[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"malignant-pleural-effusions-mpe--pleurodesis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:malignant-pleural-effusions-mpe--pleurodesis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100630048","phase-2-furmonertinib-plus-radiotherapy-for-egfr-nsclc-with-pleural-effusion-100630048",false,"NCT07482605","Furmonertinib Plus Radiotherapy for EGFR+ NSCLC With Pleural Effusion","A Prospective, Multicenter Study on the Safety and Efficacy of Furmonertinib Combined With Local Chest Radiotherapy in EGFR+ Non-small Cell Lung Adenocarcinoma Patients With Malignant Pleural Effusion","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Histologically or cytologically confirmed advanced lung adenocarcinoma.\n3. Unlimited number of metastatic lesions, but with involvement of no more than 3 organs.\n4. Previously untreated, clinical stage IV disease per AJCC\u002FUICC 9th edition.\n5. Presence of pleural effusion as indicated by chest CT or ultrasound; cytological confirmation of malignant cells in the pleural effusion is preferred. If malignant cells are not detected in the pleural effusion, chest CT with contrast or whole-body PET\u002FCT must demonstrate unequivocal pleural nodular metastases.\n6. After 8-10 weeks of furmonertinib therapy with or without therapeutic thoracentesis, the overall radiographic response is assessed as effective (CR + PR + SD), and malignant pleural effusion is adequately controlled (defined as no pleural effusion or only minimal pleural effusion on ultrasound or chest CT: maximum depth \\\u003C 3 cm, estimated volume \\\u003C 500 mL). Concurrent minimal pericardial effusion is permissible (defined as maximum diastolic width \\\u003C 1 cm on echocardiography, estimated volume \\\u003C 100 mL).\n7. No prior thoracic radiotherapy.\n8. Positive for EGFR-sensitive mutations (exon 19 deletion or exon 21 L858R).\n9. No prior systemic anticancer therapy.\n10. ECOG performance status 0-2, with a life expectancy of ≥ 12 weeks.\n11. At least one measurable lesion per RECIST 1.1.\n12. Adequate bone marrow function to tolerate anticancer treatment: WBC ≥ 3 × 10⁹\u002FL, Hb ≥ 80 g\u002FL, PLT ≥ 75 × 10⁹\u002FL, and absolute neutrophil count (NEUT) ≥ 1.5 × 10⁹\u002FL.\n13. Essentially normal hepatic and renal function:\n\n    1. Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (CrCl) ≥ 50 mL\u002Fmin;\n    2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN is acceptable in patients with liver metastases);\n    3. Total bilirubin (TBIL) ≤ 1.5 × ULN;\n    4. Albumin ≥ 30 g\u002FL and prealbumin ≥ 150 g\u002FL.\n14. Asymptomatic brain metastases.\n15. Written informed consent obtained from all subjects.\n\nExclusion Criteria:\n\n1. Pre-existing interstitial lung disease (ILD) or infectious fever prior to treatment.\n2. Radiographic progression (PD) after 8-10 weeks of TKI therapy, or development of grade ≥ 2 ILD.\n3. Concurrent autoimmune disease requiring long-term oral corticosteroid therapy.\n4. Severe anemia.\n5. Known hypersensitivity to furmonertinib.\n6. Significant respiratory symptoms (e.g., chest tightness, cough) that preclude tolerance to radiotherapy.\n7. Active hepatitis B or C virus infection with concomitant grade \\> 2 hepatic impairment. Patients may be considered eligible if liver function recovers to grade 1 after active hepatoprotective therapy and antiviral treatment.\n8. Poorly controlled or continuously progressive pleural effusion after 8-10 weeks of furmonertinib therapy.\n9. Symptomatic brain metastases.","ALL","18 Years",{"count":19,"type":20},63,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study is designed as a prospective, multi-center investigation to explore the efficacy and safety of furmonertinib combined with upfront thoracic radiotherapy with or without metastatic lesion radiotherapy in subjects with EGFR-mutant NSCLC and malignant pleural effusion (MPE), aiming to provide additional evidence-based medical support for optimizing the management of NSCLC-MPE subjects. In addition, peripheral blood ctDNA next-generation sequencing (NGS) will be performed at two time points-before the first furmonertinib treatment and one month after the completion of thoracic radiotherapy-to identify subpopulations most likely to benefit from this therapeutic approach and to elucidate resistance mechanisms specific to the radiotherapy-plus-furmonertinib combination, ultimately facilitating more personalized care for these subjects.",[26,27],"Lung Cancer (NSCLC)","Malignant Pleural Effusions (Mpe)- Pleurodesis",[29,30,31,32],"Furmonertinib","Radiotherapy","EGFR mutation","Lung adenocarcinoma","NOT_YET_RECRUITING","2026-07-16",{"date":36,"type":37},"2026-07-17","ACTUAL",{"date":39,"type":20},"2026-07-01",{"date":41,"type":20},"2028-01-01",{"name":43,"class":44},"Jiangmen Central Hospital","OTHER"]