study, or highly likely to be unable to comply with the study procedures, restrictions, or requirements.","ALL","18 Years",{"count":20,"type":21},154,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Osimertinib is a standard first-line treatment for patients with metastatic non-small cell lung cancer harboring an epidermal growth factor receptor exon 19 deletion or exon 21 L858R mutation. Although osimertinib can provide effective disease control, most patients eventually experience disease progression, and the primary lung tumor may remain an important site of treatment resistance.\n\nThis multicenter, randomized, open-label phase III trial will evaluate whether surgical removal of the primary lung tumor, in addition to continued osimertinib treatment, prolongs progression-free survival in patients with EGFR-mutated oligometastatic non-small cell lung cancer.\n\nAll participants will initially receive osimertinib 80 mg orally once daily for 12 weeks. Participants who have a partial response or stable disease according to RECIST version 1.1 and remain suitable for surgery will be randomly assigned in a 1:1 ratio to continue osimertinib alone or to undergo primary lung tumor resection followed by resumption of osimertinib. The study will also evaluate overall survival, safety, pathologic response, quality of life, patterns of disease progression, and changes in molecular biomarkers.",[27],"Lung Neoplasms, Non-Small Cell Lung Cancer",[29,30,31,32,33,34,35],"non-small cell lung cancer (NSCLC)","EGFR mutation","stage IV non-small-cell lung cancer","Osimertinib","Primary tumor resection","Oligometastatic non-small cell lung cancer","Local consolidative therapy","RECRUITING","2026-08-05",{"date":39,"type":40},"2026-08-07","ACTUAL",{"date":42,"type":21},"2026-08-01",{"date":44,"type":21},"2031-08-01",{"name":46,"class":47},"National Taiwan University Hospital","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":48},"100623589","double-dose-third-generation-egfr-tki-plus-bevacizumab-and-intrathecal-chemotherapy-for-refractory-leptomeningeal-metastatic-nsclc-a-phase-ii-study-100623589","NCT07398599","Double-Dose Third-Generation EGFR-TKI Plus Bevacizumab and Intrathecal Chemotherapy for Refractory Leptomeningeal Metastatic NSCLC: A Phase II Study","To Explore the Efficacy and Safety of Double-dose Third-generation EGFR-TKI Combined With Bevacizumab and Intrathecal Chemotherapy in Advanced NSCLC Patients With Progressive Leptomeningeal Metastasis After Prior Standard-dose Third-generation EGFR-TKI Treatment.","Inclusion Criteria\n\n* Aged ≥ 18 years at the time of signing the informed consent form, regardless of gender.\n* Histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC), staged as IV according to the 8th edition of the IASLC TNM classification (2015).\n* Presence of EGFR-sensitive mutations (exon 19 deletion or exon 21 L858R mutation).\n* Leptomeningeal metastasis (LM) progression after standard-dose first-, second-, or third-generation EGFR-TKI treatment.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n* Adequate major organ function, defined as: hemoglobin (Hb) ≥ 90 g\u002FL, absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL, platelet count (PLT) ≥ 100 × 10\\^9\u002FL, white blood cell count (WBC) ≥ 3.0 × 10\\^9\u002FL and ≤ 10.0 × 10\\^9\u002FL; total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 × ULN; creatinine clearance ≥ 50 ml\u002Fmin (for patients with liver metastases, TBIL ≤ 3.0 × ULN, ALT and AST ≤ 5.0 × ULN); activated partial thromboplastin time (APTT), international normalized ratio (INR), and prothrombin time (PT) ≤ 1.5 × ULN.\n* At least 21 days since the last radiotherapy (including whole-brain radiotherapy or local radiotherapy for brain metastases).\n* Expected survival ≥ 3 months.\n* Ability to swallow oral medications (or receive crushed medications via gastrostomy tube if unable to swallow).\n* For women: Agreement to use effective contraception (e.g., surgical sterilization or protocol contraception) within 14 days prior to enrollment, during the study, and for 3 months after the last study drug administration.\n* For men: Agreement to use effective contraception (e.g., surgical sterilization or protocol contraception) during the study and for 3 months after the last study drug administration.\n* Voluntary participation, signed informed consent, and willingness to comply with study procedures and protocols.\n\nExclusion Criteria\n\n* Major surgery within 4 weeks prior to the start of study treatment, or need for major surgery during the study.\n* Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).\n* Active bacterial\u002Ffungal\u002Fviral infections requiring intravenous antibiotic therapy.\n* Drug-induced pneumonitis or interstitial lung disease, or evidence of clinically significant active pulmonary disease.\n* Severe cardiovascular events within 6 months prior to enrollment, including cerebrovascular accident, deep vein thrombosis, or pulmonary embolism.\n* Significant cardiovascular disease, such as New York Heart Association (NYHA) class II or higher congestive heart failure, unstable angina, symptomatic arrhythmias requiring treatment, or corrected QT interval (QTcF) \\> 470 ms on consecutive electrocardiograms.\n* History of other systemic malignant tumors within the past 5 years (except for cured basal cell carcinoma, carcinoma in situ of the cervix, and ovarian cancer).\n* Use of drugs or supplements known to be strong inducers of CYP3A4.\n* Known severe allergy to any study drug or its excipients.\n* Pregnancy, lactation, or refusal of effective contraception by patients of childbearing potential.\n* History of definite neurological or psychiatric disorders (including epilepsy and dementia).\n* Other conditions deemed unsuitable for enrollment by the investigator.","99 Years",{"count":58,"type":21},30,[60],"NA","The goal of this clinical trial is to explore the efficacy and safety of double-dose third-generation EGFR-TKI combined with bevacizumab and intrathecal chemotherapy in treating advanced non-small cell lung cancer (NSCLC) patients with leptomeningeal metastasis that progressed after prior standard-dose third-generation EGFR-TKI treatment. It also aims to investigate the correlation between cerebrospinal fluid genetic characteristics and prognosis as well as subsequent efficacy prediction in patients with leptomeningeal metastasis after resistance to standard-dose third-generation EGFR-TKI. The main questions it intends to answer are:\n\nDoes this combined treatment regimen improve leptomeningeal metastasis response rate (LM-ORR) evaluated by RANO-LM? What adverse events occur in patients during the treatment with this combined regimen? Researchers will conduct a single-arm phase II prospective study to assess the effectiveness and safety of the combined treatment, without a control group comparison.\n\nParticipants will:\n\nReceive double-dose third-generation EGFR-TKI (osimertinib 160mg qd, furmonertinib 160mg qd, or almonertinib 220mg qd) + intrathecal pemetrexed (induction phase: 10mg twice a week for 4 weeks; maintenance phase: 10mg once a week for 4 weeks; consolidation phase: 30mg every 4 weeks until disease progression or intolerable toxicity) + bevacizumab 7.5mg\u002Fkg.\n\nUndergo screening assessments within 28 days before enrollment, including tumor imaging, laboratory tests, and cerebrospinal fluid examination.\n\nDuring the treatment period, conduct regular checkups and tests (such as blood routine, blood biochemistry, electrocardiogram, and imaging examinations) according to the protocol (once every 4 weeks in the first two treatment cycles, then once every 8 weeks).\n\nComplete quality of life assessment using the QLQ-C30 scale every 4 weeks and record changes in neurological symptoms and ECOG scores.",[63,27],"Leptomeningeal Metastasis",[63,65],"non-small cell lung cancer","2026-04-21",{"date":68,"type":40},"2026-04-23",{"date":70,"type":40},"2026-02-15",{"date":72,"type":21},"2027-12-30",{"name":74,"class":47},"Second Affiliated Hospital of Nanchang University",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":92,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":48},"100515395","smartphone-based-remote-symptom-monitoring-to-improve-postoperative-rehabilitation-exercise-adherence-after-video-assisted-thoracic-surgery-vats-for-lung-cancer-100515395","NCT05990946","Smartphone-based Remote Symptom Monitoring to Improve Postoperative Rehabilitation Exercise Adherence After Video-assisted Thoracic Surgery (VATS) for Lung Cancer","A Prospective, Randomized, Controlled Study to Evaluate the Impact of Remote Symptom Management Via Smartphone App Based on Electronic Patient-Reported Outcomes on Rehabilitation Exercise Adherence After Minimally Invasive Surgery in Lung Cancer Patients","Inclusion Criteria:\n\n* Age 18-75 years old\n* Undergoing minimally invasive lung cancer resection\n* Able to use smartphones and complete electronic questionnaires\n* Signed informed consent\n\nExclusion Criteria:\n\n* conversions to open thoracotomy during surgery\n* ECOG score \\> 1\n* Received neoadjuvant therapy\n* Previous lung resection surgery\n* Unable to exercise due to physical limitations\n* Continuous systemic corticosteroid use within 1 month before enrollment\n* Unresolved toxicity above Grade 1 from previous treatments\n* Significant comorbidities or medical history","75 Years",{"count":84,"type":21},736,[60],"Brief Summary: This randomized controlled trial aims to evaluate whether active remote symptom monitoring and management via a smartphone app utilizing electronic patient-reported outcomes (ePRO) can improve adherence to prescribed outpatient pulmonary rehabilitation exercises among postsurgical lung cancer patients. Eligible patients will use the app for perioperative care and be randomized to an intervention group receiving ePRO-based symptom monitoring with clinician feedback or a control group receiving ePRO without feedback. The primary outcome is rehabilitation exercise adherence rate over 1 month after discharge. If proven effective, the app-enabled remote rehabilitation model can be scaled up to enhance recovery for more postoperative patients.\n\nDue to slower-than-expected recruitment, an interim analysis was introduced through a protocol amendment. The amendment was approved by the Ethics Committee before conducting the analysis, and the plan was incorporated into the updated study record. The interim review evaluated feasibility and informed the addition of mean weekly exercise duration as a co-primary endpoint with adjusted statistical thresholds.",[27,88,89,90,91],"Postoperative Complications","Patient Reported Outcome Measures","Telerehabilitation","Exercise Therapy",[93,94,95,96,97],"Exercise Adherence","ePRO","Remote Monitoring","Postoperative Rehabilitation","Symptom Management","2025-11-27",{"date":100,"type":40},"2025-12-05",{"date":102,"type":40},"2023-06-01",{"date":104,"type":21},"2026-06-30",{"name":106,"class":47},"Zhongshan People's Hospital, Guangdong, China"]