[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Betta Pharmaceuticals Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":293},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,43,67,92,116,137,159,180,204,226,249,272],{"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":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100626392","phase-1-study-of-bpi-572270-in-patients-with-advanced-solid-tumors-harboring-specific-mutations-in-ras-100626392",false,"NCT07435038","Study of BPI-572270 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS","A Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-572270 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS.","Inclusion Criteria:\n\n* Histologically confirmed advanced solid tumor with RAS mutations identified through deoxyribonucleic acid (DNA) sequencing.\n* Have received prior standard therapy appropriate for tumor type and stage.\n* Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Adequate organ function.\n\nExclusion Criteria:\n\n* Primary central nervous system (CNS) tumors active and untreated brain metastases.\n* Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication.\n* History of any other unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and\u002For impact their ability to comply with the protocol prior\u002Fconcomitant therapy","ALL","18 Years",{"count":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","Evaluate the safety and tolerability of BPI-572270 in adult patients with specific RAS mutant advanced solid tumors.",[27,28,29,30],"Non-small Cell Lung Cancer (NSCLC)","Colorectal Cancer (CRC)","Pancreatic Ductal Adenocarcinoma (PDAC)","Advanced Solid Tumors","NOT_YET_RECRUITING","2026-03-08",{"date":34,"type":35},"2026-03-11","ACTUAL",{"date":37,"type":20},"2026-02-12",{"date":39,"type":20},"2029-10-28",{"name":41,"class":42},"Betta Pharmaceuticals Co., Ltd.","INDUSTRY",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100627398","phase-1-study-of-mcla-129-in-combination-with-ensartinib-in-patients-with-advanced-solid-tumors-100627398","NCT07448116","Study of MCLA-129 in Combination With Ensartinib in Patients With Advanced Solid Tumors.","A Multi-cohort, Open-label Phase I\u002FII Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of the Anti-EGFR\u002Fc-Met Bispecific Antibody MCLA-129 in Combination With Ensartinib Hydrochloride in Patients With Advanced Solid Tumors.","Inclusion Criteria:\n\n* Subjects should be aged 18-75 years (both inclusive), regardless of gender.\n* Subjects must have histologically or cytologically confirmed, locally advanced or metastatic solid tumors (including but not limited to non-small cell lung cancer, squamous cell carcinoma of the head and neck (primary site of oral cavity, oropharynx, hypopharynx, or larynx), gastric\u002Fgastroesophageal junction adenocarcinoma, etc.) that are not amenable to curative therapy.\n* Subjects must have MET amplification or MET overexpression as confirmed by the tests conducted by local or central laboratory.\\[MET amplification for Cohort 1 and Cohort 3 is defined as: MET copy number (CN) ≥ 5 by next-generation sequencing (NGS); or MET gene copy number (GCN) ≥ 5 or MET\u002FCEP7 ≥ 2 by fluorescence in situ hybridization (FISH). MET amplification for Cohort 2 is defined as: MET copy number (CN) ≥ 3 by next-generation sequencing (NGS); or MET gene copy number (GCN) ≥ 3 or MET\u002FCEP7 ≥ 2 by fluorescence in situ hybridization (FISH). MET overexpression is defined as 2+ or 3+ staining of ≥50% of tumor cells in tumor tissue samples by immunohistochemistry (IHC).\\]\n* For phase I study: subjects must meet the following conditions: with disease progression or intolerance to standard treatment after standard treatment, or evaluated by the investigator as ineligible for platinum-based chemotherapy (the standard treatment for the patient population enrolled in each cohort can refer to that for the phase II cohort study).\n* For phase II study, each cohort is defined as follows:\n\nCohort 1: Patients with locally advanced or metastatic non-small cell lung cancer with confirmed MET amplification or MET overexpression. Prior treatment should meet the following criteria: 1) If a previous test had identified an EGFR-sensitizing mutation (exon 19 deletion or exon 21 L858R mutation), the following requirements must be met: a) Disease progression after treatment with a third-generation EGFR-TKI and platinum-based chemotherapy ± PD-1\u002FPD-L1 inhibitor, or intolerance to such treatment, or deemed unsuitable for platinum-based chemotherapy by the investigator; or b) Disease progression after first-or second-generation EGFR-TKI treatment with T790M mutation-negative or unknown gene mutation status, followed by disease progression after treatment with platinum-based chemotherapy ± PD-1\u002FPD-L1 inhibitor, or intolerance to such treatment, or deemed unsuitable for platinum-based chemotherapy by the investigator. 2)If a previous test had identified an EGFR non-sensitizing mutation or MET exon 14 skipping mutation, disease progression after treatment with the corresponding inhibitors and platinum-based chemotherapy ± PD-1\u002FPD-L1 inhibitor is required, or intolerance to such treatment, or deemed unsuitable for platinum-based chemotherapy by the investigator. 3)If no other driver gene alterations were identified in previous tests, disease progression after treatment with platinum-based chemotherapy ± PD-1\u002FPD-L1 inhibitor is required, or intolerance to such treatment, or deemed unsuitable for platinum-based chemotherapy by the investigator.\n\nCohort 2: Patients with recurrent or metastatic (R\u002FM) squamous cell carcinoma of the head and neck (primary site in the oral cavity, oropharynx, hypopharynx, or larynx) with confirmed MET amplification or MET overexpression. Patients must have experienced disease progression or intolerance after previous treatment of platinum-based chemotherapy ± PD-1\u002FPD-L1 inhibitor\u002FEGFR monoclonal antibody therapy.\n\nCohort 3: Locally advanced or metastatic gastric cancer\u002Fgastroesophageal junction adenocarcinoma (including signet ring cell carcinoma, mucinous adenocarcinoma, hepatoid adenocarcinoma) with detected MET amplification or MET overexpression. Prior treatment should meet the following criteria:1)Disease progression or intolerance after treatment with a chemotherapy regimen consisting of platinum agents (cisplatin or oxaliplatin),paclitaxel\u002Fdocetaxel, and fluoropyrimidines (5-FU,capecitabine or S-1),with or without PD-1\u002FPD-L1 inhibitor;2)For patients with HER-2 positivity, disease progression after treatment with anti-HER-2 agents is required, or intolerance to such treatment, or deemed unsuitable for anti-HER-2 treatment by the investigator;3)For patients with Claudin 18.2 expression, disease progression after treatment with anti-Claudin 18.2 agents is required, or intolerance to such treatment.\n\n* Subjects in the phase I dose-exploration study must have evaluable lesions; other subjects (including dose-backfill stage in phase I and phase II) must have measurable lesions as per RECIST v1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Expected survival ≥ 3 months.\n* Have adequate organ function (no blood transfusion or use of blood component or G-CSF support within 14 days before testing)\n* Willing and able to follow the trial and follow-up procedures.\n* Able to understand the nature of the trial and voluntarily sign the written informed consent form.\n\nExclusion Criteria:\n\n* Subjects with non-small cell lung cancer who have been tested positive for ALK in the genetic tests conducted by the local or central laboratory.\n* Subjects have received any investigational drug or antitumor agent (for drugs with a long half-life, the time interval since the last dose should be no more than 4 weeks; for chemotherapy with delayed toxicity, such as nitrosoureas or mitomycin C, within the previous 6 weeks) within 14 days prior to the first dose of the study drug or within 5 half-lives of the drug (whichever is longer). Subjects have used any traditional Chinese medicine or Chinese herbal preparations with antitumor indications or definitive antitumor effects within 14 days prior to the first dose of the study drug.\n* Subjects who have undergone any major surgery or radiotherapy within 4 weeks prior to the first dose of the study drug (palliative local radiotherapy is allowed if it was administered at least 2 weeks prior to the first dose of the study drug).\n* For subjects with non-small cell lung cancer, prior receipt of more than two lines of systemic chemotherapy is required; for subjects with squamous cell carcinoma of the head and neck and gastric cancer\u002Fgastroesophageal junction adenocarcinoma, prior receipt of more than three lines of systemic anti-tumor treatment (excluding maintenance therapy) is required. For subjects who have received neoadjuvant\u002Fadjuvant therapy (chemotherapy or radio chemotherapy), if recurrence or metastasis occurs during treatment or within 6 months after discontinuation of treatment, it should be considered as first-line treatment.\n* Prior use of EGFR\u002Fc-Met bispecific antibody or ADC drugs.\n* Subjects who require concomitant use of strong CYP3A inhibitors or inducers within 14 days before the first administration of the investigational drug or during the study period.\n* Toxicities related to prior treatment have not resolved to Grade 1 or below (CTCAE 5.0 criteria) prior to the first dose of the study drug, except for alopecia.\n* Subjects who have had other malignancies within the past 3 years, except for malignancies that have been clearly cured or are locally curable, such as basal or squamous cell skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of the breast.\n* Cohort 1: Patients with primary central nervous system malignancy, or presence of meningeal metastases, or presence of spinal cord compression, or risk of cerebral hemorrhage, or symptomatic brain metastases, or unstable brain metastases requiring treatment with steroids and\u002For dehydration to reduce cranial pressure 2 weeks prior to enrollment.\n\nCohorts 2 and 3: Patients with known brain and\u002For meningeal metastases, or primary central nervous system malignancies are excluded. Subjects with neurological symptoms shall have a brain CT\u002FMRI scan to exclude brain metastases.\n\n• Subjects with clinically significant abnormal cardiovascular or cerebrovascular diseases, including but not limited to: Subjects with arterial thromboembolism, deep vein thrombosis, or pulmonary embolism within 3 months prior to the first dose of the study drug. Clinically insignificant non-obstructive catheter-related clots are not deemed as constituting an exclusion criterion. Subjects with a history of other venous thrombosis must be clinically stable for at least 4 weeks prior to the first dose of the study drug.\n\nSubjects with any of the following medical history within 6 months prior to the first dose of the study drug: myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, transient myocardial ischemia, coronary or peripheral artery bypass grafting (including coronary intervention), or any acute coronary syndrome.\n\nWith abnormal ECG corrected QT interval (QTcF) of ECG at rest in the screening period, with the test been repeated twice at an interval 5 minutes above, and with the average QTcF of three ECG examinations: ≥ 450 msec for male, and ≥ 470 msec for female. Various clinically significant abnormalities in rhythm, conduction, resting ECG morphology within 3 months prior to the first dose of investigational drug, such as complete left bundle branch block, third degree block, second degree block, PR interval \\>250 msec, bigeminy, trigeminy, pre-excitation syndrome, ST-segment elevation, atrial fibrillation, ventricular fibrillation, etc.\n\nPoorly controlled hypertension judged by investigators (systolic blood pressure \\> 180 mmHg, or diastolic blood pressure \\> 100 mmHg).\n\nNew York Heart Association (NYHA) Class III-IV congestive heart failure (see Appendix 2) or hospitalization for congestive heart failure within 6 months prior to the first dose of investigational drug; left ventricular ejection fraction (LVEF) \\\u003C50%.\n\nPericarditis\u002Fclinically significant pericardial effusion. Subjects with cardiomyopathy, including dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, and myocarditis.\n\nSubjects with other clinically significant cardiovascular or cerebrovascular diseases.\n\n* Subjects with active hepatitis B (HBsAg positive and serum HBV DNA quantitative results ≥ the lower limit of detection (as per criteria of local laboratory)); positive for anti-hepatitis C virus antibody, anti-HIV antibody, or anti-treponema pallidum antibody (subjects with a history of HCV who have completed antiviral treatment and have laboratory test results showing HCV-RNA below the lower limit of quantification are eligible for enrollment; and subjects with negative syphilis titer tests are eligible for enrollment).\n* Subjects with a history of interstitial lung disease or current clinical evidence of interstitial lung disease\u002Fpneumonia, including but not limited to drug-induced interstitial lung disease\u002Fpneumonia, radiation pneumonitis, or pulmonary fibrosis. Patients who cannot exclude suspected interstitial pneumonia\u002Fpulmonary fibrosis or uncontrolled stable non-infectious pneumonia\u002Fpulmonary inflammation by imaging examination during screening are not eligible for enrollment.\n* Subjects with current severe illness or medical conditions, including but not limited to uncontrolled or poorly controlled active infections, uncontrolled pleural or peritoneal effusion, unstable tuberculosis, or other clinically significant pulmonary, metabolic, or psychiatric disorders.\n* Subjects with gastric cancer\u002Fgastroesophageal junction adenocarcinoma with signs of active bleeding, active gastrointestinal (GI) diseases, or risk of gastrointestinal (GI) perforation, or other diseases that can significantly interfere with the absorption, distribution, metabolism, or excretion of the investigational drug.\n* Subjects with hepatic encephalopathy, hepatorenal syndrome, or ≥ Child-Pugh class B cirrhosis.\n* Women of childbearing potential with a positive serum pregnancy test within 7 days prior to the initiation of treatment, pregnant or breastfeeding women, and male or female subjects unwilling to use effective contraception or plan for pregnancy during the entire treatment period and for 3 months after treatment completion (see Appendix 3 for guidelines on contraception).\n* Subjects with a history of allergy or suspected allergic symptoms to the study drug MCLA-129 or ensartinib or tartrazine (a dye used in ensartinib 100 mg capsules) or any other component or excipient\n* Subjects judged by the investigator to have poor compliance, inability or unwillingness to adhere to the study and\u002For follow-up procedures listed in the protocol, or otherwise unsuitable for participation in this study.","75 Years",{"count":52,"type":20},164,[23,24],"This is a multicenter, open-label Phase I\u002FII clinical study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of the anti-EGFR\u002Fc-Met bispecific antibody MCLA-129 in combination with Ensartinib hydrochloride in patients with advanced solid tumors.",[56],"Solid Advanced Tumor","RECRUITING","2026-03-03",{"date":60,"type":35},"2026-03-04",{"date":62,"type":35},"2026-01-31",{"date":64,"type":20},"2029-08-01",{"name":41,"class":42},1,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"100433923","phase-1-study-of-mcla-129-a-human-bispecific-egfr-and-cmet-antibody-in-patients-with-advanced-nsclc-and-other-solid-tumors-100433923","NCT04930432","Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors","A Phase I\u002FII Study of MCLA-129, a Human Anti-EGFR and Anti-c-Met Bispecific Antibody, in Patients With Advanced NSCLC and Other Solid Tumors, Evaluating Safety, Pharmacokinetic Characteristics and Antitumor Activity","Inclusion Criteria:\n\n* Subjects are ≥ 18 years of age, regardless of gender.\n* Subjects must have histologically or cytologically confirmed metastatic or unresectable advanced NSCLC or other solid tumors (including but not limited to head and neck cancer, colorectal cancer, etc.), have disease progression after standard treatment, or are intolerant to standard treatment, or refuse standard treatment (Refusal of standard treatment does not apply to Part 2).\n* For Part 1, subjects must be diagnosed with EGFR positive and\u002For MET positive by testing.\n\nFor patients with advanced NSCLC, EGFR positive is defined as: EGFR mutation or EGFR amplification. MET positive is defined as: MET amplification or MET exon 14 skipping mutation.\n\nFor patients with other advanced solid tumors other than NSCLC, EGFR positive is defined as: High EGFR expression or EGFR amplification. MET positive is defined as: c-Met high expression or MET amplification.\n\n• For Part 2, patients shall meet the inclusion criteria for each cohort by biomarker testing.\n\nCohort A: Patients with advanced NSCLC who are previously diagnosed with EGFR mutations and treated with third-generation EGFR-TKIs for drug resistance.\n\nCohort B: Advanced NSCLC patients diagnosed with EGFR exon 20 insertion mutation (Exon20ins).\n\nCohort C: Advanced NSCLC patients with MET amplification. Cohort D: Advanced NSCLC patients with MET exon 14 skipping mutation (Exon14 skipping).\n\nCohort E: Patients with locally advanced or recurrent metastatic colorectal cancer (CRC) could not undergo curative treatment.\n\nCohort F: Other advanced solid tumors that have failed or are intolerant to standard therapy.\n\nCohort G: Patients with locally advanced or metastatic MET-amplified or MET-overexpressing other driver gene-negative non-small cell lung cancer, gastric\u002Fgastroesophageal junction adenocarcinoma \\[including signet ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma\\], or recurrent\u002Fmetastatic \\[R\u002FM\\] head and neck squamous cell carcinoma \\[primary sites: oral cavity, oropharynx, hypopharynx, or larynx\\], who are not candidates for curative treatment.\n\n* For subjects in the dose escalation phase of Part 1, evaluable lesions must be present; other subjects must have measurable lesions that meet the definition of RECIST v1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Expected survival ≥3 months.\n* Have adequate organ function (no blood transfusion or use of blood component or G-CSF support within 14 days before testing).\n* Willing and able to follow the trial and follow-up procedures.\n* Able to understand the nature of the trial and voluntarily sign the written informed consent form.\n\nExclusion Criteria:\n\n* For colorectal cancer subjects, HER-2 positivity (IHC 2+\u002F3+ or FISH\u002FNGS+) confirmed by local or central laboratory genetic testing.\n* Have received an investigational product or anti-tumor drug treatment within 14 days before the first dose of MCLA-129 or within 5 half-lives of the drug (whichever is longer). For cohort E1, the interval between the last dose of EGFR monoclonal antibody and the first dose of MCLA-129 was less than 6 months.\n* Have undergone a major surgery and radiotherapy (local palliative radiotherapy is allowed 2 weeks or more prior to the first dose) within 4 weeks prior to the first dose of MCLA-129.\n* For patients with colorectal cancerr, head and neck squamous cell carcinoma, or gastric\u002Fgastroesophageal junction adenocarcinoma: patients who have previously received systemic anti-tumor therapy beyond the third line (excluding maintenance therapy).\n* For subjects with non-small cell lung cancer only: have received more than 2 prior lines of cytotoxic chemotherapy for locally advanced or metastatic diseases (excluding maintenance therapy).\n* For advanced NSCLC patients with EGFR Exon20ins mutation: have received prior EGFR-TKI therapy (e.g., poziotinib, TAK-788, DZD9008, CLN-081, or furmonertinib, etc.) that is known to be effective against Exon20ins.\n* Prior use of EGFR\u002Fc-Met bispecific antibody or ADC drugs (such as Amivantamab, EMB-01, GB263T, PM1080\u002FHS-20117, TAVO412, YH013\u002F DM005, SHR-9839 or AZD9592 etc.).\n* Prior to the first dose of MCLA-129, previous treatment-related toxicities have not resolve to Grade 1 or below (CTCAE 5.0 criteria), except for alopecia.\n* Have had other malignancies within the past 3 years, except for cancers that have been totally cured or locally cured, such as basal or squamous cell carcinoma of the skin, cervical cancer in situ, or breast cancer in situ.\n* Patients with primary malignant tumor of central nervous system, or metastases to meninges, spinal cord compression, or at risk of cerebral hemorrhage, or concomitantly with symptomatic brain metastases, or new therapy naive brain metastases. For cohorts E, F and G (excluding NSCLC patients): Patients with known brain metastases and\u002For meningeal metastases, or primary malignant tumor of central nervous system. Subjects with neurological symptoms shall have a brain CT\u002FMRI scan to exclude brain metastases.\n* With clinically significant cardiovascular and cerebrovascular diseases.\n* Active hepatitis B (positive hepatitis B surface antigen (HBsAg) or core antibody (HBcAb) and serum HBV DNA ≥ 2,000 IU\u002FmL \\[equivalent to 104 copies\u002FmL\\]), positive hepatitis C virus antibody, HIV antibody and treponema pallidum antibody.\n* Subjects with a history of interstitial lung disease or current clinical evidence of interstitial lung disease, including drug-induced Interstitial lung disease, radiation pneumonitis or pulmonary fibrosis. Subjects who could not be ruled out for suspected interstitial lung disease\u002Fpulmonary fibrosis through imaging examinations during screening, or those with uncontrolled\u002Funstable non-infectious pneumonitis\u002Fpulmonary inflammation are excluded.\n* Presence of a serious disease or medical condition currently, including but not limited to uncontrolled active infection, uncontrolled pleural or peritoneal effusion, unstable\u002Funcontrolled tuberculosis, active gastrointestinal diseases, gastrointestinal obstruction or perforation risks, and clinically significant pulmonary, metabolic or psychiatric diseases.\n* Females of childbearing potential, pregnant or breastfeeding women with a positive serum pregnancy test 7 days before the start of treatment, and male and female subjects who are unwilling to use effective contraceptive measures or plan to have a child throughout the treatment period and within 3 months after the end of treatment.\n* Patients with known allergic reactions and hypersensitivity reactions, or be allergic to MCLA-129 or any of its excipients.\n* Patients with poor compliance, inability or unwillingness to follow the study and\u002For follow-up procedure listed in the protocol, or patients who are not suitable to participate in this trial, as determined by the investigator.",{"count":75,"type":20},400,[23,24],"This is a multi-center, open-label, Phase I\u002FII clinical study of MCLA-129 as monotherapy in patients with advanced solid tumors to evaluate the safety, pharmacokinetic characteristics and antitumor activity of MCLA-129.",[79,80,81,82],"Solid Tumor","Non-Small Cell Lung Cancer","Head and Neck Cancer","Colorectal Cancer","2026-02-05",{"date":85,"type":35},"2026-02-10",{"date":87,"type":35},"2021-09-24",{"date":89,"type":20},"2028-12-30",{"name":41,"class":42},87,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},"100606895","phase-2-sequential-chemotherapy-with-befotertinib-in-non-small-cell-lung-cancer-nsclc-patients-with-resistance-to-third-generation-egfr-tki-100606895","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.",{"count":100,"type":20},28,[24],"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.",[104,105,106],"NSCLC","Adjuvant Drug Therapy","EGFR","2025-09-28",{"date":109,"type":35},"2025-09-30",{"date":111,"type":20},"2025-09",{"date":113,"type":20},"2028-12",{"name":41,"class":42},2,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":21,"phases":125,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},"100584169","phase-2-study-of-mcla-129-in-the-treatment-of-advanced-non-small-cell-lung-cancer-with-aga-and-met-amplification-100584169","NCT06885840","Study of MCLA-129 in the Treatment of Advanced Non-small Cell Lung Cancer with AGA and MET Amplification.","A Multi-cohort, Open-label Phase II Study to Evaluate the Efficacy and Safety of the Anti-EGFR\u002Fc-Met Bispecific Antibody MCLA-129 in Patients with Advanced Non-Small Cell Lung Cancer with Actionable Gene Alterations and MET Amplification.","Inclusion Criteria:\n\n* Subjects are ≥ 18 years of age, regardless of gender.\n* Subjects must have histologically or cytologically confirmed locally advanced unresectable or metastatic NSCLC.\n* Subjects who must experience disease progression or intolerance after standard treatment eligible through screening will be divided into the following 4 cohorts:\n\nCohort 1 and Cohort 2: Patients with advanced NSCLC with previously detected EGFR-sensitive mutations (exon 19 deletion or exon 21 L858R mutation) who have progressed after prior standard treatment which includes 1) first-generation or second-generation EGFR-TKIs, with T790M mutation requiring third-generation EGFR-TKIs and platinum-based chemotherapy; or 2) first-generation or second-generation EGFR-TKIs, with T790M mutation negative or unknown status.\n\nSubjects in Cohort 1: Patients with MET amplification after failure of treatment with EGFR-TKIs.\n\nSubjects in Cohort 2: Patients who experienced disease progression or intolerance after MET inhibitors and benefited from such treatment.\n\nCohort 3 and Cohort 4: Patients with advanced NSCLC with previously detected actionable gene alterations who had progressed after treatment with corresponding inhibitors and platinum-based chemotherapy.\n\nSubjects in Cohort 3: Patients with MET amplification after failure of treatment with the corresponding driver gene inhibitors.\n\nSubjects in Cohort 4: Patients who experienced disease progression or intolerance after MET inhibitors and benefited from such treatment.\n\n* Subjects must have measurable lesions that meet the definition of RECIST v1.1. Selected target lesions must meet one of the following two criteria: 1) no prior local therapy or radiation or 2) subsequent progression occurs within the prior local therapy area as determined by RECIST v1.1..\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Expected survival ≥3 months.\n* Have certain functions of organ systems (no blood transfusion or use of blood component or G-CSF support within 14 days before testing), defined as follows:\n\n  * Absolute neutrophil count (ANC) ≥1.5×10\\^9 \u002FL.\n  * Platelet count (PLT）≥75×10\\^9 \u002FL.\n  * Hemoglobin (HGB) ≥100 g\u002FL.\n  * Serum albumin ≥ 30 g\u002FL.\n  * Total bilirubin ≤1.5 times the upper limit of normal (ULN).\n  * Alanine amino transferase (ALT) and aspartate amino transferase (AST) ≤3×ULN.\n  * Creatinine ≤1.5×ULN. If creatinine is \\>1.5×ULN, creatinine clearance ≥50 mL\u002Fmin as calculated by Cockcroft-Gault formula, or 24-hour urine creatinine clearance ≥50 mL\u002Fmin is measured, the patients can still be enrolled.\n* Willing and able to follow the trial and follow-up procedures.\n* Able to understand the nature of the trial and voluntarily sign the written informed consent form.\n\nExclusion Criteria:\n\n* Have received an investigational product or antitumor drug treatment (including known anti-tumor traditional Chinese medicine treatment) within 14 days before the first dose of MCLA-129 or within 5 half-lives of the drug (whichever is longer) (for a drug with a long half-life, it is required that the interval from the last dose to be at most 4 weeks; for chemotherapy with delayed toxicity, such as nitrosourea or mitomycin C, it shall be 6 weeks before \\[the treatment\\]).\n* Have undergone a major surgery and radiotherapy (local palliative radiotherapy is allowed 2 weeks or more prior to the first dose) within 4 weeks prior to the first dose of MCLA-129.\n* Have previously received systemic anti-tumor therapy beyond the fourth line (excluding maintenance therapy).\n* Prior use of EGFR\u002Fc-Met bispecific antibody or ADC drugs (Amivantamab \\[JNJ-61186372\\], EMB-01, GB263T, PM1080\u002FHS-20117, TAVO412, YH013\u002FDM005, AZD9592, or SHR-9839).\n* Prior to the first dose of MCLA-129, previous treatment-related toxicities have not resolved to Grade 1 or below (CTCAE 5.0 criteria), except for alopecia.\n* Prior to the first dose of MCLA-129, previous treatment-related toxicities have not resolved to Grade 1 or below (CTCAE 5.0 criteria), except for alopecia.\n* Have had other malignancies within the past 3 years, except for cancers that have been totally cured or locally cured, such as basal or squamous cell carcinoma of the skin, cervical cancer in situ, or breast cancer in situ.\n* Patients with primary malignant tumor of central nervous system, or metastases to meninges, or concomitantly with symptomatic brain metastases, or new therapy naive brain metastases.\n\nNote: Patients with brain metastases who have received treatment for brain metastases (including systemic and local therapies against brain metastases) with no obvious symptoms and stable condition, and do not require drug therapy such as steroids and\u002For dehydration to reduce intracranial pressure within 2 weeks before enrollment and have no risk of brain bleeding can be enrolled.\n\n* With clinically significant cardiovascular and cerebrovascular diseases.\n\n  * Arterial thromboembolism, deep vein thrombosis or lung embolism diagnosed within 3 month before first administration of the investigational drug. Non-obstructive catheter related clot and other clinically irrelevant thrombosis are not included in the exclusion criteria. Patients with a history of related thrombosis diagnosed 3 months ago must be clinically stable for at least 4 weeks before initial administration.\n  * With any of the following medical history within 6 months before first administration of the investigational drug: myocardial infarction, unstable angina, stroke, transient ischemic attack, coronary or peripheral artery bypass, or any acute coronary syndrome.\n  * With abnormal ECG corrected QT interval (QTcF) at rest in the screening period. Remeasurement is made twice at intervals of more than 5 minutes. For average QTcF of 3 ECG inspections: male: ≥ 450 msec, and female: ≥ 470 msec. With clinically significant abnormal heart rate, conduction, and ECG form at rest, e.g. complete left bundle branch block, third-degree conduction block, second-degree conduction block, and PR interval \\> 250 msec, double law, triple law, preexcitation syndrome, etc.\n  * Poorly controlled hypertension in the investigator's opinion (systolic blood pressure \\> 180 mmHg, or diastolic blood pressure \\> 100 mmHg).\n  * New York Heart Association Grade III-IV congestive heart failure, or hospitalization due to congestive heart failure within 6 months before first administration of the investigational drug.\n  * Pericarditis\u002Fclinically significant pericardial effusion.\n  * Cardiomyopathy.\n  * Other clinically significant cardiovascular disorders as believed by investigators.\n* Active hepatitis B (positive hepatitis B surface antigen (HBsAg) and serum HBV DNA ≥ 2,000 IU\u002FmL \\[equivalent to 104 copies\u002FmL\\]), positive hepatitis C virus antibody, HIV antibody and treponema pallidum antibody.\n* Subjects with a history of interstitial lung disease or current clinical evidence of interstitial lung disease, including drug-induced Interstitial lung disease or radiation pneumonitis.\n* Presence of a serious disease or medical condition currently, including but not limited to uncontrolled active infection, uncontrolled pleural or peritoneal effusion, and clinically significant pulmonary, metabolic or psychiatric diseases.\n* Females of childbearing potential, pregnant or breastfeeding women with a positive serum pregnancy test 7 days before the start of treatment, and male and female subjects who are unwilling to use effective contraceptive measures or plan to have a child throughout the treatment period and within 3 months after the end of treatment.\n* Patients with known allergic reactions and hypersensitivity reactions, or be allergic to MCLA-129 or any of its excipients.\n* Patients with poor compliance, inability or unwillingness to follow the study and\u002For follow-up procedure listed in the protocol, or patients who are not suitable to participate in this trial, as determined by the investigator.",{"count":124,"type":20},100,[24],"This is a multi-center, open-label, phase II clinical study of MCLA-129 as monotherapy in patients with advanced non-small cell lung cancer (NSCLC) with actionable gene alterations and MET amplification to evaluate the efficacy, safety, pharmacokinetic characteristics of MCLA-129.",[80],"2025-03-14",{"date":130,"type":35},"2025-03-20",{"date":132,"type":20},"2025-03-31",{"date":134,"type":20},"2028-09",{"name":41,"class":42},20,{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":21,"phases":146,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},"100499926","phase-1-a-study-of-bpi-460372-in-advanced-solid-tumor-patients-100499926","NCT05789602","A Study of BPI-460372 in Advanced Solid Tumor Patients","A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BPI-460372 in Advanced Solid Tumor Patients","Inclusion Criteria:\n\n* Signed informed consent;\n* Age ≥18, male and female patients；\n* Expected survival ≥ 3 months；\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;\n* Dose escalation phase: histologically or cytologically confirmed locally advanced or metastatic solid tumor patients, who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists;\n* Dose expansion phase: histologically or cytologically confirmed locally advanced Malignant mesothelioma, Epithelioid hemangioendothelioma or other diagnosed solid tumor patients with NF2 defects, YAP\u002FTAZ fusion, LATS1\u002F2 mutations, and other Hippo signaling pathway abnormalities , who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists;\n* Evaluable lesion required for dose escalation phase and at least 1 measurable lesion as per RECIST v1.1 or mRECIST v1.1 required for dose expansion phase;\n\nExclusion Criteria:\n\n* Patients who have previously received a TEAD inhibitor;\n* Inadequate wash-out of prior therapies described per protocol, which may include anti-tumor therapies, tumor adjuvant drugs, organ or stem cell transplantation，etc；\n* Patients with severe or unstable systemic disease, unstable\u002Fsymptomatic CNS metastasis, meningeal metastasis and spinal cord compression，malignant tumors, cardiac disease, bleeding or embolic disease, infectious disease, conditions affecting drug swallow and absorption, medical history leading to chronic diarrhea, etc;\n* Pregnancy or lactation;\n* Other conditions considered not appropriate to participate in this trial by the investigators.",{"count":145,"type":20},82,[23],"This study is an open-label, single arm, dose escalation and dose expansion phase 1 study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BPI-460372 in solid tumor patients.",[149],"Advanced Solid Tumor","2025-01-22",{"date":152,"type":35},"2025-01-27",{"date":154,"type":35},"2023-04-24",{"date":156,"type":20},"2026-04-17",{"name":41,"class":42},11,{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":21,"phases":168,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":173,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},"100465502","phase-1-a-phase-1-study-of-bpi-371153-in-subjects-with-advanced-solid-tumors-or-relapsedrefractory-lymphoma-100465502","NCT05341557","A Phase 1 Study of BPI-371153 in Subjects with Advanced Solid Tumors or Relapsed\u002FRefractory Lymphoma","A Phase 1 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-371153 in Subjects with Advanced Solid Tumors or Relapsed\u002FRefractory Lymphoma","Inclusion Criteria:\n\n* Dose escalation phase: Age ≥18 and ≤65 years, male and female patients; Dose expansion phase: Age ≥18, male and female patients;\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;\n* Dose escalation phase: histologically or cytologically confirmed locally advanced or metastatic solid tumor patients (excluding HCC patients) or relapsed\u002Frefractory lymphoma, who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists;\n* Dose expansion phase: histologically or cytologically confirmed locally advanced or relapsed\u002Fmetastatic Non-Driver Mutation NSCLC, relapsed\u002Frefractory lymphoma, HCC with Child-Pugh A or B(≤ 7 points), or other diagnosed solid tumor patients who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists;\n* Evaluable lesion required for dose escalation phase and at least 1 measurable lesion as per RECIST v1.1( for other diagnosed solid tumos excluding HCC), mRECIST(for HCC) or Lugano 2014(for lymphoma);\n* Adequate organ function;\n\nExclusion Criteria:\n\n* Dose escalation phase: Prior immune checkpoint inhibition with anti-programmed cell death-1 (PD1)\u002Fprogrammed death ligand-1(PD-L1) or programmed death ligand-2(PD-L2) therapy;\n* Dose expansion phase: Prior immune checkpoint inhibition with anti-programmed cell death-1 (PD1)\u002Fprogrammed death ligand-1(PD-L1) or programmed death ligand-2(PD-L2) therapy within 28 days prior to treatment. Subjects with a history of a Grade 3 or higher immune-related AE from prior immunotherapies;\n* Prior other specific T cell targeting agents;\n* Use of systemic or absorbable topical corticosteroids therapy(≥ 10 mg\u002Fday prednisone or equivalent) two weeks prior to start of treatment.\n* Inadequate wash-out of prior therapies described per protocol, which may include anti-tumor therapies, tumor adjuvant drugs, organ or stem cell transplantation, moderate or strong CYP3A inhibitor or inducer, and vaccine;\n* Patients with major surgery within 4 weeks, severe or unstable systemic disease, unstable\u002Fsymptomatic CNS metastasis, other malignant tumors, autoimmune disease, ILD, clinical significant cardiac disease, bleeding or embolic disease, active infectious disease, conditions affecting drug swallow and absorption, medical history leading to chronic diarrhea, etc;\n* Pregnancy or lactation;\n* Other conditions considered not appropriate to participate in this trial by the investigators.",{"count":167,"type":20},110,[23],"A first-in-human study to evaluate the safety, tolerability and maximum tolerated dose (MTD) and establish the recommended phase 2 dose (RP2D) of BPI-371153, a PD-L1 Inhibitor, in patients with advanced solid tumors or relapsed\u002Frefractory lymphoma.",[149,171,104,172],"Lymphoma","HCC",{"date":152,"type":35},{"date":175,"type":35},"2022-08-29",{"date":177,"type":20},"2027-04",{"name":41,"class":42},4,{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":21,"phases":189,"briefSummary":190,"conditions":191,"keywords":193,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":66},"100565394","phase-1-a-phase-i-study-of-cft8919-in-patients-with-advanced-nsclc-100565394","NCT06641609","A Phase I Study of CFT8919 in Patients With Advanced NSCLC","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of CFT8919 Capsules in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC).","Inclusion Criteria:\n\n1. Dose-Escalation and Dose-Expansion Phases: Patients with histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the EGFR-L858R mutation, who have failed standard treatment (disease progression or intolerance), lack standard treatment options, or are deemed unsuitable for standard treatment by the investigator, or have refused standard treatment.\n2. Cohort-Expansion Phase: In addition to the above criteria, the following must also be met:\n\n   * Cohort A: Patients with locally advanced or metastatic NSCLC harboring the EGFR-L858R mutation who have experienced disease progression after third-generation EGFR-TKI treatment and carry secondary EGFR mutations (such as C797S, L718Q, G724S, S768I, etc.).\n   * Cohort B: Patients with locally advanced or metastatic NSCLC harboring the EGFR-L858R mutation who have failed standard treatment or are unsuitable for or have refused standard treatment (patients with secondary EGFR mutations are prioritized for Cohort A).\n3. • Dose-Escalation Phase requires evaluable lesions, while Dose-Expansion and Cohort-Expansion Phases require measurable lesions as defined by RECIST V1.1.\n4. • Age ≥18 years, no gender restrictions.\n5. • Expected survival ≥12 weeks.\n6. • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n7. • Adequate organ function, meeting the following criteria:\n\n   * Hematologic: Absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL (1500\u002Fmm³), platelets ≥100 × 10⁹\u002FL, hemoglobin ≥9 g\u002FdL (90 g\u002FL) without transfusion or hematopoietic growth factors within 14 days prior to screening.\n   * Coagulation: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5 × the upper limit of normal (ULN).\n   * Liver: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN, or ≤5.0 × ULN in the presence of liver metastases; total bilirubin (TBIL) ≤1.5 × ULN, or ≤3.0 × ULN in the presence of liver metastases or known Gilbert\\'s syndrome (unconjugated hyperbilirubinemia).\n   * Kidney: Serum creatinine (Scr) ≤1.5 × ULN, or for patients with Scr \\>1.5 × ULN, creatinine clearance (Ccr) ≥50 mL\u002Fmin (calculated using the Cockcroft-Gault formula); urine protein ≤1+, or if ≥2+, 24-hour urine protein quantification showing \\<1 g.\n8. • Toxicity from prior anti-tumor treatments must have resolved to CTCAE grade ≤1 (except for toxicities that, in the investigator\\'s judgment, are long-lasting and non-recoverable but pose no safety risk and are ≤2 in grade).\n9. • Patients must have been previously diagnosed with the EGFR-L858R mutation via local testing. In the Dose-Escalation and Dose-Expansion Phases, patients who progressed on prior EGFR-TKI treatment must provide the genetic mutation results from their most recent EGFR-TKI treatment. For Cohort A patients, progression on third-generation EGFR-TKI treatment must have confirmed the presence of secondary EGFR mutations (e.g., C797S, L718Q, G724S, S768I) via tissue or blood tests.\n10. • Patients must be willing to provide blood samples and optionally provide tissue samples for exploratory biomarker research.\n11. • Non-breastfeeding women of childbearing potential must have a negative serum or urine pregnancy test within 7 days before starting study treatment, and all enrolled patients must agree to use medically accepted contraception for 1 month prior to treatment, during the entire treatment period, and for 3 months after completing treatment.\n12. • Signed informed consent form.\n\nExclusion Criteria:\n\n1. Prior or ongoing treatment with EGFR-L858R-targeted PROTAC therapies.\n2. Less than 5 half-lives or 4 weeks (whichever is shorter) since the last anti-tumor treatment before the first dose of study drug; less than 6 weeks since the last treatment with nitrosoureas or mitomycin C; less than 1 week since the last anti-tumor herbal treatment.\n3. Patients who underwent major surgery (as defined by the investigator) or experienced significant trauma within 4 weeks before the first dose of study drug; patients who received radiation therapy within 4 weeks prior to the first dose, except for palliative radiation (e.g., for bone metastases to control pain) that is unlikely to affect bone marrow function, which may allow inclusion 2 weeks post-radiation.\n4. Patients with unstable central nervous system (CNS) metastases (those who have received treatment for brain metastases, have stable brain lesions, and have discontinued corticosteroids, anticonvulsants, or mannitol treatment for ≥2 weeks before the first dose may be considered for inclusion); patients with leptomeningeal metastases or spinal cord compression.\n5. History of other primary malignancies within the past 3 years, except for malignancies that have been treated curatively with no known active disease and a low risk of recurrence, or adequately treated non-melanoma skin cancers, cervical carcinoma in situ, or papillary thyroid carcinoma.\n6. Clinically significant cardiovascular diseases, including but not limited to:\n\n   * a) Unstable angina, acute myocardial infarction, or New York Heart Association (NYHA) class II-IV heart failure;\n   * b) Ventricular arrhythmias or conduction disorders requiring clinical intervention (e.g., complete left bundle branch block, third-degree atrioventricular \\[AV\\] block, or second-degree AV block);\n   * c) Uncontrolled atrial fibrillation or atrial flutter;\n   * d) Prolonged QTcF interval (resting mean QTcF \\>450 msec for men or \\>470 msec for women);\n   * e) Left ventricular ejection fraction (LVEF) \\<50% on echocardiography;\n   * f) Hypertension not controlled with medication.\n7. • History of interstitial lung disease (ILD) or non-infectious pneumonitis.\n8. • Adrenal insufficiency.\n9. • Use of proton pump inhibitors, strong CYP3A4 inhibitors or inducers, or P-glycoprotein inhibitors or inducers within 7 days before the first dose.\n10. • History of chronic diarrhea or diseases causing chronic diarrhea, such as Crohn\\'s disease or irritable bowel syndrome, or any condition that might affect drug absorption (e.g., continuous diarrhea \\>CTCAE grade 1 within 1 week prior to the first dose).\n11. • Known severe hypersensitivity to the study drug or any of its excipients.\n12. • History of deep vein thrombosis, pulmonary embolism, or any other serious thromboembolic events within 6 months before the first dose, except for catheter-related or superficial venous thrombosis, or lacunar infarcts.\n13. • Clinically significant gastrointestinal bleeding or hemoptysis within 3 months before the first dose, or any other significant bleeding history (e.g., pulmonary hemorrhage).\n14. • Clinically significant third-space fluid accumulation (e.g., uncontrolled ascites, pleural effusion, or pericardial effusion requiring repeated drainage).\n15. • Receipt of autologous transplantation within 3 months or allogeneic organ or stem cell transplantation within 6 months prior to the first dose.\n16. • Active hepatitis B virus (HBV) infection (screening positive for HBsAg or anti-HBc, and HBV DNA levels above the detection limit; patients with stable disease for at least 4 weeks after antiviral therapy may be included), active hepatitis C virus (HCV) infection (positive HCV antibodies and detectable HCV RNA), human immunodeficiency virus (HIV) infection, or active syphilis infection.\n17. • Active infection requiring systemic treatment within 1 week before the first dose.\n18. • History of substance abuse or any condition that, in the investigator\\'s judgment, may interfere with study participation or assessment of study results, or any unstable condition that may compromise patient safety or compliance.",{"count":188,"type":20},166,[23],"The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of CFT8919 capsules in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying EGFR mutations. The main questions it aims to answer are:\n\n* What is the maximum tolerated dose (MTD) of CFT8919?\n* Does CFT8919 demonstrate antitumor activity in these patients?\n\nParticipants will:\n\n* Take CFT8919 capsules at different doses.\n* Undergo regular assessments for safety, pharmacokinetics, and tumor response. Researchers will compare different dose levels to determine the best balance between safety and efficacy.",[192],"Non-Small Cell Lung Cancer With EGFR Mutation",[194,195],"Non-small cell lung cancer","EGFR mutation","2024-10-12",{"date":198,"type":35},"2024-10-15",{"date":200,"type":20},"2024-12-13",{"date":202,"type":20},"2026-04-03",{"name":41,"class":42},{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":21,"phases":213,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":66},"100465504","phase-3-ensartinib-as-adjuvant-treatment-in-anaplastic-lymphoma-kinase-alk-positive-non-small-cell-lung-cancer-100465504","NCT05341583","Ensartinib as Adjuvant Treatment in Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer","A Phase Ⅲ, Double-blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of Ensartinib Versus Placebo as Adjuvant Therapy in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive Stage IB- IIIB Non-small Cell Lung Cancer.","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of primary non-small cell carcinoma of the lung.\n* Patients must be classified post-operatively as Stage IB-IIIB(T3N2M0) on the basis of pathologic criteria after complete surgical resection(R0).\n* Complete recovery from surgery and standard post-operative therapy (if applicable) at the time of randomization.\n* Confirmation by the central laboratory that the tumour harbours ALK positive.\n* At least 1-year life expectancy.\n* Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1.\n* The laboratory test values should meet the following requirements:\n\n  1. Absolute neutrophil count ≥ 1.5 x 109\u002FL , Platelets ≥ 100 x 109\u002FL ，hemoglobin ≥9g\u002FdL\n  2. Total bilirubin≤ 1.5 x institutional upper limit of normal,AST and ALT≤ 2.5 x institutional upper limit of normal\n  3. Creatinine≤ 1.5 x institutional upper limit of normal ,if not, Creatinine Clearance ≥ 50 ml\u002Fmin\n  4. International normalized ratio (INR) and prothrombin time ≤1.5 x institutional upper limit of normal; and activated partial thromboplastin time (aPTT) ≤1.5 x institutional upper limit of normal\n* Female patients must have a negative pregnancy test at baseline.\n\nExclusion Criteria:\n\n* Patients who are participating in other clinical studies or are receiving other investigational drugs , or investigational devices within 4 weeks before the first dose of our study drugs. If patients are participating in non-interventional clinical trials, they can be included in this study.\n* Patients who have a presence of unresectable or metastatic disease, the pathological diagnosis show the microscopically positive surgical margins or extranodal invasion, or residual disease of surgery，or had only segmentectomies or wedge resections.\n* Patients with superior sulcus cancer.\n* Patients who have received a surgery with total right lung resection.\n* History of other malignancies within 5 years of the first dose of the study drug, except: malignant tumors that can be expected to recover after treatment.\n* Prior treatment with other anti-cancer treatments or NSCLC including chemotherapy, radiotherapy, targeted therapy (such as small molecule tyrosine kinase inhibitors targeting EGFR, VEGFR or other pathways, monoclonal antibodies, etc.), immunotherapy, investigational therapy, etc. but except platinum based chemotherapy for adjuvant therapy.\n* Major surgery within 3 weeks of the first dose of the study drug.\n* Patients who have used traditional Chinese medicines and traditional Chinese medicine preparations with indications for anti-tumor therapy or adjuvant therapy for tumors within 14 days of the first dose of the study drug.\n* Patients who have used the following drugs within 14 days before the first dose : strong inhibitors, strong inducers of CYP3A or CYP3A substrates with a narrow therapeutic index.\n* Patients who have severe cardiovascular disease.\n* Patients with a known allergy to Tartrazine，a dye used in 100mg capsules.\n* Severe active infection, interstitial lung disease\u002Fpneumonitis, or any serious underlying disease that may interfere with the subject's treatment with the regimen within 2 weeks prior to the first dose of study drug.\n* Active HIV virus antibody,Treponema pallidum antibody positive.\n* Active hepatitis B, hepatitis C virus antibody positive, or active tuberculosis.\n* Presence of active gastrointestinal (GI) disease or other conditions that will interfere significantly with the absorption, distribution, metabolism, or excretion of study drugs.\n* According to the judgment of the investigator, other conditions may affect the compliance of the protocol or affect the subject's signing of the informed consent, or is not suitable for participating in this clinical trial.",{"count":212,"type":20},202,[214],"PHASE3","This double-blind, randomized, placebo-controlled, multicenter, Phase III study is designed to evaluate the efficacy and safety of ensatinib compared with placebo as adjuvant treatment in ALK positive stage II-IIIB non-small cell lung cancer after surgical resection with or without chemotherapy.",[217],"Non-small Cell Lung Cancer","2024-08-21",{"date":220,"type":35},"2024-08-23",{"date":222,"type":35},"2022-05-24",{"date":224,"type":20},"2025-07-23",{"name":41,"class":42},{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":233,"sex":16,"minAge":17,"maxAge":234,"enrollmentInfo":235,"targetDuration":4,"studyType":21,"phases":237,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":66},"100553933","phase-1-a-study-to-evaluate-the-effect-of-rifampicin-or-ltraconazole-on-pharmacokinetics-of-ensartinib-in-healthy-volunteers-100553933","NCT06492525","A Study To Evaluate The Effect Of Rifampicin Or Ltraconazole On Pharmacokinetics Of Ensartinib In Healthy Volunteers","A Phase 1, Open-label, 2-period, Fixed Sequence, Cross-over Study To Investigate The Effect Of Multiple Doses Of Rifampicin Or Itraconazole On The Pharmacokinetics Of Single Dose Ensartinib In Healthy Volunteers.","Inclusion Criteria:\n\n* Male body weight ≥ 50kg, female body weight ≥ 45kg, body mass index (BMI) within the range of 19 \\~ 26kg \u002Fm2;\n* Clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator;\n* The subjects should took effective contraceptive measures voluntarily from informed consent until 3 months after Study Completion；\n* Able to comprehend and willing to sign an informed consent form.\n\nExclusion Criteria:\n\n* Those with a history of chronic systemic or serious diseases such as cardiovascular, liver, kidney, lung, gastrointestinal, nervous, musculoskeletal, hematopoietic or metabolic diseases, especially surgical conditions or conditions that may affect drug absorption, distribution, metabolism and excretion；\n* Family history or presence of long QTc syndrome; History or presence of an abnormal ECG；\n* Hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), treponema pallidum antibody or human immunodeficiency virus antigen\u002Fantibody (HIV-Ag\u002FAb) is positive；\n* Use of any medications (prescription drugs, over-the-counter drugs, Chinese herbal medicines, health products, moderate or strong CYP3A inhibitors or inducers, etc) within 14 days prior to the first administration；\n* Those who have special dietary requirements (habitual consumption of grapefruit juice or excessive tea, coffee and\u002For caffeinated beverages) and are unable to withdraw during the trial；\n* Drug abusers, smokers or alcoholics；\n* Those with a history of fear of needles and hemophobia, difficulty in blood collection or inability to tolerate venipuncture blood collection;\n* Donation of blood ≥ 400 mL or receipt of blood products within 3 months before enrollment;\n* Receive any vaccine within 1 months before enrollment；\n* Participation in any other investigational drug study within 3 months before enrollment；\n* History of significant hypersensitivity to any drug compound or food；\n* Other conditions that, in the opinion of the investigator, are not suitable for the subject to participate in this study.",true,"45 Years",{"count":236,"type":20},36,[23],"The purpose of this study is to estimate the effect of rifampicin or itraconazole on the single dose PK of ensartinib.",[240],"Healthy","2024-07-01",{"date":243,"type":35},"2024-07-09",{"date":245,"type":20},"2024-07",{"date":247,"type":20},"2024-12",{"name":41,"class":42},{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":21,"phases":258,"briefSummary":259,"conditions":260,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":271},"100519302","phase-3-adjuvant-befotertinib-in-stage-ib-iiib-non-small-cell-lung-cancer-with-positive-egfr-sensitive-mutations-100519302","NCT06041776","Adjuvant Befotertinib in Stage IB-IIIB Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations","A Multicenter, Randomized, Controlled, Double Blind, Double Simulated, Phase III Clinical Study of Befotertinib vs Icotinib for Postoperative Adjuvant Treatment of IB-IIIB (T3N2M0) Stage Non Small Cell Lung Cancer With Positive EGFR Sensitive Mutations","Inclusion Criteria:\n\n1. Willingness to sign informed consent prior to any study specific procedures, and ability to with scheduled visits, treatment plans, laboratory tests, and other study procedures.\n2. Male or female, aged at least 18 years.\n3. Histologically confirmed primary NSCLC, and mainly non-squamous cell carcinoma (including mixed type carcinoma mainly composed of adenocarcinoma components).\n4. Absence of brain metastasis.\n5. Complete resection of histologically confirmed Stage IB, II, IIIA or IIIB(T3N2M0) according to the TNM staging system for lung cancer (AJCC\u002FUICC 8th edition), with negative margins.\n6. Confirmation by the central laboratory that the tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R).\n7. Patients who fully recover from surgery during randomization (any surgery must achieve complete postoperative wound healing) and should receive adjuvant treatment within 4-10 weeks after surgery.\n8. ECOG-PS score of 0 or 1 and did not deteriorate 2 weeks before the first administration of the investigational drug, with a minimum expected survival greater than 12 weeks.\n9. Female subjects with fertility need to have a negative serum pregnancy test during screening.\n10. Female subjects who have possibility of becoming pregnant, as well as male subjects whose partners are women of childbearing age, must use a highly effective contraceptive method (such as oral contraceptives, intrauterine devices, abstinence or barrier contraception combined with spermicides) throughout the study and continue to use contraception for 3 months after the end of treatment.\n\nExclusion Criteria:\n\n1. There are unresectable or metastatic diseases, pathological reports showing positive surgical margins under the microscope or extranodal invasion, or lesions left after surgery, or suspicious lesions determined by imaging after surgery. Subjects receiving only wedge resection.\n2. Upper lung groove cancer.\n3. Patient with complete resection of the right lung with NSCLC.\n4. Malignancies other than NSCLC within 5 years prior to first dosage, except for malignant tumors that can be cured after treatment (including but not limited to fully treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or breast ductal carcinoma in situ treated with radical surgery).\n5. Received systematic anti-tumor therapy, including chemotherapy, radiotherapy or targeted therapy (including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitors), immunotherapy, investigational therapy, etc., before being enrolled in this study.\n6. Within 3 weeks prior to the first administration of the investigational drug, the patient underwent major surgery (including primary tumor surgery, craniotomy, thoracotomy, or laparotomy, excluding vascular pathway establishment procedures).\n7. Within 14 days prior to first dose of the investigational drug, Traditional Chinese medicine with anti-tumor indications have been received.\n8. After the start of the study, any form of systemic or local anti-tumor treatment (including maintenance therapy with another drug, radiotherapy, and\u002For surgical resection) is still required.\n9. Clinically significant cardiovascular diseases, including:\n\n   1. QTcF interval \\>450 ms (men) or \\>470 ms (women), symptomatic bradycardia (\\\u003C45 beats \u002Fmin), or other significant ECG abnormalities as determined by the investigator (e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval \\>250 msec).\n   2. Echocardiography showed LVEF \\\u003C50%.\n   3. Hypertension was clinically uncontrollable (e.g., blood pressure \\>160\u002F100 mmHg; Except that isolated elevated readings that were determined by the investigators to be clinically insignificant or controllable hypertension.)\n\n   Within 6 months before the first medication, there were the following situations:\n   1. Congestive heart failure (New York Heart Association rating III or IV).\n   2. Arrhythmias or conduction abnormalities that require medication treatment. Note: Patients with drug-controlled atrial fibrillation\u002Fflutter, as well as those with pacemaker- controlled arrhythmia, can be selected.\n   3. Severe\u002Funstable angina, coronary artery\u002Fperipheral bypass grafting, or myocardial infarction (Note: Severe angina is classified as Grade III or IV by the Canadian Society of Cardiology).\n   4. Cerebrovascular accidents or transient ischemic attacks, transient myocardial ischemia.\n10. Previous history of concomitant interstitial lung disease (ILD), drug-induced ILD, radiation pneumonia requiring hormone therapy, or clinical evidence of concomitant active interstitial lung disease.\n11. Patients who have a history of thrombosis or are currently present with thrombosis or have a potential risk of thrombosis assessed by the investigator.\n12. Any clinical evidence of a serious active infection, or any serious concomitant disease that may affect the subject's acceptance of investigational drugs, such as active bleeding predisposition, active hepatitis B, hepatitis C, or tuberculosis, syphilis, or HIV antibody positive.\n13. There are serious gastrointestinal functional abnormalities in clinical practice that may affect drug intake, transportation, or absorption, such as inability to take medication orally, uncontrollable nausea or vomiting, history of extensive gastrointestinal resection, untreated recurrent diarrhea, atrophic gastritis, untreated stomach diseases requiring long-term use of proton pump inhibitors, gastrointestinal obstruction, active diverticulitis, Crohn's disease, ulcerative colitis, etc.\n14. Abnormal laboratory parameters.\n15. Known hypersensitivity to the befotertinib, icotinib or their inactive excipients.\n16. Within one week before the first administration of the investigational drug, it is currently in use or needs to be combined with CYP3A strong inhibitors or inducers during the study period.\n17. Patients who are still using warfarin within 7 days prior to initial dosing (low molecular weight heparin sodium is allowed).\n18. Participating in clinical research and receiving treatment with the study drug or research device, or participating in clinical research and receiving treatment with the study drug or research device within 4 weeks before the first administration, or planning to participate in any other clinical trial during this study period.\n19. Inoculate with a live vaccine within 180 days before the first medication.\n20. Researchers believe that it may affect protocol compliance or affect the signing of informed consent forms by participants (such as a history of mental illness or drug abuse, alcoholism or other addiction), or any other clinically significant disease or condition that is not suitable for participation in this clinical trial (such as laboratory abnormal results, clinically active diverticulitis, abdominal abscess).",{"count":257,"type":20},570,[214],"This multicenter, randomized, controlled, double-blind, double-simulated, Phase III study is designed to evaluate the efficacy and safety of Befotertinib compared with Icotinib as adjuvant treatment in EGFR-sensitive mutation-positive stage IB-IIIB (T3N2M0) non-small cell lung cancer after surgical resection.",[80,261,262],"EGFR Sensitive Mutation","Adjuvant Therapy","2023-09-20",{"date":265,"type":35},"2023-09-22",{"date":267,"type":35},"2023-03-28",{"date":269,"type":20},"2029-11-30",{"name":41,"class":42},3,{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":279,"targetDuration":4,"studyType":21,"phases":281,"briefSummary":282,"conditions":283,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":271},"100517286","phase-1-study-of-mcla-129-combined-with-befotertinib-in-the-treatment-of-advanced-non-small-cell-lung-cancer-with-egfr-sensitive-mutation-100517286","NCT06015568","Study of MCLA-129 Combined With Befotertinib in the Treatment of Advanced Non-small Cell Lung Cancer With EGFR Sensitive Mutation","Phase I Study of Anti-EGFR\u002Fc-Met Bispecific Antibody MCLA-129 Combined With Befotertinib in Patients of Advanced Non-small Cell Lung Cancer With EGFR Sensitive Mutation To Evaluate The Safety, Pharmacokinetic Characteristics and Antitumor Activity","Inclusion Criteria:\n\n* Age from 18 to 75 years.\n* Histologically or cytologically confirmed locally advanced or metastatic NSCLC that is not suitable for radical surgery or radiotherapy, and harbored EGFR exon 19 deletion or exon 21 L858R mutation( either alone or in combination with other EGFR mutations) in NSCLC assessed by genetic testing.\n* For Part 1: patients with advanced NSCLC must be progression, or intolerance, or rejected to standard therapy(subjects treated with Befotertinib must be progression of the disease).\n* For Part 2, each cohort is defined as follows:\n\n  * Cohort A: Previously diagnosed EGFR-sensitive mutations and no systemic antitumor therapy for locally advanced or metastatic NSCLC.\n  * Cohort B: Advanced NSCLC patients with previously diagnosed EGFR-sensitive mutations and third generation EGFR-TKI resistance.\n  * Cohort C: Advanced NSCLC patients who had previously been diagnosed with EGFR-sensitive mutations and first or second EGFR-TKI resistance.\n\nPatients in cohorts B and C must also resistance, or intolerance, or rejection of platinum-containing chemotherapy.\n\n•Patients of the dose escalation phase in Part 1 must have evaluable diseases, and others must have measurable diseases as defined in RECIST V1.1 definition.\n\nNote: The selected target lesions must meet one of two criteria: 1) no previous local treatment or 2) subsequent progression within the previous local treatment area as determined by RECIST V1.1.\n\n* Eastern Cooperative Oncology Group (ECOG) performance status scores are 0-1.\n* Expected survival is ≥3 months.\n* With certain organ system functions (without transfusion, use of blood components, or G-CSF support within 14 days before testing), as defined below:\n\noAbsolute neutrophil count (ANC)≥1.5×10\\^9\u002FL oPlatelet count (PLT)≥100×10\\^9\u002FL oHemoglobin (HB)≥10 g\u002FdL oSerum albumin≥30 g\u002FL oTotal bilirubin≤1.5 times the upper limit of normal (ULN) oAlanine amino transferase ( ALT) and aspartate amino transferase (AST) ≤3×ULN oCreatinine≤1.5×ULN.If creatinine is\\>1.5×ULN, creatinine clearance is≥50 mL\u002Fmin as calculated by Cockcroft-Gault formula, or urinary creatinine clearance≥50 mL\u002Fmin within 24 hours as measured, the patients can still be enrolled.\n\n* Willing and able to follow the trial and follow-up procedures.\n* Capable of understanding the trial nature and voluntarily signing the written informed consent form.\n\nExclusion Criteria:\n\n* Use of certain investigational drug or antineoplastic agent within 14 days or 5 half lives (whichever is longer) before first administration of investigational drug (For drugs with a longer half-life, a maximum of 4 weeks is required from the last administration; 6 weeks for chemotherapy with delayed toxicity, such as Nitroso urea or Mitomycin C).\n* Execution of large surgery and radiotherapy (except focal palliative radiotherapy at least 2 weeks before first administration) within 4 weeks before first administration.\n* For the dose extension stage of part 2 and part 2: having previously received systemic anti-tumor therapy exceeding three lines (excluding maintenance therapy).\n* Previously received EGFR\u002Fc-Met bispecific antibody drugs (such as JNJ-61186372, EMB-01, or GB263T) for treatment.\n* Prior to the first administration of the study drug, previous treatment-related toxic reactions did not alleviate to level 1 or below (CTCAE 5.0 standard), except for hair loss.\n* With other malignant tumors in the past 3 years, except cancers that have been cured significantly or can be focally cured, e.g. basosquamous carcinoma of skin, carcinoma cervix in situ, or in situ breast carcinoma.\n* Primary malignant tumor of the central nervous system, meningeal metastasis, or brain metastasis with spinal cord compression, or risk of cerebral hemorrhage, or symptomatic brain metastasis, or unstable brain metastasis requiring steroid and\u002For dehydration to reduce intracranial pressure 2 weeks before enrollment (subjects with brain metastases who are Asymptomatic or stable for more than 2 weeks after treatment and do not need steroids and\u002For dehydration to reduce intracranial pressure can be included in the group).\n* With clinically significant cardiovascular disorder, including but not limited to:\n\n  * Arterial thromboembolism, deep vein thrombosis or lung embolism diagnosed within 3 month before first administration of the investigational drug. Non- obstructive catheter related clot and other clinically irrelevant thrombosis are not included in the exclusion criteria. Patients with a history of related thrombosis diagnosed 3 months ago must be clinically stable for at least 4 weeks before initial administration.\n  * With any of the following medical history within 6 months before first administration of the investigational drug: myocardial infarction, unstable angina, stroke, transient ischemic attack, coronary or peripheral artery bypass, or any acute coronary syndrome.\n  * With abnormal ECG corrected QT interval (QTcF) at rest in the screening period. Remeasurement is made twice at intervals of more than 5 minutes. For average QTcF of 3 times ECG inspections: male: ≥ 450 msec, and female: ≥ 470 msec. With clinically significant abnormal heart rate, conduction, and ECG form at rest, e.g. complete left bundle branch block, third-degree conduction block, second-degree conduction block, and PR interval \\> 250 msec, double law, triple law, preexcitation syndrome, etc.\n  * Poorly controlled hypertension in the investigator's opinion (systolic blood pressure \\> 180 mmHg, or diastolic blood pressure \\> 100 mmHg).\n  * New York Heart Association Grade III-IV congestive heart failure, or hospitalization due to congestive heart failure within 6 months before first administration of the investigational drug.\n  * Pericarditis\u002Fclinically significant pericardial effusion.\n  * Cardiomyopathy.\n  * ther clinically significant cardiovascular disordesr as believed by investigators.\n* Active hepatitis B (hepatitis B surface antigen (HBsAg) positive and serum HBV DNA quantitative results higher than or equal to the detection limit), hepatitis C virus antibody, HIV antibody and treponema pallidum antibody positive (subjects who have a history of HCV and have completed antiviral treatment, and whose laboratory test results show that HCV-RNA is below the lower limit of quantification, can be selected for the study; those who test negative for syphilis titer can be selected).\n* Patients with Interstitial lung disease, including drug-induced Interstitial lung disease or radiation pneumonia requiring long-term use of steroids or other Immunosuppressive drug in the past 1 year.\n* Subjects with active gastrointestinal (GI) disease, or with a risk of GI perforation, or with other diseases that significantly interfere with the absorption, distribution, metabolism, or excretion of investigational drugs. Including but not limited to: unable to take oral medicine, uncontrollable nausea or vomiting, Bowel obstruction, inflammatory bowel disease or extensive intestinal resection, etc.\n* Current severe disease or medical condition, including but not limited to uncontrolled active infection, uncontrollable pleural or abdominal effusion, and clinically significant lung, metabolic or psychiatric disorders.\n* Women with child bearing potential, pregnant women or lactating women with pregnancy test positive 7 days before treatment, and male and female unwilling to take effective contraception measures or having a birth plan during the treatment and within 3 months after end of treatment.\n* Subjects with a history of allergies or suspected allergic symptoms to the study drug MCLA-129, Befotertinib, or any component of both study drugs (see the investigator's brochure).\n* Within one week before the first administration of the investigational drug, it is currently in use or needs to be combined with CYP3A strong inhibitors or inducers during the study period.\n* Subjects still using Warfarin within 7 days before the first administration (low molecular weight heparin sodium is allowed).\n* Patients poorly compliant, unable or unwilling to follow the study and\u002For follow-up procedures listed in the protocol, or unsuitable to participate in this trial in the investigator's opinion.",{"count":280,"type":20},172,[23],"To evaluate the safety and tolerance of MCLA-129 combined with Befotertinib in patients with advanced non-small cell lung cancer with EGFR-sensitive mutations.",[284],"Non-Small Cell Lung Cancer、EGFR Sensitive Mutation","2023-08-28",{"date":287,"type":35},"2023-08-29",{"date":289,"type":20},"2023-09-01",{"date":291,"type":20},"2029-07-04",{"name":41,"class":42},""]