[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-nsclc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-nsclc":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,50,74,102,131,147,166,181,211],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100219375","phase-2-t-cell-receptor-immunotherapy-for-patients-with-metastatic-non-small-cell-lung-cancer-100219375",false,"NCT02133196","T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer","A Phase II Study Using Autologous Young Tumor-Infiltrating Lymphocytes Derived From Patients With Non-Small Cell Lung Cancer Following Non-Myeloablative Lymphocyte Depleting Preparative Regimen","* INCLUSION CRITERIA:\n\n  1. Measurable metastatic (stage IV) or unresectable non-small cell lung cancer (including but not limited to squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinomas) with at least one lesion that is resectable for TIL generation. (Note: neuroendocrine tumors are not eligible.)\n  2. Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.\n  3. All patients must have had at least one appropriate first line systemic therapy and progressed.\n  4. Clinical performance status of ECOG 0 or 1.\n  5. Age \\>= 18 years of age and \\\u003C= 72 years of age.\n  6. Patients of both sexes must be willing to practice birth control from the time of enrollment on this study and for 12 months after the last dose of combined chemotherapy for individuals of childbearing potential (IOCBP) and for four months after treatment for individuals able to father a child.\n  7. Willing to sign a durable power of attorney\n  8. Able to understand and sign the Informed Consent Document\n\nI. Hematology:\n\n* Absolute neutrophil count \\> 1000\u002Fmm\\^3 without support of filgrastim\n* Normal WBC (\\>= 2500\u002Fmm\\^3).\n* Hemoglobin \\> 8.0 g\u002Fdl. Subjects may be transfused to reach this cut-off.\n* Platelet count \\>= 80,000\u002Fmm\\^3\n\n  j. Serology:\n* Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune competence and thus may be less responsive to the experimental treatment and more susceptible to its toxicities.)\n* Seronegative for active hepatitis B, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.\n\n  k. Chemistry:\n* Serum ALT\u002FAST \\\u003C= 2.5 times the upper limit of normal.\n* Serum creatinine \\\u003C= 1.6 mg\u002Fdl.\n* Total bilirubin \\\u003C= 2 mg\u002Fdl, except in patients with Gilbert's Syndrome, who must have a total bilirubin \\\u003C= 3 mg\u002Fdl.\n\n  l. IOCBP must have a negative pregnancy test or evidence that they are not pregnant (e.g., ultrasound or serial HCG measurements) prior to the start of treatment because of the potentially dangerous effects of the treatment on the fetus.\n\n  m. Patients must have completed any prior systemic therapy at the time of enrollment.\n\nNote: Patients may have undergone minor surgical procedures or local radiotherapy within the past 4 weeks, as long as related major organ toxicities have recovered to grade 1 or less.\n\nn. More than two weeks must have elapsed since any prior palliation for major bronchial occlusion or bleeding at the time the patient receives the preparative regimen, and patient's toxicities must have recovered to a grade 1 or less.\n\no. Subjects must be co-enrolled in protocol 03-C-0277.\n\nEXCLUSION CRITERIA:\n\n1. Participants who are nursing because of the potentially dangerous effects of the treatment on the infant.\n2. Ongoing need for pharmacological immunosuppression, including steroids\n3. Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other active or uncompensated major medical illnesses\n4. Major bronchial occlusion or bleeding not amenable to palliation.\n5. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency\n\n   Disease and AIDS).\n6. Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)\n7. History of severe immediate hypersensitivity reaction to any of the agents used in this study.\n8. For select patients with a clinical history prompting cardiac evaluation: last known LVEF \\\u003C= 45%.\n9. For select patients with a clinical history prompting pulmonary evaluation: known FEV1 \\\u003C= 50%\n10. Any of the following will exclude patients from the high-dose aldesleukin arm, but may be eligible for the low-dose aldesleukin arm:\n\n    * Greater than 2 invasive thoracic procedures\n    * Poor exercise tolerance\n    * Greater than 66 years of age\n    * Clinically significant patient history which in the judgment of the Principal Investigator would compromise the patient s ability to tolerate high-dose.\n11. Patients who are receiving any other investigational agents.","ALL","18 Years","72 Years",{"count":20,"type":21},85,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Background:\n\nThe NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 100 patients. In this study, we are selecting a specific subset of white blood cells from the tumor that we think are the most effective in fighting tumors and will use only these cells in making the tumor fighting cells.\n\nObjective:\n\nThe purpose of this study is to see if these specifically selected tumor fighting cells can cause non-small cell lung cancer (NSCLC) tumors to shrink and to see if this treatment is safe.\n\nEligibility:\n\n\\- Adults age 18-72 with NSCLC who have a tumor that can be safely removed.\n\nDesign:\n\n* Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed\n* Surgery: If the patients meet all of the requirements for the study they will undergo surgery to remove a tumor that can be used to grow the TIL product.\n* Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood cells. {Leukapheresis is a common procedure, which removes only the white blood cells from the patient.}\n* Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the hospital for about 4 weeks for the treatment.\n\nFollow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits take up to 2 days.",[27,28,29,30,31],"Advanced Non-Small Cell Lung Cancer","Squamous Cell Carcinoma","Advanced NSCLC","Adenosquamous Carcinoma","Adenocarcinoma",[33,34,35,36],"Metastatic","Non-Small Cell Lung Cancer","NSCLC","Lung Cancer","RECRUITING","2026-06-05",{"date":40,"type":41},"2026-06-08","ACTUAL",{"date":43,"type":41},"2014-10-23",{"date":45,"type":21},"2027-10-23",{"name":47,"class":48},"National Cancer Institute (NCI)","NIH",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100587147","phase-2-evaluating-the-preliminary-efficacy-and-safety-of-js207-in-nsclc-after-progression-following-platinum-based-chemotherapy-and-immunotherapy-100587147","NCT06924606","Evaluating the Preliminary Efficacy and Safety of JS207 in NSCLC After Progression Following Platinum-based Chemotherapy and Immunotherapy","A Phase II Study of JS207 (PD-1\u002FVEGF Dual Antibody) in Combination With or Without JS004 or Docetaxel in Advanced Non-small Cell Lung Cancer With Disease Progression During or After the Treatment of Platinum-based Chemotherapy and Immunotherapy","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed locally advanced (stage IIIB\u002FIIIC) NSCLC that is not amenable to radical surgery or radical radiochemotherapy, or Metastatic or recurrent NSCLC.\n2. Subjects with unresectable locally advanced or metastatic or recurrent NSCLC who have failed first-line treatment with PD-1\u002FPD-L1 inhibitors combined with platinum-based doublet chemotherapy (excluding docetaxel); or who have failed sequential first- and second-line treatment with PD-1\u002FPD-L1 inhibitors followed by platinum-based doublet chemotherapy (excluding docetaxel).\n3. Subjects must have at least one measurable lesion according to RECIST v1.1.\n\nExclusion Criteria:\n\n1. Histopathologically or cytopathologically confirmed to have combined neuroendocrine component.\n2. Sensitivity mutation of EGFR or ALK fusion.\n3. Tumor encircles important blood vessels or has obvious necrosis and air space, and the investigator considers that it may cause hemorrhage risk.","75 Years",{"count":59,"type":21},66,[24],"This is a multiple-arm, open phase II clinical trial evaluating the safety, tolerability,and preliminary efficacy of JS207 in NSCLC after progression following Platinum-based chemotherapy and immunotherapy.",[29],"2026-02-04",{"date":65,"type":41},"2026-02-06",{"date":67,"type":41},"2025-07-15",{"date":69,"type":21},"2026-06-26",{"name":71,"class":72},"Shanghai Junshi Bioscience Co., Ltd.","OTHER",18,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":57,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":101},"100574382","phase-1-a-study-to-evaluate-the-safety-and-efficacy-of-hb0025-injection-in-patients-with-advanced-solid-tumor-100574382","NCT06758557","A Study to Evaluate the Safety and Efficacy of HB0025 Injection in Patients With Advanced Solid Tumor","A Multicenter, Open Phase Ib\u002FII Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of HB0025 Injection Combined With Chemotherapy in Patients With Advanced Solid Tumor","Inclusion Criteria:\n\n1. Male or female, age between 18-75 years old (include 18- and 75-year-old);\n2. Be able to fully understand and voluntarily sign the informed consent form, and be willing and able to comply with the clinical research and follow-up visit procedures；\n3. Dose escalation phase 3.1 Non-small cell lung cancer and meet all following conditions； 3.1.1 Non-small cell lung cancer (NSCLC) confirmed by histology or cytology; 3.1.2 Not suitable for surgical resection, recurrence, metastasis, or locally advanced stage; 3.1.3 Patients with tyrosine kinase inhibitor (TKI) drug sensitivity mutations of epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) translocation, who have experienced disease progression after standard treatment with TKI targeted drugs, or are intolerant to standard treatment with TKI targeted drugs; 3.1.4 No known ROS proto-oncogene 1 (ROS1), neurogenic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), RET mutations or other oncogenic driver gene mutations, and there are approved therapeutic drugs for the above gene mutations (there are therapeutic drugs for genomic changes).\n\n   3.2 Endometrial cancer and meet all following conditions 3.2.1 Endometrial cancer confirmed by histology or cytology, the pathological types include but are not limited to endometrioid carcinoma, serous carcinoma, clear cell carcinoma, undifferentiated carcinoma, dedifferentiated carcinoma, mixed carcinoma, and carcinosarcoma; 3.2.2 Not suitable for surgical resection, recurrence, metastasis, locally advanced stage; 3.2.3 No previous systemic anti-tumor treatment (excluding adjuvant therapy and neoadjuvant therapy);\n4. Dose expansion phase 4.1 Non-small cell lung cancer and meet all following conditions 4.1.1 Non-squamous non-small cell lung cancer (Nonsq-NSCLC) or squamous non-small cell lung cancer (Sq-NSCLC) confirmed by histology or cytology (for central squamous cell carcinoma, the investigator and the sponsor jointly decide whether to enroll based on the risk of bleeding and the benefit-risk ratio of the subject); 4.1.2 Not suitable for surgical resection, recurrent, metastatic, locally advanced; Negative for TKI drug sensitivity mutations of epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) translocation; 4.1.3 Negative for TKI drug sensitivity mutations of epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) translocation; 4.1.4 No known ROS proto-oncogene 1 (ROS1), neurogenic tyrosine receptor kinase (NTRK)，proto-oncogene B-raf (BRAF), RET mutations or other oncogenic driver gene mutations, for which there are approved therapeutic drugs for the above gene mutations (there are therapeutic drugs for genomic changes); 4.1.5 No previous systemic anti-tumor treatment (for subjects who have received adjuvant\u002Fneoadjuvant treatment for non-metastatic disease with the purpose of cure, if disease progression occurs within 6 months of the end of the last treatment, the treatment regimen is considered as one systemic treatment and is not allowed to be included).\n\n   4.2 Endometrial cancer and meet all following conditions 4.2.1 Endometrial cancer confirmed by histology or cytology, with pathological types including but not limited to endometrioid carcinoma, serous carcinoma, clear cell carcinoma, undifferentiated carcinoma, dedifferentiated carcinoma, mixed carcinoma, and carcinosarcoma; 4.2.2 Not suitable for surgical resection, recurrence, metastasis, locally advanced stage; 4.2.3 No previous systemic anti-tumor treatment (for subjects who have received adjuvant\u002F neoadjuvant treatment for non-metastatic disease with the purpose of cure, if disease progression occurs within 6 months of the end of the last treatment, the treatment regimen is considered as 1 systemic treatment and is not allowed to be included in the group);\n5. Patients who have not received anti-tumor treatment or other clinical trial drugs within 4 weeks before the first administration of HB0025 (for small molecule targeted drugs, this is within 2 weeks before the first use of the study drug or within 5 half-lives of the drug (whichever is longer); have completed systemic palliative radiotherapy for at least 4 weeks or local palliative radiotherapy for at least 2 weeks (in the baseline tumor assessment, the target lesions defined can be excluded if they are not in the local radiotherapy area); have not systematically used (for 2 consecutive weeks) traditional Chinese medicine with anti-tumor indications within 2 weeks before the first use of the study drug;\n6. There is at least one measurable tumor lesion (according to RECIST 1.1 standard); Note: Lesions that have been previously treated with local therapy (e.g., radiofrequency ablation, anhydrous ethanol or acetic acid injection, cryoablation, high-intensity focused ultrasound, trans-arterial chemoembolization, local radiotherapy, etc.) are not considered measurable lesions unless there is clear progression.\n7. ECOG score of 0 or 1;\n8. The expected survival period is not less than 12 weeks;\n9. The following laboratory indicators must be met:\n\n   9.1 Absolute neutrophil count ≥1.5×10⁹\u002FL; 9.2 Platelet count ≥90×10⁹\u002FL; 9.3 Hemoglobin ≥90 g\u002FL; Note: The above three requirements require that the patient has not received any blood component or cell growth factor support therapy within two weeks before blood collection.\n\n   9.4 Creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault Formula); 9.5 Total bilirubin ≤1.5×ULN; 9.6 Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5× ULN; If the investigator determines that the increase is due to liver metastasis of the tumor, ALT和AST≤5×ULN; 9.7 Prothrombin time (PT)≤1.5×ULN, partial thromboplastin time (APTT)≤1.5×ULN; 9.8 Urine dipstick test results show protein in urine\\\u003C1+; if urine protein ≥1+, 24-hour urine protein content\\\u003C1 g.\n10. The toxicity from previous treatment has recovered to grade 1 (except for toxicity such as alopecia that the investigator determines does not pose a safety risk);\n11. Females and males of childbearing age must agree to take effective contraceptive measures during the study and within 3 months after the last dose of HB0025 after signing the informed consent form. Female subjects of childbearing age must have a negative pregnancy test result during the screening period.\n\nExclusion Criteria:\n\n1. Brain metastasis with central nervous system symptoms; for subjects with asymptomatic brain metastasis: after receiving relevant treatment, imaging and neurological examinations are in a stable state for more than 4 weeks. If there is no imaging evaluation, the neurological examination is in a stable state for more than 4 weeks under glucocorticoid treatment, and the treatment dose for at least 2 weeks is ≤10mg\u002Fday of prednisone or other hormones of the same dose, they can be included in the group;\n2. Active autoimmune diseases or a history of autoimmune diseases requiring systemic treatment within 2 years before screening, including hypothyroidism, Graves' ophthalmo-pathy, Hashimoto's thyroiditis or type 1 diabetes, but childhood asthma or allergic asthma that did not occur within 2 years before screening can be excluded;\n3. Patients who received \\>10 mg\u002Fday of prednisone or equivalent dose of systemic glucocorticoids or other immunosuppressants within 2 weeks before screening, or who received topical, intraocular, intraarticular, intranasal or inhaled hormones for prevention (such as contrast agent allergy) or treatment of non-autoimmune diseases (such as delayed hypersensitivity reactions caused by contact allergens) were allowed to be included in the group;\n4. Any of the following infections:\n\n   4.1 Active infection within 2 weeks prior to screening, requiring antibiotic treatment for \\>7 days; 4.2 Active pulmonary tuberculosis (based on history); 4.3 HIV positive; 4.4 Active hepatitis B or hepatitis C. Asymptomatic hepatitis B virus carriers (HBV DNA titer below the detection limit) or clinically cured hepatitis C (HCV RNA test negative) are allowed to enroll;\n5. Patients who have received immune checkpoint inhibitors (ICI) combined with anti-vascular therapy, such as anti-PD-(L)-1 antibody combined with anti-VEGF, VEGFR antibody, or TKI drugs with anti-vascular effects such as anlotinib;\n6. Patients with a history of severe allergies, previous grade 3-4 immune-related adverse events (irAEs) or treatment discontinuation (except for grade 3 endocrine abnormalities that can be controlled by hormone replacement therapy); patients with grade 3-4 allergic reactions when receiving other monoclonal antibody treatments, or patients with known allergies to protein drugs or recombinant proteins, HB0025 drug components, and chemotherapy drug components;\n7. Uncontrolled arterial hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg) despite standard treatment;\n8. Suffering from the following serious comorbidities:\n\n   8.1 Subjects with a history of arterial thrombosis or deep vein thrombosis within 6 months before screening, or subjects with evidence or history of bleeding tendency within 2 months before enrollment, regardless of severity (For the EC cohort: the decision on whether to enroll subjects with evidence or history of bleeding tendency within 2 months before enrollment was made by the investigator and the sponsor); 8.2 Previous or current bleeding or coagulation disorders; 8.3 Past history of myocarditis, cardiomyopathy, or malignant arrhythmias. Clinically significant (e.g., active) cardiovascular and cerebrovascular diseases within 6 months prior to screening, including but not limited to unstable angina requiring hospitalization, myocardial infarction, New York Heart Association-classified congestive heart failure ≥ II, severe arrhythmias that cannot be controlled by drugs, transient ischemic attack (TIA), cerebrovascular accident (CVA) or vascular disease (e.g., aortic aneurysm with risk of rupture), or other cardiac damage that may affect the safety evaluation of the study drug (e.g., poorly controlled arrhythmias, myocardial ischemia), etc.; 8.4 Gastrointestinal disorders or conditions that may cause gastrointestinal bleeding or perforation (history of intestinal obstruction, acute Crohn's disease, ulcerative colitis, esophageal varices, unhealed ulcers, unhealed wounds, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months prior to screening). Subjects with chronic Crohn's disease and ulcerative colitis (except those with total colon and rectal resection), even in the inactive stage, should be excluded; 8.5 Those who have had digestive tract perforation or fistula, urogenital system fistula, and have not recovered after surgical treatment; 8.6 Current clinically significant hydronephrosis that has not been relieved by nephrostomy or ureteral stenting; 8.7 Patients with third space effusion (such as pleural effusion, pericardial effusion or ascites) that is currently clinically poorly controlled and requires repeated puncture drainage or other local treatment; 8.8 Imaging (CT or MRI) shows that the tumor has invaded or surrounded important blood vessels (lung cancer cohort only) or the investigators judge that the tumor is very likely to invade important blood vessels and cause fatal bleeding during the follow-up study; 8.9 Acute exacerbation of COPD within 1 month before first dose;\n9. Patients who have used or are currently taking anticoagulants such as warfarin, heparin (except for tube sealing and deep vein catheterization), dabigatran etexilate, rivaroxaban, etc. within 7 days before the first study treatment; or patients who have received aspirin, clopidogrel, dipyridamole, cilostazol, or other drugs known to inhibit platelet aggregation;\n10. Received major surgical treatment, open biopsy or significant trauma within 4 weeks before drug administration; or required major elective surgical treatment during the study period. Received local invasive procedures (such as needles) within 1 week before drug administration. Core biopsy), except for placement of a vascular access device;\n11. Those with past and\u002For current interstitial lung disease, pneumoconiosis, drug-related pneumonia, severe lung function impairment, etc. that may interfere with the detection and treatment of suspected drug-related pulmonary toxicity;\n12. Pregnant or breastfeeding women;\n13. History of allogeneic organ transplantation or hematopoietic stem cell transplantation;\n14. Second tumor within 5 years before screening, excluding cured cervical cancer in situ, localized skin squamous cell carcinoma, basal cell carcinoma, breast ductal carcinoma in situ or T1 urothelial carcinoma;\n15. Received live virus vaccine within 30 days before screening;\n16. During the screening period, patients with advanced Nonsq-NSCLC who are intolerant to the chemotherapy regimen of pemetrexed combined with carboplatin;\n17. During the screening period, patients with advanced sq-NSCLC or EC who are intolerant to paclitaxel combined with carboplatin chemotherapy;\n18. Subjects who are assessed by the investigator to be unsuitable for participating in the trial due to other reasons.",{"count":82,"type":21},282,[84,24],"PHASE1","This study is a multicenter, two-tumor, multi-cohort, dose-escalation and dose-expansion Phase Ib\u002FII clinical trial of HB0025 combined with chemotherapy, consists of two phases: the dose escalation phase (Ib) and the dose expansion phase (II).\n\n1. The dose escalation phase (Phase Ⅰb) The primary purpose is to determine the Maximum Tolerated Dose(MTD) and\u002For dose limiting toxicity (DLT) of HB0025 combined with chemotherapy. The dose escalation is carried out using the \"3+3 dose escalation\" principle. In the initial stage of the dose escalation process, the chemotherapy dose remains unchanged to explore the safety and tolerability of the currently confirmed safe doses of HB0025 as monotherapy at 10mg\u002Fkg, and 20mg\u002Fkg, combined with chemotherapy(Pemetrexed 500 mg\u002Fm² iv d1+Carboplatin AUC 5 iv d1) in the treatment of advanced non-squamous non-samll cell lung cancer(Non-sq-NSCLC), and combined with chemotherapy( Paclitaxel 175 mg\u002Fm² iv d1+ Carboplatin AUC 5 iv d1 ) in advance Endometrial carcinoma(EC).\n\n   After completing the first cycle of treatment (DLT evaluation period), if the investigator determines that the subject may benefit from the combined treatment, the subject will continue the treatment cycles (2nd to 4th\u002F5th\u002F6th cycle of HB0025 combined with chemotherapy); if there is no disease progression and no intolerable toxicity, the subject can continue to receive the maintenance treatment with HB0025 + pemetrexed (for non-sq NSCLC) or HB0025 alone (for EC, sq NSCLC), until when intolerable toxicity occurs, disease progression, the subject is lost to follow-up or died, the subject withdraws informed consent, the subject receives other anti-tumor treatment or the study is terminated early, whichever occurs first.\n2. Dose expansion phase (Phase II) Based on 1-2 recommended Phase II doses selected by the sponsor and the investigator during the dose escalation process, a multicenter, single-arm study will be conducted to evaluate the efficacy and safety of different doses of HB0025 combined with chemotherapy. Each dosing regimen cohort will be expanded by 40 subjects. If a dosing regimen is not safe or effective, the enrollment of the dosing regimen cohort may be stopped, and the subject quota may be allocated to other dosing regimen cohorts (which may exceed 40 subjects). The dose expansion phase initially plans to expand the following cohorts to further observe the safety of HB0025 combined with chemotherapy and the preliminary efficacy of HB0025 combined with chemotherapy in advanced NSCLC and EC.\n\nAfter receiving 4-6 cycles of HB0025 combined with chemotherapy, the subjects will enter HB0025 + pemetrexed (for non-sq-NSCLC) or HB0025 alone (for EC, sq-NSCLC) maintenance treatment until when intolerable toxicity, disease progression or death occurs, withdraw informed consent, or receives other anti-tumor treatment or study ends early, early, whichever occurs first.",[29,87],"Advanced Endometrial Cancer",[35,89,90],"Endometrial Cancer","Clinical Trial","2025-01-22",{"date":93,"type":41},"2025-01-23",{"date":95,"type":41},"2024-01-31",{"date":97,"type":21},"2026-02-28",{"name":99,"class":100},"Huabo Biopharm Co., Ltd.","INDUSTRY",14,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":115,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100573866","phase-2-neoantigen-loaded-dc-vaccine-pd-1-inhibitor-and-radiotherapy-for-advanced-nsclc-progressed-after-second-line-treatment-100573866","NCT06751849","Neoantigen-loaded DC Vaccine, PD-1 Inhibitor, and Radiotherapy for Advanced NSCLC Progressed After Second-line Treatment","Personalized Tumor Neoantigen-loaded DC Vaccine Combined with PD-1 Inhibitor and Radiotherapy for Advanced NSCLC Progressed After Second-line Treatment","Inclusion Criteria:\n\n* Patients with histologically or cytologically confirmed advanced NSCLC who require radiotherapy for metastatic lesions;\n* At least one measurable lesion;\n* Aged 18-70, regardless of gender;\n* Disease progression after standard second-line therapy, and more than 2 weeks since the end of the last antitumor treatment;\n* Expected survival of ≥3 months;\n* ECOG performance status of 0-1;\n* Female patients of childbearing age must have a negative pregnancy test and be able to take effective contraceptive measures with no plans for pregnancy within six months of the study;\n* Able to undergo all screening period laboratory tests as required by the protocol;\n* Normal major organ function, such as heart, liver, and kidney;\n* Hematologic parameters: neutrophil count ≥1.5×10\\^9\u002FL, hemoglobin ≥10g\u002FdL, platelet count ≥100×10\\^9\u002FL, total bilirubin ≤1.5 times the upper limit of normal, AST and ALT ≤2.5 times the upper limit of normal, creatinine and blood urea nitrogen ≤1.5 times the upper limit of normal, activated partial thromboplastin time ≤1.5×ULN, and International Normalized Ratio or prothrombin time ≤1.5×ULN;\n* No active hepatitis, AIDS, syphilis, or other infectious diseases;\n* Rheumatoid panel: C-reactive protein (CRP) ≤10.0mg\u002FL; Anti-streptolysin O (ASO) \\\u003C500U; Erythrocyte sedimentation rate ≤15mm\u002Fh (men) or 20mm\u002Fh (women);\n* Thyroid function tests: 0.27mIU\u002FL ≤ Thyroid-stimulating hormone (TSH) ≤ 4.2mIU\u002FL; 3.1pmol\u002FL ≤ Free triiodothyronine (FT3) ≤ 6.8pmol\u002FL; 12pmol\u002FL ≤ Serum free thyroxine (FT4) ≤ 22pmol\u002FL; 1.3nmol\u002FL ≤ Serum total triiodothyronine (TT3) ≤ 3.1nmol\u002FL; 66nmol\u002FL ≤ Serum total thyroxine (TT4) ≤ 181nmol\u002FL;\n* Adrenocorticotropic hormone (ACTH): 1.1-17.6pmol\u002FL;\n* Ability to understand and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\nDisease-specific exclusion criteria:\n\n* Patients with uncontrollable brain metastases;\n* Subjects expected to require any form of antitumor treatment during the study, including maintenance therapy with other drugs, chemotherapy, and\u002For surgical resection.\n\nExclusion criteria for medical history and comorbidities:\n\n* Subjects who have required systemic treatment with corticosteroids (\\>10 mg\u002Fday of prednisone or equivalent) or other immunosuppressants within 14 days before the first dose. Inhalational or topical corticosteroids are allowed in the absence of active autoimmune diseases;\n* Subjects who have been treated with anticancer immunotherapies or other immunostimulatory anticancer drugs (interferons, interleukins, thymosin, immune cell therapy, etc.) within 3 months before the first dose;\n* Subjects participating in other clinical trials or whose first dose is less than 4 weeks (or 5 half-lives of the study drug) after the end of the previous clinical trial (last dose);\n* Subjects with severe cardiovascular diseases, such as those meeting NYHA Class II or higher criteria, myocardial infarction, or cerebrovascular accidents (cerebral ischemia, symptomatic cerebral embolism, etc.) occurring within 3 months before the first dose, or unstable arrhythmias or unstable angina within 1 month before starting study treatment;\n* Subjects with uncontrolled myocardial ischemia or myocardial infarction, poorly controlled arrhythmias are excluded;\n* Subjects with hypertension that cannot be well controlled by antihypertensive medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg) (Note: a stable antihypertensive regimen should be in place within 1 week before the first dose);\n* Subjects who have had significant clinically relevant bleeding symptoms or a clear bleeding tendency within 3 months before the first dose, as well as tumors that have invaded major blood vessels or, in the investigator's judgment, are highly likely to invade major blood vessels and cause major bleeding during treatment. Subjects with obvious hemoptysis, coughing up 2.5 mL or more of blood in the month before the first dose;\n* Subjects who have experienced arterial\u002Fvenous thrombotic events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral embolism), deep vein thrombosis, and pulmonary embolism, within 3 months before screening;\n* Subjects with active tuberculosis;\n* Subjects who have had a serious infection within 4 weeks before the first dose, including but not limited to infections requiring hospitalization, bacteremia, severe pneumonia, etc.; Subjects with any active infection;\n* Subjects preparing for or who have previously undergone tissue\u002Forgan transplantation;\n* Subjects with uncontrolled epilepsy, central nervous system disorders, or neurological diseases resulting in cognitive impairment;\n* Subjects with a history of splenectomy.\n\nOther exclusion criteria:\n\n* Pregnant or breastfeeding women;\n* Subjects with a severe history of allergies or atopic constitution;\n* Subjects with a history of chronic alcohol or drug abuse within 6 months before enrollment;\n* Subjects deemed unsuitable for the study by the investigator.","70 Years",{"count":111,"type":21},10,[24],"In this study, the investigators provide a combined treatment of personalized tumor neoantigen-loaded dendritic cell (DC) vaccine, PD-1 Inhibitor, and radiotherapy to patients with advanced non-small cell lung cancer (NSCLC) progressed after second-line treatment. The investigators observe the objective response rate (ORR), disease control rate (DCR), adverse event (AE), serious adverse event (SAE), progression-free survival (PFS), and overall survival (OS) , aiming to evaluate the effectiveness and safety of the treatment.",[29],[116,117,35,118,119,120],"Tumor Neoantigen","DC Vaccine","Immunotherapy","PD-1 Inhibitor","Radiotherapy","2024-12-27",{"date":123,"type":41},"2024-12-30",{"date":125,"type":41},"2024-03-11",{"date":127,"type":21},"2026-06-10",{"name":129,"class":72},"The First Affiliated Hospital of Nanchang University",2,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":109,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":139,"conditions":140,"keywords":141,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":143,"startDateStruct":144,"completionDateStruct":145,"leadSponsor":146,"locationsCount":130},"100573870","phase-2-neoantigen-based-peptide-vaccine-pd-1-inhibitor-and-radiotherapy-for-advanced-nsclc-progressed-after-second-line-treatment-100573870","NCT06751901","Neoantigen-based Peptide Vaccine, PD-1 Inhibitor, and Radiotherapy for Advanced NSCLC Progressed After Second-line Treatment","Personalized Tumor Neoantigen-based Peptide Vaccine Combined with PD-1 Inhibitor and Radiotherapy for Advanced NSCLC Progressed After Second-line Treatment",{"count":111,"type":21},[24],"In this study, the investigators provide a combined treatment of personalized tumor neoantigen-based peptide vaccine, PD-1 Inhibitor, and radiotherapy to patients with advanced non-small cell lung cancer (NSCLC) progressed after second-line treatment. The investigators observe the objective response rate (ORR), disease control rate (DCR), adverse event (AE), serious adverse event (SAE), progression-free survival (PFS), and overall survival (OS) , aiming to evaluate the effectiveness and safety of the treatment.",[29],[116,142,35,118,119,120],"Peptide Vaccine",{"date":123,"type":41},{"date":125,"type":41},{"date":127,"type":21},{"name":129,"class":72},{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":109,"enrollmentInfo":154,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":157,"conditions":158,"keywords":159,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":160,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":130},"100573882","neoantigen-loaded-dc-vaccine-pd-1-inhibitor-and-radiotherapy-for-advanced-nsclc-progressed-after-first-line-treatment-100573882","NCT06752057","Neoantigen-loaded DC Vaccine, PD-1 Inhibitor, and Radiotherapy for Advanced NSCLC Progressed After First-line Treatment","A Multicenter Clinical Study of Personalized Tumor Neoantigen-loaded DC Vaccine Combined with PD-1 Inhibitor and Radiotherapy for Advanced NSCLC Progressed After First-line Treatment","Inclusion Criteria:\n\n* Patients with histologically or cytologically confirmed advanced NSCLC who require radiotherapy for metastatic lesions;\n* At least one measurable lesion;\n* Aged 18-70, regardless of gender;\n* Disease progression after standard first-line therapy, and more than 2 weeks since the end of the last antitumor treatment;\n* Expected survival of ≥3 months;\n* ECOG performance status of 0-1;\n* Female patients of childbearing age must have a negative pregnancy test and be able to take effective contraceptive measures with no plans for pregnancy within six months of the study;\n* Able to undergo all screening period laboratory tests as required by the protocol;\n* Normal major organ function, such as heart, liver, and kidney;\n* Hematologic parameters: neutrophil count ≥1.5×10\\^9\u002FL, hemoglobin ≥10g\u002FdL, platelet count ≥100×10\\^9\u002FL, total bilirubin ≤1.5 times the upper limit of normal, AST and ALT ≤2.5 times the upper limit of normal, creatinine and blood urea nitrogen ≤1.5 times the upper limit of normal, activated partial thromboplastin time ≤1.5×ULN, and International Normalized Ratio or prothrombin time ≤1.5×ULN;\n* No active hepatitis, AIDS, syphilis, or other infectious diseases;\n* Rheumatoid panel: C-reactive protein (CRP) ≤10.0mg\u002FL; Anti-streptolysin O (ASO) \\\u003C500U; Erythrocyte sedimentation rate ≤15mm\u002Fh (men) or 20mm\u002Fh (women);\n* Thyroid function tests: 0.27mIU\u002FL ≤ Thyroid-stimulating hormone (TSH) ≤ 4.2mIU\u002FL; 3.1pmol\u002FL ≤ Free triiodothyronine (FT3) ≤ 6.8pmol\u002FL; 12pmol\u002FL ≤ Serum free thyroxine (FT4) ≤ 22pmol\u002FL; 1.3nmol\u002FL ≤ Serum total triiodothyronine (TT3) ≤ 3.1nmol\u002FL; 66nmol\u002FL ≤ Serum total thyroxine (TT4) ≤ 181nmol\u002FL;\n* Adrenocorticotropic hormone (ACTH): 1.1-17.6pmol\u002FL;\n* Ability to understand and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\nDisease-specific exclusion criteria:\n\n* Patients with uncontrollable brain metastases;\n* Subjects expected to require any form of antitumor treatment during the study, including maintenance therapy with other drugs, chemotherapy, and\u002For surgical resection.\n\nExclusion criteria for medical history and comorbidities:\n\n* Subjects who have required systemic treatment with corticosteroids (\\>10 mg\u002Fday of prednisone or equivalent) or other immunosuppressants within 14 days before the first dose. Inhalational or topical corticosteroids are allowed in the absence of active autoimmune diseases;\n* Subjects who have been treated with anticancer immunotherapies or other immunostimulatory anticancer drugs (interferons, interleukins, thymosin, immune cell therapy, etc.) within 3 months before the first dose;\n* Subjects participating in other clinical trials or whose first dose is less than 4 weeks (or 5 half-lives of the study drug) after the end of the previous clinical trial (last dose);\n* Subjects with severe cardiovascular diseases, such as those meeting NYHA Class II or higher criteria, myocardial infarction, or cerebrovascular accidents (cerebral ischemia, symptomatic cerebral embolism, etc.) occurring within 3 months before the first dose, or unstable arrhythmias or unstable angina within 1 month before starting study treatment;\n* Subjects with uncontrolled myocardial ischemia or myocardial infarction, poorly controlled arrhythmias are excluded;\n* Subjects with hypertension that cannot be well controlled by antihypertensive medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg) (Note: a stable antihypertensive regimen should be in place within 1 week before the first dose);\n* Subjects who have had significant clinically relevant bleeding symptoms or a clear bleeding tendency within 3 months before the first dose, as well as tumors that have invaded major blood vessels or, in the investigator's judgment, are highly likely to invade major blood vessels and cause major bleeding during treatment. Subjects with obvious hemoptysis, coughing up 2.5 mL or more of blood in the month before the first dose;\n* Subjects who have experienced arterial\u002Fvenous thrombotic events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral embolism), deep vein thrombosis, and pulmonary embolism, within 3 months before screening;\n* Subjects with active tuberculosis;\n* Subjects who have had a serious infection within 4 weeks before the first dose, including but not limited to infections requiring hospitalization, bacteremia, severe pneumonia, etc.; Subjects with any active infection;\n* Subjects preparing for or who have previously undergone tissue\u002Forgan transplantation;\n* Subjects with uncontrolled epilepsy, central nervous system disorders, or neurological diseases resulting in cognitive impairment;\n* Subjects with a history of splenectomy.\n\nOther exclusion criteria:\n\n* Pregnant or breastfeeding women;\n* Subjects with a severe history of allergies or atopic constitution;\n* Subjects with a history of chronic alcohol or drug abuse within 6 months before enrollment;\n* Subjects deemed unsuitable for the study by the investigator.",{"count":111,"type":21},[156],"NA","In this study, the investigators provide a combined treatment of personalized tumor neoantigen-loaded dendritic cell (DC) vaccine, PD-1 Inhibitor, and radiotherapy to patients with advanced non-small cell lung cancer (NSCLC) progressed after first-line treatment. The investigators observe the objective response rate (ORR), disease control rate (DCR), adverse event (AE), serious adverse event (SAE), progression-free survival (PFS), and overall survival (OS) , aiming to evaluate the effectiveness and safety of the treatment.",[29],[116,117,35,118,119,120],{"date":123,"type":41},{"date":162,"type":41},"2024-09-01",{"date":164,"type":21},"2027-02-28",{"name":129,"class":72},{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":109,"enrollmentInfo":172,"targetDuration":4,"studyType":22,"phases":173,"briefSummary":174,"conditions":175,"keywords":176,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":177,"startDateStruct":178,"completionDateStruct":179,"leadSponsor":180,"locationsCount":130},"100573881","neoantigen-based-peptide-vaccine-pd-1-inhibitor-and-radiotherapy-for-advanced-nsclc-progressed-after-first-line-treatment-100573881","NCT06752044","Neoantigen-based Peptide Vaccine, PD-1 Inhibitor, and Radiotherapy for Advanced NSCLC Progressed After First-line Treatment","A Multicenter Clinical Study of Personalized Tumor Neoantigen-based Peptide Vaccine Combined with PD-1 Inhibitor and Radiotherapy for Advanced NSCLC Progressed After First-line Treatment",{"count":111,"type":21},[156],"In this study, the investigators provide a combined treatment of personalized tumor neoantigen-based peptide vaccine, PD-1 Inhibitor, and radiotherapy to patients with advanced non-small cell lung cancer (NSCLC) progressed after first-line treatment. The investigators observe the objective response rate (ORR), disease control rate (DCR), adverse event (AE), serious adverse event (SAE), progression-free survival (PFS), and overall survival (OS) , aiming to evaluate the effectiveness and safety of the treatment.",[29],[116,142,35,118,119,120],{"date":123,"type":41},{"date":162,"type":41},{"date":164,"type":21},{"name":129,"class":72},{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":22,"phases":191,"briefSummary":192,"conditions":193,"keywords":196,"overallStatus":200,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":210},"100505273","phase-2-a-study-of-combining-cabozantinib-and-atezolizumab-for-advancedmetastatic-nsclc-cabatezo-1-100505273","NCT05859217","A Study of Combining Cabozantinib and Atezolizumab for Advanced\u002FMetastatic NSCLC (Cabatezo-1)","A Multi-center Phase II Study of Combining Cabozantinib and Atezolizumab as the 1st Line Therapy for PD-L1 Negative Advanced\u002FMetastatic NSCLC (Cabatezo-1)","Cabatezo-1","INCLUSION CRITERIA:\n\n* Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent\n* Males and females age ≥ 18 years\n* ECOG Performance Status 0 - 1\n* Pathologically confirmed advanced\u002Fmetastatic NSCLC, with PD-L1\\\u003C1% based on IHC using 22C3 antibody\n* At least one target lesion that can be assessed by RECIST 1.1\n* For candidates who are not qualified for upfront FDA-approved targeted therapy, must be systemic treatment naïve (local palliative RT more than 4 weeks prior is allowed)\n* For candidates who are qualified for upfront FDA-approved targeted therapy (e.g. having sensitizing mutations in EGFR, ALK and BRAF, etc.), treatment must have failed and received at least one line of ONLY FDA-approved targeted therapy\n* Availability of a representative tumor specimen for correlative research. Optional but highly recommended: willing to undergo tumor tissue biopsy only if deemed safe and feasible by the investigator.\n* Recovery to baseline or ≤ Grade 1 CTCAE v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and\u002For stable on supportive therapy.\n* Women of childbearing potential must have a negative serum pregnancy test 72 hours prior to initiating treatment. Female participants are considered to be of childbearing potential unless one of the following criteria is met: documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\> 45 years-of-age in the absence of other biological or physiological causes. In addition, females \\\u003C 55 years-of-age must have a serum follicle stimulating (FSH) level \\> 40 mIU\u002FmL to confirm menopause). Note: Documentation may include review of medical records, medical examinations, or medical history interview by study site.\n* Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence or to use two forms of adequate contraception (hormonal AND barrier method of birth control) prior to study entry, for the duration of study participation and for 6 months following completion of therapy.\n* Men of child-bearing potential must not father a child or donate sperm while on this study and for 6 months after the last study treatment.\n* Adequate organ function\n* Negative HIV test at screening, with the following exception: patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count \\>200\u002FuL, and have an undetectable viral load. They must agree to continue on such anti-retroviral therapy per local standard treatment guideline\n* Negative HBV and HCV tests at screening, with the following exception:\n\n  * For HBV: DNA must be \\\u003C 500 IU\u002FmL (or must be \\\u003C 2500 copy\u002FmL if copy\u002FmL is the only unit available in the study site; if the normal ranges of the study sites are different, the positive standard must not be met), and have received anti-HBV therapy for at least 14 days prior to the first dose of study treatment (treatment in accordance with local standard of care, e.g., entecavir) and are willing to receive antiviral therapy throughout the study if indicated;\n  * For HCV (with positive HCV RNA): must receive anti-viral therapy in accordance with the local standard treatment guideline and hepatic function resolve to CTCAE Grade ≤1\n\nEXCLUSION CRITERIA:\n\n* Simultaneously enrolled in any therapeutic clinical trial\n* Current or anticipating use of other investigational agents while participating in this study\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment\n* Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements\n* Active Grade 3 (per the NCI CTCAE, Version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment\n* Patients harboring targetable mutations (e.g., EGFR, ALK and BRAF, etc.) who have not had at least one frontline targeted therapy fail, or have received other systemic therapies (e.g. chemotherapy, immunotherapy, etc.)\n* Patients with carcinomatous meningitis (leptomeningeal metastasis)\n* Undergone major surgery within 2 weeks prior to the start of study regimen, or has not achieved complete wound healing\n* Presence of another cancer with disease manifestations or therapy that could adversely affect participant safety or longevity, create the potential for drug-drug interactions, or compromise the interpretation of study results. Otherwise, patients can be considered eligible, for example, locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.\n* Prior treatment with cabozantinib and\u002For atezolizumab.\n* Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.\n* Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment\n* Radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Participants with clinically relevant ongoing complications from prior radiation therapy are not eligible.\n* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks prior to first dose of study treatment after radiotherapy or at least 4 weeks prior to first dose of study treatment after major surgery (e.g., removal or biopsy of brain metastasis). Participants must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Eligible participants must be neurologically asymptomatic and with corticosteroid no more than 10mg prednisone or equivalent at the time of first dose of study treatment.\n* Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following:\n\n  * Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).\n  * Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors such as rivaroxaban, edoxaban, or apixaban in participants without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.\n* Live, attenuated vaccines (e.g., FluMist) are prohibited within 4 weeks prior to initiation of study treatment, during treatment with atezolizumab, and for 5 months after the last dose of atezolizumab.\n* The participant has uncontrolled, significant cardiovascular disorders\n* Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before first dose of study treatment\n* Lesions invading or encasing any major blood vessels.\n* Other clinically significant disorders that would preclude safe study participation\n* Major surgery (e.g., laparoscopic nephrectomy, GI surgery, removal or biopsy of brain metastasis) within 2 weeks before first dose of study treatment. Minor surgeries within 10 days before first dose of study treatment. Participants must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Participants with clinically relevant ongoing complications from prior surgery are not eligible\n* Pregnant or lactating females.\n* Inability to swallow tablets or unwillingness or inability to receive IV administration.\n* Previously identified allergy or hypersensitivity to Chinese hamster ovary cell products, or components of the study treatment formulations or history of severe infusion-related reactions to monoclonal antibodies.\n* Uncontrolled tumor-related pain\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters (e.g., PleurX) are allowed.\n* Uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL or corrected serum calcium \\> ULN)\n* Active or history of autoimmune disease or immune deficiency (see Appendix I), including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis.\n* Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies\n* Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \\[IL-2\\]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment\n* Any serious illness, uncontrolled inter-current illness, psychiatric illness, active or uncontrolled infection, or other medical history, including laboratory results, which, in the Investigator's opinion, would be likely to interfere with the patient's participation in the study, or with the interpretation of the results",{"count":190,"type":21},40,[24],"NSCLC patients with low expression level of PD-L1, esp. those with its level less than 1%, do not derive much benefit from anti-PD-1\u002FL1 therapy (e.g. atezoilzumab). In this study, investigators hypothesize that the combination of cabozantinib (a multi-kinase inhibitor) and atezolizumab will result in better therapeutic value.",[36,194,195,29],"NSCLC Stage IV","Metastatic NSCLC - Non-Small Cell Lung Cancer",[197,198,199],"Cancer immunotherapy","anti-angiogenesis","Investigator-initiated clinical trial","NOT_YET_RECRUITING","2024-05-06",{"date":203,"type":41},"2024-05-08",{"date":205,"type":21},"2024-12",{"date":207,"type":21},"2028-06",{"name":209,"class":72},"Jun Zhang, MD, PhD",4,{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":57,"enrollmentInfo":217,"targetDuration":4,"studyType":22,"phases":219,"briefSummary":221,"conditions":222,"keywords":223,"overallStatus":200,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":4},"100543500","phase-4-a-single-arm-pilot-study-of-tislelizumab-combined-with-anlotinib-in-patients-with-advanced-nsclc-with-driver-negative-after-progression-to-immunotherapy-100543500","NCT06356675","A Single-arm Pilot Study of Tislelizumab Combined With Anlotinib in Patients With Advanced NSCLC With Driver-negative After Progression to Immunotherapy","Inclusion Criteria:\n\n1. voluntary participation in clinical research; Fully understand and Informed the study and sign the Informed Consent Form (ICF); Be willing to follow and be able to complete all trial procedures;\n2. age of 18-75 years old (including boundary value), regardless of gender;\n3. Pathologically confirmed locally advanced, metastatic non-small cell lung cancer (NSCLC), including squamous non-small cell lung cancer and non-squamous non-small cell lung cancer. Patients with non-squamous non-small cell lung cancer should exclude known EGFR mutation or ALK gene rearrangement.\n4. patients with resistance to first-line PD-(L)1 inhibitors combined with chemotherapy;\n5. patients with tumor response of CR\u002FPR\u002FSD after at least one first-line immunotherapy;\n6. Subjects' ECOG PS score was 0-1 (including boundary value);\n7. Patients had to have ≥1 measurable lesion (according to RECIST1.1 criteria).\n8. predicted survival time ≥6 months;\n\nExclusion Criteria:\n\n1. Frontline treatment with anlotinib, anti-angiogenic macromolecular monoclonal antibody or other small molecule TKI drugs;\n2. central lung cancer with large blood vessel invasion;\n3. patients with any signs or history of bleeding that may affect treatment according to the investigator's judgment; Patients with bleeding events ≥CTCAE grade 3, unhealed wounds, ulcers, or fractures within 4 weeks before the first dose of study drug;\n4. hemoptysis \\> 50ml\u002Fd;\n5. inability to swallow capsules or diseases that significantly affect gastrointestinal function, such as malabsorption syndrome, gastric or small bowel resection, bariatric surgery, inflammatory bowel disease, partial or complete intestinal obstruction;\n6. Poorly controlled hypertension (defined as systolic blood pressure \\>150 mmHg and\u002For diastolic blood pressure \\>100 mmHg)\n7. other known malignant tumors that are developing or require active treatment;\n8. Currently participating or has participated in the clinical research of other drugs;\n9. interstitial lung disease or (non-infectious) pneumonia requiring steroid therapy",{"count":218,"type":21},33,[220],"PHASE4","Immune resistance after treatment, there is no standard treatment, one of the most important and the most effective measures is immune to combination therapy。Targeted angiogenesis therapy has always been the focus of research on the treatment of NSCLC patients with progressive disease after immunotherapy. From the mechanism of action, angiogenesis and immunosuppression are interrelated processes.",[29],[224],"Progress in first-line immunotherapy","2024-04-07",{"date":227,"type":41},"2024-04-10",{"date":229,"type":21},"2024-07-01",{"date":231,"type":21},"2028-07-01",{"name":233,"class":72},"The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine"]