[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"small-cell-lung-cancer-limited-stage\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:small-cell-lung-cancer-limited-stage":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,42,65,90,115,139],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100597214","phase-2-durvalumab-as-consolidation-for-patients-ls-sclc-100597214",false,"NCT07055581","Durvalumab as Consolidation for Patients LS-SCLC","A Phase II Study of Durvalumab Combined With EP Prior to Chemoradiotherapy and Followed by Durvalumab as Consolidation for Patients With Limited-stage Small-cell Lung Cancer (CONCUR Study)","Inclusion Criteria:\n\n* 1.Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n* 2.Histologically or cytologically confirmed small cell lung cancer\n* 3.Limited-stage, defined as stage I-III SCLC (T any, N any, M0). Patients who are Stage I or II must be medically inoperable as determined by investigator.\n* 4.Age \\> 18 years.\n* 5.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* 6.Adequate normal organ and marrow function.\n* 7.Must have a life expectancy of at least 12 week.\n* 8.At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion (TL) at baseline. Tumor assessment by computed tomography (CT) scan or magnetic resonance imaging (MRI) must be performed within 28 days prior to enrollment.\n\nExclusion Criteria:\n\n* 1.Patients with extensive disease small-cell lung cancer.\n* 2.Patients who previously received radiotherapy to the thorax or chemotherapy for small cell lung cancer.\n* 3.Any previous diagnosis of transformed non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that has transformed to SCLC, or mixed SCLC NSCLC histology. Patients with mixed histology tumors with predominant SCLC histology are allowed.\n* 4.Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values.\n* 5.Any concurrent chemotherapy other than study treatment, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.\n* 6.History of allogenic organ transplantation.\n* 7.Active or prior documented autoimmune or inflammatory disorders.\n* 8.Uncontrolled intercurrent illness.\n* 9.History of leptomeningeal carcinomatosis.\n* 10.Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart)\n* 11.History of active primary immunodeficiency\n* 12.Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening. Participants with a past or resolved HBV infection (defined as the presence of antiHBc and absence of HBsAg) and with undetectable HBV DNA (\\\u003C 10 IU\u002Fml or under the limit of detection per local lab standard) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n* 13.Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.\n* 14.Prior treatment in a previous durvalumab clinical study.\n* 15.Known allergy or hypersensitivity to IP or any excipient.","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Small-Cell Lung Cancer (SCLC) accounts for 10% to 15% of new lung cancers and is a highly aggressive neuroendocrine tumor. In the past 30 years, the treatment of SCLC has made very limited progress, and basically made breakthroughs in radiotherapy and chemotherapy. With the advent of the immune era, immunotherapy has achieved initial results in the treatment of SCLC. Approximately one-third of patients with small cell lung cancer are in limited-stage (LS-SCLC) disease at first diagnosis. Except for a very small number of patients with T1-2N0 who can be treated with surgery or stereotactic radiation therapy (SBRT), the standard treatment for the rest of the patients with LS-SCLC is concurrent chemoradiotherapy. The ORR of platinum-combined etoposide regimen combined with thoracic radiotherapy in LS-SCLC can reach 70% to 90%, and the median OS is 16-24 months, which significantly improves the survival of patients. Although many measures have been taken in the treatment of LS-SCLC, only 20% of LS-SCLC can be cured, and most patients have relapse and metastasis after treatment. This study is a single arm phase II preliminary pilot study, aim to assess the efficacy and safety of durvalumab combined with EP prior to CRT and followed by durvalumab consolidation therapy for LS-SCLC.",[26],"Small Cell Lung Cancer Limited Stage",[28],"small cell lung cancer","RECRUITING","2026-03-26",{"date":32,"type":33},"2026-03-27","ACTUAL",{"date":35,"type":33},"2026-02-24",{"date":37,"type":20},"2029-07-31",{"name":39,"class":40},"Qian Chu","OTHER",2,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":64},"100553222","phase-2-a-study-of-adebrelimab-combined-with-apatinib-mesylate-and-chemotherapy-for-neoadjuvant-therapy-and-biomarker-analysis-in-limited-stage-small-cell-lung-cancer-100553222","NCT06483282","A Study of Adebrelimab Combined With Apatinib Mesylate and Chemotherapy for Neoadjuvant Therapy and Biomarker Analysis in Limited-stage Small Cell Lung Cancer","A Single-arm, Prospective, Exploratory Study of Adebrelimab Combined With Apatinib Mesylate and Chemotherapy for Neoadjuvant Therapy and Biomarker Analysis in Limited-stage Small Cell Lung Cancer","Inclusion Criteria:\n\n* Age between 18 and 75 years old;\n* Histologically or cytologically confirmed limited-stage small cell lung cancer (T1-3N0-1M0).\n* All lesions of the patient (including the primary lesion, lymph nodes\u002Flesions assessed as metastatic) must be jointly evaluated and confirmed as resectable by a surgeon, a radiation oncologist, and a radiologist;\n* The subject must have measurable target lesions (according to RECIST 1.1 criteria);\n* ECOG performance status score of 0-1;\n* No history of other malignancies;\n* No previous treatment for small cell lung cancer-related surgery, radiotherapy, chemotherapy, immunotherapy, or other anti-tumor treatments;\n* The patient must have adequate cardiopulmonary function: the patient's FEV1 and DLCO are both ≥50% of the predicted value, echocardiography shows LVEF ≥55%, and no clear signs of heart failure, severe coronary artery stenosis, etc., are seen on various tests, and the cardiopulmonary function is assessed by a surgeon as being able to tolerate surgical treatment;\n* The levels of important organ functions must meet the following requirements: a. Bone marrow: Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL, platelets ≥100×10\\^9\u002FL, hemoglobin ≥9 g\u002Fdl; b. Good coagulation function: defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5 times the upper limit of normal (ULN); c. Liver: Total bilirubin ≤1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal; d. Kidney: Serum creatinine ≤1.25 times the upper limit of normal or creatinine clearance (calculated using the Cockcroft-Gault formula) ≥60 ml\u002Fmin;\n* Males with reproductive capacity and women of childbearing age must agree to use effective contraception from the time of signing the main informed consent form until 180 days after the last administration of the study drug. Women of childbearing age include pre-menopausal women and post-menopausal women within 2 years. The pregnancy test result of women of childbearing age must be negative within ≤7 days before the first administration of the study drug;\n* Voluntarily participate in clinical research; fully understand and be informed about this study and sign the informed consent form.\n\nExclusion Criteria:\n\n* Inability to completely remove all lesions through surgery;\n* Received anti-tumor treatment for SCLC (including but not limited to chemotherapy, radiotherapy of the lesion area).\n* Previously used immunocheckpoint inhibitors such as PD-1\u002FPD-L1 inhibitors for treatment.\n* Any history of active autoimmune diseases or autoimmune diseases (such as uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy), tuberculosis); patients with childhood asthma that has completely resolved and does not require any intervention in adulthood or vitiligo can be included, but patients requiring medical intervention with bronchodilators are not eligible for inclusion;\n* Have congenital or acquired immune system deficiencies, such as human immunodeficiency virus (HIV) infected individuals, active hepatitis B (HBV DNA ≥ 500 IU\u002Fml), hepatitis C (positive for hepatitis C antibodies and HCV-RNA is above the lower limit of detection of the analytical method) or co-infection with both hepatitis B and C;\n* Existence of uncontrollable third-space effusions, such as a large amount of pleural effusion or ascites or pericardial effusion;\n* Subjects who need systemic treatment with corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) or other immunosuppressants within 14 days before the first administration of the drug. Inhaled or topical corticosteroids are allowed, as well as adrenal hormone replacement therapy with a dose \\>10 mg\u002Fday prednisone equivalent, in the absence of active autoimmune diseases;\n* Subjects who have been treated with anti-tumor vaccines or other immunostimulatory anti-tumor drugs (interferons, interleukins, thymosin, immune cell therapy, etc.) within 1 month before the first administration of the drug;\n* Currently participating in other interventional clinical studies;\n* Evidence of previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonia, and severe lung function impairment;\n* Patients with severe heart disease, such as congestive heart failure grade III or above (NYHA standard), or angina grade III or above (CCS standard), or a history of myocardial infarction within 6 months before treatment initiation, or arrhythmias requiring drug treatment;\n* Major surgery, open biopsy, or significant trauma within 28 days before enrollment;\n* Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n* Pregnant or breastfeeding women; patients with fertility who are unwilling or unable to take effective contraceptive measures;\n* Known allergic reactions, hypersensitivity, or intolerance to the study drug;\n* Hypertension that cannot be well controlled with antihypertensive drug treatment (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);\n* Abnormal coagulation function (INR \\> 2.0 or prothrombin time (PT) \\> 16s), with a tendency to bleed or currently undergoing thrombolysis or anticoagulant treatment (preventive use of low-dose aspirin, low molecular weight heparin is allowed);\n* Significant clinical bleeding symptoms within the last 3 months or a clear tendency to bleed, such as gastrointestinal bleeding, bleeding gastric ulcers, or patients with vasculitis, etc., if the baseline fecal occult blood is positive, it can be retested, and if it is still positive after retesting, an endoscopy is required (except for those who have undergone endoscopy within 3 months and before the baseline period to rule out such conditions);\n* Arterial\u002Fvenous thrombotic events within the last 6 months, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;\n* Known genetic or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation disorders, thrombocytopenia, etc.). Other conditions deemed unsuitable for participating in the study by the researcher.","75 Years",{"count":51,"type":20},38,[23],"This is a single-arm, prospective, exploratory phase II clinical study. The study enrolled newly diagnosed stage T1-3N0-1M0 resectable limited-stage small cell lung cancer. Adebrelimab combined with chemotherapy for 4 cycles and apatinib mesylate for 3 cycles. Surgery was performed within 4-8 weeks after the above treatment (the operation was performed 4 weeks after apatinib was discontinued). According to the results of MDT discussion, adebrelimab combined with apatinib mesylate combined with or without radiotherapy was started 4 weeks after surgery. Preoperative prophylactic radiotherapy (PCI) is recommended for patients with preoperative stage N1. Patients with postoperative stage N1 received postoperative thoracic radiotherapy.",[26],"2025-04-13",{"date":57,"type":33},"2025-04-15",{"date":59,"type":33},"2024-06-21",{"date":61,"type":20},"2026-12-31",{"name":63,"class":40},"Jin Ying",1,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":64},"100576354","phase-2-adebrelimab-maintenance-therapy-after-concurrent-chemoradiotherapy-with-hyperfractionated-radiotherapy-in-limited-stage-small-cell-lung-cancer-100576354","NCT06784206","Adebrelimab Maintenance Therapy After Concurrent Chemoradiotherapy with Hyperfractionated Radiotherapy in Limited-Stage Small Cell Lung Cancer","An Exploratory Clinical Study of Adebrelimab Maintenance Treatment Following Concurrent Chemoradiotherapy with Hyperfractionated Radiotherapy in Patients with Limited-Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n* Age: 18-75 years, both genders are eligible;\n* Histologically or cytologically confirmed limited-stage small cell lung cancer (according to the 8th edition of AJCC staging);\n* Patients who have previously received no more than 2 cycles of standard chemotherapy or are treatment-naive;\n* ECOG performance status: 0-1;\n* Presence of measurable lesions according to RECIST 1.1 criteria (for RECIST 1.1 criteria, the longest diameter of tumor lesions on CT scan ≥10mm, and the shortest diameter of lymph node lesions on CT scan ≥15mm);\n* Estimated life expectancy of at least three months;\n* Participants must have adequate pulmonary function;\n\nNormal function of major organs, which means meeting the following criteria:\n\nComplete blood count:\n\nHemoglobin (HGB) ≥90 g\u002FL; Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL; Platelet count (PLT) ≥100×10⁹\u002FL; White blood cell count (WBC) ≥3.0×10⁹\u002FL;\n\nBiochemical tests:\n\nSerum albumin (ALB) ≥30 g\u002FL; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C3×ULN; Total bilirubin (TBIL) ≤1.5×ULN; this does not apply to patients diagnosed with Gilbert's syndrome (persistent or recurrent hyperbilirubinemia \\[mainly unconjugated bilirubin\\], without evidence of hemolysis or liver pathology). After consultation with a physician, patients with this condition may be allowed to participate in the study.\n\n* Creatinine ≤1.5×ULN;\n* Women of childbearing potential must have taken reliable contraceptive measures or have had a negative pregnancy test (serum or urine) within 7 days before enrollment. Both men and women of childbearing age must agree to take adequate contraceptive measures throughout the study period and for 6 months after the end of treatment;\n* Participants voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-ups.\n\nExclusion Criteria:\n\n* Histological mixture of SCLC and NSCLC components;\n* Extensive-stage SCLC;\n* Patients with a history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant or planned for transplant;\n* Use of immunosuppressive drugs (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor drugs) within 14 days before the first use of Adebrelimab, excluding nasal and inhaled corticosteroids or physiologic doses of systemic corticosteroids (i.e., no more than 10 mg\u002Fday of prednisolone or equivalent physiologic dose of other corticosteroids);\n* Known allergy to etoposide, cisplatin, Adebrelimab, or drug excipients; or severe allergic reactions to other monoclonal antibodies; Vaccination with live attenuated vaccines within 4 weeks before the first dose or planned during the study period;\n* Presence of any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism) is not eligible. Exceptions to this criterion include:\n\nPatients with vitiligo or alopecia;\n\n* Patients with stable hypothyroidism under hormone replacement therapy (e.g., after Hashimoto's syndrome);\n* Participants undergoing systemic treatment with bronchodilators, with unsatisfactory asthma control, are not eligible (those who had complete remission of asthma in childhood and require no intervention in adulthood may be included);\n* Urinalysis showing proteinuria ≥++, or confirmed 24-hour urine protein ≥1.0g;\n\nPreviously diagnosed with any other malignancy, except for the following conditions:\n\n* Adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix;\n* Malignancies treated with curative intent, with no known active disease for ≥5 years before the first dose in the study and with a low potential risk of recurrence;\n* Infection with human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS);\n* Within 6 months before enrollment, occurrence of the following conditions: myocardial infarction, severe\u002Funstable angina, NYHA class 2 or higher heart failure, poorly controlled arrhythmias (including QTcF interval \\>450 ms for males, \\>470 ms for females, QTcF interval calculated by Fridericia formula), symptomatic congestive heart failure;\n* Infections requiring drug intervention (e.g., intravenous antibiotics, antifungal, or antiviral drugs) within 4 weeks before the first dose, or unexplained fever ≥38.5°C during the screening period or before the first dose;\n* Active tuberculosis, hepatitis B (HBV-DNA ≥500 IU\u002Fml), hepatitis C (positive hepatitis C antibody, and HCV-RNA above the lower limit of detection of the analytical method), or co-infection with hepatitis B and C;\n* Participation in any other drug clinical trial within 4 weeks before the first dose; Known history of abuse of psychoactive drugs or drug addiction;\n* Presence of other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participation in the study, interfere with the study results, or patients whom the investigator deems unsuitable for participation in this study for other reasons.",{"count":73,"type":20},30,[23],"Small cell lung cancer (SCLC) remains a challenging disease with poor prognosis and limited treatment options despite decades of research. SCLC is an immunogenic tumor, and the use of T-cell immune checkpoint inhibitors targeting the PD-1\u002FPD-L1 axis has shown promising antitumor activity, potentially extending patient survival. The combination of concurrent chemoradiotherapy followed by immune maintenance therapy has demonstrated significant efficacy in limited-stage SCLC. Moreover, hyperfractionated accelerated radiotherapy (HART) has been shown to improve overall survival in limited-stage SCLC compared to standard dose radiotherapy without increasing toxicity. However, there is a lack of exploration into the use of immune checkpoint inhibitors following concurrent chemoradiotherapy with HART in limited-stage SCLC.\n\nThis exploratory clinical study aims to investigate the efficacy and safety of adebrelimab maintenance treatment following concurrent chemoradiotherapy with HART in patients with limited-stage SCLC through a single-arm, open-label, prospective, single-center clinical trial.",[77,78,79],"Small Cell Lung Cancer, Limited Stage","Hyperfractionated Accelerated Radiotherapy","Simultaneous Radiotherapy and Chemotherapy","NOT_YET_RECRUITING","2025-01-14",{"date":83,"type":33},"2025-01-20",{"date":85,"type":20},"2025-02",{"date":87,"type":20},"2028-01",{"name":89,"class":40},"Peking University Cancer Hospital & Institute",{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":64},"100511922","molecular-analysis-and-treatment-options-of-sclc-100511922","NCT05945745","Molecular Analysis and Treatment Options of SCLC","Molecular Landscape Analysis and Clinical Implications for SCLC","Inclusion Criteria:\n\n* Histologically proven diagnosis of SCLC\n* 18 years of age or older\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Histologically proven diagnosis of non-SCLC",{"count":98,"type":20},500,"OBSERVATIONAL","Small cell lung cancer (SCLC) is an aggressive disease that is characterized by rapid growth and the early development of metastases. Patients typically respond to initial chemotherapy but quickly experience relapse, resulting in a poor long-term outcome. Therapeutic innovations that substantially improve survival have historically been limited, and reliable, predictive biomarkers are lacking.\n\nOngoing research has advanced the understanding of molecular categories and the immunologic microenvironment of SCLC, which in turn has helped improve disease classification and staging. Considering the role of molecular alterations has not yet fully to be defined in the treatment of SCLC, there is an urgent recognition that molecular alterations in the SCLC are important to predict response and survival for novel therapies and ongoing clinical trials. Advances in research have revealed critical information regarding biologic characteristics of the disease, which may lead to the identification of vulnerabilities and the development of new therapies. Further research focused on identifying biomarkers and evaluating innovative therapies will be paramount to improving treatment outcomes for patients with SCLC.\n\nIn summary, identification of (genetic) biomarkers in SCLC is increasingly essential to perform molecular diagnostics and individualized treatments. This project aims to create a registry of patients with SCCL to further the characterization of molecular alterations and develop (novel) treatments based on the detection.",[102,103,104,105,26],"Small-cell Lung Cancer","Small Cell Lung Cancer, Combined Type","Small Cell Lung Carcinoma","Small Cell Lung Cancer Extensive Stage","2024-11-26",{"date":108,"type":33},"2024-11-29",{"date":110,"type":33},"2016-01-01",{"date":112,"type":20},"2028-12-31",{"name":114,"class":40},"Shanghai Chest Hospital",{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":122,"targetDuration":4,"studyType":21,"phases":124,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":138},"100552191","phase-3-a-clinical-study-of-tqb2450-combined-with-anlotinib-in-limited-stage-small-cell-lung-cancer-patients-100552191","NCT06469879","A Clinical Study of TQB2450 Combined With Anlotinib in Limited-Stage Small Cell Lung Cancer Patients","A Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2450 Combined With Anlotinib as Maintenance Therapy in Patients With Limited-stage Small Cell Lung Cancer","Inclusion Criteria:\n\n* The subjects voluntarily joined the study, signed the informed consent, and the compliance was good;\n* Age: 18\\~75 years old (when signing the informed consent form); Eastern Cooperative Oncology Group Performance Status score: 0-1 points; expected survival of more than 6 months; weight \\> 40 kg;\n* Pathologically confirmed patients with limited stage small cell lung cancer (according to the Veterans Administration Lung Study Group (VALG) stage);\n* There was no evidence of metastatic disease by diagnostic quality enhanced CT of the neck, chest, abdomen, and pelvic cavity, and craniocerebral plain scan plus enhanced MRI (PET-CT is recommended before chemoradiotherapy. Bone scan should be performed if PET-CT is not performed before chemoradiotherapy. PET-CT must be performed during the screening period after chemoradiotherapy to rule out metastasis.);\n* It is anticipated that no tumor resection will be required during the study（Patients who are not suitable for surgery or those who do not want surgery can be treated);\n* Receive the chemoradiotherapy regimen prescribed below, unless an alternative is acceptable after consultation with the investigator:\n\n  1. Four cycles of platinum-containing chemotherapy with concurrent or sequential radiotherapy were received, and these treatments had to be completed within 1 to 42 days of randomization and the first administration of the study drug;\n  2. According to the standard treatment regimen at each study center, chemotherapy regimens must contain cisplatin\u002Fcarboplatin drugs and etoposide administered intravenously\n  3. For the standard Quaque Die radiotherapy regimen, the total radiation dose received was 60 Gy±10% (6-week regimen), and for the hyperfractionated Bis in die radiotherapy regimen, the total radiation dose received was 45 Gy (3-week regimen), and the dose was calculated based on the planned target area (PTV). Research centers are encouraged to follow the following doses of radiation to organs at risk：\n\n  c.1 Average lung dose \\\u003C20 Gy and\u002For V20 must be \\\u003C35% c.2 Cardiac V50 \\\u003C25% d. If synchronous Cardiac resynchronization therapy is used, chest radiotherapy must be started no later than the first day of the 3rd cycle of chemotherapy; e. If sequential radiotherapy is used, thoracic radiotherapy should be preceded by at least 2 cycles of induction chemotherapy, with no more than 35 days between the end of the chemotherapy cycle and the start of radiotherapy;\n* Precision radiotherapy techniques such as three-dimensional conformal radiotherapy, conformal intensity modulated radiotherapy and tomographic radiotherapy are adopted;\n* Patients receiving radical platinum-based chemoradiotherapy must achieve complete response, partial response, or stable disease without disease progression;\n* Prophylactic brain radiotherapy (PCI) is permitted according to the judgment of the investigator and the standard treatment at each study center, and must be performed after the completion of Cardiac resynchronization therapy, but it is allowed to be targeted at the last chemotherapy;\n* The patient provided tumor tissue as far as possible for Programmed cell Death ligand 1 (PD-L1) expression level determination. Any available tumor tissue sample can be submitted: histology or cytology (if tissue samples are not available). Pathology reports of these specimens must also be provided;\n* The patient was confirmed to have at least one measurable lesion according to RECIST 1.1 criteria prior to chemoradiotherapy;\n* Having an adequate Pulmonary function test, defined as Forced expiratory volume in one second \\> 50% of predicted normal expiratory volume and Diffusing capacity of the lung for carbon monoxide (DLCO) \\> 40% of predicted normal. For subjects without diffusing capacity of the lungs for carbon monoxide measurements, adequate oxygen transport is considered if the pulse oxygen saturation (O2 saturation) measured in indoor air is ≥ 90%.\n\nExclusion Criteria:\n\n* Tumor disease and history\n\n  1. Present or present with other malignant tumors within 3 years. The following two conditions can be included: 5 consecutive years of disease-free survival (DFS) without any treatment for other malignancies; Cured of thyroid cancer, Cervical carcinoma in situ, Non-melanoma skin cancer and superficial bladder tumors【Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basal membrane)】;\n  2. Complex small cell lung cancer confirmed by histopathology or cytopathology;\n  3. Subjects with known central nervous system metastatic and\u002For cancerous meningitis;\n  4. Malignant pleural effusion and pericardial effusion；\n  5. Patients whose imaging (CT or MRI) shows that the tumor has invaded an important blood vessel or who are judged by the investigator to be highly likely to invade an important blood vessel during subsequent studies and cause a fatal hemorrhage;\n* Previous antitumor therapy\n\n  1. Within 2 weeks prior to the start of the study treatment, the patients were treated with proprietary Chinese medicines with anti-tumor indications specified in theNational Medical Products Administration approved drug specification (Including compound cantharidin capsule, Kangai injection, Kanglaite capsule\u002Finjection, Aidi injection, Brucea oil injection\u002Fcapsule, Xiaoaiping tablet\u002Finjection, Huachansu capsule and so on);\n  2. Patients who have received immunomodulatory drugs (e.g., interleukin-2, thymosin, lentinan, etc.) within 30 days before starting treatment；\n  3. Prior treatment with an anti-programmed death-1, anti-Programmed cell death 1 ligand 1, or anti-Programmed death ligand-2 drug or against another irritating or co-inhibitory T cell receptor (e.g. cytotoxic T lymphocyte-associated antigen-4, OX 40, TNFRSF9, 4-1BB)；\n  4. In the past, he used bevacizumab,Anlotinib, Apatinib and other anti-angiogenic drugs；\n  5. Received more than 4 courses of chemotherapy。Chemotherapy regiments other than etoposide and platinum are not allowed；\n  6. Unmitigated toxic effects above Common Terminology Criteria for Adverse Events grade 1 due to any prior treatment（Hearing loss, hair loss, fatigue and abnormal lymphocyte count due to prior chemoradiotherapy were not included）；\n  7. Subjects with ≥ grade 2 pulmonary inflammation after prior chemoradiotherapy;\n* Combined disease and history\n\n  1. Cirrhosis, active hepatitis\\*:\n\n     Active hepatitis（Hepatitis B reference: HBsAg positive, and Hepatitis B virus DNA detection value exceeds the upper limit of normal value; Hepatitis C reference: Hepatitis C virus antibody positive and Hepatitis C (HCV) virus titer test values above the upper limit of normal); Note: Participants who are eligible for enrollment, hepatitis B surface antigen positive or core antibody positive, and hepatitis C patients need continuous antiviral therapy to prevent virus activation.\n  2. Patients with renal failure requiring hemodialysis or peritoneal dialysis have pre-existing or existing nephrotic syndrome or chronic nephritis\n  3. Cardio-cerebrovascular abnormalities:\n\n  c.1 Have grade 2 myocardial ischemia or myocardial infarction, arrhythmia (including QT Interval Correction ≥450ms in men, QT Interval Correction ≥470ms in women), and grade 2 congestive heart failure (NYHA rating); c.2 Severe arterial\u002Fvenous thrombosis events, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc., occurred within 6 months; c.3 After two or more medications, blood pressure control remained unsatisfactory (systolic ≥150 mmHg or diastolic ≥90 mmHg) d. History of immunodeficiency: d.1 A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; d.2 Active autoimmune disease requiring systemic treatment (such as use of disease-modifying drugs, corticosteroids, or immunosuppressants) occurred within 2 years prior to study treatment initiation(Such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; Subjects with asthma requiring medical intervention with bronchodilators were not included). Hormone replacement therapy (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) may not be considered systemic treatment; e. Have been diagnosed with an immune deficiency or are receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy (dose \\>10mg\u002F day prednisone or other therapeutic hormone) and continue to use within 2 weeks prior to initial administration; f. Patients with active tuberculosis within 1 year prior to enrollment; Participants with a history of active pulmonary tuberculosis infection before 1 year were required to provide clear evidence of cure. If tuberculosis was suspected during the screening period, the patients could be enrolled only after being excluded by chest radiography or chest CT, sputum and clinical symptoms;\n* Study live attenuated vaccine vaccination history within 28 days before the start of treatment or planned live attenuated vaccine vaccination during the study period;\n* Had participated in other anti-tumor drug clinical trials within 4 weeks before the first drug use, and only those who had not used drugs were not subject to the 4-week time limit.",{"count":123,"type":20},358,[125],"PHASE3","This study is a randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of TQB2450 in combination with anlotinib as maintenance therapy in patients with limited-stage small cell lung cancer who have not progressed after chemoradiotherapy.",[26],"2024-06-28",{"date":130,"type":33},"2024-07-01",{"date":132,"type":20},"2024-09",{"date":134,"type":20},"2026-09",{"name":136,"class":137},"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","INDUSTRY",16,{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":21,"phases":148,"briefSummary":150,"conditions":151,"keywords":152,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":41},"100489337","pci-and-brain-mri-follow-up-vs-brain-mri-follow-up-alone-in-limited-stage-sclc-patients-100489337","NCT05651802","PCI and Brain MRI Follow-up vs Brain MRI Follow-up Alone in Limited-stage SCLC Patients","Prophylactic Cranial Irradiation and Brain MRI Follow-up Versus Brain MRI Follow-up Alone in Patients With Limited-stage Small Cell Lung Cancer Who Achieved Complete Remission After Definitive Radio-chemotherapy: a Prospective Randomized Trial","Inclusion Criteria:\n\n* Histologically\u002Fcytologically proven diagnosis of SCLC.\n* Age ≥ 18 years.\n* Karnofsky performance status ( KPS) ≥80.\n* The limited-stage is defined as the tumor confined to one side of the chest, including ipsilateral hilar, bilateral mediastinum, and bilateral supraclavicular lymph nodes. (The definition of metastatic lymph nodes is that the short diameter ≥ 1cm or PET-CT shows increased metabolism with SUV≥2.5, or proved by mediastinoscopy\u002FEBUS\u002FTBNA biopsy. The thickness of pleural effusion on chest CT is less than 1cm (unless cytology proves to be malignant pleural effusion). According to 8th AJCC\u002FUICC TNM staging system, it is the I-IIIC without intrapulmonary metastasis.\n* Patients who have received definitive chest radiotherapy and chemotherapy and achieved complete remission of tumor within 4-6 weeks after the end of radio-chemotherapy (in accordance with the Response Evaluation Criteria in Solid Tumors v.1.1 including enhanced CT scan of chest and abdomen, enhanced brain MRI, bone scan and tumor markers).\n* Good follow-up compliance;\n* Fully understand this study, and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Patients with a history of malignant tumors (past or concurrent) within 5 years, excluding papillary thyroid cancer, non-malignant melanoma skin cancer and cervical carcinoma in situ.\n* Patients who have received radical surgery (excluding biopsy).\n* Patients with psychiatric history, pregnancy and lactation.\n* Uncontrolled diabetes, hypertension, severe active infection.\n* Patients with chronic diseases of central nervous system.\n* Patients with contraindications of brain MRI examination.\n* Other situations deemed unsuitable by the doctor in charge.",{"count":147,"type":20},220,[149],"NA","At present, prophylactic cranial irradiation (PCI) is part of standard care for patients with limited-stage small cell lung cancer (SCLC) who have achieved good response after definitive thoracic radiotherapy and chemotherapy. However, the value of PCI is being challenged in the era when MRI examination of brain has been popularized.\n\nThe goal of this clinical study is to compare PCI and regular brain MRI follow-up (control arm) and regular brain MRI follow-up alone (study arm) in patients with limited-stage SCLC who have received definitive radiotherapy and chemotherapy and acheived complete remission (CR) of tumor.\n\nThe main questions to answer are:\n\n1. Whether the 2-year brain metastasis-free survival rate of the study group is not inferior to that of the control group.\n2. The difference of 2-year overall survival rate between the control group and the study group.\n3. Whether the patients in the study group have better overall quality of life than those in the control group.\n\nParticipants will randomly receive either PCI and regular brain MRI follow-up or regular brain MRI follow-up alone.",[26],[153,154,155],"prophylactic cranial irradiation","brain MRI follow-up","prognosis","2023-12-16",{"date":158,"type":33},"2023-12-19",{"date":160,"type":33},"2023-01-01",{"date":162,"type":20},"2026-06",{"name":164,"class":40},"Zhejiang Cancer Hospital"]