[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hunan Province Tumor Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":526},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,38,0,25,[9,40,67,90,111,134,160,181,201,222,241,265,283,306,326,343,360,383,400,418,434,450,468,485,509],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"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":4},"100644429","phase-2-the-efficacy-and-safety-of-trastuzumab-deruxtecan-in-advanced-or-metastatic-nsclc-with-her2-over-expression-100644429",false,"NCT07662473","The Efficacy and Safety of Trastuzumab Deruxtecan in Advanced or Metastatic NSCLC With HER2 Over Expression","The Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd) in Advanced or Metastatic NSCLC With Human Epidermal Growth Factor Receptor2(HER2) Overexpression(OE)：A Single-arm, Multicenter, Prospective Study","Inclusion Criteria:\n\n1. Male and female participants must be at least 18 years of age at the time of signing the ICF.\n2. Histologically documented Stage III locally advanced and unresectable non-squamous NSCLC not amenable to curative surgery or radiation and\u002For Stage IV NSCLC.\n3. Participants must have HER2 overexpression (IHC 3+).\n4. progressed following at least one or two prior systemic treatment.\n5. Prior anti-HER2 are eligible except for HER2 ADC.\n6. At least 1 measurable lesion by the investigator based on RECIST 1.1.\n7. LVEF ≥ 50% within 28 days before enrollment.\n8. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1.\n9. Adequate organ and bone marrow function within 14 days before enrolment. All parameters must be the most recent results available.\n10. Adequate treatment washout period before enrolment.\n11. Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner.\n\nExclusion Criteria:\n\n1. Has spinal cord compression or clinically active central nervous system metastases.\n2. Corrected QT interval (QTcF) prolongation to \\> 470 msec (females) or \\>450 msec (males) based on average of the screening triplicate12-lead ECG.\n3. History of (non-infectious) ILD \u002F pneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n4. Uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals\n5. Active primary immunodeficiency, known uncontrolled active human immunodeficiency virus (HIV) infection or active hepatitis B (hepatitis B virus surface antigen or hepatitis B virus core antibody positive, at screening) or C infection.\n6. Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of trastuzumab deruxtecan.\n7. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline.\n8. Known allergy or hypersensitivity to study treatment or any of the study drug excipients\n9. History of severe hypersensitivity reactions to other monoclonal antibodies.\n10. Pregnant or breastfeeding female participants, or participants who are planning to become pregnant.\n11. A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).\n12. Any other clinically significant medical conditions, that may, in the opinion of the investigator, interfere with the participant's participation in the clinical study or evaluation of the clinical study results.","ALL","18 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a single arm, multicenter and prospective study to evaluate the efficacy and safety of T-DXd for the treatment in locally advanced, unresectable, or metastatic participants with selected HER2 positive (IHC 3+) NSCLC which are not eligible for curative therapy",[27],"NSCLC","NOT_YET_RECRUITING","2026-06-19",{"date":31,"type":32},"2026-06-23","ACTUAL",{"date":34,"type":21},"2026-07-29",{"date":36,"type":21},"2028-06-30",{"name":38,"class":39},"Hunan Province Tumor Hospital","OTHER",{"id":41,"slug":42,"hasResults":12,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100552743","the-recurrence-gene-profiles-of-adjuvant-osimertinib-therapy-in-resected-non-small-cell-lung-cancer-100552743","NCT06477055","The Recurrence Gene Profiles of Adjuvant Osimertinib Therapy in Resected Non-Small-Cell Lung Cancer","A Multicenter, Real-World, Observational Study: Genomic Landscape of Recurrence in Early-Stage (Clinical Stage IB-IIIA) Non-Small Cell Lung Cancer (NSCLC) Patients With EGFR Sensitizing Mutations After Adjuvant Osimertinib Treatment","RAISE","Inclusion Criteria:\n\n1. Informed consent signed;\n2. Age ≥ 18 years;\n3. Histologically confirmed diagnosis of non-squamous non-small cell lung cancer;\n4. Patients with stage IB-IIIA (TNM 8#) NSCLC undergo confirmed radical R0 resection;\n5. Confirmed EGFR sensitive-mutations (exon 19 deletions, 21 L858R point mutations) prior to adjuvant osimertinib therapy;\n6. Recurrence after\u002Fon Osimertinib treatment according to RECIST 1.1;\n7. NGS gene test report (tumor or blood sample) at the time of recurrence;\n8. Receiving or not receiving neoadjuvant treatment before surgery.\n\nExclusion Criteria:\n\n1. Patients with stage I-III NSCLC whose surgical resection cannot be confirmed;\n2. Received adjuvant therapy other than that specified in the ADAURA study;\n3. No NGS test report at recurrence;\n4. History of other malignant tumors within 2 years;\n5. Patients assessed by the investigator as unfit for enrollment, such as neurological disorders or metabolic disorders, physical examination or laboratory examination suspected that the patient has a possible disease, or has treatment-related complications High risk etc.",{"count":49,"type":21},60,"OBSERVATIONAL","This study was a multicenter, real-world observational study aimed at characterizing the genomic landscape of recurrence in patients with EGFR-sensitizing mutation-positive early-stage (clinical stage IB-IIIA) non-small cell lung cancer who received adjuvant osimertinib after surgery.",[53],"Non-small Cell Lung Cancer",[55,56],"EGFR","Osimertinib","RECRUITING","2026-04-08",{"date":60,"type":32},"2026-04-13",{"date":62,"type":32},"2025-12-02",{"date":64,"type":21},"2026-04-30",{"name":38,"class":39},2,{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},"100570359","phase-2-efficacy-and-safety-of-sacituzumab-tirumotecan-skb264-in-combination-with-toripalimab-in-patients-with-initially-unresectable-stage-iii-nsclc-100570359","NCT06706219","Efficacy and Safety of Sacituzumab Tirumotecan (SKB264) in Combination With Toripalimab in Patients With Initially Unresectable Stage III NSCLC","Efficacy and Safety of Sacituzumab Tirumotecan (SKB264) in Combination With Toripalimab in Patients With Initially Unresectable Stage III Non-small Cell Lung Cancer (NSCLC): a Phase II Study","Inclusion Criteria:\n\n1. Patients who voluntarily participate in this clinical study, understand the study procedures and are able to sign the informed consent form in writing;\n2. Men or women aged 18-70 years (inclusive) at the time of signing the informed consent form.\n3. ECOG PS score of 0 or 1.\n4. Histologically or cytologically confirmed stage III non-small cell lung cancer that cannot be surgically treated as determined by the investigator. Disease staging should be based on the American Joint Committee on Cancer (AJCC)\u002FUnion for International Cancer Control (UICC) NSCLC staging system, 8th edition.\n5. Ability to provide tumor tissue specimens, either archived within 6 months prior to the first dose of study drug or freshly obtained. See the laboratory manual for specific requirements.\n6. Pulmonary function of at least FEV1 \\> 1.0 L and FEV1% \\> 40% within 3 months.\n7. Patients must have measurable target lesions examined by CT or MRI per RECIST v1.1 criteria. Tumor imaging assessments are performed within 28 days prior to the first dose.\n8. Adequate hematologic and vital organ functions, as defined by the following laboratory findings, which need to be completed within 14 days prior to the first study treatment:\n\n(1). Hematology (no hematopoietic stimulating factor drugs or blood transfusion within 14 days before the first study treatment): absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL, absolute lymphocyte count (LC) ≥ 0.5 × 109\u002FL; platelet count (PLT) ≥ 100 × 109\u002FL, hemoglobin (Hb) ≥ 90 g\u002FL (2). Liver function: aspartate transferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN; ; serum total bilirubin (TBIL) ≤ 1.5 x ULN (total bilirubin ≤ 3.0 mg\u002FdL in patients with confirmed Gilbert syndrome); albumin (ALB) ≥ 3 g\u002FdL; (3). Renal function: creatinine clearance rate (CrCl) ≥ 45 mL\u002Fminute (by Cockcroft-Gault formula); (4). Coagulation: international normalized ratio (INR) ≤ 1.5, activated partial thromboplastin time (APTT) ≤ 1.5 x ULN; (5). Cardiac color ultrasound: left ventricular ejection fraction (LVEF) ≥ 50% 9.Female patients of childbearing potential must have a negative pregnancy test (serum or urine) within 72 hours prior to receiving the study drug. Reliable contraception, such as intrauterine devices, oral contraceptives, or condoms, must be used during the trial and for 90 days following the final dose. Male participants with partners of childbearing potential must use condoms during the trial and for 30 days following the study's conclusion.\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed mixed small cell and non-small cell lung cancer, large cell neuroendocrine carcinoma, or sarcomatoid carcinoma.\n2. Patients with EGFR gene mutations or ALK\u002FROS1 gene rearrangements.\n3. Prior systemic anti-tumor therapy for NSCLC (including investigational agents in clinical trials) or prior thoracic radiotherapy.\n4. History of other malignancies within 3 years prior to the first dose, except for those cured by local therapy (e.g., basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, etc.).\n5. Presence of any of the following cardiovascular or cerebrovascular diseases or risk factors: (1) Myocardial infarction, unstable angina, acute or persistent myocardial ischemia, New York Heart Association (NYHA) Class III or IV heart failure, symptomatic or poorly controlled severe arrhythmia, cerebrovascular accident, transient ischemic attack, or other serious cardiovascular or cerebrovascular events occurring within 6 months prior to the first dose; (2) History of myocardial diseases, including myocarditis, primary cardiomyopathy, or specific cardiomyopathy; (3) Any deep vein thrombosis (DVT) within 3 months prior to the first dose (enrollment is permitted if DVT has been stabilized with low molecular weight heparin or equivalent therapy for ≥2 weeks), peripheral arterial thromboembolic events, pulmonary embolism, or other serious thromboembolic events; (4) Presence of aortic aneurysm, aortic dissection, or other major vascular diseases that are potentially life-threatening or requiring surgical intervention within 6 months prior to the first dose\n6. Uncontrolled systemic diseases as judged by the investigator, including but not limited to: (1) Poorly controlled diabetes mellitus (fasting blood glucose ≥10 mmol\u002FL on two consecutive measurements); (2) Poorly controlled hypertension (systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>100 mmHg).\n7. History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid therapy; current ILD or non-infectious pneumonitis; or suspected ILD or non-infectious pneumonitis at screening that cannot be excluded by imaging.\n8. Clinically significant pulmonary impairment caused by pulmonary comorbidities, including but not limited to any underlying pulmonary conditions (e.g., pulmonary embolism within 3 months prior to the first dose, severe asthma, severe chronic obstructive pulmonary disease \\[COPD\\], restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory diseases potentially involving the lungs (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.).\n9. Active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulceration, gastrointestinal perforation, intra-abdominal abscess, or acute gastrointestinal hemorrhage.\n10. Active autoimmune diseases requiring systemic therapy within the past 2 years (including but not limited to autoimmune hepatitis, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, etc.); systemic therapy is defined as disease-modifying agents, immunosuppressants, or systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent). Note: Hormone replacement therapies, such as thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency, are not considered systemic therapies. Patients who have received systemic corticosteroid therapy at a dose of \\>10 mg\u002Fday prednisone or equivalent, or other immunosuppressive medications within 2 weeks prior to the first dose are excluded.\n11. Known active pulmonary tuberculosis (TB). Subjects with suspected active TB must undergo clinical evaluation to rule out the diagnosis.\n12. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n13. Active hepatitis B \\[hepatitis B surface antigen (HBsAg) positive with HBV-DNA ≥500 IU\u002FmL or above the lower limit of detection (whichever is higher)\\] or active hepatitis C \\[hepatitis C antibody positive with HCV-RNA above the lower limit of detection\\]. Note: HBsAg-positive subjects are required to receive anti-HBV antiviral therapy throughout the study treatment period.\n14. Known positive human immunodeficiency virus (HIV) test result or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.\n15. Known hypersensitivity to disitamab vedotin, toripalimab, platinum-based agents, pemetrexed, paclitaxel, docetaxel, or any of their excipients (including polysorbate-20); known history of severe hypersensitivity reactions to other monoclonal antibodies.\n16. Major surgical procedure within 4 weeks prior to the first dose, or anticipated need for major surgery during the study period.\n17. Serious infection within 4 weeks prior to the first dose, including but not limited to infections with complications requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic anti-infective therapy within 2 weeks prior to the first dose.\n18. Receipt of non-specific immunomodulatory therapy (including but not limited to interferon, IL-2) or approved traditional Chinese medicine preparations with anti-tumor indications within 2 weeks prior to the first dose.\n19. Administration of a live vaccine within 30 days prior to the first dose, or planned live vaccination during the study period.\n20. Rapid disease deterioration observed during the screening period prior to the first dose, such as significant decline in performance status.\n21. Pregnant or breastfeeding women.\n22. Presence of local or systemic diseases attributable to non-malignant causes, or conditions secondary to the tumor, that may confer significant medical risk and\u002For uncertainty in survival assessment, such as leukemoid reaction or cachexia.\n23. Documented severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or history of corneal disease that impairs delayed corneal healing.\n24. Any condition that, in the opinion of the investigator, may interfere with the evaluation of the investigational drug, compromise patient safety, or confound the interpretation of study results; or any other condition deemed by the investigator to render the subject unsuitable for participation in this study.","70 Years",{"count":76,"type":21},50,[24],"This study is a phase 2 open-label, single-center clinical study to evaluate the efficacy and safety SKB264 in combination with toripalimab in patients with unresectable stage III non-small cell lung cancer",[80],"Non Small Cell Lung Cancer (Stage III)","2026-03-30",{"date":83,"type":32},"2026-04-03",{"date":85,"type":21},"2026-05-10",{"date":87,"type":21},"2029-12-31",{"name":38,"class":39},1,{"id":91,"slug":92,"hasResults":12,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":4},"100629679","phase-3-megestrol-acetate-for-first-line-treatment-of-malnourished-non-small-cell-lung-cancer-100629679","NCT07477808","Megestrol Acetate for First-Line Treatment of Malnourished Non-Small Cell Lung Cancer","A Prospective, Randomized, Parallel-Controlled Clinical Study of Megestrol Acetate Oral Suspension for First-Line Treatment of Malnourished Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Voluntarily provide written informed consent (ICF).\n* Age ≥18 years at enrollment.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n* Expected survival ≥6 months.\n* According to the 8th edition of the Lung Cancer TNM Staging Classification by the International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC), subjects have histologically or cytologically confirmed locally advanced (Stage ⅢB\u002FⅢC) or metastatic (Stage IV) NSCLC that cannot be completely resected by surgery and cannot receive radical concurrent\u002Fsequential chemoradiotherapy.\n* Subjects have not received systemic chemotherapy for locally advanced or metastatic NSCLC before. For patients who have previously received adjuvant chemotherapy\u002Fradiotherapy, neoadjuvant chemotherapy\u002Fradiotherapy for non-metastatic diseases with curative intent, or radical chemoradiotherapy for locally advanced diseases, they are eligible to participate in this study if disease progression occurs more than 6 months after the end of the last treatment.\n* Subjects who have previously received PD-1\u002FL1 inhibitors in the neoadjuvant phase are allowed to participate in this study after evaluation and approval by the investigator; subjects who have previously received PD-1\u002FL1 inhibitors in the adjuvant phase or the consolidation treatment phase after radical chemoradiotherapy are not allowed to participate in this study.\n* No EGFR sensitive mutation or ALK gene translocation. For squamous NSCLC subjects with a smoking history or current smoking, if the previous EGFR and ALK status is unknown, it is considered negative.\n* Body mass index (BMI) ≤ 25.\n* At least one measurable tumor lesion according to RECIST v1.1.\n\nExclusion Criteria:\n\n* Diagnosis of NSCLC with EGFR sensitive mutation or ALK gene translocation; subjects with small cell carcinoma components in histology.\n* Presence of any condition affecting gastrointestinal absorption, such as difficulty swallowing, malabsorption, or uncontrollable vomiting; currently receiving tube feeding or parenteral nutrition; suffering from anorexia due to neurological or psychiatric disorders, or difficulty eating due to pain.\n* Currently taking or planning to take other medications that increase appetite or body weight, such as corticosteroids (excluding short-term dexamethasone during chemotherapy), androgens, progestins, thalidomide, olanzapine, anamorelin, or other appetite stimulants.\n* Patients with Cushing's syndrome, adrenal or pituitary insufficiency; patients with poorly controlled diabetes.\n* Postmenopausal women with a history of abnormal vaginal bleeding within one year; premenopausal women with a history of abnormal endometrial thickening (\\>15 mm) within one year.\n* Current radiological or clinical evidence of gastrointestinal obstruction.",{"count":98,"type":21},116,[100],"PHASE3","This study is a prospective, randomized, parallel-controlled clinical trial, primarily aimed at evaluating the level of body weight improvement of megestrol acetate combined with standard treatment compared with standard treatment in the first-line treatment of non-small cell lung cancer.",[53],"2026-03-20",{"date":105,"type":32},"2026-03-23",{"date":107,"type":21},"2026-04-01",{"date":109,"type":21},"2029-04-01",{"name":38,"class":39},{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":120,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":89},"100593096","phase-2-limertinib-plus-carboplatin-and-etoposide-for-egfr-mutant-nsclc-with-sclc-transformation-after-egfr-tki-progression-100593096","NCT07001995","Limertinib Plus Carboplatin and Etoposide for EGFR-mutant NSCLC With SCLC Transformation After EGFR-TKI Progression","A Single-center, Single-arm Phase II Study of Limertinib Plus Carboplatin and Etoposide in EGFR-mutant NSCLC Patients With SCLC Transformation After EGFR-TKI Progression","Inclusion Criteria:\n\n* Patients must meet all of the following to be eligible for enrollment:\n* Signed written informed consent prior to any study-related procedures.\n* Age ≥ 18 and ≤ 80 years.\n* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with a sensitizing EGFR mutation (exon 19 deletion or L858R, with or without concurrent mutations).\n* Prior treatment with EGFR-TKI, with documented disease progression and histologically confirmed small-cell lung cancer (SCLC) transformation.\n* At least one measurable target lesion per RECIST v1.1.\n* ECOG performance status 0-1 (see Appendix for ECOG scale).\n* Estimated life expectancy \\> 3 months.\n* Adequate bone marrow function, defined as:\n* ANC ≥ 1,500\u002Fmm³\n* Hemoglobin ≥ 9 g\u002FdL\n* Platelets ≥ 90,000\u002Fmm³\n* Adequate hepatic function, defined as:\n* Total bilirubin ≤ 1.5 × ULN\n* AST and ALT ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with known hepatic metastases)\n* Adequate renal function, defined as:\n* Serum creatinine within normal limits OR creatinine clearance ≥ 50 mL\u002Fmin (Cockcroft-Gault)\n* For patients with BMI \\\u003C 18.5 or \\> 30, eGFR ≥ 50 mL\u002Fmin (MDRD) is acceptable\n* Adequate cardiac function, defined as LVEF ≥ 50% by MUGA scan or echocardiography.\n* Women of childbearing potential and men with partners of childbearing potential must agree to use effective contraception.\n\nExclusion Criteria:\n\n* Patients meeting any of the following criteria will be excluded from the study:\n* Histology at initial diagnosis of small-cell lung cancer (SCLC), large-cell carcinoma, or mixed tumor with predominant SCLC, large-cell, or neuroendocrine components.\n* Prior treatment with a standard SCLC chemotherapy regimen (e.g., carboplatin\u002Fetoposide or cisplatin\u002Fetoposide) after SCLC transformation.\n* Symptomatic or unstable brain metastases. Patients with a history of unstable brain metastases must have undergone definitive surgery or radiotherapy, remain clinically stable, and be off corticosteroids for cerebral edema for at least 14 days before enrollment.\n* Any concurrent malignancy other than basal cell carcinoma of the skin or carcinoma in situ of the cervix. (Patients with a prior malignancy must be disease-free for ≥ 5 years to be eligible.)\n* Pregnancy (confirmed by serum ß-hCG) or breastfeeding. Note: Women who have been postmenopausal for ≥ 12 months, or who have undergone hysterectomy, bilateral oophorectomy, or bilateral tubal ligation, are exempt from contraception requirements. Male participants must use effective contraception from the first dose of study drug until 180 days after the last dose.\n* Active hepatitis B (HBV DNA \\> 1,000 IU\u002FmL) or hepatitis C infection (anti-HCV positive and\u002For HCV RNA \\> 15 IU\u002FL), or known HIV infection.\n* Known hypersensitivity to lietinib, carboplatin, or etoposide.\n* Psychiatric or cognitive disorders that would preclude informed consent or compliance with study requirements.\n* Women planning pregnancy during the screening period or who, along with their partners, are not using effective contraception.\n* Any other medical or psychosocial condition judged by the investigator to compromise patient safety or study integrity (e.g., poor compliance or comorbidities affecting efficacy assessment).","80 Years",{"count":20,"type":21},[24],"This single-center, prospective study and aims to evaluate the efficacy and safety of limertinib combined with etoposide and carboplatin in EGFR-mutant NSCLC patients who develop small-cell lung cancer transformation following progression on EGFR-TKI therapy.",[123,124,125],"Small Cell Lung Cancer","Non Small Cell Lung Cancer","Non Small Cell Lung Cancer NSCLC","2026-03-12",{"date":128,"type":32},"2026-03-16",{"date":130,"type":21},"2026-05-01",{"date":132,"type":21},"2028-12-30",{"name":38,"class":39},{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":66},"100612284","phase-3-effect-of-infusion-timing-on-pathologic-response-to-neoadjuvant-immunotherapy-in-resectable-non-small-cell-lung-cancer-100612284","NCT07251582","Effect of Infusion Timing on Pathologic Response to Neoadjuvant Immunotherapy in Resectable Non-Small Cell Lung Cancer","A Prospective Study on the Effect of Infusion Timing of Immune Checkpoint Inhibitors on Pathologic Response in Patients With Resectable Stage II-III Non-Small Cell Lung Cancer Undergoing Neoadjuvant Therapy","LungTime-C02","Inclusion Criteria:\n\nParticipants must meet all of the following criteria:\n\n1. Age ≥18 and ≤75 years at the time of enrollment.\n2. Histologically or cytologically confirmed diagnosis of resectable stage II to III non-small cell lung cancer (NSCLC).\n3. Deemed suitable for neoadjuvant immunotherapy combined with platinum-based chemotherapy and subsequent surgical resection based on multidisciplinary team (MDT) assessment.\n4. ECOG Performance Status of 0 or 1.\n5. No prior systemic antitumor therapy for the current NSCLC diagnosis.\n6. Adequate bone marrow, hepatic, renal, and cardiac function based on local laboratory standards.\n7. Willing and able to comply with scheduled visits, treatment plans, and other study procedures.\n8. Signed informed consent prior to participation.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded:\n\n1. Presence of EGFR-sensitive mutations (e.g., exon 19del, L858R) or ALK\u002FROS1 rearrangements.\n2. Presence of uncontrolled or symptomatic brain metastases.\n3. History of any other malignancy within 3 years prior to enrollment, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or cervical carcinoma in situ.\n4. History of prior systemic therapy (immunotherapy, chemotherapy, or targeted therapy) for lung cancer.\n5. Known severe allergic reactions to PD-1 or PD-L1 inhibitors (Grade ≥3 by CTCAE).\n6. Active autoimmune disease requiring systemic immunosuppression.\n7. Active infections, including active HBV, HCV, or HIV infection.\n8. Pregnant or breastfeeding women.\n9. Any comorbid condition or uncontrolled illness that, in the opinion of the investigator, may interfere with study participation or pose unacceptable risk.","75 Years",{"count":144,"type":21},156,[100],"This prospective study aims to investigate whether the time of day when immune checkpoint inhibitors (ICIs) are administered affects the efficacy of neoadjuvant immunotherapy in patients with resectable stage II-III non-small cell lung cancer (NSCLC). Eligible patients will receive standard-of-care neoadjuvant ICI plus platinum-based chemotherapy and be randomly assigned to either a morning infusion group (08:00-11:00) or an afternoon infusion group (15:00-18:00). The primary objective is to compare the pathological complete response (pCR) rates between groups. Secondary outcomes include major pathological response (MPR) and event-free survival (EFS). The study will include independent imaging and pathology review for endpoint assessment.",[148],"Resectable Stage II-III Non-Small Cell Lung Cancer (NSCLC)",[27,150,151],"Time of day","neoadjuvant treatment","2025-11-19",{"date":154,"type":32},"2025-11-26",{"date":156,"type":21},"2025-12-07",{"date":158,"type":21},"2029-05-31",{"name":38,"class":39},{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":142,"enrollmentInfo":167,"targetDuration":4,"studyType":22,"phases":169,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":89},"100422150","phase-2-the-efficacy-and-safety-of-the-bispecific-anti-pd-1pd-l1-antibody-ibi318-combined-with-lenvatinib-in-nsclc-100422150","NCT04777084","The Efficacy and Safety of the Bispecific Anti-PD-1\u002FPD-L1 Antibody IBI318 Combined with Lenvatinib in NSCLC.","A Prospective, Multi-cohort Clinical Research of Efficacy and Safety of Bispecific Anti-PD-1 \u002F PD-L1 Antibody IBI318 Combined with Lenvatinib in the Treatment of Advanced NSCLC","Inclusion Criteria:\n\n* Eligible subjects selected for this study must meet all of the following criteria:\n\n  1. Sign written informed consent before implementing any trial-related procedures;\n  2. Age ≥18 years old and ≤75 years old;\n  3. No limit on the gender;\n  4. Cohort A: histological or cytological confirmed locally advanced (IIIB-IIIC) or metastatic (stage IV) NSCLC (International Association for the Study of Lung Cancer and Joint Committee on the American Classification of Cancer, TNM Lung cancer stage 8) without EGFR gene sensitive mutations, ALK gene fusion or ROS1 gene fusion confirmed by histological specimens, Relapse after failure of first-line anti-PD-1 \u002FPD-L1 antibody therapy, as follows:\n\n  \u003C!-- -->\n\n  1. Only one anti-PD-1\u002FPD-L1 antibody monotherapy or combination therapy is accepted in the advanced stage of the disease, and other immunotherapy is not allowed;\n  2. Previous anti-PD-1\u002FL1 antibody monotherapy or combination therapy has the best curative effect (according to RECIST 1.1 criteria) as partial remission, complete remission, or stable disease for ≥6 months (defined as within 6 months from the first medication) No disease progression has occurred);\n  3. Disease progression confirmed by imaging studies occurred during or after the most recent treatment.\n\nCohort B: histological or cytological confirmed locally advanced (IIIB-IIIC) or metastatic (stage IV) NSCLC (International Association for the Study of Lung Cancer and Joint Committee on the American Classification of Cancer, TNM Lung cancer stage 8) with histologically confirmed EGFR-sensitive mutations or ALK fusion, Relapse after failure of anti-EGFR-TKI or ALK-TKI therapy, as follows:\n\nIn patients with EGFR-tKI sensitive mutations, the specific history of previous EGFR-TKI treatment can be one of the following:\n\n1. There is no T790M mutation in 20 exon after the failure of previous one or two generations of EGFR-TKI (including gefitinib, erlotinib, icotinib and afatinib);\n2. The 20 exon T790M mutation occurred after the treatment failure of the first or second generation EGFR-TKI monotherapy (including gefitinib, erlotinib, icotinib, and afatinib, etc.), and disease progression recurred after treatment with osimertinib or other third generation EGFR-TKI;\n3. Failure of prior osimertinib or other third-generation EGFR-TKI therapy as first-line therapy (regardless of EGFR T790M mutation status);\n4. Those who are allowed to receive neoadjuvant\u002Fadjuvant targeted therapy in the early stage and develop drug resistance after subsequent adjuvant targeted therapy, and their drug resistance status meets one of the three requirements of appeal.\n\n   For patients with ALK fusion NSCLC, disease progression should occur after adequate ALK-TKI treatment, and there is no opportunity for subsequent targeted therapy.\n\n   Cohort C: Locally advanced NSCLC that is not suitable for radical surgery or radiotherapy, or that has relapsed without systematic treatment, or that has metastasized without systematic treatment and is negative for PD-L1 expression. Patients who have previously received neoadjuvant or adjuvant therapy can also receive neoadjuvant or adjuvant therapy (but neoadjuvant or adjuvant therapy is chemotherapy\u002Fradiotherapy, not immunotherapy), and the end of neoadjuvant\u002Fadjuvant therapy should be ≥6 months after tumor progression; If the pathological type is adenocarcinoma, the absence of EGFR-sensitive mutations or ALK fusion or ROS1 fusion should be confirmed. Negative expression of PD-L1 was defined as TPS \\\u003C1% using 22C3 test.\n\n5\\. According to the evaluation criteria for the efficacy of solid tumors (RECIST v1.1 version), there is at least one imaging measurable lesion. The lesions located in the radiation field of the previous radiotherapy can be regarded as measurable lesions if the progress is confirmed; 6. Subjects with brain metastases asymptomatic or with stable symptoms after local treatment are allowed to be included in the group, as long as the subjects meet the following conditions:\n\n1. There are measurable lesions outside the central nervous system;\n2. no symptoms of the central nervous system or no worsening of symptoms within at least 2 weeks;\n3. No need for glucocorticoid therapy, or stop glucocorticoid therapy within 7 days before the first administration, or the dosage of glucocorticoid is stable and reduced to less than 10mg\u002Fday prednisone (or equivalent dose) within 7 days before the first administration ; 7. Subjects are allowed to receive palliative radiotherapy (including craniocerebral radiotherapy for symptomatic brain metastases), but the radiotherapy must be completed at least 1 week before enrollment, and the radiotherapy-related toxicity should be restored to less than or equal to 1 degree (CTCAE 5.0, except for hair loss).\n\n8\\. ECOG score 0-1 points; 9. Expected survival time\\> 3 months; 10. Sufficient organ function, subjects need to meet the following laboratory indicators:\n\n1. The absolute value of neutrophils (ANC) ≥1.5x109\u002FL when no granulocyte colony-stimulating factor is used in the past 14 days;\n2. In the case of no blood transfusion in the past 14 days, platelets ≥100×109\u002FL;\n3. In the past 14 days without blood transfusion or erythropoietin, hemoglobin\\>9g\u002FdL;\n4. Total bilirubin≤1.5×upper limit of normal (ULN);\n5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) within ≤2.5×ULN (subjects with liver metastases are allowed to have ALT or AST ≤5×ULN);\n6. Serum creatinine ≤1.5×ULN and creatinine clearance rate (calculated by Cockcroft-Gault formula) ≥50ml\u002Fmin;\n7. Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 times ULN;\n8. Normal thyroid function is defined as thyroid-stimulating hormone (TSH) within the normal range. If the baseline TSH is out of the normal range, subjects whose total T3 (or FT3) and FT4 are within the normal range can also be included in the group;\n9. Myocardial enzyme spectrum is within the normal range (for example, simple laboratory abnormalities that are judged by the investigator to be of no clinical significance are also allowed to be included in the group); 11. For female subjects of childbearing age, a urine or serum pregnancy test and the result should be negative within 3 days before receiving the first study drug administration (day 1 of cycle 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non-bearing age are defined as at least 1 year after menopause, or have undergone surgical sterilization or hysterectomy; 12. If there is a risk of conception, all subjects (whether male or female) need to adopt a low annual failure rate during the entire treatment period until 120 days after the last study drug administration (or 180 days after the last study drug administration) Less than 1% of contraceptive measures; 13. Blood pressure can be adequately controlled with or without anti hypertensive medication, defined as blood pressure≤150\u002F 90 mm Hg, and blood pressure was under stable control within 1 week before randomization.\n\n14\\. Patients must have recovered from toxicity or complications if they have previously received surgery or radiation \\> 30Gy.\n\nExclusion Criteria:\n\n* Subjects who meet the following criteria cannot be selected for this study:\n\n  1. The pathology is small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC;\n  2. There is imaging evidence of tumor voids, tumor inclusion or invasion of large vessels. In addition, the proximity of the tumor to the large blood duct should be considered and the risk of severe bleeding associated with tumor shrinkage\u002Fnecrosis after lenvatinib treatment should be excluded. (The large vessels in the chest include the main pulmonary artery, left pulmonary artery, right pulmonary artery, 4 pulmonary veins, superior vena cava, inferior vena cava and aorta);\n  3. To cohort A: subjects who have previously used anti-PD-1, PD-L1 or other immunotherapy and meet the following conditions:\n\n  \u003C!-- -->\n\n  1. The toxicity that caused permanent discontinuation occurred before the termination of immunotherapy;\n  2. Prior to the administration of the study drug, the toxicity of the previous immunotherapy has not recovered or has not recovered to level 0-1. Asymptomatic and stable control of endocrine toxicity level 2 with appropriate replacement therapy is allowed to enter the group;\n  3. Adverse events that require additional immunosuppressive agents in addition to corticosteroids, or adverse events that still recur in the use of corticosteroids during previous immunotherapy.\n\nTo cohort B and C: Prior treatment: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulating or co-inhibiting T-cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.); Anti-pd-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulating or co-inhibiting T cell receptor (including but not limited to CTLA-4, OX-40, CD137, etc.); 4. Have received the following treatments:\n\n1. Received systemic anti-tumor therapy within 2 weeks before treatment, such as chemotherapy, targeted therapy, immunotherapy (including Chinese herbal medicine with anti-tumor indications), etc.;\n2. Previously received lenvatinib, bevacizumab, anlotinib monotherapy, or in combination with anti-PD-1 \u002F PD-L1 drugs\n3. Have received any investigational drug treatment within 4 weeks before treatment;\n4. Received large doses of immunosuppressive drugs within 4 weeks before treatment (systemic glucocorticoid exceeding 10mg\u002Fday prednisone or its equivalent dose);\n5. Received live attenuated vaccine within 4 weeks before treatment (or plan to receive live attenuated vaccine during the study period);\n6. Have received major surgery (such as open cavity, thoracotomy, or Kaifu surgery), or unhealed surgical wounds, ulcers or fractures within 4 weeks before treatment.\n\n5\\. Clinically significant cardiovascular damage occurred within 12 months of the first dose of study treatment.\n\n6\\. Gastrointestinal diseases that may affect oral absorption of study drugs. 7. Prior gastrointestinal or grade ≥3 non-gastrointestinal fistula. 8. A history of other malignancies is known, and unless the participant has undergone potentially curative treatment, there is no evidence of disease recurrence in the 3 years since the start of that treatment.\n\n9\\. Severe allergy to IBI318 and lenvatinib. 10. There is clinically uncontrollable pleural effusion\u002Fabdominal effusion (subjects who do not need to drain the effusion or stop drainage for 3 days without a significant increase in effusion can be included in the group); 11. Subjects who have received thoracic radiotherapy of greater than 30 Gy within 6 months before treatment or palliative radiotherapy of 30 Gy or less within 7 days before treatment (allowing palliative treatment of bone lesions or intracranial lesions) Radiation Therapy); 12. An active autoimmune disease that requires systemic treatment (such as the use of disease-relieving drugs, glucocorticoids, or immunosuppressive agents) occurred within 2 years before the first administration. Alternative therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments; 13. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 14. Before starting treatment, have not fully recovered from toxicity and\u002For complications caused by any intervention (ie, ≤ Grade 1 or reached baseline, excluding fatigue or hair loss); 15. Known history of human immunodeficiency virus (HIV) infection (ie HIV 1\u002F2 antibody positive); 16. Untreated active hepatitis B (defined as HBsAg positive and the number of HBV-DNA copies detected at the same time is greater than the upper limit of the normal value of the laboratory department of the research center);\n\nNote: Hepatitis B subjects who meet the following criteria can also be included in the group:\n\n1. Before the first administration, the HBV viral load is less than 1000 copies\u002Fml (200 IU\u002Fml), and the subject should receive anti-HBV treatment during the entire study chemotherapy drug treatment to avoid viral reactivation\n2. For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-), there is no need to receive preventive anti-HBV treatment, but close monitoring of virus reactivation is required 17. Active HCV infected subjects (HCV antibody-positive and HCV-RNA level is higher than the lower limit of detection); 18. Live vaccines have been vaccinated within 30 days before the first administration (cycle 1, day 1); Note: It is allowed to receive inactivated virus vaccine for seasonal influenza injection within 30 days before the first administration; however, it is not allowed to receive live attenuated influenza vaccine for intranasal administration.\n\n19\\. Pregnant or lactating women; 20. There are any serious or uncontrollable systemic diseases, such as:\n\n1. The resting electrocardiogram has major abnormalities in rhythm, conduction or morphology that are severe and difficult to control, such as complete left bundle branch block, heart block above degree II, ventricular arrhythmia or atrial fibrillation;\n2. Left ventricular ejection fraction (LVEF) was lower than normal; 3）QTc interval is extended to more than 480 ms；\n\n4\\) Unstable angina pectoris, congestive heart failure, chronic heart failure of New York Heart Association (NYHA) grade ≥ 2; 5) Myocardial infarction occurred within 6 months before enrollment; 6) A history of non-infectious pneumonia requiring glucocorticoid treatment within 1 year before the first administration, or current clinically active interstitial lung disease; 7) Active tuberculosis; 8) There is an active or uncontrolled infection that requires systemic treatment; 9) There is clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction; 10) Liver diseases such as liver cirrhosis, decompensated liver disease, acute or chronic active hepatitis; 11) Poor control of diabetes (fasting blood glucose (FBG)\\> 10mmol\u002FL); 12) Urine routines suggest that urine protein is ≥++, and the 24-hour urine protein quantification is confirmed to be greater than 1.0 g; 13) Subjects who have mental disorders and cannot cooperate with treatment; 21. The medical history or disease evidence, abnormal treatment or laboratory test values that may interfere with the test results, prevent the subject from participating in the study, or the investigator believes that it is not suitable for inclusion this research.",{"count":168,"type":21},120,[24],"The study is a prospective multi-cohort clinical study. Cohort A is evaluating the efficacy and safety of IBI318 in combined with lenvatinib in advanced NSCLC patients who had failed first-line PD-1\u002FPD-L1 inhibitor therapy. Cohort B is the efficacy and safety of advanced NSCLC with EGFR-sensitive mutation \u002FALK fusion after EGFR-TKI \u002FALK-TKI treatment resistance. Cohort C is the efficacy and safety of first-line treatment of advanced NSCLC with negative PD-L1 expression and EGFR, ALK, and ROS1 wild-type. After being screened to meet the inclusion criteria, they will receive IBI318 combined with lenvatinib until the disease progresses, death, toxicity is intolerable, informed consent is withdrawn, new anti-tumor therapy is started, or the treatment is terminated for other reasons specified in the plan.",[172],"Non-Small Cell Lung Cancer","2025-03-03",{"date":175,"type":32},"2025-03-05",{"date":177,"type":32},"2021-08-01",{"date":179,"type":21},"2025-12-25",{"name":38,"class":39},{"id":182,"slug":183,"hasResults":12,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":22,"phases":190,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":89},"100579781","phase-3-clinical-study-of-nanocrystalline-megestrol-in-malnourished-patients-with-first-line-non-small-cell-lung-cancer-100579781","NCT06828757","Clinical Study of Nanocrystalline Megestrol in Malnourished Patients With First-Line Non-Small Cell Lung Cancer","A Phase III Prospective, Randomized, Parallel-Controlled Clinical Study of Nanocrystalline Megestrol in Malnourished Patients With First-Line Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* (1) Voluntarily sign a written ICF. (2) The age at the time of enrollment is ≥18 years old. (3) The physical fitness score of Eastern Tumor Cooperation Organization (ECOG) is 0-2.\n\n  (4) The expected survival period is ≥6 months. (5) According to the 8th edition of the TNM stage classification of lung cancer with histological or cytologic evidence that cannot undergo complete surgical resection and cannot undergo radical synchronous\u002Fsequential chemoradiation and treatment ( ⅢB\u002FⅢC phase), metastatic (IV phase) NSCLC.\n\n  (6) The subject has not received systemic chemotherapy for locally advanced or metastatic NSCLC. For patients who have received adjuvant\u002Fradiotherapy, neoadjuvant\u002Fradiotherapy or radical chemotherapy for locally advanced diseases, if the disease progression occurs after the end of the last treatment\\> After 6 months, you are eligible to participate in this study.\n\n  (7) Subjects who had previously received PD-1\u002FL1 inhibitors in the neoadjuvant stage were allowed to participate in this study after the investigator's evaluation and consent. Participants who had received PD-1\u002FL1 inhibitors in the adjuvant stage or in the consolidation treatment stage after radical chemoradiotherapy were not allowed to participate in this study.\n\n  (8) No EGFR-sensitive mutation or ALK gene translocation changes. For scaly NSCLC subjects with a history of smoking or who are still smoking, they are considered negative if the previous EGFR and ALK status are unknown.\n\n  (9) There is at least one measurable lesion according to RECIST v1.1, and the lesion is suitable for repeated and accurate measurement.\n\n  (10) There is a high risk of malnutrition (nutrition risk screening 2002 score ≥3 points); (11) Determine good organ functions through the following requirements:\n\n  a) Hematology (no blood components and cell growth factor support therapy were used within 7 days before the start of the study): i. Absolute neutrophil value ANC ≥ 1.5 × 109\u002FL (1,500\u002Fmm3); ii.Platelet count ≥ 100 × 109\u002FL (100,000\u002Fmm3); iii.Hymoglobin ≥ 90 g\u002FL. b) Kidney: i. Creatinine clearance\\* (CrCl) Calculated value ≥ 50 mL\u002Fmin\n\n  \\* The Cockcroft-Gault formula will be used to calculate CrCl (Cockcroft-Gault formula) CrCl (mL\u002Fmin) = {(140 Age) × Weight (kg) × F\u002F (SCr (mg\u002FdL) × 72) F=1 for males; F=0.85 for females; SCr = serum creatinine. ii. Urine protein ≤1 or 24 hours (h) Urine protein quantification \\\u003C 1.0 g. c) Liver: i. serum total bilirubin (TBil) ≤ 1.5 × ULN; for patients with liver metastasis or evidence-confirmed\u002Fsuspected Gilbert disease, TBil ≤ 3 × ULN ii. AST and ALT ≤ 2.5 × ULN; for patients with liver metastasis or evidence-confirmed\u002Fsuspected Gilbert disease, TBil ≤ 3 × ULN; for patients with AST and ALT ≤ 2.5 × ULN; for patients with liver Metastatic patients, AST and ALT ≤ 5× ULN iii. Serum albumin (ALB) ≥28 g\u002FL d) Coagulation function: i. International standardized ratio and activated partial thromboplastin time ≤ 1.5 × ULN (unless the patient is receiving anticoagulant treatment and the coagulation parameters (PT\u002FINR and APTT) at screening are within the expected range of treatment with anticoagulant).\n\n  e) Cardiac function: i. Left ventricular ejaculation fraction (LVEF) ≥50%. (12) Female patients with fertility must undergo urine or serum pregnancy test within 3 days before the first medication (if the urine pregnancy test result cannot be confirmed to be negative, serum pregnancy test is required, and the serum pregnancy result shall prevail), and The result was negative. If a female patient with fertility has sex with an unsterilized male partner, the patient must adopt an acceptable contraceptive method from screening and must agree to the contraceptive method for continuous use within 120 days of the last dose of the study drug; Whether to stop contraceptive after this time point should be discussed with the researchers. If a male patient who is not sterilized has sex with a female partner with fertility, the patient must adopt an effective contraceptive method from the beginning of screening to the 120th day after the last dose; as to whether contraceptive is stopped after this time point, the patient should use the following: Researcher discussion.\n\n  (13) The patient is willing and able to comply with the visits, treatment plans, laboratory tests specified in the schedule, and comply with other research requirements.\n\nExclusion Criteria:\n\n* (1) NSCLC diagnosed with EGFR sensitivity mutation or ALK gene translocation; Histologic presence of a small cell carcinoma component is not allowed to enroll.\n\n  (2) Presence of dysphagia, malabsorption or uncontrollable vomiting and any other condition that affects gastrointestinal absorption; Ongoing tube feeding or parenteral nutrition; Presence of anorexia nervosa, anorexia due to psychiatric disorders, or pain that makes it difficult to eat.\n\n  (3) Is taking or plans to take other appetite or weight increasing drugs, such as: adrenal corticosteroids (except for short-term use of dexamethasone during chemotherapy), androgens, progesterones, thalidomide, olanzapine, and anamolin or other appetite stimulants.\n\n  (4) Patients with Cushing's syndrome, adrenal or pituitary insufficiency; Difficult to control diabetes patients.\n\n  (5) Current imaging or clinical manifestations of gastrointestinal obstruction. (6) Active autoimmune disease requiring systemic therapy within the past two years (such as treatment with disease-modifying drugs, corticosteroids, immunosuppressants). Previous history of non-infectious pneumonitis\u002Finterstitial lung disease requiring systemic glucocorticoid therapy or current presence of non-infectious pneumonitis.\n\n  (7) Current presence of uncontrolled comorbid diseases, including but not limited to decompensated cirrhosis, renal failure, uncontrolled metabolic disorders, severely active peptic ulcer disease, or gastritis, or psychiatric illness\u002Fsocial conditions that would limit the patient's compliance with study requirements or affect the patient's ability to provide written informed consent.\n\n  (8) Unstable angina, myocardial infarction, congestive heart failure (grade 2 and above determined by the functional classification of the New York Heart Association) or vascular disease (such as aortic aneurysm with risk of rupture) requiring hospitalization within 12 months prior to the first dose, or other cardiac damage that may affect the safety evaluation of the study drug (such as poorly controlled arrhythmia, myocardial ischemia); History of esophageal and gastric varices, severe ulcers, gastrointestinal perforation and\u002For fistulas, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose.\n\n  (9) Any arterial thromboembolic event within 6 months prior to the first dose, venous thromboembolic event of NCI CTCAE version 5.0 grade 3 and above (requiring urgent medical intervention, such as pulmonary embolism or intracavenital embolism), transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy; Acute exacerbation of chronic obstructive pulmonary disease within 1 month prior to the first dose; Current hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg after treatment with oral antihypertensive medications.\n\n  (10) Have a history of severe bleeding tendency or coagulation dysfunction; Significant clinically significant bleeding symptoms within 1 month prior to the first dose, including but not limited to gastrointestinal bleeding, hemoptysis (defined as coughing up or coughing up ≥1 teaspoon of fresh blood or small blood clots or only coughing up blood without sputum, patients with blood in sputum are allowed to be enrolled), nasal bleeding (excluding epistaxis bleeding and retracting rhinoblood).\n\n  (11) Serious infection within 4 weeks prior to the first dose, including but not limited to comorbidities requiring hospitalization, sepsis or severe pneumonia; Active infection (excluding antiviral therapy for hepatitis B or C) that has received systemic anti-infective therapy within 2 weeks prior to the first dose.\n\n  (12) Any previous or current disease, treatment, or laboratory abnormality that may confound the results of the study, affect the patient's full participation in the study, or may not be in the best interest of the patient.",{"count":189,"type":21},94,[100],"This prospective interventional clinical study evaluates the efficacy of nanocrystalline megestrol combined with standard care in improving appetite and weight compared to standard care alone in first-line treatment of NSCLC.",[124],"2025-02-17",{"date":195,"type":32},"2025-02-19",{"date":197,"type":21},"2025-05-01",{"date":199,"type":21},"2027-04-30",{"name":38,"class":39},{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":211,"conditions":212,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":89},"100335413","survival-outcomes-of-lung-cancer-100335413","NCT03647098","Survival Outcomes of Lung Cancer","Survival Outcomes for Lung Cancer","Soul","Inclusion Criteria:\n\n1. Understand the requirements and contents of the clinical trial .\n2. Age ≥ 18 years.\n3. Histopathology or cytology confirmed lung cancer\n4. ECOG \\\u003C=2.\n5. Predicted survival ≥ 12 weeks.\n6. Adequate bone marrow hematopoiesis and organ function\n7. Presence of measurable lesions according to RECIST 1.1.\n\nExclusion Criteria:\n\n1. Subjects who have received any of the following treatments must be excluded:\n\n   * Have received radiation within 14 days prior to the first dose or have not recovered from radiation-related toxicity. Chest and extra-brain palliative radiotherapy, stereotactic radiosurgery, and stereotactic body radiotherapy may be performed 7 days prior to the first dose.\n   * Ongoing (or inability to discontinue) possibly potent CYP1A2, CYP3A inhibitor (1 week), or inducer (2 weeks) drug therapy or herbal supplements within 1-2 weeks prior to the first dose.\n2. Presence of spinal cord compression or meningeal metastasis.\n3. History of other malignant tumors within 2 years.\n4. Adverse events (except alopecia of any degree) of CTCAE \\> grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.\n5. History of stroke or intracranial hemorrhage within 6 months prior to the first dose.\n6. The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.\n7. Subjects with persistent or active infection, including but not limited to hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and COVID-19 infection.\n8. Heart-related diseases or abnormalities\n9. Past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy or interstitial lung disease with active clinical symptoms, immune pneumonia caused by immunotherapy.\n10. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb drugs due to previous bowel resection.\n11. Live vaccine was given 2 weeks before the first medication.\n12. Women who are breastfeeding or pregnant.\n13. Hypersensitivity to the test drug and the ingredients.\n14. Other conditions assessed by the investigator to be unsuitable for participation in the study.",{"count":210,"type":21},20000,"This is a prospective study to analyze the survival outcomes of different groups about lung cancer patients.",[213],"Lung Cancer","2025-02-12",{"date":216,"type":32},"2025-02-14",{"date":218,"type":32},"2018-08-01",{"date":220,"type":21},"2030-12-31",{"name":38,"class":39},{"id":223,"slug":224,"hasResults":12,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":231,"conditions":232,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":89},"100387394","survival-outcome-of-egfr-tki-in-uncommon-egfr-mutant-advanced-nsclc-100387394","NCT04324164","Survival Outcome of EGFR-TKI in Uncommon EGFR Mutant Advanced NSCLC","Survival Outcome of EGFR-TKI in Uncommon EGFR Mutant Advanced Non-small Cell Lung Cancer in China","Inclusion Criteria:\n\n* 18，Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology\n\n  * Uncommon EGFR Mutant Advanced NSCLC\n\nExclusion Criteria:\n\n* Patients with contraindication of chemotherapy\n* Pregnant or breast feeding women",{"count":230,"type":21},800,"This study aims to explore Survival Outcome of EGFR-TKI in Uncommon EGFR Mutant Advanced Non-small Cell Lung Cancer in China",[53],"2025-01-23",{"date":235,"type":32},"2025-01-27",{"date":237,"type":32},"2020-03-24",{"date":239,"type":21},"2027-12-24",{"name":38,"class":39},{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":22,"phases":251,"briefSummary":252,"conditions":253,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":264,"locationsCount":89},"100387296","phase-2-treatment-strategies-and-survival-outcome-for-non-small-cell-lung-cancer-with-oncogenic-mutation-100387296","NCT04322890","Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation","Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation.","PIKACHU","Inclusion Criteria:\n\n1. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.\n2. Age ≥ 18 years.\n3. Histologically or cytologically confirmed, Stage IV NSCLC.\n4. Oncogenic mutations confirmed by an accredited local laboratory, including EGFR, ALK, ROS1 etc.\n5. ECOG 0-1.\n6. Predicted survival ≥ 12 weeks.\n7. Adequate bone marrow hematopoiesis and organ function\n8. Presence of measurable lesions according to RECIST 1.1.\n\nExclusion Criteria:\n\nThe patient did not match from the Inclusion Criteria.",{"count":250,"type":21},6000,[24],"The purpose of this study is to assess the Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation.",[124,254,255,256,257],"EGFR Gene Mutation","ALK Gene Mutation","ROS1 Gene Mutation","MET Gene Mutation","2024-10-19",{"date":260,"type":32},"2024-10-22",{"date":262,"type":32},"2020-04-16",{"date":239,"type":21},{"name":38,"class":39},{"id":266,"slug":267,"hasResults":12,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":22,"phases":273,"briefSummary":274,"conditions":275,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":282,"locationsCount":89},"100564860","phase-2-third-generation-egfr-tki-plus-anlotinib-as-maintenance-for-nsclc-with-small-cell-transformation-after-egfr-tki-resistance-100564860","NCT06634667","Third-generation EGFR-TKI Plus Anlotinib as Maintenance for NSCLC With Small Cell Transformation After EGFR-TKI Resistance","Efficacy and Safety of Third-generation EGFR-TKI Combined With Anlotinib as Maintenance Therapy Following 4-6 Cycles of Chemotherapy and Immunotherapy in NSCLC With Small Cell Transformation After EGFR-TKI Resistance: a Single-arm Prospective Phase II Study","Inclusion Criteria:\n\n* 1\\. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.\n* 2\\. Age ≥ 18 years.\n* 3\\. Histopathology is confirmed non-small cell lung cancer .\n* 4.Patients with advanced non-small cell lung cancer (NSCLC) who experienced small cell transformation after EGFR-TKI resistance.\n* 5\\. Predicted survival ≥ 12 weeks. .\n* 6\\. ECOG 0-2.\n* 7\\. Adequate bone marrow hematopoiesis and organ function.\n\nExclusion Criteria:\n\n* 1\\. History of other malignant tumors within 2 years.\n* 2\\. Adverse events (except alopecia of any degree) of CTCAE \\> grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.\n* 3\\. History of stroke or intracranial hemorrhage within 6 months prior to the first dose.\n* 4\\. The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.\n* 5\\. Subjects with persistent or active infection, including but not limited to hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and COVID-19 infection.\n* 6\\. Heart-related diseases or abnormalities\n* 7\\. Past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy or interstitial lung disease with active clinical symptoms, immune pneumonia caused by immunotherapy.\n* 8\\. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb sunvozertinib or anlotinib due to previous bowel resection.\n* 9\\. Live vaccine was given 2 weeks before the first medication.\n* 10\\. Women who are breastfeeding or pregnant.\n* 11\\. Hypersensitivity to the test drug and the ingredients.\n* 12\\. Other conditions assessed by the investigator to be unsuitable for participation in the study.",{"count":20,"type":21},[24],"This study aimed to evaluate the efficacy and safety of third-generation EGFR-TKI plus anlotinib as maintenance after chemotherapy plus immunotherapy in advanced NSCLC with small cell transformation after EGFR-TKI resistance.",[53],"2024-10-08",{"date":278,"type":32},"2024-10-10",{"date":280,"type":21},"2024-11-30",{"date":199,"type":21},{"name":38,"class":39},{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":142,"enrollmentInfo":291,"targetDuration":4,"studyType":22,"phases":293,"briefSummary":295,"conditions":296,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":4},"100531209","phase-1-ak112-plus-platinum-based-chemotherapy-for-egfralkros1-positve-nsclc-100531209","NCT06196814","AK112 Plus Platinum-based Chemotherapy for EGFR\u002FALK\u002FROS1 Positve NSCLC","Efficay and Satety of PD-1\u002FVEGR Bispecific Antibodies (AK112) Plus Platinum-based Chemotherapy for EGFR\u002FALK\u002FROS1 Positve NSCLC: A Multiple Centers, Multiple Cohorts, Dose Escalation Phase II Apple Study","Apple","Inclusion Criteria:\n\n* Eligible subjects selected for this study must meet all of the following criteria:\n\n  1. Sign written informed consent before implementing any trial-related procedures;\n  2. Age ≥18 years old and ≤75 years old;\n  3. No limit on the gender;\n  4. The ECOG score is 0 or 1.\n* The investigators want to evaluated the Efficay and Satety of PD-1\u002FVEGR bispecific antibodies (AK112) plus Platinum-based Chemotherapy for EGFR\u002FALK\u002FROS1 Positve NSCLC who Failed from First-Line Standard Treatment.\n\nThis study will be devided into three cohorts.\n\n* Cohort A for EGFR mutation NSCLC, Patient with NGS idenfied EGFR sensitive mutation NSCLC who failed from first line Osimertinib will be included. The 3+3 stud will conducted for dose escalation for AK112 （from 20mg to 30mg), and than the fix dose will be set up for cohort A, B and C.\n* Cohort B for ALK fusion NSCLC, Patient with NGS idenfied ALK fusion NSCLC who failed from first line Alectinib will be included. All the patients will be devided two group,3'ALK and 3'ALK with reteintion of 5'ALK. All the patients will be treated with PD-1\u002FVEGR bispecific antibodies (AK112) plus Platinum-based Chemotherapy.\n* Cohort C for ROS1 fusion NSCLC, Patient with NGS idenfied ROS1 fusion NSCLC who failed from first line crizotinib or Entrectinib will be included. All the patients will be treated with PD-1\u002FVEGR bispecific antibodies (AK112) plus Platinum-based Chemotherapy.\n\nThe investigators will collect the satety and efficacy data for all the patients.\n\nExclusion Criteria:\n\n* Histological or cytological pathology confirmed the presence of a small cell carcinoma component, or a squamous cell carcinoma as a major component\n* Patients who have received immunotherapy previously, including immune checkpoint inhibitors (such as anti-PD-1\u002FL1, anti-CTLA-4 , anti-LAG-3, etc.), immune checkpoint activators (such as ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immune cell therapy and any other treatment targeting the immunity mechanism.\n* Previously received other anti-tumor therapy for advanced stages of NSCLC (stages IIIB to IV) (including cytotoxic chemotherapy used with radiotherapy, systemic chemotherapy, and anti-VEGFR therapy) .\n\nPatients who have previously undergone adjuvant\u002Fneoadjuvant chemotherapy with the aim of curing non-metastatic diseases are eligible for inclusion in this study if disease progression occurs at least 6 months after the completion of the last chemotherapy cycle.\n\n* Concurrent enrollment in another clinical trial is allowed, unless it involves a non-interventional clinical study or the follow-up period of an interventional study (defined as the time elapsed from the initiation of the first drug to at least 4 weeks after the last drug administration in the previous clinical study or beyond 5 half-lives of the investigational drug in that study, whichever is shorter).\n* Received TKI treatment within the 2 weeks preceding the first dose; underwent palliative local therapy for non-target lesions within the 2 weeks preceding the first dose; received non-specific immunomodulatory therapy within the 2 weeks preceding the first dose, such as interleukins, interferons, thymosin alpha-1, tumor necrosis factor, etc. (excluding IL-11 used for treating thrombocytopenia); received herbal medicine or traditional Chinese medicine with anti-tumor indications within the 1 week preceding the first dose.",{"count":292,"type":21},150,[294,24],"PHASE1","The investigators want to evaluated the Efficay and Satety of PD-1\u002FVEGR bispecific antibodies (AK112) plus Platinum-based Chemotherapy for EGFR\u002FALK\u002FROS1 Positve NSCLC who Failed from First-Line Standard Treatment.",[297],"Efficacy","2024-10-06",{"date":300,"type":32},"2024-10-09",{"date":302,"type":21},"2024-10-01",{"date":304,"type":21},"2027-02-01",{"name":38,"class":39},{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":118,"enrollmentInfo":314,"targetDuration":4,"studyType":22,"phases":316,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":325,"locationsCount":89},"100562529","phase-2-bronchoscopic-cryoablation-combined-with-chemo-immunotherapy-in-nsclc-with-central-airway-obstruction-100562529","NCT06604351","Bronchoscopic Cryoablation Combined With Chemo-Immunotherapy in NSCLC With Central Airway Obstruction","The Efficacy and Safety of Bronchoscopic Cryoablation Combined With Sintilimab Plus Platinum-based Chemotherapy as First-line Treatment for Locally Advanced or Metastatic NSCLC With Central Airway Obstruction: A Phase II Study","Example","Inclusion Criteria:\n\n* Understand the requirements and contents of the clinical trial and provide a signed and dated informed consent form.\n* Age≥18 years and≤80 years.\n* Histologically or cytologically confirmed and documented locally advanced or metastatic non-small cell lung cancer (NSCLC) without prior systemic therapy and EGFR-sensitive mutations (19del, L858R and T790M).\n* Presence of a palliative treatment lesion in the central airway that is amenable to ablation, endoscopically assessed to be≥1\u002F3 obstruction, such as primary or metastatic malignancy to the trachea, main bronchi, intermediate bronchi, or segmental bronchi. corresponding respiratory symptoms or obstructive pneumonia is permission to be included.\n* Eastern Cooperative Oncology Group (ECOG) ： 0-2.\n* Predicted survival ≥ 12 weeks.\n* Adequate bone marrow hematopoiesis and organ function (cardiac function, hepatic, and renal function).\n* Presence of measurable lesions according to RECIST 1.1 criteria.\n* Subjects with stable brain metastases may be included in the study.\n\nExclusion Criteria:\n\n* Histological diagnosis of small cell, large cell lung cancer; mixed tumors will be classified based on the primary cell type; if the primary component is small cell, large cell, or neuroendocrine carcinoma, the subject will not be eligible for enrollment; however, mixed adenocarcinoma-squamous cell carcinoma is acceptable. Subjects with driver gene mutations are generally not eligible for enrollment.\n* Malignant central airway obstruction with acute dyspnea or severe life-threatening symptoms of malignant airway stenosis, or assessed by the investigator to be unable to tolerate subsequent treatment; extrinsic airway compression; large pleural effusion, severe coughing, massive hemoptysis, dyspnea, or inability to cooperate; severely impaired lung function with a maximal voluntary ventilation (MVV) \\\u003C 39% or inability to ambulate.\n* Prior systemic therapy for locally or metastatic disease.\n* Uncorrectable coagulation disorders, severe bleeding tendencies, platelet count \\\u003C 50 \\*10\\^9\u002FL, or severe coagulation dysfunction.\n* Presence of symptomatic brain metastases.\n* Known severe hypersensitivity to anti-PD-1 monoclonal antibodies or similar drugs (allergic reactions with CTCAE≥ grade 3 toxicity).\n* Subjects with persistent or active infection, including but not limited to hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV).\n* Any concurrent malignancy other than basal cell carcinoma or cervical carcinoma in situ. (Patients with a history of malignant tumors but with no evidence of disease for≥ 3 years may be included ).\n* Women who are breastfeeding or pregnant.\n* Other conditions assessed by the investigator to be unsuitable for participation in the study.",{"count":315,"type":21},39,[24],"This study aimed to evaluate the efficacy and safety of bronchoscopic cryoablation combined with sintilimab plus platinum-based chemotherapy as First-line Treatment for locally advanced or metastatic NSCLC with central airway obstruction.",[172],"2024-09-17",{"date":321,"type":32},"2024-09-19",{"date":323,"type":21},"2024-09-15",{"date":158,"type":21},{"name":38,"class":39},{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":22,"phases":334,"briefSummary":335,"conditions":336,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":342,"locationsCount":89},"100557375","phase-2-intrathecal-pemetrexed-combined-with-high-dose-furmonertinib-and-beva-for-egfr-m-nsclc-with-leptomeningeal-metastases-100557375","NCT06537297","Intrathecal Pemetrexed Combined With High-dose Furmonertinib and Beva for EGFR-m NSCLC With Leptomeningeal Metastases","The Efficacy and Safety of Intrathecal Pemetrexed With High-dose Furmonertinib Plus Bevacizumab for EGFR-mutant NSCLC Patients With Leptomeningeal Metastases Resistant to Third-generation EGFR-TKIs: A Phase II Study.","Inclusion Criteria:\n\n* 1\\. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.\n* 2\\. Age ≥ 18 years.\n* 3\\. Histopathology confirmed Non-small cell lung cancer.\n* 4\\. confirmed or probable leptomeningeal metastases according to EANO-ESMO guidelines or known leptomeningeal metastases progression after third generation of EGFR-TKIs failure.\n* 5.Leptomeningeal metastasis (LM) is defined by the presence of typical clinical symptoms, positive cerebrospinal fluid (CSF) cytology, detection of cell-free DNA (cfDNA) in CSF by next-generation sequencing (NGS), or imaging findings consistent with typical meningeal metastases.\n* 6.ECOG 0 - 2.\n* 7\\. Predicted survival ≥ 12 weeks.\n* 8\\. Adequate bone marrow hematopoiesis and organ function.\n\nExclusion Criteria:\n\n* 1\\. Previously received intrathecal pemetrexed therapy for locally advanced or metastatic disease.\n* 2\\. Subjects who have received any of the following treatments must be excluded: Have received radiation within 14 days prior to the first dose or have not recovered from radiation-related toxicity. Chest and extra-brain palliative radiotherapy, stereotactic radiosurgery, and stereotactic body radiotherapy may be performed 7 days prior to the first dose.\n* 3\\. Presence of spinal cord compression.\n* 4\\. History of other malignant tumors within 2 years.\n* 5\\. Adverse events (except alopecia of any degree) of CTCAE \\> grade 4 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.\n* 6\\. History of stroke or intracranial hemorrhage within 6 months prior to the first dose.\n* 7\\. The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.\n* 8\\. Subjects with persistent or active infection, including but not limited to hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and COVID-19 infection.\n* 9\\. Heart-related diseases or abnormalities\n* 10\\. Past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy or interstitial lung disease with active clinical symptoms, immune pneumonia caused by immunotherapy.\n* 11\\. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb Furmonertinib due to previous bowel resection.\n* 12\\. Live vaccine was given 2 weeks before the first medication.\n* 13\\. Women who are breastfeeding or pregnant.\n* 14\\. Hypersensitivity to the test drug and the ingredients.\n* 15\\. Other conditions assessed by the investigator to be unsuitable for participation in the study.",{"count":20,"type":21},[24],"This study aimed to evaluate the efficacy and safety of intrathecal pemetrexed with high-dose Furmonertinib plus bevacizumab for EGFR-mutant non-small cell lung cancer patients with leptomeningeal metastases after resistance to third-generation EGFR-TKIs.",[53],{"date":338,"type":32},"2024-09-20",{"date":340,"type":21},"2024-09-30",{"date":64,"type":21},{"name":38,"class":39},{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":22,"phases":352,"briefSummary":353,"conditions":354,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":356,"startDateStruct":357,"completionDateStruct":358,"leadSponsor":359,"locationsCount":89},"100554319","phase-2-intrathecal-pemetrexed-for-sclc-patients-with-refractory-brain-metastases-or-leptomeninges-metastatic-100554319","NCT06497543","Intrathecal Pemetrexed for SCLC Patients With Refractory Brain Metastases or Leptomeninges Metastatic","The Efficacy and Safety of Intrathecal Pemetrexed for SCLC Patients With Refractory Brain Metastases or Leptomeningeal Metastasis: A Phase II Study","Inclusion Criteria:\n\n* 1\\. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.\n* 2\\. Age ≥ 18 years.\n* 3\\. Histopathology is confirmed small cell lung cancer .\n* 4.Leptomeningeal metastasis (LM) is defined by the presence of typical clinical symptoms, positive cerebrospinal fluid (CSF) cytology, detection of cell-free DNA (cfDNA) in CSF by next-generation sequencing (NGS), or imaging findings consistent with typical meningeal metastases.\n* 5.Patients with brain progression after whole-brain radiotherapy.\n* 6\\. Predicted survival ≥ 12 weeks. .\n* 7\\. ECOG 0-2.\n* 8\\. Adequate bone marrow hematopoiesis and organ function.\n\nExclusion Criteria:\n\n* 1\\. Previously received intrathecal pemetrexed therapy for locally advanced or metastatic disease.\n* 2\\. Subjects who have received any of the following treatments must be excluded:\n* Have received radiation within 14 days prior to the first dose or have not recovered from radiation-related toxicity. Chest and extra-brain palliative radiotherapy, stereotactic radiosurgery, and stereotactic body radiotherapy may be performed 7 days prior to the first dose.\n* 3\\. Presence of spinal cord compression or meningeal metastasis.\n* 4\\. History of other malignant tumors within 2 years.\n* 5\\. Adverse events (except alopecia of any degree) of CTCAE \\> grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.\n* 6\\. History of stroke or intracranial hemorrhage within 6 months prior to the first dose.\n* 7\\. The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.\n* 8\\. Subjects with persistent or active infection, including but not limited to hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and COVID-19 infection.\n* 9\\. Heart-related diseases or abnormalities\n* 10\\. Past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy or interstitial lung disease with active clinical symptoms, immune pneumonia caused by immunotherapy.\n* 11\\. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb sunvozertinib or anlotinib due to previous bowel resection.\n* 12\\. Live vaccine was given 2 weeks before the first medication.\n* 13\\. Women who are breastfeeding or pregnant.\n* 14\\. Hypersensitivity to the test drug and the ingredients.\n* 15\\. Other conditions assessed by the investigator to be unsuitable for participation in the study.",{"count":351,"type":21},80,[24],"This study aimed to evaluate the efficacy and safety of intrathecal pemetrexed for SCLC patients with refractory brain metastases or leptomeningeal metastasis.",[355],"Small-cell Lung Cancer",{"date":321,"type":32},{"date":302,"type":21},{"date":64,"type":21},{"name":38,"class":39},{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":366,"eligibilityCriteria":367,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":368,"targetDuration":4,"studyType":22,"phases":370,"briefSummary":371,"conditions":372,"keywords":373,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":377,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":89},"100543418","phase-2-sunvozertinib-plus-anlotinib-as-1l-treatment-in-egfr-mutant-advanced-nsclc-rw-100543418","NCT06355609","Sunvozertinib Plus Anlotinib as 1L Treatment in EGFR Mutant Advanced NSCLC-RW","A Perspective Observation Phase II, Single-Arm Study Evaluating the 1st Line Efficacy and Safety of Sunvozertinib Plus Anlotinib in EGFR-Sensitive Mutations Combined With Co-Mutations Locally Advanced or Metastatic NSCLC","WUKONG-32-RW","Inclusion Criteria:\n\n1. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.\n2. Age ≥ 18 years.\n3. Histopathology or cytology confirmed and recorded local progression or metastatic non-small cell lung cancer without systemic treatment.\n4. EGFR-sensitive mutations confirmed by an accredited local laboratory, including exon 19 deletions, exon 21 L858R point mutations, and T790M mutations, combined with co-mutations, including but not limited to TP53, PIK3CA, catenin beta-1 (CTNB1), and retinoblastoma (RB1).\n5. ECOG 0 - 1.\n6. Predicted survival ≥ 12 weeks.\n7. Adequate bone marrow hematopoiesis and organ function\n8. Presence of measurable lesions according to RECIST 1.1.\n9. Subjects with stable brain metastases may be included in the study.\n\nExclusion Criteria:\n\n1. Prior systemic therapy for locally advanced or metastatic disease.\n2. Subjects who have received any of the following treatments must be excluded:\n\n   * Treatment with molecules such as EGFR, VEGFR antibodies within 4 weeks prior to the first dose of study drug.\n   * Have received radiation within 14 days prior to the first dose or have not recovered from radiation-related toxicity. Chest and extra-brain palliative radiotherapy, stereotactic radiosurgery, and stereotactic body radiotherapy may be performed 7 days prior to the first dose.\n   * Ongoing (or inability to discontinue) possibly potent CYP1A2, CYP3A inhibitor (1 week), or inducer (2 weeks) drug therapy or herbal supplements within 1-2 weeks prior to the first dose.\n3. Presence of spinal cord compression or meningeal metastasis.\n4. History of other malignant tumors within 2 years.\n5. Adverse events (except alopecia of any degree) of CTCAE \\> grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.\n6. History of stroke or intracranial hemorrhage within 6 months prior to the first dose.\n7. The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.\n8. Subjects with persistent or active infection, including but not limited to hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and COVID-19 infection.\n9. Heart-related diseases or abnormalities\n10. Past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy or interstitial lung disease with active clinical symptoms, immune pneumonia caused by immunotherapy.\n11. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb sunvozertinib or anlotinib due to previous bowel resection.\n12. Live vaccine was given 2 weeks before the first medication.\n13. Women who are breastfeeding or pregnant.\n14. Hypersensitivity to the test drug and the ingredients.\n15. Other conditions assessed by the investigator to be unsuitable for participation in the study.",{"count":369,"type":21},100,[24],"This is a phase II, open-label, single-arm, single-center clinical study to evaluate the preliminary efficacy of sunvozertinib in combination with anlotinib in patients with EGFR-sensitive mutations and co-mutations in locally advanced or metastatic treatment-naive non-small cell lung cancer.",[53],[374,375,376],"sunvozertinib","anlotinib","EGFR mutations",{"date":338,"type":32},{"date":379,"type":32},"2024-07-01",{"date":381,"type":21},"2027-12-30",{"name":38,"class":39},{"id":384,"slug":385,"hasResults":12,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":389,"eligibilityCriteria":367,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":22,"phases":392,"briefSummary":393,"conditions":394,"keywords":395,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":396,"startDateStruct":397,"completionDateStruct":398,"leadSponsor":399,"locationsCount":89},"100542904","phase-2-sunvozertinib-plus-anlotinib-as-1l-treatment-in-egfr-sensitive-mutations-combined-with-co-mutations-advanced-nsclc-100542904","NCT06348927","Sunvozertinib Plus Anlotinib as 1L Treatment in EGFR-Sensitive Mutations Combined With Co-Mutations Advanced NSCLC","A Phase II, Single-Arm Study Evaluating the 1st Line Efficacy and Safety of Sunvozertinib Plus Anlotinib in EGFR-Sensitive Mutations Combined With Co-Mutations Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) (WUKONG-32)","WUKONG-32",{"count":391,"type":21},52,[24],"This is a phase II, open-label, single-arm, single-center clinical study to evaluate the preliminary efficacy of sunvozertinib in combination with anlotinib in patients with EGFR-sensitive mutations and co-mutations in locally advanced or metastatic treatment-naive non-small cell lung cancer.\n\nCondition or disease Intervention\u002Ftreatment Phase Non-Small Cell Lung Cancer Drug: sunvozertinib Drug: anlotinib Phase 2",[172],[374,375,376],{"date":321,"type":32},{"date":379,"type":32},{"date":199,"type":21},{"name":38,"class":39},{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":409,"conditions":410,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":412,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":89},"100530206","a-real-world-study-of-treatment-patterns-and-effectiveness-in-met-mutation-positive-advanced-lung-cancer-100530206","NCT06183762","A Real-World Study of Treatment Patterns and Effectiveness in MET Mutation-Positive Advanced Lung Cancer","Real-World Treatment Patterns and Effectiveness of Targeted and Systemic Therapy in Patients With Advanced Lung Cancer Carrying MET Mutation-Positive","Inclusion Criteria:\n\n1. Patients must be ≥18 years of age.\n2. Provision of fully informed consent prior to any study specific procedures.\n3. Histologically or cytologically confirmed, unresectable stage IIIB\u002FIIIC or stage IV NSCLC.\n4. Genetic variants of tumor tissue detected by NGS.\n\nExclusion Criteria:\n\nNone.",{"count":408,"type":21},200,"This is a descriptive observational study in which data are collected in an epidemiological manner. This study is not intended to alter or interfere with the current medical practice of the enrolled patients. Data will be collected in a forward-looking manner. This is a descriptive observational study in which data are collected in an epidemiological manner. This study is not intended to alter or interfere with the current medical practice of the enrolled patients. Data from patients on prior treatment will be collected retrospectively, and data from patients who will be treated later and included in the study will be collected in a prospective manner. The criteria for retrospective collection were consistent with those for prospective collection. Eligible patients will be enrolled after NGS analysis of tumor tissue and informed consent has been obtained. Information required for the study will be collected (every 3 months).",[411],"Advanced Lung Cancer",{"date":321,"type":32},{"date":414,"type":32},"2020-01-01",{"date":416,"type":21},"2025-06-30",{"name":38,"class":39},{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":4,"eligibilityCriteria":424,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":142,"enrollmentInfo":425,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":426,"conditions":427,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":429,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":433,"locationsCount":89},"100521772","compassionate-use-study-of-nhwd-870-in-patients-with-advanced-solid-tumors-or-lymphomas-carrying-nut-rearrangement-100521772","NCT06073938","Compassionate Use Study of NHWD-870 in Patients With Advanced Solid Tumors or Lymphomas Carrying NUT Rearrangement","A Real-World Study of NHWD-870 in Patients With Advanced Solid Tumors or Lymphomas Carrying NUT Rearrangement","Inclusion Criteria:\n\n1. Signing an informed consent form;\n2. Patients with advanced solid tumors or lymphomas definitively diagnosed by pathology;\n3. Age ≥18 and ≤75 years;\n4. Eastern Cooperative Oncology Group (ECOG) score physical status score of 0 to 1;\n5. Expected survival of \\>3 months;\n6. NUT positive confirmed by molecular testing.\n\nExclusion Criteria:\n\nSubjects who meet one or more of the following criteria will be excluded:\n\n1. Other serious complications (such as uncontrolled infection, myocardial infarction within 6 months, high blood pressure (≥ 160\u002F100mmHg) and thromboembolic disease that cannot be controlled by drug intervention, etc.);\n2. The adverse reactions of previous anti-tumor therapy have not been restored to CTCAE 5.0 ≤ Grade1 (except for hair loss, anemia and other toxicities judged by researchers to be unsafe);\n3. History of substance abuse;\n4. Inability to take drugs due to dysphagia (except for patients who receive nutrients through a gastric tube due to dysphagia), or conditions that the investigator determines seriously affect gastrointestinal absorption;\n5. Patients with a history of other serious systemic diseases who are judged by the investigator to be unsuitable for participating in clinical trials;\n6. Alcoholics or those who drink more than 28 units of alcohol per week (1 unit = 285 mL of beer or 25 mL of spirits or 1 glass of wine);\n7. Suffering from uncontrollable mental illness;\n8. Pregnant or lactating women, or patients of childbearing age (including male subjects) with pregnancy plans;\n9. Active hepatitis B (viral titer \\>103), hepatitis C or HIV ( );\n10. Long-term treatment with high-dose corticosteroids or other immunosuppressants, such as those who have undergone organ transplantation, or those who have received systemic glucocorticoids (such as prednisone\\> 10 mg\u002Fday or equivalent drugs) or other immunosuppressant therapy within 14 days before the first use of the study drug; Exceptions are given for topical, ocular, intra-articular, intranasal and inhaled corticosteroid therapy; short-term use of glucocorticoids for prophylaxis (e.g., prevention of contrast allergy);\n11. The investigator believes that the subject is not suitable to participate in this clinical study for other objective reasons.",{"count":20,"type":21},"The NHWD-870 Phase I clinical trial evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics in patients with advanced tumors. The objectives of this retrospective study were to preliminarily evaluate the anti-tumor efficacy of NHWD-870 HCl in patients with advanced solid tumors or lymphomas and to preliminarily evaluate biomarkers associated with the efficacy of NHWD-870 HCl in the treatment of patients with advanced solid tumors or lymphomas, to provide a basis for identifying the enriched population for the late-stage trial.",[428],"Advanced Solid Tumors or Lymphomas",{"date":321,"type":32},{"date":431,"type":32},"2022-09-20",{"date":416,"type":21},{"name":38,"class":39},{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":4,"eligibilityCriteria":440,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":442,"conditions":443,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":444,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":89},"100515414","a-study-with-central-nervous-system-metastatic-egfr-mutation-positive-non-small-cell-lung-cancer-100515414","NCT05991193","A Study With Central Nervous System Metastatic EGFR Mutation Positive Non-small Cell Lung Cancer","A Non-interventional Study and Its Clinical Relevance With Central Nervous System Metastatic Epidermal Growth Factor Receptor Mutation Positive Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Patients must be ≥18 years.\n* Provision of fully informed consent prior to any study specific procedures.\n* Patient with EGFR 19Del or L858R mutation diagnosed histologically or cytologically. The mutations above may exist alone or together.\n* Patients must have untreated advanced Non-Small Cell Lung Cancer (NSCLC).\n* According to the RECIST 1.1 standard, the patient must have at least one measurable lesion.\n\nExclusion Criteria:\n\n* None",{"count":369,"type":21},"This is a descriptive observational study, in which data are collected in an epidemiological fashion and prospective. This study does not intend to intervene the current medical practice of the recruited patients.",[27],{"date":338,"type":32},{"date":446,"type":32},"2023-12-29",{"date":448,"type":21},"2025-12-31",{"name":38,"class":39},{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":457,"targetDuration":4,"studyType":22,"phases":459,"briefSummary":460,"conditions":461,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":462,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":89},"100468440","phase-2-high-dose-furmonertinib-for-first-line-treatment-of-egfr-mutated-nsclc-with-central-nervous-system-cns-metastases-100468440","NCT05379803","High-dose Furmonertinib for First-line Treatment of EGFR Mutated NSCLC With Central Nervous System (CNS) Metastases","A Single Arm, Multicenter Clinical Study of High-dose Furmonertinib in First-line Treatment of EGFR Mutated NSCLC With Central Nervous System (CNS) Metastases","Inclusion Criteria:\n\n* Signed written informed consent before any study-related procedure.\n* Age ≥ 18 years.\n* ECOG PS of 0 to 1 at screening,and with no clinically significant deterioration in the previous 2 weeks.\n* Expected survival ≥12 weeks.\n* Histologically or cytologically confirmed metastatic Non-Small Cell Lung Cancer (International Association for the Study of Lung Cancer and Joint Committee on the American Classification of Cancer, TNM Lung cancer stage 8). Documented validated results from local testing of either tumor tissue or blood confirming the presence of EGFR 19del or exon 21del L858R mutation. These mutations above may exist alone or together.\n* According to RECIST 1.1, patients must have at least one central nervous system (CNS) metastatic tumor lesion at baseline that meets the following requirements: accurately and repeatably measurable at baseline, have no radiotherapy or biopsy.\n* Patients who have untreated for advanced\u002Fmetastatic non-small cell lung cancer, including chemotherapy, biological therapy, targeted therapy, immunotherapy, or experimental therapy, prior to initiation of study drug therapy. Patients who have received adjuvant therapy or neoadjuvant therapy (chemotherapy and\u002For radiotherapy) are allowed to enroll if there is no progression within 6 months of treatment. Patients who have received topical therapy (radiotherapy or perfusion therapy) are allowed to enroll if the lesion within the local therapeutic area is non-targeted.\n* For premenopausal women with childbearing potential, a pregnancy test must be performed within 14 days before the first dose, and the pregnancy test (blood or urine test) must be negative; female subjects must not be lactating;\n* Willing to use contraception.\n* Voluntary and agree to follow the study treatment protocol as well as follow-up plan, and can accept the oral medicine treatment.\n\nExclusion Criteria:\n\n* Small cell lung carcinoma;\n* History of hypersensitivity to active or inactive excipients of investigational agent with a similar chemical structure.\n* Confirmed EGFR 20 exon insertion mutations at any time after the initial diagnosis.\n* Patient who receive prior treatment including any of the following:\n* Any Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI).\n* The patients who have received intrapleural perfusion therapy can only be enrolled 28 days or more after the pleural effusion is stable;\n* Major surgery within 4 weeks of the first dose of investigational agent.\n* Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of investigational agent;\n* CYP3A4 strong inhibitor or strong inducer is used within 7 days prior to the first dose, or need to receive these drugs during the study period.\n* Traditional Chinese medicine and traditional Chinese medicine preparations with anti-tumor as indications and with adjuvant treatment of tumor is used within 7 days prior to the first dose, or need to receive these drugs during the study period.\n* Patients who are receiving drugs known to prolong QTc interval or may cause torsade de pointe and need to continue to receive these drugs during the study period.\n* The time from the treatment with any other investigational product or its analogue to the first dose does not exceed 5 half-lives of the drug or 14 days, whichever is longer.\n* Prior treatment with any systemic anti-cancer therapy for advanced Non-Small Cell Lung Cancer (NSCLC) including chemotherapy, biologic therapy, target therapy, immunotherapy, or any investigational drug, except neoadjuvant or adjuvant therapy before 6 months prior to the first dose investigational treatment.\n* At the beginning of study treatment, any unresolved toxic reaction to prior treatment is present, which exceeds Grade 1 in accordance with Common Terminology Criteria for Adverse Events (CTCAE) (except for alopecia), and exceeds Grade 2 for prior platinum treatment-related neuropathy.\n* Spinal cord compression; symptomatic and unstable brain metastases, except for those patients who have completed definitive therapy, are not on steroids, and have a stable neurological status for at least 2 weeks after completion of the definitive therapy and steroids.\n* Diagnosed other malignant tumors or had a history of other malignant tumors in last 5 years, except for skin basal cell carcinoma, cervical carcinoma in situ and breast ductal carcinoma in situ which have been effectively controlled;\n* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of investigational agent.\n* Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, and active infection, which in the Investigator's opinion makes it undesirable for the patient to participate in the trial.\n* Past medical history of Interstitial Lung Disease (ILD), drug-induced Interstitial Lung Disease, radiation pneumonitis that required steroid treatment, or any evidence of clinically active Interstitial Lung Disease.\n* Any evidence of corneal injury:\n* Inadequate bone marrow reserve or organ function.\n* QT prolongation or any clinically important abnormalities in rhythm and heart function.\n* Patients who may have poor compliance with the research procedures and requirements, etc., as judged by investigators.\n* Pregnancy or lactation.",{"count":458,"type":21},40,[24],"EGFR mutated NSCLC patiens with CNS metastases have poor prognosis. High-dose furmonertinib (160mg\u002Fday) have produced high CNS PFS and ORR in second-line for EGFR T790M mutated NSCLC. Whether EGFR mutated NSCLC with CNS metastases can benefit from first-line treatment of high-dose furmonertinib has not been reported. This study aims to investigate the efficacy and safety of high dose furmonertinib in first-line treatment of EGFR mutated NSCLC patiens.",[172],{"date":321,"type":32},{"date":464,"type":32},"2022-05-01",{"date":466,"type":21},"2025-03-31",{"name":38,"class":39},{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":4,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":475,"targetDuration":4,"studyType":22,"phases":476,"briefSummary":477,"conditions":478,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":479,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":89},"100461942","phase-2-atezolizumab-combined-with-platinum-based-chemotherapy-as-neoadjuvant-therapy-for-patients-with-resectable-stage-ii-iiib-100461942","NCT05295212","Atezolizumab Combined With Platinum-based Chemotherapy as Neoadjuvant Therapy for Patients With Resectable Stage II-IIIB","A Prospective, Multicenter Phase II Clinical Study of Atezolizumab Combined With Platinum-based Chemotherapy as Neoadjuvant Therapy for Patients With Resectable Stage II-IIIB Driver Gene-negative Non-small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n* Eligible subjects selected for this study must meet all of the following criteria:\n\n  1. Sign written informed consent before implementing any trial-related procedures;\n  2. Age ≥18 years old and ≤75 years old; No limit on the gender;\n  3. Previously untreated, histologically confirmed resectable stage II, IIIA, IIIB (N2) (AJCC stage VIII) NSCLC; cTNM stage can be confirmed by PET-CT or pathological biopsy; resectable stage II non-small cell lung cancer is defined as radical resection as assessed by a qualified thoracic surgeon; resectable is resectable and potentially resectable as defined by the Expert Consensus on Multidisciplinary Diagnosis and Treatment of Stage III Non-small Cell Lung Cancer (2019 version); resectable includes IIIA (N0-1), some single-station mediastinal lymph node metastases with N2 and some T4 (satellite nodules present in adjacent lobes) N1; potentially resectable includes some stage IIIA and IIIB, including single-station N2 mediastinal lymph node short diameter \\\u003C 3 cm stage IIIA NSCLC, potentially resectable T3 or T4 central tumors; Solid\u002Fsolid pulmonary nodules, not pure ground-glass opacity (GGO), are strongly recommended for pathological puncture verification;\n  4. Patients diagnosed with squamous cell carcinoma do not require genetic testing, and if they test positive for EGFR, ALK or ROS1, they are considered as exclusion criteria; if they are adenocarcinoma, they must undergo genetic testing containing at least EGFR, ALK and ROS1, and the acceptable detection method is ARMS or NGS, of which NGS is a cFDA-approved kit;\n  5. Measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1;\n  6. Twenty tissue sections (4-6 microns in thickness) should be submitted before enrollment for biomarker evaluation (tumor tissue samples must be fresh or archival samples obtained within 3 months before enrollment; fresh tissues must be biopsy specimens by hollow needle aspiration, resection or incision);\n  7. ECOG score 0-1;\n  8. Good organ function: (1) hematology: absolute neutrophil count (ANC) ≥ 1500\u002FμL; platelets ≥ 100,000\u002FμL; hemoglobin ≥ 9.0 g\u002FdL or ≥ 5.6 mmol\u002FL; (2) kidney: serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance (CrCl) ≥ 60 mL\u002Fmin (using the Cock-Gault formula); (3) liver: total bilirubin ≤ 1.5 × ULN or for subjects with total bilirubin levels \\> 1.5 × ULN, direct bilirubin is within normal limits; AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN; (4) endocrine system: thyroid stimulating hormone (TSH) is within normal limits. Note: If TSH is not within normal range at baseline, if T3 and free T4 are within normal range, then the subject can still meet the inclusion criteria; (5) Coagulation function: international normalized ratio (INR) or prothrombin time (PT), activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN, except: subjects receiving anticoagulant therapy, as long as PT or aPTT is within the proposed use range of anticoagulant drugs; (6) Cardiac function tests: baseline ECG showed no PR interval prolongation or atrioventricular block;\n  9. The total lung function can withstand the proposed pneumonectomy surgery according to the surgeon's assessment;\n  10. Women should agree to use contraceptive measures (such as intrauterine device (IUD), contraceptives or condoms) during the study and within 6 months after the end of the study; serum or urine pregnancy test is negative within 7 days before study entry, and must be non-lactating patients; men should agree to use contraceptive measures during the study and within 6 months after the end of the study period.\n\nExclusion Criteria:\n\n* Subjects who meet the following criteria cannot be selected for this study:\n\n  1. Histopathology is neuroendocrine carcinoma and sarcomatoid tumor；\n  2. The presence of locally advanced unresectable or metastatic disease; unresectable including stage III non-small cell lung cancer multidisciplinary diagnosis and treatment expert consensus (2019 version) defined unresectable, including partial IIIA, IIIB and all IIIC, usually including single-station N2 mediastinal lymph nodes short diameter ≥ 3 cm or multi-station lymph nodes fused into a mass (CT lymph nodes short diameter ≥ 2 cm) N2, invading the esophagus, heart, aorta, pulmonary veins T4 and all N3;\n  3. Subjects with known EGFR mutations or ALK, ROS1 translocations, non-squamous cell carcinoma subjects need to clarify the EGFR, ALK and ROS1 mutation status；\n  4. Early stage NSCLC previously treated with systemic anticancer therapy, including treatment with investigational agents；\n  5. History of (non-infectious) pneumonia\u002Finterstitial lung disease requiring steroid therapy, or current pneumonia\u002Finterstitial lung disease requiring steroid therapy；\n  6. Known history of active tuberculosis;\n  7. Known active infection requiring systemic treatment;\n  8. Any known or suspected autoimmune disease or immunodeficiency subjects, except: patients with a history of hypothyroidism, if hormone therapy is not required, or are receiving physiological doses of hormone replacement therapy; subjects with stable type I diabetes whose blood glucose is controlled;\n  9. Subjects with active hepatitis B (defined as positive hepatitis B virus surface antigen \\[HBsAg\\] test results and HBV-DNA test values higher than the upper limit of normal of the laboratory of the study site) or hepatitis C (defined as positive hepatitis C virus surface antibody \\[HCsAb\\] test results and positive HCV-RNA test results during the screening period);\n  10. Known human immunodeficiency virus (HIV) infection (known HIV antibody positive);\n  11. Live vaccines within 30 days prior to the first dose. Including but not limited to the following: mumps, rubella, measles, varicella\u002Fherpes zoster (chickenpox), yellow fever, rabies, bacillus Calmette-Guerin (BCG) and typhoid vaccines (inactivated viral vaccines are allowed);\n  12. Have ≥ grade 2 peripheral neuropathy;\n  13. Previous treatment with PD-1\u002FPD-L1 drugs or treatment with another drug targeting T cell receptor (such as CTLA-4, OX-40, etc.);\n  14. Patients with any severe and\u002For uncontrolled diseases, such as: (1) unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months before randomization, severe uncontrolled arrhythmia; patients with unsatisfactory blood pressure control (systolic blood pressure \\> 140 mmHg, diastolic blood pressure \\> 90 mmHg); (2) active or uncontrolled severe infection; (3) liver diseases such as cirrhosis, decompensated liver disease, chronic active hepatitis; (4) poor control of diabetes (fasting blood glucose (FBG) \\> 10 mmol\u002FL); (5) urine routine showed urine protein ≥ + +, and confirmed 24-hour urine protein \\> 1.0g; (6) a history of psychiatric drug abuse and can not quit or mental disorders;\n  15. Use of immunosuppressive drugs 2 times before the first study drug treatment, excluding topical glucocorticoids or systemic glucocorticoids no more than 10 mg\u002Fday prednisone or equivalent doses of other glucocorticoids;\n  16. Pregnant or lactating women;\n  17. Prisoners who are unlawfully incarcerated or compulsorily detained for non-mental illness or physical (such as infectious diseases) diseases;\n  18. Patients with bleeding tendency (such as active gastrointestinal ulcers) or treatment with anticoagulants or vitamin K antagonists such as warfarin, heparin or its analogues;\n  19. History of allergy to study drug ingredients;\n  20. According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.",{"count":168,"type":21},[24],"This study aimed to evaluate the efficacy, safety, tolerability, feasibility of surgery, and incidence of preoperative and postoperative complications of atezolizumab in combination with platinum-based chemotherapy with resectable stage II-IIIB non-small cell lung cancer.",[124],{"date":321,"type":32},{"date":481,"type":32},"2023-02-01",{"date":483,"type":21},"2025-07-01",{"name":38,"class":39},{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":491,"eligibilityCriteria":492,"healthyVolunteers":493,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":494,"targetDuration":4,"studyType":22,"phases":496,"briefSummary":497,"conditions":498,"keywords":499,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":503,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":89},"100440374","phase-2-alk-tyrosine-kinase-inhibitors-in-alk-rearranged-advanced-squamous-cell-carcinoma-100440374","NCT05014464","ALK Tyrosine Kinase Inhibitors in ALK-rearranged Advanced Squamous Cell Carcinoma","Molecular Characterization and Clinical Outcomes of ALK Tyrosine Kinase Inhibitors in ALK-rearranged Advanced Squamous Cell Carcinoma","ATPase","Inclusion Criteria:\n\n1. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.\n2. Age ≥ 18 years.\n3. Histopathology or cytology confirmed and recorded local progression or metastatic Advanced Squamous Cell Carcinoma without systemic treatment.\n4. ALK fusion positive evaluated by IHC (ventana), NGS or FISH.\n5. ECOG 0 - 1.\n6. Predicted survival ≥ 12 weeks.\n7. Adequate bone marrow hematopoiesis and organ function\n8. Presence of measurable lesions according to RECIST 1.1.\n9. Subjects with stable brain metastases may be included in the study.\n\nExclusion Criteria:\n\n1. Prior systemic therapy for locally advanced or metastatic disease.\n2. Subjects who have received any of the following treatments must be excluded:\n\n   * Treatment with molecules such as EGFR, VEGFR antibodies within 4 weeks prior to the first dose of study drug.\n   * Have received radiation within 14 days prior to the first dose or have not recovered from radiation-related toxicity. Chest and extra-brain palliative radiotherapy, stereotactic radiosurgery, and stereotactic body radiotherapy may be performed 7 days prior to the first dose.\n   * Ongoing (or inability to discontinue) possibly potent CYP1A2, CYP3A inhibitor (1 week), or inducer (2 weeks) drug therapy or herbal supplements within 1-2 weeks prior to the first dose.\n3. Presence of spinal cord compression or meningeal metastasis.\n4. History of other malignant tumors within 2 years.\n5. Adverse events (except alopecia of any degree) of CTCAE \\> grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.\n6. History of stroke or intracranial hemorrhage within 6 months prior to the first dose.\n7. The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.\n8. Subjects with persistent or active infection, including but not limited to hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and COVID-19 infection.\n9. Heart-related diseases or abnormalities\n10. Past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy or interstitial lung disease with active clinical symptoms, immune pneumonia caused by immunotherapy.\n11. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb sunvozertinib or anlotinib due to previous bowel resection.\n12. Live vaccine was given 2 weeks before the first medication.\n13. Women who are breastfeeding or pregnant.\n14. Hypersensitivity to the test drug and the ingredients.\n15. Other conditions assessed by the investigator to be unsuitable for participation in the study.",true,{"count":495,"type":21},90,[24],"This study was to explore the efficacy of ALK-TKI in lung squamous cell carcinoma. Approximately 5% of lung adenocarcinomas have oncogenic fusions of EML-4 and ALK a mutation associated with tumorigenesis and migration.",[53],[500,501,502],"ALK rearrangement","Squamous cell lung cancer","ALK-TKI",{"date":338,"type":32},{"date":505,"type":32},"2021-11-13",{"date":507,"type":21},"2027-08-08",{"name":38,"class":39},{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":142,"enrollmentInfo":516,"targetDuration":4,"studyType":22,"phases":517,"briefSummary":518,"conditions":519,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":520,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":89},"100435571","phase-2-js-201-combined-with-lenvatinib-in-the-treatment-of-small-cell-lung-cancer-100435571","NCT04951947","JS-201 Combined With Lenvatinib in the Treatment of Small-cell Lung Cancer","A Prospective, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of JS-201 Combined With Lenvatinib in the Treatment of Small-cell Lung Cancer With Previous Chemotherapy Combined With PD-L1 Failure","Inclusion Criteria:\n\n* 1\\. The imaging diagnosis is the extensive stage of SCLC\n* 2\\. The patient failed first-line EC+PD-L1 treatment\n* 3 PS 0-1\n\nExclusion Criteria:\n\n* 1\\. Diagnosed as non-small cell lung cancer\n* 2\\. Women during pregnancy\n* 3\\. Patients with symptomatic brain metastases\n* 4\\. PS≥2",{"count":20,"type":21},[24],"This is a prospective, single-arm phase II clinical study to evaluate the efficacy and safety of JS-201 combined with lenvatinib in the treatment of small-cell lung cancer that has failed previous chemotherapy combined with PD-L1. The primary observational endpoint is ORR, and the secondary observational endpoint is PFS, OS. The intervention mode is JS201 300mg i.v Q2w, lenvatinib 8mg po. Qd.",[355],{"date":321,"type":32},{"date":522,"type":32},"2023-06-01",{"date":524,"type":21},"2025-06-01",{"name":38,"class":39},""]