[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Beijing Pearl Biotechnology Limited Liability Company\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":90},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100587623","phase-3-a-study-of-vebreltinib-and-platinum-containing-double-agents-in-subjects-with-met-positive-100587623",false,"NCT06930794","A Study of Vebreltinib and Platinum-Containing Double Agents in Subjects With MET-Positive","An Open-label, Randomized, Controlled, Multicenter Phase IIIb Clinical Study to Evaluate the Efficacy and Safety of Vebreltinib Enteric Capsule Combined With Platinum-based Doublet Chemotherapy Compared With Platinum-based Doublet Chemotherapy in Subjects With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Who Have Not Received Previous Systemic Treatment and MET-Positive","KUNPENG-3","Inclusion Criteria:\n\n1. male or female subjects ≥ 18 years of age at the time of signing ICF.\n2. histologically or cytologically confirmed diagnosis of non-radical, locally advanced (Stage IIIB and IIIC) or metastatic (Stage IV) non-squamous cell type NSCLC (refer to the American Joint Committee on Cancer \\[AJCC\\] Lung Cancer Stages, 8th edition for lung cancer staging criteria).\n3. Part 1 (introductory stage)Subjects with MET-positive (MET amplification or MET overexpression) tumors will be enrolled. MET amplification is defined as the presence of MET amplification confirmed by second-generation sequencing (NGS) or fluorescence in situ hybridization (FISH) with a mean MET GCN ≥ 4 cells\u002Fcell or MET\u002FCEP7 ≥ 2. MET overexpression is defined as c-Met showing strong positive (3+) staining in ≥50% of tumor cells as determined by immunohistochemistry (IHC) (central laboratory results). And subjects are required to provide sufficient tumor tissue (archived or fresh samples) for retrospective analysis in the central laboratory (see Laboratory Manual) to support the development of concomitant diagnostic reagents required for the marketing of Vebreltinib. Part 2 (Randomized Control Phase) MET amplification is defined as subjects' tumor tissue (archived or fresh samples) with an average MET GCN ≥ 4 cells\u002Fcell or MET\u002FCEP7 ≥ 2 as confirmed by fluorescence in situ hybridization (FISH) in the central laboratory, and subjects will be required to provide sufficient tumor tissue (archived or fresh samples) for retrospective assay analysis by a central laboratory (see Laboratory Manual). Laboratory Manual) to support the development of concomitant diagnostic reagents required for the marketing of Vebreltinib.\n4. Part 1 (Lead-in Period): Documented evidence confirms that the tumor tissue specimen tested negative for sensitive epidermal growth factor receptor (EGFR) mutations (including exon 19 deletion, exon 21 L858R or L861Q mutations, exon 18 G719X mutations, exon 20 S768I\u002FT790M mutations, or exon 20 insertion mutations), ALK fusion-negative, ROS1 fusion-negative, and MET exon 14 skipping mutation-negative. Additionally, if the subject has already undergone testing for BRAF V600E mutation, NTRK fusion, RET fusion, or ERBB2 (HER-2) mutation, the results must be negative.\n\n   Part 2 (Randomized Controlled Period): Documented evidence confirms that the tumor tissue specimen tested negative for sensitive EGFR mutations (including exon 19 deletion, exon 21 L858R or L861Q mutations, exon 18 G719X mutations, exon 20 S768I\u002FT790M mutations, or exon 20 insertion mutations), ALK fusion-negative, ROS1 fusion-negative, and MET exon 14 skipping mutation-negative. Additionally, if the subject has already undergone testing for BRAF V600E mutation, KRAS mutation, NTRK fusion, RET fusion, or ERBB2 (HER-2) mutation, the results must be negative.\n5. no prior systemic therapy for locally advanced or metastatic non-squamous NSCLC. Note: Subjects are permitted to receive neoadjuvant\u002Fadjuvant therapy as long as the relevant therapy has been completed for at least 6 months prior to disease diagnosis of locally progressive or metastatic tumor.\n6. at least one measurable target lesion as defined by the Response to Criteria for Evaluation of Efficacy in Solid Tumors (RECIST) V1.1 criteria (see Chapter 10.4).\n7. ECOG PS ≤ 1.\n8. expected survival ≥ 12 weeks as determined by the investigator.\n9. good organ function as determined by medical evaluation (within 7 days prior to first study dose), including:\n\n   * Good hematologic status, defined as absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL, hemoglobin ≥ 90 g\u002FL, platelets ≥ 100 x 10\\^9\u002FL. No platelet transfusions within 3 days prior to the test, no red blood cell transfusions within 14 days prior to the test, and no hematopoietic growth factor therapy within 7 days prior to the test (polyethylene glycolated granulocyte colony-stimulating factor \\[G-CSF\\] or erythropoietin \\[EPO\\] within 14 days prior to testing).\n   * Good hepatic function, defined as serum TBIL ≤ 1.5 x ULN (TBIL ≤ 3 x ULN and direct bilirubin \\[DBIL\\] ≤ 1.5 x ULN in subjects known to have Gilbert's syndrome), serum ALT\u002FAST ≤ 2.5 x ULN (≤ 5.0 x ULN for subjects with confirmed liver metastases) .\n   * The organ function is well-determined by medical evaluation (within 7 days prior to the first study drug administration), including:\n   * Good renal function , defined as: creatinine clearance rate ≥50 mL\u002Fmin (≥60 mL\u002Fmin for those receiving cisplatin, calculated using the Cockcroft-Gault formula).\n   * Good coagulation function, defined as (including when receiving anticoagulation): prothrombin time (PT) \\\u003C 1.5 x ULN and activated partial thromboplastin time (APTT) \\\u003C 1.5 x ULN If subjects are receiving anticoagulant therapy, they must have received a stabilized dose of anticoagulant for at least 1 month prior to the first study dose.\n10. Female subjects must be using adequate contraception and not breastfeeding during study participation and for 90 days after completion of study treatment; female subjects of childbearing potential must have had a serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test performed within 7 days prior to the first dose of the drug and be negative; and female subjects of no childbearing potential must meet one of the following criteria at screening:\n\n    * Reached postmenopausal status, refer to the NCCN Breast Cancer Guidelines (2024 V3.0) for a detailed definition of menopause.\n    * Have undergone and documented irreversible sterilization such as hysterectomy, bilateral salpingo-oophorectomy, or bilateral salpingo-oophorectomy (not tubal ligation).\n11. Male subjects of childbearing potential must use adequate contraception (e.g., barrier methods of contraception) during study participation and for 90 days after completion of study treatment. Male subjects must also refrain from sperm donation during study participation and for 90 days after the last dose of study treatment.\n12. be able to provide a signed ICF that complies with the requirements and restrictions outlined in the ICF and this study protocol.\n\nExclusion Criteria:\n\n1. has participated in another therapeutic clinical trial within 28 days prior to the first study dose.\n2. have undergone major surgery within 28 days prior to the first study dose or anticipate the need for major surgery during the study period. Diagnostic procedures such as thoracoscopic biopsy and mediastinoscopy may be enrolled 7 days after the procedure. No waiting period is required after implantable infusion port and catheter placement.\n3. lung field or whole brain radiotherapy within 28 days prior to first study dose or palliative localized radiotherapy within 14 days prior to first study dose.\n4. have received a proprietary Chinese medicine with an antitumor indication within 1 week prior to the first study dose. Has received local antitumor drug therapy (e.g., thoracic or abdominal perfusion, etc.) within 14 days or 5 half-lives, whichever is shorter, prior to the first study dose.\n5. a history of another primary malignancy diagnosed or requiring treatment within the past 3 years (with the exception of localized basal cell carcinoma of the skin or squamous cell carcinoma of the skin, which has been adequately treated, or any other carcinoma in situ currently in complete remission)\n6. toxicity from prior therapy that has not returned to ≤ Grade 1 or baseline levels (as assessed by NCI-CTCAE v5.0), except for alopecia, skin pigmentation, and any other toxicity that is assessed by the investigator to be stable and does not affect the safety of participation in this study\n7. presence of clinically symptomatic CNS metastases. Note: Subjects with symptomatic CNS metastases may be enrolled in the study after they have been treated and their symptoms are controlled, have no lesion progression for at least 2 weeks during the Screening Period as confirmed by clinical and imaging studies, and have not had an increase in their steroid dose (\\\u003C10 mg\u002Fday of prednisolone or its equivalent) for the management of CNS symptoms in the 4 weeks prior to the first study dose.\n\n   Those with combined carcinomatous meningitis or meningeal spread or spinal cord compression were not eligible for enrollment, regardless of whether they had clinical symptoms.\n8. subjects with poorly controlled clinical third space effusions, including but not limited to pleural effusions, abdominal effusions, or pericardial effusions, who, in the judgment of the investigator, are not suitable for enrollment.\n9. presence of severe cardiovascular or cerebrovascular disease, including but not limited to:\n\n   * Mean QT interval (QTcF) corrected by the Fridericia formula from three ECG examinations at rest \\> 470 ms.\n   * Symptomatic heart failure with a New York Heart Association (NYHA) cardiac function classification of II or higher (see Chapter 10.6).\n   * Echocardiographic (ECHO) assessment showing a baseline left ventricular ejection fraction (LVEF) below the lower limit of institutional normal (LLN) or \\\u003C50%.\n   * Any clinically significant rhythmic, conduction, or morphologic abnormality as demonstrated by resting ECG results, such as complete left bundle branch block, third-degree heart block, and ventricular arrhythmias requiring antiarrhythmic drug therapy.\n   * Presence of any factor that increases the risk of QTc prolongation or the risk of arrhythmia, such as heart failure, Severe hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or use of any comorbid medication known to prolong the QT interval within 14 days prior to the first dose of study treatment.\n   * Any of the following within 6 months prior to first study administration: myocardial infarction, severe\u002Funstable angina, coronary artery bypass grafting, congestive heart failure, cardiomyopathy, pulmonary embolism, cerebrovascular accident, or transient ischemic attack.\n10. the presence of serious or uncontrolled systemic disease, as judged by the Investigator, including but not limited to:\n\n    * Uncontrolled hypertension, defined as a systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg despite pharmacological treatment Subjects with a history of hypertension will be allowed to enroll if their blood pressure control is stable on antihypertensive therapy and within the above ranges.\n    * Current unstable or clinically significant interstitial lung disease or interstitial pneumonia, or high risk of interstitial lung disease or interstitial pneumonia (e.g., interfering with activities of daily living or requiring therapeutic intervention).\n    * Unstable or decompensated other systemic disease, deep vein thrombosis, active bleeding, etc.\n11. presence of uncontrolled co-infections, including but not limited to:\n\n    \\- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. If hepatitis B surface antigen (HBsAg) positive, HBV DNA testing should be performed. If the HBV DNA test value is ≤500 IU\u002FmL (or 2000 copies\u002FmL), the subject is eligible to participate in the study.\n\n    If HCV antibody positive, HCV RNA testing should be performed. If HCV RNA is negative, the subject is eligible to participate in the study.\n    * Known human immunodeficiency virus (HIV) infection or known history of acquired immunodeficiency syndrome (AIDS).\n    * Active Syphilis positive infection.\n    * Active tuberculosis infection.\n    * Other active infection requiring systemic therapy within 14 days prior to the first study dose.\n12. presence of dysphagia, or active gastrointestinal disease, or major gastrointestinal surgery that may interfere with the administration or absorption of Vebreltinib (e.g., refractory nausea\u002Fvomiting\u002Fdiarrhea, ulcerative lesions, malabsorption syndrome, etc.).\n13. hypersensitivity to Pertinib or its excipients, or history of allergic reaction to drugs with similar chemical or biological structure or analogs to Pertinib, or history of severe allergic reaction to Pemetrexed, Cisplatin, Carboplatin (NCI CTCAE v5.0 ≥ Grade 3).\n14. have received any live attenuated vaccination within 30 days prior to the first study dose.\n15. known psychiatric or substance abuse disorders that may affect study compliance.\n16. the presence of other conditions that, in the investigator's assessment, make participation in the study inappropriate, such as participation in a study that, in the investigator's opinion, is not in the subject's best interest, or that may increase the risk of toxicity, or that may interfere with absorption, distribution, metabolism, or excretion of the study medication, or that may impair the assessment of study results, or that the subject is not able to comply with the study protocols and study limitations.","ALL","18 Years",{"count":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study is an open-label, randomized, controlled, multicenter Phase IIIb clinical study, aiming to evaluate the efficacy, safety, and tolerability of Vebreltinib Enteric Capsule combined with platinum-based doublet chemotherapy compared with platinum-based doublet chemotherapy in treating subjects with locally advanced or metastatic non-squamous NSCLC who have not received previous systemic treatment and MET-positive.\n\nThe target population of this study is subjects with histologically confirmed locally advanced or metastatic non-squamous NSCLC who have not received previous systemic anti-tumor treatment and MET-positive( MET Amplification or Overexpression).\n\nThis study adopts an enrichment design. The enriched population is those with MET GCN ≥ 6, and the overall population is those with MET GCN ≥ 4.\n\nThis study consists of two parts: the lead-in period (Part 1) and the randomized controlled period (Part 2). Both the lead-in period (Part 1) and the randomized controlled period (Part 2) will include a screening period (from Day -28 to Day -1), a treatment period (until the termination of treatment), and a follow-up period (including safety follow-up and survival follow-up).",[27],"Non-Small Cell Lung Cancer","RECRUITING","2026-04-30",{"date":31,"type":32},"2026-05-01","ACTUAL",{"date":34,"type":32},"2025-07-07",{"date":36,"type":21},"2030-02",{"name":38,"class":39},"Beijing Pearl Biotechnology Limited Liability Company","INDUSTRY",2,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100614865","phase-1-a-study-to-evaluate-ans014004-in-combination-with-egfr-tki-in-non-small-cell-lung-cancer-100614865","NCT07285148","A Study to Evaluate ANS014004 in Combination With EGFR-TKI in Non-Small Cell Lung Cancer","An Open-label, Multicenter Phase Ib\u002FII Study to Evaluate the Safety, Efficacy and Pharmacokinetic Characteristics of ANS014004 in Combination With EGFR-TKI in Patients With EGFR Mutation-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer","Inclusion Criteria\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n1. Male or female participants ≥18years of age at the time of signing the informed consent form.\n2. Patients with histologically or cytologically confirmed diagnosis of unresectable locally advanced (Stage IIIB and IIIC) or metastatic (Stage IV) NSCLC (according to the lung cancer staging criteria, refer to the eighth edition of the American Joint Committee on Cancer \\[AJCC\\] Lung Cancer Staging).\n3. Have a documented EGFR positive mutation (EGFR classic mutations including ex19del and ex21 L858R, uncommon mutations and ex20 insertion mutations) in tumor tissue samples or pleural fluid or blood samples.\n4. For Phase Ib dose escalation: have disease progression after the existing standard of care or intolerance to the existing standard of care or inappropriate or no effective standard of care is available (standard of care is defined as treatment recommended by the National Comprehensive Cancer Network \\[NCCN\\] guidelines \\[including but not limited to chemotherapy, radiotherapy, targeted therapy based on mutation status, immunotherapy, and surgery\\]). For participants who are considered intolerant to or ineligible for available standard therapy, or for whom effective standard therapy does not exist, the documentation of these reasons is required.\n\n   For Phase Ib dose optimization and Phase II study: have or haven't received prior standard systemic therapy for advanced disease.\n\n   Standard systemic therapy is referred to as (country-specific approved treatment will also be applied):\n   * EGFR classic mutations: EGFR-TKIs alone or in combination (examples, gefitinib and osimertinib with or without chemotherapy) for ex19del and ex21 L858R. Osimertinib or other third-generation EGFR TKI for T790M mutation.\n   * EGFR uncommon mutations: EGFR-TKIs or chemotherapy for uncommon mutations including but not limited to G719X, S768I, L861Q mutations.\n   * EGFR exon 20 activating insertions: chemotherapy with or without amivantamab or country-specific approved EGFR TKIs.\n5. For China only: the presence of MET amplification and\u002For overexpression in tumor tissue samples or pleural fluid or blood samples collected after progression on prior EGFR-TKI treatment, confirmed by a central \u002Flocal laboratory.\n\n   MET amplification is defined as the presence of MET amplification confirmed by nextgeneration sequencing (NGS) technology or mean MET gene copy number (GCN) ≥ 4 per cell or the ratio of MET to chromosome enumerating probe against chromosome 7 (MET\u002FCEP7) ≥2.0 confirmed by fluorescence in situ hybridization (FISH) testing.\n\n   MET overexpression is defined as immunohistochemistry (IHC) ≥ 2+ (local or central lab test results are accepted).\n6. Have at least one measurable target lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n7. ECOG PS ≤ 1.\n8. Life expectancy of ≥12 weeks, in the opinion of the investigator.\n9. Adequate organ function as determined by medical evaluation (within 7 days prior to study treatment) including:\n\n   * Adequate hematologic status, defined as: absolute neutrophil count (ANC) ≥1.5×109\u002FL, hemoglobin ≥90 g\u002FL, platelets ≥75×109\u002FL. Platelet transfusions are not permitted within 3 days, red blood cell transfusions are not permitted within 14 days, hematopoietic growth factors are not permitted within 7 days (14 days for PEGylated granulocyte colony stimulating factor \\[G-CSF\\] or erythropoietin) prior to obtaining these laboratory values.\n   * Adequate hepatic function, defined as: serum TBIL ≤1.5× ULN (in participants with known Gilbert's syndrome, TBIL ≤3× ULN with direct bilirubin ≤1.5× ULN), serum ALT or AST ≤2.5× ULN (or 5.0× ULN for documented liver metastasis).\n   * Adequate renal function, defined as: creatinine clearance ≥60 mL\u002Fmin (calculated by Cockcroft-Gault formula or CKD EPI formula \\[Appendix 4 of Section 12.4\\]).\n   * Adequate coagulation profile, defined as (including if receiving anticoagulant therapy):\n\n   prothrombin time (PT)\\\u003C 1.5 × ULN, activated partial thromboplastin time (APTT)\\\u003C 1.5 × ULN. If the participant is on anticoagulant therapy, must be on a stable dose of anticoagulant for at least1month prior to the study treatment.\n10. Female participants should be using adequate contraceptive measures until 90 days after the EOT, should not be breast feeding and must have a negative serum beta human chorionic gonadotropin (β-hCG) pregnancy test within 7 days prior to start of dosing if of childbearing potential; or must have evidence of non-child bearing potential by fulfilling one of the following criteria at screening.\n\n    * Achieved postmenopausal status, refer to NCCN Guidelines for Breast Cancer (2024V3.0) for the detailed definition of menopause.\n    * Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.\n11. Male participants of childbearing potential are required to use adequate contraception (i.e., barrier method of birth control), during their participation in the study and for 90 days following the EOT. Male participants must also refrain from donating sperm during their participation in the study and for 90 days following the last dose of study treatment.\n12. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this study.\n\nExclusion Criteria\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. Have other known primary driver gene alterations. For example, NSCLC with a targetable alteration in ALK, RET, ROS1, BRAF, KRAS, etc. The investigators should discuss enrollment with the sponsor regarding co-mutations.\n2. Prior treated with hepatocyte growth factor (HGF) targeted therapy or other MET-TKIs (including Type I and Type II), e.g., gulmonertinib, savolitinib, capmatinib, tepotinib, bozitinib, cabozantinib, glenitinib and almonertinib.\n3. Participation in other therapeutic clinical trials within 28 days prior to the first dose of study treatment.\n4. Received anti-tumor therapy (chemotherapy, immunotherapy, hormone therapy, targeted therapy, biological therapy or other anti-tumor therapy, except for hormones for hypothyroidism or estrogen replacement therapy, anti-estrogen analogs, and agonists required to inhibit serum testosterone levels) within 14 days or 5 half-lives (whichever is shorter) of the first dose of study treatment. The following exceptions are:\n\n   * Nitrosourea or mitomycin-C within 6 weeks prior to the first dose of study treatment.\n   * Chinese medicines with anti-tumor indications within 7 days prior to the first dose of study treatment.\n5. Radiotherapy with a wide field of radiation within 28 days, or radiotherapy with a limited field of radiation for palliation within 14 days of the first dose of study treatment.\n\n   Participants must have recovered from all radiation related toxicity, not requiring corticosteroids.\n6. Major surgery, other than diagnostic surgery, within 4 weeks of the first study treatment or is expected during the study.\n7. Toxicities of prior therapy have not been resolved to Grade ≤1 or to baseline, as evaluated by NCI-CTCAE v5.0. NOTE: Participants with Grade 2 toxicities can be enrolled if the toxicities as stable and do not affect the safety of participating in this study (e.g., alopecia, skin hyperpigmentation, neuropathy).\n8. History of another primary malignancy that has been diagnosed or required therapy within the past 3 years (other than adequately treated local basal cell or squamous cell carcinoma of the skin; or any other cancer in situ currently in complete remission).\n9. Have central nervous system (CNS) metastases that are symptomatic or clinically unstable or require increased steroid dose to manage CNS symptoms within 4 weeks prior to the first dose of study treatment.\n\n   * Participants with symptomatic CNS metastases may participate in the study providing that symptoms are controlled after treatment, clinically stable for at least 4 weeks and have no evidence of new or enlarged brain metastases.\n   * Participants with carcinomatous meningitis or meningeal metastases, or spinal cord compression are excluded regardless of clinical stability.\n   * Participants with asymptomatic CNS metastases with a maximum diameter of brain metastases \\\u003C3 cm by imaging (such as MRI) without significant cerebral edema are eligible for the study.\n10. Participants with clinically uncontrollable third-space effusion, including but not limited to pleural effusion, peritoneal effusion or pericardial effusion, are assessed by the investigator to be unsuitable for the study treatment.\n11. Participants receiving unstable or increasing doses of corticosteroids. For participants receiving corticosteroids for endocrine deficiencies or symptoms associated to their disease (excluding CNS disease), the dose must have been stabilized (or reduced) for at least 14 days before the first dose of study treatment.\n12. Have a history of or ongoing severe retinopathy.\n13. Presence of serious cardiovascular or cerebrovascular disease, including but not limited to:\n\n    * Mean resting corrected QT interval corrected by Fridericia's formula (QTcF) \\>470 msec obtained from triplicate 12-lead electrocardiograms (ECGs).\n    * Symptomatic heart failure per New York Heart Association (NYHA) classification Class II or above.\n    * Baseline left ventricular ejection fraction (LVEF) below institution's lower limit of normal (LLN) or \\\u003C50% if assessed by echocardiography (ECHO) or Multigated Radionuclide Angiography (MUGA).\n    * Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG, e.g., complete left bundle branch block, third degree heart block, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.\n    * Presence of any factors that increase the risk of QTc prolongation or the risk of arrhythmia, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or use of any concomitant medication known to prolong the QT interval within 14 days prior to the first dose of study treatment.\n    * Any of the following within 6 months prior to the first dose of the study treatment: myocardial infarction, severe\u002Funstable angina, coronary artery bypass graft, congestive heart failure, cardiomyopathy, pulmonary embolism, cerebrovascular accident, or transient ischemic attack.\n14. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including but not limited to:\n\n    * Uncontrolled hypertension, defined as a systolic blood pressure (BP) ≥160 mmHg or diastolic BP ≥100 mmHg despite medical therapy. Participant with a history of hypertension is allowed if BP is stable and controlled within these limits by antihypertensive treatment.\n    * Previous history of, or presence of clinically symptomatic or at high risk for interstitial lung disease or interstitial pneumonitis, including radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic treatment).\n    * Unstable or uncompensated respiratory and renal disease, active bleeding diseases.\n15. Uncontrolled concurrent infection including but not limited to:\n\n    * Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n\n      * If hepatitis B surface antigen (HBsAg) is positive, HBV DNA assay should be performed. Participants may be eligible if HBV DNA test value ≤ ULN.\n      * If HCV antibody is positive, HCV ribonucleic acid (RNA) assay should be performed. Participants may be eligible if HCV RNA negative.\n    * Known human immunodeficiency virus (HIV) infection or known history of acquired immunodeficiency syndrome (AIDS).\n    * Syphilis positive.\n    * Active tuberculosis infection.\n    * Onset period of keratitis or ulcerative keratitis.\n    * Other active infections requiring systemic treatment within 14 days prior to the first dose of study treatment.\n16. Unwilling or unable to comply with the requirements of oral drug administration, or presence of gastrointestinal disorders such as refractory nausea and vomiting, any acute or chronic gastrointestinal disorder, inability to swallow the formulation, or prior major bowel resection that may prevent adequate absorption of ANS014004 or PLB1004.\n17. Hypersensitivity to ANS014004, PLB1004 or their excipients, or history of allergic reactions to ANS014004 and PLB1004 with similar chemical or biological structure or similar drugs.\n18. Concomitant use of drugs metabolized by P-glycoprotein (P-gp)\u002Fbreast cancer resistance protein (BCRP) or OCT2\u002FOATP1B1\u002FMATE1, or moderate or strong inducers or inhibitors of P-gp\u002FBCRP or CYP2B6\u002FCYP2C9\u002FCYP2C19\u002FOCT2\u002FOATP1B1\u002FMATE1 within 5 half-lives before the use of the study treatment. For dose escalation part only: concomitant treatment with moderate or strong P-gp\u002FBCRP or CYP2C8\u002FCYP2D6\u002FCYP3A4 inducers or inhibitors within 5 half-lives prior to administration of study treatment.\n19. In receipt of any live attenuated vaccination within 30 days prior to the first dose of study therapy.\n20. Have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.\n21. Have prior or ongoing clinically significant illness, medical condition, surgical history, physical findings, or laboratory abnormality that, in the investigator's opinion, would not be in the best interest of the participant; or that could alter the absorption, distribution, metabolism, or excretion of the study treatment; or impair the assessment of study results.",{"count":49,"type":21},253,[51,52],"PHASE1","PHASE2","Protocol Title\n\nA Study to Evaluate ANS014004 in Combination with EGFR-TKI in Patients with EGFR Mutation-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer\n\nThe main purpose of this research study is to\n\nFind a safe and tolerable dose of two investigational drugs, ANS014004 and PLB1004, when used together.\n\nLearn how effective this drug combination is at treating a type of lung cancer called \"EGFR mutation-positive non-small cell lung cancer (NSCLC)\" that has spread to other parts of the body (locally advanced or metastatic).\n\nThis study is trying to answer the following questions:\n\nSafety \\& Dosing: What are the side effects of combining ANS014004 and PLB1004? What is the best dose to use that patients can tolerate well?\n\nEffectiveness: Can this combination of drugs help shrink patients' tumors or stop them from growing?\n\nBackground Information\n\nFor patients with advanced lung cancer that has a specific gene change called an \"EGFR mutation,\" targeted therapies known as EGFR-TKIs are a standard treatment. While these treatments often work well at first, most tumors eventually stop responding to the drug (this is called \"acquired resistance\"). The investigational drug ANS014004 is designed to block a protein called MET, which is one of the ways that tumors become resistant to EGFR-TKIs. The researchers believe that by combining ANS014004 with the EGFR-TKI PLB1004, they may be able to prevent or delay resistance, offering patients a more effective and longer-lasting treatment option.\n\nHow will the study be conducted?\n\nThis study is divided into two parts:\n\nPart 1 (Dose Escalation and Optimization): A small number of participants will receive different dose levels of ANS014004 combined with a fixed dose of PLB1004. The goal is to find the safest and most tolerable dose combination.\n\nPart 2 (Phase II Study): Once a recommended dose is identified, more participants will be enrolled to further evaluate how well the drug combination works against the cancer.\n\nThroughout the study, participants' health will be closely monitored, and their tumors will be measured regularly using imaging scans (like CT scans) to see how they respond to the treatment.",[27,55,56,57],"EGFR Mutation","Metastatic Lung Cancer","MET Alteration","NOT_YET_RECRUITING","2025-12-09",{"date":61,"type":32},"2025-12-16",{"date":63,"type":21},"2026-06",{"date":65,"type":21},"2029-12",{"name":38,"class":39},1,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":67},"100515287","phase-3-a-confirmatory-clinical-study-in-nsclc-patients-with-met-exon-14-mutation-kunpeng-2-100515287","NCT05989542","A Confirmatory Clinical Study in NSCLC Patients With MET Exon 14 Mutation (KUNPENG-2)","An Open, Multi-center, Single-arm Phase IIIb Confirmatory Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Vebreltinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer With MET Exon 14 Mutation","KUNPENG-2","Inclusion Criteria:\n\n1. voluntarily sign a written informed consent to participate in the study and be willing and able to comply with study-related visits and procedures;\n2. Male or female aged 18 years and above;\n3. patients with histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (including sarcomatoid carcinoma of the lung, according to the AJCC 8th edition of lung cancer staging, Stage IIIB - Stage IV) (non-site pathology reports are acceptable);Patients have not received any prior systemic antineoplastic drug therapy for advanced diseaseor disease progression or toxicity intolerance after prior systemic therapy (≤3 lines);\n4. The presence of MET exon 14 jump mutation was confirmed by the NGS test in the central laboratory, and the 'Combined Human 9 Gene Mutation Detection Kit (Reversible End Termination Sequencing)' produced by Guangzhou Burning Stone Medical Laboratory Ltd. will be used for the testing and analysis of the samples in the central laboratory. Patients are required to provide sufficient blood samples for retrospective analysis by the central laboratory ('Human Circulating Tumour DNA Multi-Gene Mutation Test Kit (Reversible End Termination Sequencing Method)' manufactured by Guangzhou Burnstone Medical Laboratory Co. Ltd. to support the development of blood companion diagnostic reagents required for the marketing of Piratinib. Note: For patients who have received previous systemic anti-tumour therapy, tumour tissue obtained after disease progression on the most recent anti-tumour therapy will be preferred for biomarker testing;\n5. Tissue sample testing confirms EGFR wild-type, ALK rearrangement negative, ROS1 rearrangement negative, and KRAS mutation negative;\n6. at least one measurable lesion (per RECIST 1.1 criteria). For a lesion that has received prior radiotherapy, it may be counted as a target lesion only if definitive disease progression has occurred since radiotherapy;\n7. an ECOG performance status score of 0-1;\n8. expected survival ≥ 3 months;\n9. Laboratory tests that meet the following requirements:\n\n   * Aspartate aminotransferase (AST): ≤ 3 x ULN (no liver metastases)\n   * Alanine aminotransferase (ALT): ≤3 × ULN (no liver metastases)\n   * Total bilirubin (TBIL): ≤1.5 × ULN (no liver metastases)\n   * AST: ≤5.0 × ULN (with liver metastases)\n   * ALT: ≤5.0 × ULN (with liver metastasis)\n   * Total bilirubin: ≤3.0 × ULN (with liver metastases)\n   * Platelet count: ≥75 × 10⁹\u002FL (without blood transfusion or mono-collected platelet transfusion or growth factor use within 10 days prior to the start of treatment)\n   * Absolute neutrophil count: ≥ 1.5 × 10⁹\u002FL (in the absence of growth factors within 10 days prior to the start of treatment)\n   * Hemoglobin \\> 90 g\u002FL (in the absence of blood transfusion or use of growth factors within 10 days prior to the start of treatment)\n   * Coagulation index: INR≤2.0\n   * Creatinine clearance (Ccr) \\>50 mL\u002Fmin, with Ccr using the Cockcroft-Gault formula: (140 - age\\[yr\\]) × body weight (kg) × 1.23 × (0.85, if female)\u002Fserum creatinine (μmol\u002FL)\n   * Urea\u002Furea nitrogen: ≤1.5 × ULN\n   * Asymptomatic serum amylase ≤ grade 2 (NCI-CTCAE 5.0). For patients with Grade 2 serum amylase abnormalities prior to first dose, it is important to confirm that there are no signs and\u002For symptoms suggestive of pancreatitis or pancreatic injury (e.g., elevated P-amylase, abnormal pancreatic imaging results, etc.)\n   * Serum lipase ≤ 1.5 × ULN;\n10. the investigator is judged to be compliant and able to complete scheduled visits, treatments and laboratory tests according to the protocol;\n11. men and women of childbearing potential must agree to use effective contraception from the time of signing the informed consent until 3 months after the last dose of study drug. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of study drug.\n\nExclusion Criteria:\n\n1. unwilling to provide tumor tissue or blood samples for molecular testing;\n2. previous treatment with MET inhibitors or HGF-targeted therapy;\n3. have symptomatic and neurologically unstable central nervous system (CNS) metastases or CNS disease that requires increased steroid doses for control; NOTE: Patients with CNS metastases whose symptoms have been controlled may be enrolled in this trial. Patients with symptomatic or unstable CNS metastases must have completed radiotherapy, or at least 2 weeks after surgical treatment of CNS tumor metastases, prior to study entry. Patients must have stable neurologic function with no new neurologic deficits identified on clinical examination and no new problems identified on CNS imaging. If the patient requires steroids for the treatment of CNS metastases, they must have been stabilized on a therapeutic dose of steroids for at least 2 weeks prior to signing the informed consent form;\n4. patients with clinically poorly controlled pleural, abdominal or pericardial effusions who, in the judgment of the investigator, are not suitable for enrollment;\n5. unstable or uncontrolled disease or conditions related to or affecting cardiac function (e.g., unstable angina pectoris, congestive heart failure \\[NYHA \\> Class II\\], unstably controlled hypertension \\[defined as diastolic blood pressure \\> 100 mmHg and\u002For systolic blood pressure \\> 160 mmHg regardless of antihypertensive medications. initiation of antihypertensive medications or adjustment of antihypertensive medications prior to Screening is permitted\\]);\n6. a coagulation disorder or bleeding tendency, including an arterial or venous thromboembolic event (including myocardial infarction, cerebrovascular accident or transient ischemic attack, pulmonary artery embolism, deep vein thrombosis, or any other history of severe thromboembolism) within 6 months prior to the administration of the first study medication, any life-threatening bleeding event (including the need for transfusional therapy, surgical or topical therapy, and ongoing drug therapy) that Tendency to bleed in the judgment of the investigator;\n7. The presence of risk factors for QTc interval prolongation such as chronic hypokalaemia not corrected by complementary therapies, congenital or familial long QT interval syndrome, family history of unexplained sudden death in a first-degree relative under the age of 40 years, or initiation of Piratinib. Patients with a family history of unexplained sudden death in a first-degree relative younger than 40 years of age, or use of a drug that prolongs the QT interval and results in tip-twist ventricular tachycardia for ≤5 half-lives prior to the initiation of the first dose of ponatinib should be excluded.\n\n   Patients with ≤5 half-lives of drugs that prolong the QT interval and cause tip-twist ventricular tachycardia prior to initiation of Brentinib should be excluded.\n8. any significant rhythm abnormality such as complete left bundle branch block, second or third degree heart block, medically uncontrolled ventricular arrhythmias, supraventricular, nodal arrhythmias, and medically uncontrolled other cardiac arrhythmias;\n9. active gastrointestinal disorders (e.g., ulcerative lesions, uncontrollable nausea, vomiting, diarrhea, and malabsorption syndromes) or other conditions (e.g., inability to swallow the test medication, or prior major gastrointestinal surgery) that significantly interfere with absorption, distribution, metabolism, or excretion of the oral study drug;\n10. the presence of an active infection, including but not limited to: 1) Hepatitis B (Hepatitis B Surface Antigen \\[HBsAg\\] positive and Hepatitis B Virus \\[HBV\\] DNA ≥ 500 IU\u002Fml), Hepatitis C (positive for both anti-Hepatitis C Virus \\[HCV\\] antibodies and HCV-RNA) or Human Immunodeficiency Virus (HIV) (HIV antibody positive) infections, and syphilis positive infections; 2) Active tuberculosis; 3) Active infection (e.g., pneumonia) requiring systemic anti-infective therapy within 2 weeks prior to first study drug administration;\n11. known history of hypersensitivity to the active or inactive excipients of Vebreltinib, hypersensitivity to drugs with a chemical structure similar to that of Vebreltinib.\n12. patients being treated with warfarin or any other coumarin derivative anticoagulant, with the exception of low-dose warfarin (\\\u003C 2 mg) for the prevention of central catheter-related thrombosis;\n13. presence of prior antineoplastic therapy toxicity not recovered to ≤ Grade 1 (NCI-CTCAE 5.0) or baseline, except for alopecia, skin hyperpigmentation, and Grade 2 peripheral neurotoxicity\n14. any comorbid medical condition that may increase the risk of toxicity;\n15. antineoplastic and investigational drug therapy within 2 weeks or ≤ 5 drug half-lives (whichever is longer, up to a maximum of 4 weeks) prior to initiation of the first dose of Vebreltinib. If the prior therapy was a monoclonal antibody, the therapy must be discontinued at least 2 weeks prior to the first dose of Vebreltinib. If the prior therapy was an oral targeted drug, the therapy must be discontinued at least 5 drug half-lives (up to 4 weeks) prior to the first dose of Vebreltinib. If prior therapy was an herbal antineoplastic therapy, it must be discontinued at least 1 week prior to the first dose of Vebreltinib;\n16. chest radiotherapy to the lung field ≤ 4 weeks prior to initiating treatment with Vebreltinib or if the patient has not recovered to ≤ Grade 1 from radiotherapy-related toxicity. For all other sites (including radiotherapy to the thoracic spine or ribs), radiotherapy ≤ 2 weeks prior to initiation of Vebreltinib therapy or the patient has not recovered from radiotherapy-related toxicity. Palliative radiotherapy to bone metastatic lesions for pain relief does not require a washout period;\n17. major surgery (e.g., intrathoracic, intra-abdominal, or intra-pelvic) within 4 weeks prior to initiation of treatment with Vebreltinib, brain metastasectomy may be relaxed to within 2 weeks or if the patient has not recovered from the side effects of these surgeries or is significantly traumatized, or if the patient is expected to have a significant surgical need during the study period. Thoracoscopic biopsy procedures and mediastinoscopy are not considered major surgery and patients may be enrolled ≥1 week after the procedure;\n18. another malignancy diagnosed within the last 3 years in addition to NSCLC and\u002For requiring treatment. Completely resected basal cell and squamous skin cancers, and completely resected carcinoma in situ of any type are excluded;\n19. patients are treated with CYP3A4 potent inducer and\u002For potent inhibitor medications that cannot be discontinued for at least 1 week prior to initiation of treatment with Vebreltinib and for the duration of the study;\n20. is pregnant or is breastfeeding\n21. is currently participating in another interventional clinical trial or has received an investigational drug within 2 weeks prior to the first dose of the test drug\n22. other circumstances that, in the opinion of the investigator, make participation in the study inappropriate, such as the presence of evidence of severe or uncontrolled systemic disease, including, but not limited to, active primary immunodeficiency disease, allogeneic organ transplantation, that make the patient unsuitable for participation in this trial or that would impede adherence to the study protocol.",{"count":77,"type":21},136,[24],"The goal of this clinical trial is to test if PLB1001 works well and safely in Non-small cell lung cancer patients with MET exon 14 mutation. The main questions it aims to answer are:\n\n* If it is works well in Non-small cell lung cancer patients with MET exon 14 mutation\n* If it is safety and tolerant in Non-small cell lung cancer patients with MET exon 14 mutation\n\nParticipants will\n\n1. be given PLB1001 200mg BID,oral.\n2. be received hematology and urine and ECG examinations every 14 days (First 3 months) or every 28 days (After 3 months)\n3. be received Image examination every 8 weeks(First year) or every 12 weeks(After one year)",[81],"Non-small Cell Lung Cancer","2025-06-25",{"date":84,"type":32},"2025-06-29",{"date":86,"type":32},"2023-10-16",{"date":88,"type":21},"2027-09-30",{"name":38,"class":39},""]