[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606895":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":45,"locations":50,"responsibleParty":80,"collaborators":21,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":21,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":21,"enrollmentInfo":91,"targetDuration":21,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":21,"overallStatus":53,"whyStopped":21,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Betta Pharmaceuticals Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1","EXPERIMENTAL","pemetrexed (500 mg\u002Fm2) and carboplatin (AUC 5), administered every 3 weeks. After 2 to 4 cycles, received Befotertinib (75-100 mg)",[13,14],"Drug: Befotertinib","Drug: Pemetrexed + Carboplatin",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Befotertinib","Befotertinib was administered orally at a starting dose of 75 mg per day for 21 days, which could be increased to 100 mg per day if grade 2 or higher thrombocytopenia or headache did not occur within 21 days, or maintained at the original dose (75 mg per day) if grade 2 or higher thrombocytopenia or headache occurred within 21 days.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Pemetrexed + Carboplatin","pemetrexed (500 mg\u002Fm²) and carboplatin (AUC 5), administered every 3 weeks, for a total of 2\\~4 cycles.",[9],[27,31,35,38,41],{"name":28,"affiliation":29,"role":30},"XiaoFeng Pei","The Fifth Affliated Hospital, Sun Yat-sen University","STUDY_DIRECTOR",{"name":32,"affiliation":33,"role":34},"YingNi Lian","First People's Hospital of Zhaoqing","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":37,"role":34},"DongYing Liu","Jiangmen Central Hospital",{"name":39,"affiliation":40,"role":34},"GuiNan Lin","Zhongshan People's Hospital, Guangdong, China",{"name":42,"affiliation":43,"role":44},"Shaodong Hong","Sun Yat-Sen University Cancer Center","STUDY_CHAIR",[46],{"name":42,"role":47,"phone":48,"phoneExt":21,"email":49},"CONTACT","15920527656","hongshd@sysucc.org.cn",[51,67],{"facility":52,"status":53,"city":54,"state":55,"zip":21,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","China","CN",{"type":59,"coordinates":60},"Point",[61,62],113.25,23.11667,{"lat":62,"lon":61},[65],{"name":66,"role":47,"phone":48,"phoneExt":21,"email":49},"Shao dong Hong",{"facility":68,"status":53,"city":69,"state":55,"zip":21,"country":56,"countryCode":57,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"The Cancer Center of The Fifth Affiliated Hospital of Sun Yat-sen University","Zhuhai",{"type":59,"coordinates":71},[72,73],113.56778,22.27694,{"lat":73,"lon":72},[76],{"name":77,"role":47,"phone":78,"phoneExt":21,"email":79},"Xiaofeng Pei","+86 139 2338 1037","peixf3@mail.sysu.edu.cn",{"type":81,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100606895","phase-2-sequential-chemotherapy-with-befotertinib-in-non-small-cell-lung-cancer-nsclc-patients-with-resistance-to-third-generation-egfr-tki-100606895",false,"NCT07181499","Sequential Chemotherapy With Befotertinib in Non-Small Cell Lung Cancer (NSCLC) Patients With Resistance to Third-Generation EGFR-TKI","A Study Evaluating the Efficacy and Safety of Pemetrexed Combined With Platinum-Based Chemotherapy Followed by Befotertinib in Patients With Non-Small Cell Lung Cancer After Third-Generation EGFR TKI Resistance","Inclusion Criteria:\n\n1. Age ≥18 years;\n2. Histologically or cytologically confirmed advanced or metastatic non-squamous NSCLC; and prior resistance to third-generation EGFR TKIs, with EGFR-sensitive mutations confirmed via tissue or blood samples (defined as: 19 Del or 21 L858R);\n3. Exclusion of small cell lung cancer (SCLC) or squamous cell carcinoma (SqCC) transformation, and known NSCLC with clear targetable mutations for targeted therapy, such as HER2, MET amplification (GCN ≥ 5), KRAS G12C mutation, BRAF V600E mutation, RET fusion mutation, ALK fusion mutation, NTRK fusion mutation, etc.;\n4. ECOG performance status (PS) score of 0-2;\n5. Life expectancy of at least 12 weeks;\n6. Ability to swallow oral medications;\n7. Adequate organ system function, defined as follows and determined based on investigator judgment:\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹\u002FL\n   2. Platelets ≥ 100 x 10⁹\u002FL;\n   3. Hemoglobin ≥ 9 g\u002FdL (≥ 90 g\u002FL). Note: Blood transfusions are permitted to achieve the required hemoglobin level;\n   4. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN);\n   5. If no liver metastases: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; if liver metastases present: ≤ 5 × ULN;\n   6. Creatinine ≤1.5 × ULN. If ≥1.5 × ULN, patients remain eligible if the Cockcroft-Gault-calculated creatinine clearance ≥50 mL\u002Fmin (0.83 mL\u002Fs);\n8. Female subjects of childbearing potential must have a negative serum pregnancy test within 3 days prior to study drug initiation and agree to use a medically approved highly effective contraceptive method (e.g., intrauterine device, oral contraceptives, or condoms) during the study and for 3 months after the last study drug administration; Male subjects with female partners of childbearing potential must be surgically sterilized or agree to use an effective method of contraception during the study period and for 3 months after the last study dose.\n9. Voluntarily agree and be capable of adhering to the trial and follow-up procedures.\n10. Be able to understand the nature of the trial and complete the written informed consent form.\n\nExclusion Criteria:\n\n1. Rare EGFR mutations;\n2. Prior treatment with pemetrexed and platinum-based chemotherapy regimens;\n3. Advanced and\u002For symptomatic brain metastases (measurable or non-measurable) and\u002For leptomeningeal metastases;\n4. Active hepatitis B (serum HBV DNA ≥10⁴ copies\u002FmL \\[i.e., 20,000 IU\u002FmL\\]), hepatitis C virus antibody positive, HIV antibody positive, or treponema pallidum antibody positive;\n5. Women of childbearing potential with a positive serum pregnancy test within 7 days prior to treatment initiation, pregnant or lactating women, or male and female subjects not using effective contraception or planning pregnancy during treatment and for 3 months post-treatment;\n6. Patients who used or require concomitant use of the following drugs within 14 days prior to the first dose or during treatment: drugs associated with QTc prolongation and\u002For risk of torsades de pointes ventricular tachycardia; strong CYP3A inhibitors or inducers;\n7. Patients who underwent major surgery or immunotherapy within 4 weeks prior to the first dose; patients who received radiotherapy within 2 weeks prior to the first dose.\n8. Imaging (CT or MRI) demonstrating tumor invasion of major vessels, or a high likelihood of tumor invasion into critical vessels causing fatal hemorrhage during the study period;\n9. History of interstitial lung disease, drug-induced interstitial disease, or any clinically evident active interstitial lung disease; presence of idiopathic pulmonary fibrosis identified on baseline CT scan;\n10. Other severe acute or chronic medical conditions, including uncontrolled diabetes, medical or psychiatric disorders, or laboratory abnormalities, that in the investigator's judgment may increase study-related risks or interfere with interpretation of study results;\n11. Other conditions deemed by the investigator to be unsuitable for participation in this trial.","ALL","18 Years",{"count":92,"type":93},28,"ESTIMATED","INTERVENTIONAL",[96],"PHASE2","Non-small cell lung cancer (NSCLC) accounts for over 85% of lung cancers. Approximately 30-40% of East Asian adenocarcinoma patients harbor EGFR mutations. Third-generation EGFR-TKIs achieve a median PFS of about 20 months as first-line therapy, but resistance eventually develops. Studies like MARIPOSA-2 confirm that amivantamab combined with chemotherapy ± lazertinib or immunotherapy regimens (ivucitinib\u002Fsintilimab + bevacizumab + chemotherapy) can extend median PFS post-resistance from approximately 4 months to 6-8 months. As a third-generation TKI, befitinib has demonstrated PFS of 16-22 months in both first-line and post-T790M mutation settings. This study aims to further evaluate the feasibility and safety of \"pemetrexed + carboplatin followed by befotertinib\" for patients resistant to third-generation TKIs.",[99,100,101],"NSCLC","Adjuvant Drug Therapy","EGFR","2025-09-28",{"date":104,"type":105},"2025-09-30","ACTUAL",{"date":107,"type":93},"2025-09",{"date":109,"type":93},"2028-12",{"name":5,"class":6},2]