[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"egfr-mutant-advanced-non-small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:egfr-mutant-advanced-non-small-cell-lung-cancer":118},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,73,94],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100639103","phase-1-material-balance-of-14czorifertinib-in-healthy-adult-male-participants-in-china-100639103",false,"NCT07620951","Material Balance of [14C]Zorifertinib in Healthy Adult Male Participants in China","Phase I Clinical Study on Material Balance of [14C]Zorifertinib in Healthy Adult Male Participants in China","Inclusion Criteria:\n\n1. Healthy Chinese males;\n2. Age at the time of signing the informed consent form: 18-45 years (inclusive);\n3. Body mass index (BMI) ranging from 19-26 kg\u002Fm2 (inclusive), with a body weight of no less than 50 kg;\n4. Fully understand the purpose and requirements of this study and voluntarily sign the informed consent form;\n5. Be able to communicate well with the investigators and complete the trial according to the protocol.\n6. The 14C content in plasma and urine samples obtained during screening are within general environmental 14C background levels. Directly analyzed plasma samples must have values ≤150 pMC, and urine samples containing petroleum-based carbon carriers must have values ≤50 pMC.\n\nExclusion Criteria:\n\nAncillary Examinations:\n\n1. Abnormal findings from comprehensive physical examination, vital signs, laboratory tests (hematology, blood biochemistry, coagulation function, urinalysis, routine stool + occult blood, thyroid function), 12-lead ECG, chest X-ray (posteroanterior view), abdominal ultrasound, digital rectal examination, etc., that are judged by the investigator as clinically significant.\n2. Resting corrected QT interval (Fridericia correction, QTcF = QT\u002FRR1\u002F3) obtained from 12-lead ECG \\>450 ms in males, or other abnormalities judged by the investigator as clinically significant.\n3. Positive result for any of the following: hepatitis B surface antigen or hepatitis B e antigen, hepatitis C virus antibody, Treponema pallidum antibody, or human immunodeficiency virus antigen\u002Fantibody combination test (HIV-Ag\u002FAb).\n4. Abnormal findings from ophthalmic examination (slit lamp, intraocular pressure, fundus photography) that are clinically significant.\n\n   Medication History:\n5. Use of any drugs that inhibit or induce the drug-metabolizing enzyme CYP3A4 within 30 days prior to the screening period.\n6. Use of any prescription drugs, over-the-counter drugs, herbal medicines, or food supplements (e.g., vitamins, calcium supplements) within 14 days prior to the screening period.\n\n   Medical and Surgical History:\n7. History of any clinically serious disease or condition that the investigator believes may affect the trial results, including but not limited to circulatory, respiratory, endocrine, nervous, digestive, urinary, hematologic, immune, psychiatric, or metabolic diseases;\n8. History of dysphagia or any condition that may affect drug absorption, e.g., gastrectomy, cholecystectomy, gastric bypass, duodenotomy, colectomy, inflammatory bowel disease;\n9. History of organic heart disease, heart failure, myocardial infarction, angina pectoris, arrhythmia, ventricular tachycardia, clinically symptomatic AV block, long QT syndrome, or family history of long QT syndrome (evidenced by genetic proof or sudden cardiac death of a close relative at a young age);\n10. Major surgery within 6 months prior to the screening period, or surgical incision not fully healed; Major surgery includes, but is not limited to, any procedure with significant bleeding risk, prolonged general anesthesia, incisional biopsy, or significant traumatic injury;\n11. Allergic constitution, e.g., known history of allergy to two or more substances; Or judged by the investigator as potentially allergic to the investigational drug;\n12. Hemorrhoids or perianal diseases with regular\u002Fongoing hematochezia, irritable bowel syndrome, inflammatory bowel disease.\n\n    Lifestyle Habits:\n13. Habitual constipation or diarrhea;\n14. Alcoholism or regular alcohol consumption within 6 months prior to screening, i.e., alcohol intake exceeding 14 units per week (1 unit = 360 mL beer, or 45 mL spirit with 40% alcohol, or 150 mL wine), or a breath alcohol test result ≥20 mg\u002FdL at screening, or inability to abstain from alcohol during the trial period;\n15. Smoking \\>5 cigarettes per day or habitual use of nicotine-containing products within 3 months prior to screening, or inability to abstain during the trial period;\n16. Drug abuse or use of soft drugs (e.g., cannabis) within 3 months prior to screening, or use of hard drugs (e.g., amphetamines, phencyclidine) within 1 year prior to screening; Or positive urine screen for drugs of abuse during the screening period;\n17. Habitual consumption of grapefruit juice or excessive tea, coffee, and\u002For caffeinated beverages, and inability to abstain during the study period.\n\n    Others:\n18. Participation in a radiolabeled drug trial within 1 year prior to screening, or participation in a 14C-labeled breath test within 3 months prior to screening;\n19. History of needle phobia or blood phobia, difficulty with blood collection, or inability to tolerate venous puncture;\n20. Participation in any other clinical trial (including drug and device trials) within 3 months prior to the screening period;\n21. Vaccination within 1 month prior to screening, or planned vaccination during the study period;\n22. Plan to father a child or donate sperm during the study period or within 1 year after study completion, or disagreement to use strict contraceptive measures (see Appendix 1) for themselves and their partners during the study period and within 1 year after study completion;\n23. Blood loss or blood donation of ≥400 mL within 3 months prior to screening, or blood transfusion within 1 month;\n24. Any other factor that, in the investigator's opinion, makes the participant unsuitable for participation in this trial.",true,"MALE","18 Years","45 Years",{"count":21,"type":22},8,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a single-center, single-dose, open-label, Phase I study to evaluate the mass balance, biotransformation, pharmacokinetic characteristics, excretion pathways, and safety of a single oral 200 mg\u002F5 µCi dose of \\[14C\\]Zorifertinib in healthy Chinese adult male participants. The study includes a screening period (Day -14 to Day -1) and a dosing and observation period (Day 1 to Day 14). Blood, urine, and feces samples will be collected to measure radioactivity, drug concentrations, and metabolites. Safety will be assessed by adverse events, vital signs, laboratory tests, 12-lead ECG, and ophthalmic examinations. The target total radioactivity recovery is ≥90% of the administered dose.",[28,29],"EGFR Mutant Advanced Non-small Cell Lung Cancer","Central Nervous System (CNS) Metastases","NOT_YET_RECRUITING","2026-06-01",{"date":33,"type":34},"2026-06-03","ACTUAL",{"date":36,"type":22},"2026-06",{"date":38,"type":22},"2026-08",{"name":40,"class":41},"Alpha Biopharma (Jiangsu) Co., Ltd.","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":49,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":42},"100634863","phase-2-efficacy-and-safety-of-skb264-plus-anlotinib-in-egfr-tki-resistant-advanced-nsclc-with-liver-metastasis-100634863","NCT07545213","Efficacy and Safety of SKB264 Plus Anlotinib in EGFR-TKI-Resistant Advanced NSCLC With Liver Metastasis","Inclusion Criteria:\n\nTo be eligible for this study, participants must meet all of the following criteria:\n\n1. Aged ≥ 18 years, both male and female;\n2. ECOG performance status score of 0-1;\n3. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) that is locally advanced (stage IIIB\u002FIIIC) or metastatic (stage IV) and not amenable to curative surgery and\u002For curative radiotherapy (with or without concurrent chemotherapy), according to the IASLC 9th edition lung cancer TNM staging system.\n4. At least one measurable target lesion in the liver (according to RECIST version 1.1);\n5. Has previously received EGFR-TKI therapy for locally advanced or metastatic NSCLC with treatment failure (radiographic disease progression)；\n6. Life expectancy ≥12 weeks.\n7. Adequate organ and bone marrow function (without receiving blood transfusion, recombinant human thrombopoietin, or colony-stimulating factor therapy within 2 weeks prior to the first dose), defined as follows:\n\n   1. Complete blood count: absolute neutrophil count (NEUT#) ≥ 1.5 × 10⁹\u002FL; platelet count (PLT) ≥ 100 × 10⁹\u002FL; hemoglobin ≥ 9 g\u002FdL;\n   2. Liver function: aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) ≤ 2.5 × upper limit of normal (ULN); total bilirubin (TBIL) ≤ 1.5 × ULN;\n   3. Renal function: creatinine clearance (Ccr) ≥ 60 mL\u002Fmin (Cockcroft-Gault formula see appendix);\n   4. Cardiac function: left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiography (ECHO) or multigated acquisition (MUGA) scan;\n8. Female participants of childbearing potential and male participants with partners of childbearing potential must use a medically approved contraceptive method (e.g., intrauterine device, contraceptive pills, or condoms) during the study treatment period and for 6 months after the last dose;\n9. Participants voluntarily enroll in this study, sign the informed consent form, have good compliance, and cooperate with follow-up visits.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will not be enrolled in this study:\n\n1. Histologically or cytologically confirmed presence of small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components;\n2. Previous treatment with TROP2-targeted therapy and\u002For topoisomerase I inhibitors;\n3. Has had other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin;\n4. Known or screening-detected symptomatic active central nervous system (CNS) metastases or carcinomatous meningitis (Note: ① Patients who have been treated and have stable disease for ≥4 weeks and have discontinued systemic corticosteroids (at any dose) for \\>3 days may be enrolled. ② Patients with asymptomatic brain metastases (i.e., no neurological symptoms, no requirement for corticosteroids, and no lesion \\>1.5 cm) are eligible but require regular brain imaging as part of disease site evaluation)；\n5. Known history of allergy to the study drugs or their components, history of immunodeficiency, or history of organ transplantation;\n6. History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment; current ILD or non-infectious pneumonitis; or suspected ILD or non-infectious pneumonitis that cannot be ruled out by imaging at screening; clinically severe pulmonary impairment due to concurrent pulmonary diseases, including but not limited to any underlying pulmonary disease (e.g., pulmonary embolism within 3 months prior to dosing, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory disease that may affect the lungs (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or prior pneumonectomy;\n7. Active infection requiring systemic therapy within 2 weeks prior to the first dose;\n8. According to the investigator's judgment, presence of concomitant diseases that seriously jeopardize patient safety or affect the patient's ability to complete the study, including but not limited to hypertension uncontrolled by medication, severe diabetes, active infection, etc;\n9. Occurrence of arterial\u002Fvenous thrombotic events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, within 12 weeks prior to signing the informed consent form;\n10. Current active bleeding, or central lung cancer with potential for massive hemorrhage; or history of bleeding disorders (e.g., von Willebrand disease or hemophilia); clinically significant bleeding within 6 months prior to enrollment (e.g., gross hematuria, gastrointestinal bleeding, and hemoptysis); or receipt of therapeutic anticoagulants or aspirin within 14 days prior to enrollment;\n11. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment, or minor surgical procedure within 7 days prior to enrollment;\n12. Documented severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or a history of corneal disease that prevents or delays corneal healing;\n13. Any other conditions that, in the investigator's opinion, make the patient unsuitable for participation in this study.","ALL",{"count":51,"type":22},27,[53],"PHASE2","The goal of this clinical trial is to learn if the combination therapy with SKB264 and anlotinib works to treat EGFR-TKI-resistant, liver-metastatic non-squamous non-small cell lung cancer (NSCLC). It will also learn about the safety of the combination therapy with SKB264 and anlotinib. The main questions it aims to answer are:\n\nDoes combination therapy with SKB264 and anlotinib increase response rate and disease control rate, prolong duation of response and progressioin-free survival.\n\nWhat medical problems do participants have when taking combination therapy with SKB264 and anlotinib? Researchers will compare combination therapy with SKB264 and anlotinib to a historical data (the response rate of other drugs reported in literature) to see if combination therapy with SKB264 and anlotinib works better to treat EGFR-TKI-resistant, liver-metastatic non-squamous non-small cell lung cancer (NSCLC).\n\nParticipants will:\n\n1. receive SKB264 4 mg\u002Fkg intravenously on a 14-day cycle, and take anti-H1\u002FH2 antihistamines, acetaminophen, and dexamethasone is recommended before infusion for the first 4 infusions to prevent side effects; the regimen may be simplified starting from the 5th infusion.\n2. take anlotinib 10 mg orally once daily for 14 consecutive days, followed by a 7-day rest period.\n3. Visit the clinic once every week for checkups and tests",[56,28],"Non-small Cell Lung Cancer",[58,59,60,61,62],"non-small cell lung cancer","NSCLC","EGFR-TKI resistance","SKB264","anlotinib","2026-04-16",{"date":65,"type":34},"2026-04-22",{"date":67,"type":22},"2026-04-20",{"date":69,"type":22},"2028-08-15",{"name":71,"class":72},"The Fourth Affiliated Hospital of Zhejiang University School of Medicine","OTHER",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":49,"minAge":18,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},"100603940","a-prospective-cohort-study-of-zorifertinib-as-a-first-line-treatment-in-patients-with-epidermal-growth-factor-receptor-mutant-advanced-non-small-cell-lung-cancer-with-central-nervous-system-cns-metastases-100603940","NCT07143045","A Prospective Cohort Study of Zorifertinib as a First-line Treatment in Patients With Epidermal Growth Factor Receptor-mutant Advanced Non-small Cell Lung Cancer With Central Nervous System (CNS) Metastases","Inclusion criteria:\n\n1. Male or female, aged ≥18 years.\n2. Histologically or cytologically confirmed NSCLC with EGFR sensitizing mutations (including L858R or Exon 19Del), ineligible for curative surgery or radiotherapy.\n3. CNS metastases diagnosed as brain metastases (BM) and\u002For leptomeningeal metastases (LM) by imaging and\u002For cerebrospinal fluid pathological examination.\n4. Planning to receive zorifertinib (zorifertinib group) or other anti-tumor treatments (other treatment group) as first-line treatment.\n5. Voluntarily agreeing to participate in this study and signing the informed consent form.\n\nExclusion criteria:\n\n1. Currently participating or planning to participate in any interventional clinical study for first-line treatment (patients who have participated in non-interventional, real-world studies may still be included).\n2. Other reasons that, in the Investigator's opinion, make the patient unsuitable for this study.\n\nFor patients in Cohort A of the zorifertinib group, the following inclusion\u002Fexclusion criteria of the EVEREST study must also be met:\n\nInclusion Criteria A:\n\n1. . No prior treatment with chemotherapy, EGFR-TKIs, biological therapy, immunotherapy, or any investigational drug that is considered first line treatment for advanced NSCLC.\n2. . Eligible patients are not candidates for definitive surgical resection or radiation of all lesions in the opinion of the treating physician.\n3. . All patients must be stable without any systemic (oral or parenteral) corticosteroid or anticonvulsant therapy for at least 2 weeks prior to study treatment. Inhaled non-absorbable and topical corticosteroid use are permitted as indicated.\n4. . Patients may have prior placement of a properly functioning CNS shunt or Ommaya reservoir.\n5. . ECOG performance status 0 or 1, with no deterioration over the past 2 weeks, and expected survival time ≥ 3 months.\n6. . Women of child-bearing potential (WOCBP) and male patients should agree to take medically acceptable contraception measures while on study treatment and for 3 months following completion of study treatment. All WOCBP must have a negative pregnancy test at screening.\n7. . Patients with measurable CNS lesions must have at least one site of CNS lesion, which has not been previously irradiated, can be accurately measured at baseline as ≥ 10 mm in the longest diameter by MRI, and is suitable for accurate repeated measurements. Measurable extracranial lesions are not required. Patients with non-measurable CNS lesions must have at least one extracranial lesion, which has not been previously irradiated, can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except for lymph nodes which must have a short diameter ≥ 15 mm) by CT\u002FMRI, and is suitable for accurate repeated measurements.\n\nExclusion Criteria A:\n\n1. . Prior treatment with EGFR-TKIs (if EGFR-TKIs were used as adjuvant therapy, patients may be enrolled if the time from discontinuation to relapse meets the following requirements: \\>6 months for Cohort A, and \\>3 months for Cohorts B and C).\n2. . Positive for T790M mutation documented by central or local laboratory using an approved or validated test method, or documented positive KRAS or cMET.\n3. . Patients who have received any investigational drug, biological therapy, or immunotherapy for their malignant tumors within the past 21 days.\n4. . Patients who have had a major surgical procedure (excluding the need for placement of vascular access or a CNS shunt), or significant traumatic injury within 4 weeks of the first dose of study treatment, or have an anticipated need for major surgery during the study.\n5. . Presence of only leptomeningeal metastases (LM) disease confirmed by MRI and\u002For positive cerebrospinal fluid (CSF) pathology, with no brain metastases (BM).\n6. . Prior radiation therapy for CNS metastases that involves measurable or non-measurable sites of disease to assess efficacy.\n7. . Patients who have received radiation to more than 30% of the bone marrow within 2 weeks before the first dose of study treatment.\n8. . Patients currently receiving (or unable to stop use at least 1 week prior to receiving the first dose of study treatment) certain medications or herbal supplements that are known to be potent inhibitors or inducers of CYP3A4\u002F5 (see Appendix A).\n9. . Unmanageable nausea and vomiting, chronic gastrointestinal diseases, or prior gastric resection or surgical procedure that may interfere with adequate absorption of study drug.\n10. . History of concurrent and\u002For other active malignant tumors requiring treatment within 5 years of study treatment, excluding prior treated squamous cell carcinoma or basal cell carcinoma or carcinoma in situ.\n11. . History of any type of documented interstitial lung disease or radiation pneumonitis.\n12. . Presence of any severe or uncontrolled systemic disease or condition, including: (i) uncontrolled hypertension or diabetes; (ii) serious cardiac, pulmonary or renal disorders; (iii) active bleeding diatheses; (iv) any active type of bacterial, viral, fungal or other infection that would pose a significant risk to the patient in the opinion of the Investigator; or (v) active hepatitis B virus positive (defined as hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) positive, and hepatitis B DNA positive (or detectable) or above the cut-off value) or positive HCV antibodies or positive HIV test result.\n13. . Women who are pregnant or lactating. WOCBP and fertile men with a WOCBP-partner not using adequate contraception measures.\n14. . Patients with unstable and symptomatic metastases: Any unstable and symptomatic CNS or distant metastasis that is not symptomatically controlled by prior surgery, radiotherapy or corticosteroid therapy within 2 weeks of initial study treatment.\n15. . Any unresolved toxicities from prior therapy, greater than Common Terminology Criteria for Adverse Events (CTCAE 5.0) Grade 1 at the time of starting study treatment, with exception of alopecia.\n16. . Patients with a significant cardiovascular disorder or condition, including any of the following:\n\n    1. Congestive heart failure (CHF) currently requiring treatment and patients with New York Heart Association (NYHA) Class III\u002FIV CHF (see Appendix B).\n    2. Need for antiarrhythmic drug therapy for a ventricular arrhythmia or patients with uncontrolled or unstable arrhythmias.\n    3. Severe conduction disturbance (e.g., second- or third-degree AV block).\n    4. Angina pectoris requiring treatment.\n    5. QTc interval \\> 450 msec (males) or \\> 470 msec (females).\n    6. History of congenital long QT syndrome, congenital short QT syndrome, Torsades de Pointes, or Wolff Parkinson White syndrome.\n    7. Left ventricular ejection fraction (LVEF) \\\u003C50% as determined by echocardiography or MUGA scan.\n    8. Myocardial infarction diagnosed within the past 6 months.\n17. . Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:\n\n    1. Absolute neutrophil count \\\u003C1.5 × 109\u002FL.\n    2. Platelet count \\\u003C100 × 109\u002FL (Transfusion-dependent patients are excluded from this study).\n    3. Hemoglobin \\\u003C90 g\u002FL.\n    4. Alanine aminotransferase (ALT) \\> 2.5 times the upper limit of normal (ULN) in the absence of documented metastases to liver or \\> 5 times the ULN in the presence of metastases to liver.\n    5. Aspartate aminotransferase (AST) \\> 2.5 times the ULN in the absence of documented metastases to liver or \\> 5 times the ULN in the presence of metastases to liver.\n    6. Total bilirubin \\> 1.5 times the ULN in the absence of metastases to liver or \\>3 times the ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or metastases to liver.\n    7. Creatinine \\>1.5 times the ULN concurrent with creatinine clearance \\\u003C50 mL\u002Fmin (measured or calculated by Cockcroft-Gault equation). Confirmation of creatinine clearance is only required when creatinine is \\>1.5 times the ULN.\n    8. If bone metastases are present and liver function is otherwise considered adequate by the Investigator, then isolated elevated alkaline phosphatase (ALP) is not an exclusion criterion.\n18. . History of hypersensitivity to active or inactive excipients of the study drug or drugs with a similar chemical structure or class to the study drug.\n19. . Judgment by the Investigator that the patient should not participate in the study if the patient is unwilling to comply with all study procedures and treatment.\n20. . History of recent stroke (\\\u003C6 months), or prior central nervous system injury that has persistent neurologic deficits that would affect neurologic assessments.\n21. . Significant medical or psychiatric illness that would interfere with the compliance to the protocol and ability to tolerate treatment.\n22. . Patients who have received any anti-neoplastic herbal medicines for their malignant tumors within the past 2 weeks.",{"count":80,"type":22},800,"OBSERVATIONAL","This study is a patient-centered, two-group, three-cohort, multi-center, prospective study to further evaluate the survival benefits and safety of zorifertinib as a first-line treatment in EGFRm+ advanced NSCLC patients with CNS metastases, and to compare the clinical value of zorifertinib with other epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs).",[28,29],"RECRUITING","2026-02-06",{"date":87,"type":34},"2026-02-09",{"date":89,"type":34},"2025-12-29",{"date":91,"type":22},"2031-11",{"name":40,"class":41},34,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":49,"minAge":18,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":23,"phases":103,"briefSummary":104,"conditions":105,"keywords":106,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":117},"100469593","phase-1-a-phase-12-study-to-evaluate-the-safety-tolerability-and-pk-of-jin-a02-in-patients-with-egfr-mutant-advanced-nsclc-100469593","NCT05394831","A Phase 1\u002F2 Study to Evaluate the Safety, Tolerability and PK of JIN-A02 in Patients With EGFR Mutant Advanced NSCLC","A Phase 1\u002F2, Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of JIN-A02 in Patients With EGFR Mutant Advanced Non-small Cell Lung Cancer","\\[Inclusion Criteria\\]\n\n1. Subjects age 18 or above (19 or above for South Korea)\n2. Subjects with pathologically confirmed and finally diagnosed advanced and\u002For metastatic NSCLC with active EGFR mutant\n3. Subjects who show disease progression after receiving standard anticancer therapy, including approved EGFR-TKI therapeutic and\u002For up to 1 time of platinum-based anticancer chemotherapy. For the Part C dose expansion phase, approved EGFR-TKI with activity against T790M mutant such as Osimertinib must be included.\n4. Subjects with a test result of locally confirmed EGFR mutant obtained through a test method approved by the sponsor using either a tumor tissue and\u002For plasma ctDNA. It is preferred that samples used for analysis are collected during or after disease progression from the last EGFR-TKI administration. If there is a sample retained after disease progression from prior therapy, it may be submitted.\n\n   1. Part A dose escalation and Part B exploration studies: Advanced NSCLC subjects who are positive to EGFR mutant C797S or T790M\n   2. Part C dose expansion study: Advanced NSCLC subjects who are positive for EGFR mutations C797S and T790M in Cohort 1, those who are positive for C797S and negative for T790M in Cohort 2, those who are negative for C797S and positive for T790M in Cohort 3, subjects who are positive for any EGFR mutations and stable brain metastasis in Cohort 4, and those who have any EGFR dependent mutations other than C797S or T790M in Cohort 5.\n5. For Part C, subjects with at least 1 measurable lesion that has not been previously radiated as defined by RECIST version 1.1\n6. Subjects with ECOG performance status 0 or 1\n7. Acute effect from a previous therapy that recovers to the baseline severity or ≤ Common Terminology Criteria for Adverse Events (CTCAE) grade 1, except for an AE not corresponding to a safety risk, as determined by the investigator based on discussion with the sponsor. Note: A chronic condition not expected to recover (≤ grade 2, e.g. neuropathy, myalgia, alopecia) is an exception, and a subject with such a condition can be enrolled.\n8. Appropriate bone marrow and organ functions, including the following:\n\n   1. Hemoglobin ≥ 9.0 g\u002FdL\n   2. Platelet ≥ 75 × 109\u002FL\n   3. Absolute neutrophil count ≥ 1.0 × 109\u002FL\n   4. Serum Total Bilirubin (TBL) ≤ 1.5 × Upper Limit of Normal Range (ULN) (≤ 3.0 x ULN for a subject with documented Gilbert syndrome)\n   5. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3.0 ×ULN, or if there is a hepatic metastasis caused by tumor, ≤ 5.0 × ULN\n   6. \\*Estimated creatinine clearance calculated using the Cockcroft-Gault formula to ≥ 60 mL\u002Fmin\u002F1.73m2\n\n      * CrCl (male) = (\\[140 - age\\] × weight (kg)) \u002F (serum creatinine (mg\u002FdL) × 72), CrCl (female) = CrCl (male) ×0.85\n9. For women with childbearing potential\n\n   1. The serum pregnancy test result must be negative before screening and the first dose of the investigational product\n   2. Women of childbearing potential who are sexually active with a non-sterilized male partner must use at least 1 or more effective contraceptive methods from the first dose of the investigational product to 90 days after the last dose\n\n      \\*Progesterone hormone contraceptive inhibiting ovulation, including an oral, injectable and implant type, intrauterine device, bilateral tubal ligation, use of spermicide or condom by the male partner, etc.\n   3. Must not breastfeed during the study and up to 90 days after the last dose of the investigational product\n10. Male subjects who are sexually active with a non-sterilized female partner of childbearing potential must agree to using an effective contraceptive method (spermicide, condom, etc.) from the first dose of the investigational product to 90 days after the last dose and not donating their sperms\n\n\\[Exclusion Criteria\\]\n\n1. NSCLC with mixed squamous cell histology and tumor with histological transformation (presence of transition from NSCLC to SCLC and epithelial mesenchymal transition)\n2. For Part A, B, and Cohort 4 of Part C\n\n   \\- Subjects requiring steroid escalation within 28 days before start of the study due to spinal cord compression with uncontrolled symptoms or Central Nervous System (CNS) metastasis or for CNS disease treatment; patients requiring local CNS disease treatment; and subjects with leptomeningeal disease. However, these subjects may be included in the study if they are systemically asymptomatic and stable 2 weeks after gamma knife therapy or 4 weeks after whole-brain irradiation\n3. For Part Part C: all Cohorts except for Cohort 4\n\n   \\- Subjects without CNS metastasis\n4. Subjects who received the following treatments:\n\n   1. EGFR-TKI treatment within 7 days from the first dose of the investigational product\n   2. Systemic anticancer treatment within 14 days or 5 half-lives (whichever is the shorter period) from the first dose of the investigational product\n   3. Limited field radiation treatment within 7 days or extended field chest radiation treatment within 14 days from the first dose of the investigational product\n   4. Immunotherapy or other antibody therapy within 28 days from the first dose of the investigational product\n   5. Subjects who did not recover from a major surgery or side effects of such treatment, except for vascular access placement, within 28 days from the first dose of the investigational product as determined by the investigator \\*A major surgery refers to a surgery on the abdomen, pelvis, cranium or intrapleural site or local site tissue and is defined as a procedure that may cause a risk to function or recovery of an organ and tissue based on the applicable site, subject's condition, and difficulty or duration of the surgery. A major surgery generally requires hospitalization of a varying period (often 1 week) and can be conducted by a surgical professional.\n5. Subjects with the following cardiac dysfunctions or clinically significant cardiac diseases:\n\n   1. Corrected QT interval using Frederica formula (QTcF) \\> 470 ms\n   2. Cardiac arrhythmia that is clinically significant and uncontrolled (e.g. Type II second degree heart block or third degree heart block)\n   3. Any factors increasing the risk of QTc prolongation or arrhythmia occurrence, such as hypokalemia, congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death of a family member or direct family member at the age less than 40 years, or concomitant drugs known to prolong the QT interval or cause Torsades de Pointes\n   4. Uncontrolled (persistent) hypertension: Systolic blood pressure \\> 180 mmHg, diastolic blood pressure \\> 100 mmHg\n   5. Congestive heart failure defined as New York Heart Association Class III-IV, or hospitalization due to congestive heart failure within 6 months before the first dose of the study intervention\n   6. Medical history of acute myocardial infarction or unstable angina within 6 months before screening\n6. Subjects with active malignancy other than appropriately treated basal cell cancer or squamous cell skin cancer or carcinoma in situ within 2 years before enrollment. However, those who completed all anticancer treatments at least 2 years ago and are considered previously cured at the time of enrollment can be enrolled.\n7. Subjects with evidence\u002Fpast history of interstitial lung disease (ILD) or radiological pneumonia requiring steroid treatment. Subjects with prior ILD related to clinically resolved COVID-19 infection may be enrolled after discussion with and approval by the medical monitor.\n8. Subjects who are not able to swallow and keep in the body an orally administered drug and subjects who have a clinically significant gastrointestinal disorder such as major limitations to the stomach or intestine or malabsorption syndrome\n9. Subjects with other uncontrolled active infections, e.g. human immunodeficiency virus (HIV), HBV or HCV, including subjects with suspected active or latent tuberculosis (confirmed with interferon-gamma emission analysis positivity)\n\n   \\*The referential protocol about COVID-19\u002FSARS-CoV2 excludes subjects with active infections mentioned above. Though SARS-CoV2 test is not required for enrollment to this protocol, it should follow the standard of the local clinical practice. Subjects testing positive for SARS-CoV2 infection or known to have asymptomatic infection or suspected to have SARS-CoV2 are excluded, but they may be rescreened according to the protocol requirements if they test negative in a subsequent test.\n10. Subjects with known sensitivity to the study drug or its related substance\n11. Subjects who have a history of drug abuse or unstable medical, mental or social conditions that may interfere with participation in the study or result interpretation\n12. Subjects considered not able to follow the protocol as determined by the investigator",{"count":102,"type":22},150,[25,53],"This study is a Phase I\u002FII open-label, multi-center study to evaluate the safety, tolerability, PK, and an anti-tumor activity of JIN-A02, a 4th generation EGFR-TKI agent for oral administration, in EGFR mutant-positive, advanced NSCLC subjects who showed disease progression after receiving standard anticancer therapy, including approved EGFR-TKI therapy and\u002For no more than a single platinum-based anticancer chemotherapy. In Part A of the study, dose escalation is carried out where MTD is evaluated using Bayesian Optimal Interval (BOIN) design in subjects with advanced NSCLC harboring EGFR-mutation of C797S or T790M. In Part B, dose exploration is carried out to further evaluate the safety of JIN-A02 and to determine the RP2D using 2 preliminary effective dose levels and with the help of a safety review committee (SRC) in advanced NSCLC subjects harboring EGFR mutant C797S or T790M. In Part C dose expansion study, subjects with EGFR mutant who show disease progression after receiving standard anticancer therapy, including approved EGFR-TKI therapy with activity against T790M such as Osimertinib and\u002For no more than one platinum-based anticancer chemotherapy, are divided into 5 different cohorts based on the EGFR mutation and the anti-tumor activity of JIN-A02 is evaluated. Before enrollment in the study, the EGFR mutant profile is determined using either tumor tissue and\u002For plasma ctDNA. The profile is determined locally through a test method approved by the sponsor. The sponsor reviews and approves each potential subject for enrollment. Study eligibility evaluation will utilize local test(s).",[28],[107],"4th generation EGFR inhibitors","2025-05-13",{"date":110,"type":34},"2025-05-16",{"date":112,"type":34},"2023-07-30",{"date":114,"type":22},"2026-09-30",{"name":116,"class":41},"J Ints Bio",10,"EGFR Mutant Advanced Non Small Cell Lung Cancer"]