[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"limited-stage-small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:limited-stage-small-cell-lung-cancer":55},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,41,66,95,129,157,197,219,244,265,286,311,332,360,385,411],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100605351","durvalumab-consolidation-after-chemoradiation-therapy-for-limited-stage-sclc-in-china-100605351",false,"NCT07161388","Durvalumab Consolidation After Chemoradiation Therapy for Limited Stage SCLC in China","Durvalumab Consolidation After Chemoradiation Therapy (CRT) for Patients With Limited Stage Small-Cell Lung Cancer in China: A Multicentre, Observational Study (DREAM)","DREAM","Inclusion Criteria:\n\n* Able to provide informed consent\n* Age ≥18 years\n* Histologically or cytologically documented LS-SCLC (Stage I-III SCLC \\[T any, N any, M0\\] according to the American Joint Committee on Cancer Staging Manual \\[AJCC Cancer Staging Manual, 8th Edition\\], that can be safely treated with definitive radiation doses. Excludes T3-4 due to multiple lung nodules that are too extensive or have tumor\u002Fnodal volume that is too large to be encompassed in a tolerable radiation plan)\n* ECOG PS 0-2 (prior to the first dose of durvalumab after CRT)\n* No disease progression following cCRT\u002FsCRT (cCRT refers to chemotherapy and radiotherapy are administered with overlap; sCRT refers to chemotherapy and radiotherapy are delivered in a sequential manner with no overlap)\n* Patients who received platinum-based cCRT\u002FsCRT followed by durvalumab consolidation as first-line treatment at the discretion of physicians are eligible (the time interval from the end of cCRT\u002FsCRT to the first dose of durvalumab consolidation should be within 3 months)\n\n  * Patients who started durvalumab consolidation ≤3 months before enrolment in the study will be allowed (irrespective of whether they continue to receive durvalumab at time of enrolment or already discontinued treatment)\n\nExclusion Criteria:\n\n* Patients treated with CRT only without subsequent durvalumab consolidation\n* Patients received durvalumab or any other anti-PD-1\u002Fanti-PD-L1 antibodies along with CRT\n* Patients who previously were involved, or currently are, or plan to be involved in any other interventional anti-cancer clinical studies for LS-SCLC\n* Prior exposure to immune-mediated therapy including, but not limited to, other anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines\n* Judgment by the investigator that the patient should not participate in the study because the patient is unlikely to comply with study procedures","ALL","18 Years",{"count":20,"type":21},200,"ESTIMATED","OBSERVATIONAL","This prospective, multicentre, observational study aims to assess the effectiveness and safety of durvalumab as consolidation treatment for patients with LS-SCLC who have not progressed following CRT in real-world setting.",[25],"Limited Stage Small-Cell Lung Cancer",[27],"SCLC","RECRUITING","2026-06-23",{"date":31,"type":32},"2026-06-24","ACTUAL",{"date":34,"type":32},"2025-11-17",{"date":36,"type":21},"2028-09-30",{"name":38,"class":39},"AstraZeneca","INDUSTRY",21,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":65},"100629319","phase-3-effect-of-trilaciclib-in-the-prevention-of-myelosupression-in-subjects-with-limited-stage-small-cell-lung-cancer-100629319","NCT07473128","Effect of Trilaciclib in the Prevention of Myelosupression in Subjects With Limited-stage Small Cell Lung Cancer","A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre Trial Comparing Efficacy and Safety of Trilaciclib Versus Placebo in Participants With Limited-stage Small Cell Lung Cancer","Inclusion Criteria:\n\n* Confirmed diagnosis of Limited-Stage Small Cell Lung Cancer\n* Complete recovery from prior anti-tumor surgical procedures\n* Measurable and evaluable disease through tumor assessment\n* Willingness to participate and sign informed consent form\n\nExclusion Criteria:\n\n* Extensive Stage Small Cell Lung Cancer\n* Active cardiovascular disease\n* Known hypersensitivity to trilaciclib, etoposide, carboplatin, cisplatin or any component in their formulations\n* Pregnant or nursing women",{"count":49,"type":21},120,"INTERVENTIONAL",[52],"PHASE3","The goal of this clinical trial is to compare the efficacy and safety of trilaciclib versus placebo in subjects with limited stage small cell lung cancer. The main question it aims to answer is:\n\nDoes trilaciclib have a myeloprotective effect in subject with limited stage small cell lung cancer?\n\nParticipants will be randomised to receive either trilaciclib or placebo.",[55],"Limited Stage Small Cell Lung Cancer","2026-06-15",{"date":58,"type":32},"2026-06-17",{"date":60,"type":21},"2026-06-30",{"date":62,"type":21},"2027-06",{"name":64,"class":39},"Pharmacosmos A\u002FS",1,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":50,"phases":76,"briefSummary":77,"conditions":78,"keywords":79,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":4},"100643381","phase-3-tarlatamab-and-durvalumab-vs-durvalumab-alone-for-limited-stage-small-cell-lung-cancer-100643381","NCT07637513","Tarlatamab and Durvalumab vs. Durvalumab Alone for Limited-Stage-Small Cell Lung Cancer","Phase III Trial of Consolidation Tarlatamab + Durvalumab vs. Durvalumab Alone for Limited-Stage-Small Cell Lung Cancer (LS-SCLC)","PrE0512","* Patient must have histologically or cytologically confirmed Small Cell Lung Cancer (SCLC).\n* SCLC must be diagnosed as Limited-Stage-SCLC (LS-SCLC) (Stage I-III, disease can be encompassed within a radical radiation portal per investigator assessment) and treated with 3 to 4 cycles of chemotherapy and radiation therapy. Three cycles of chemotherapy will be acceptable if the planned radiation therapy course is completed concurrently with chemotherapy.\n\n  * Patient must not be eligible for surgical resection or have had prior surgical resection for the current diagnosis of LS-SCLC.\n  * Small cell carcinoma may not be transformed from previous diagnosis of non-small cell lung cancer (e.g., Epidermal Growth Factor Receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) with SCLC transformation). Mixed histology (aka combined small cell) histology tumors are permitted if the majority component is small cell histology.\n  * Chemotherapy must consist of a platinum agent (carboplatin or cisplatin) and etoposide.\n  * Definitive radiation may include daily treatment ≥ 60 gray (Gy) or twice-daily treatments 45 Gy or other biologically equivalent regimens given concurrently with chemotherapy.\n  * For early LS-SCLC (e.g., T1-2, N0, M0) without lymph node involvement, treatment with stereotactic ablative radiotherapy (SABR\u002FSBRT) and chemotherapy is allowed.\n  * Prophylactic cranial radiation (PCI) is permitted but not required. If PCI is administered, 7 day wash-out period is required before start of study treatment.\n\n    * PCI consists of whole brain radiation therapy delivered in the absence of brain metastases. Hippocampal-sparing whole brain plans are considered PCI.\n  * Patient must be able to be randomized and have planned cycle 1 day 1 treatment within 42 days of the last dose of thoracic radiation therapy or end of last cycle of chemotherapy, whichever was given most recently.\n* Completed chemotherapy and radiation with no evidence of progression of disease per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1 (i.e., achieved complete response, partial response, or stable disease), including no evidence of metastatic disease on brain MRI, after treatment but prior to randomization.\n* Patient must be ≥ 18 years of age.\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Patient must have the ability to understand and willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible.\n* Patient must be willing to provide archived tumor tissue (if available) for research.\n* Patient must have adequate organ function and marrow function as defined below, obtained ≤ 14 days prior to randomization (Echocardiogram (ECHO)\u002FMulti-Gated Acquisition (MUGA) ≤ 28 days).\n\n  * Absolute Neutrophil Count (ANC) ≥ 1500\u002Fmicroliter (mcL)\n  * Hemoglobin ≥ 8.0 g\u002FdL\n  * Platelets ˃100,000\u002FmcL\n  * Prothrombin time (PT)\u002Finternational normalized ratio (INR) ≤ 1.5x upper limit normal (ULN) except for patients on stable dose anticoagulation for 6 weeks prior to randomization.\n  * Activated partial thromboplastin Time (aPTT) ≤ 1.5x ULN except for patients on stable dose anticoagulation for 6 weeks prior to randomization.\n  * Serum Creatinine ≤ 2x ULN\n  * Creatinine clearance(CrCl) ≥ 30 mL\u002Fmin\n  * ALT (Alanine Aminotransferase) and AST (Aspartate Aminotransferase) ≤ 2.5x ULN\n  * Total Bilirubin ≤ 1.5x ULN or ≤ 2x ULN for patients with documented Gilbert's disease\n  * No evidence of human immunodeficiency virus (HIV) within 6 months of randomization.\n  * Hepatitis B virus (HBV) and Hepatitis C virus (HCV) negative within 6 months of randomization.\n  * Pulmonary Function: No oxygen supplementation\n  * Electrocardiogram (ECG) with no findings of acute\u002Fsubacute ischemia and\u002For clinically significant arrythmia\n  * Cardiac Function: Cardiac ejection fraction ≥ 50% and no large or symptomatic pericardial effusion requiring intervention\n* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.\n* Patient must not expect to conceive, or father children by using an accepted and highly effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study, and for 90 days after the last dose of study drug(s). Also, patient must not expect to breastfeed, donate eggs, or donate sperm during study or for 90 days after the last dose of study drug(s).\n* Patient with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Patient must not have had major surgery within 28 days, or minor surgery within 10 days, before randomization.\n* Patient must not have a history of clinically significant interstitial lung disease or active pneumonitis requiring steroid treatment. Patients with grade 1 radiation pneumonitis or fibrosis are permitted to enroll.\n* Patient with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association (NYHA) Functional Classification (NYHA Classification). To be eligible for this trial, patient must be class IIB or better.\n* Patients with history of autoimmune disorders are eligible to enroll only if no disease flares and not requiring any systemic immunosuppressive agents in the past 5 years. Topical or inhaled steroids are permitted. The following are not exclusionary: vitiligo, asthma, endocrine disorders that required only hormone replacement, psoriasis or other skin disorders that do not require systemic treatment, celiac disease controlled by diet alone.\n* Patients with active primary immunodeficiency are not permitted to enroll.\n* Prior history of severe or life-threatening events (Common Terminology Criteria for Adverse Events (CTCAE) V6.0 grade ≥ 3) from any immune-related therapy.\n* Patients with any condition requiring chronic oral corticosteroids is eligible if steroid dose is ≤ 10 mg\u002Fday prednisone equivalent. Physiologic replacement doses for adrenal insufficiency are permitted even if dose exceeds 10 mg\u002Fday. Inhaled corticosteroids and local steroid injections are permitted. All other uses of steroids must be tapered to ≤ 10 mg\u002Fday before randomization.\n* Patients must not have a history of allogeneic solid organ, allogeneic bone marrow or stem cell transplantation.\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within for 6 months of before randomization are eligible for this trial.\n* Patient must not have received any live vaccine within 28 days prior to randomization.\n* Patients with a known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent are not eligible.\n* Any prior therapy with a selective inhibitor of the DLL3 pathway is not permitted.\n* Any prior therapy with immune-mediated therapy including anti-CTLA-4, anti-PD-1, or anti PD-L1 is not permitted.\n* Receiving another anti-cancer therapy is not permitted except for hormonal therapy for breast or prostate cancer, topical therapies for cutaneous malignancies, or superficial treatments for non-muscle invasive bladder cancers.\n* Patients with any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of the treatment according to the protocol are not eligible.\n* Patients may not participate in any other therapeutic clinical trials, including those with other investigational agents not included in this trial during treatment on this study without prior approval from PrECOG.",{"count":75,"type":21},430,[52],"Eligible participants with limited stage-small cell lung cancer (LS-SCLC) will be enrolled after completion of chemotherapy and radiation. Participants will be randomized to either tarlatamab in combination with durvalumab or durvalumab alone as consolidation therapy. Treatment will continue until disease progression, unacceptable side effects or withdrawal of consent.\n\nTarlatamab is a targeted cancer treatment. It works by acting as a matchmaker between the immune system's T-cells and the cancer cells, forcing them to come together so the T-cells can attack the cancer.\n\nImage testing will be done standardly during treatment. These tests show whether the cancer has progressed and if further treatment may be needed.\n\nThe purpose of this trial is to evaluate how well the treatment works (how long before your cancer comes back and how long you live).",[25],[80,81,82,83],"Tarlatamab","Durvalumab","Consolidation","Small Cell Lung Cancer","NOT_YET_RECRUITING","2026-06-04",{"date":87,"type":32},"2026-06-09",{"date":89,"type":21},"2027-01",{"date":91,"type":21},"2038-06",{"name":93,"class":94},"PrECOG, LLC.","OTHER",{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":50,"phases":105,"briefSummary":107,"conditions":108,"keywords":113,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":128},"100611589","phase-2-study-of-tarlatamab-as-maintenance-treatment-after-chemo-radiotherapy-for-limited-stage-sclc-patients-100611589","NCT07242547","Study of Tarlatamab as Maintenance Treatment After Chemo-radiotherapy for Limited Stage SCLC Patients","A Phase II Clinical Trial of Tarlatamab as Maintenance Treatment After Sequential Chemo-radiotherapy for Limited Stage SCLC Patients Not Eligible for Concurrent Chemo-radiotherapy","MERLIN","Inclusion Criteria:\n\n* Histologically or cytologically documented new diagnosis of LS-SCLC by histology or cytology from brushing, washing, or needle aspiration. Mixed tumors are not eligible.\n* Patients who:\n\n  1. were treated with sequential chemo-radiotherapy\n  2. were treated only with chemotherapy\n* Have at least one lesion that meets criteria for being measurable or non-measurable, as defined by RECIST 1.1.\n* Has completed chemo-radiation or chemotherapy alone without progression of disease per RECIST v1.1\n* Be male or female ≥18 years of age inclusive, on the day of signing informed consent.\n* Have a life expectancy of at least 3 months from the study start.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days prior to the first dose of study intervention.\n* Toxicities attributed to chemo-radiotherapy treatment have to be resolved to grade ≤1, unless otherwise specified.\n* No clinically significant electrocardiogram (ECG) findings\n* Correct pulmonary function without oxygen supplementation\n* Have voluntarily agreed to participate by giving written consent for the study prior to any specific protocol procedures.\n* Have adequate organ function (hematological and biochemistry parameters).\n\nExclusion Criteria:\n\n* Patients expected to require any other form of radiation therapy for LS-SCLC as concurrent radiotherapy.\n* Extensive-stage SCLC (ES-SCLC) or any previous diagnosis of transformed non-small cell lung cancer. Mixed tumors (SCLC-NSCLC) are not eligible.\n* Has known history of, or active, neurologic paraneoplastic syndrome of autoimmune nature.\n* Has had major surgery within 4 weeks prior to first dose of study interventions.\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n* Has known history of a second malignancy other than SCLC, unless potentially curative treatment has been completed with no evidence of malignancy for at least 3 years since the initiation of that therapy.\n* Uncontrolled intercurrent active infection at the time of enrollment requiring systemic therapy.\n* Evidence of interstitial lung disease or active, non-infectious pneumonitis.\n* History of solid organ transplantation.\n* Myocardial infarction and\u002For symptomatic congestive heart failure (New York Heart Association \\>class II) within 6 months prior to first dose of study treatment.\n* Has a known history of Human Immunodeficiency Virus (HIV) infection.\n* Has a known history of Hepatitis B or known active Hepatitis C virus infection.\n* Has a known history of active tuberculosis.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Has serious nonhealing wound, ulcer, or bone fracture within 28 days before first dose of study intervention.\n* Female subjects of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 60 days after the last dose of study treatment.\n* Female subjects who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of study treatment.\n* Female subjects planning to become pregnant or donate eggs while on study through 60 days after the last dose of study treatment.\n* Female subjects of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive serum pregnancy test.\n* Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence or use contraception during treatment and for an additional 60 days after the last dose of study treatment.\n* Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 60 days after the last dose of study treatment.\n* Subject has known sensitivity to any of the products or components to be administered during dosing.",{"count":104,"type":21},37,[106],"PHASE2","This is an open-label, phase II, exploratory and multi-centre clinical trial. 37 Limited stage SCLC patients not eligible for concurrent chemo-radiotherapy will be enroll.\n\nPatients will be enrolled in the trial after receiving sequential chemo-radiotherapy, if there is no progression disease, patients will be treated with maintenance Tarlatamab.\n\nPatients will receive maintenance with Tarlatamab IV until disease progression unacceptable toxicity, patient or physician decision to discontinue or death.\n\nThe primary objective is to evaluate the Progression free survival (PFS).\n\nPatient accrual is expected to be completed within 2 years. Treatment and follow-up are expected to extend the study duration to a total of 5 years. Patients will be followed for 2 years after enrollment. The study will end once survival follow-up has concluded.",[109,110,111,112],"Limited-stage Small-cell Lung Cancer","Carcinoma, Small Cell Lung","Respiratory Tract Neoplasms","Thoracic Neoplasms",[114,80,115,116,117,118],"Non small cell lung cancer","Maintenance treatment","Antineoplastic Agents","Chemo-radiotherapy","Immunotherapy","2026-04-29",{"date":121,"type":32},"2026-05-05",{"date":123,"type":21},"2026-05-28",{"date":125,"type":21},"2030-06-01",{"name":127,"class":94},"Fundación GECP",20,{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":50,"phases":139,"briefSummary":140,"conditions":141,"keywords":143,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":156},"100508643","phase-2-monalizumab-in-combination-with-durvalumab-medi4736-for-trreatment-of-small-cell-lung-cancer-100508643","NCT05903092","MOnaliZumab in Combination With durvAlumab (MEDI4736) for tRreatmenT of Small Cell Lung Cancer","A Phase II Trial of MOnaliZumab in Combination With durvAlumab (MEDI4736) for tReatmenT of Small Cell Lung Cancer (MOZART)","MOZART","General Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. Note: HIPAA authorization may be included in the informed consent or obtained separately.\n2. Age ≥ 18 years at the time of consent.\n3. Demonstrate adequate organ function. All screening labs to be obtained within 28 days prior to registration.\n\n   * Absolute Neutrophil Count (ANC) \\> 1500mm\\^3\n   * Hemoglobin ≥ 9 g\u002FdL\n   * Platelet Count (PLT) ≥ 100,000 per mm3\n   * Calculated creatinine clearance ≥ 40 mL\u002Fmin\n   * Bilirubin ≤ 1.5 × upper limit of normal (ULN); subjects with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), may be allowed with sponsor-investigator approval.\n   * Apsartate aminotransferase (AST) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN\n   * Alanine aminotransferase (ALT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN\n4. Females of childbearing potential must have a negative serum pregnancy test at screening.\n5. Females of childbearing potential and male subjects must be willing to abstain from heterosexual intercourse or to use an effective method(s) of contraception.\n6. Life expectancy of ≥ 12 weeks.\n7. Patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, the HCV viral load must be undetectable through PCR to be eligible for this trial. Testing is not required for screening unless mandated by local authorities. Local guidelines for testing should be followed.\n\nExtensive Stage Specific Inclusion Criteria:\n\n1. Histologically or cytologically confirmed diagnosis of small cell lung cancer:\n\n   \\- Extensive disease (American Joint Committee on Cancer Stage (8th edition) IV SCLC \\[T any, N any, M1 a\u002Fb\\]), OR T3-4 disease due to multiple lung nodules that are too extensive or have tumor\u002Fnodal volume that is too large to be encompassed in a tolerable radiation plan.\n2. No prior systemic therapy for small-cell lung cancer, with the following exceptions: Up to one cycle of platinum doublet chemotherapy with or without durvalumab is allowed up to 4 weeks prior to registration on this study. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab and monalizumab may be included only after consultation with the sponsor-investigator. Patients should not have received Trilaciclib.\n3. Measurable disease according to RECIST v1.1.\n4. Subjects with treated brain metastasis or untreated asymptomatic brain metastasis that is clinically stable per investigator discretion and not requiring systemic steroids for ≥ 7 days. NOTE: Prophylactic cranial radiation (PCI) is allowed per investigator's discretion.\n5. ECOG Performance Status of 0-2.\n\nLimited Stage Specific Inclusion Criteria:\n\n1. Histologically or cytologically confirmed diagnosis of small cell lung cancer:\n\n   \\- Limited-stage disease (American Joint Committee on Cancer Stage (8th edition) I-III SCLC \\[T any, N any, M0\\])\n2. Has received platinum (cis- or carboplatin) and etoposide chemotherapy (4 cycles preferred; 3 cycles allowed if disease control is achieved and no additional benefit is expected with an additional cycle of chemotherapy in the opinion of the investigator) administered concurrently with radiation (60-66Gy daily or 45Gy BID). Radiation should have started no later than end of cycle 2 of chemotherapy.\n3. Non-progressive disease following completion of chemo-radiation.\n4. No evidence of brain metastasis. NOTE: PCI is allowed per investigator's discretion.\n5. Ability to start study treatment within 56 days of completing chemo-radiation, counting from whichever ends later\n6. ECOG Performance Status of 0-1.\n\nExclusion Criteria:\n\n1. Body weight ≤ 40 kg.\n2. Active infection requiring intravenous antibiotic therapy.\n3. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n4. Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of study treatment. NOTE: Local surgery of isolated lesions for palliative intent is acceptable.\n5. History of active primary immunodeficiency.\n6. Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1\u002F2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).\n7. Presence of neurologic paraneoplastic syndrome.\n8. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., ulcerative colitis or Crohn's disease\\], systemic lupus erythematosus, sarcoidosis, Wegener syndrome \\[granulomatosis with polyangiitis\\], rheumatoid arthritis, hypophysitis, uveitis, etc). The following are exceptions to this criterion:\n\n   * Patients with vitiligo or alopecia\n   * Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\n   * Any chronic skin condition that does not require systemic therapy\n   * Patients without active disease in the last 2 years may be included but only after consultation with the study physician\n   * Patients with celiac disease controlled by diet alone\n9. Receipt of live attenuated vaccine within 30 days prior to the first dose of study treatment. NOTE: Subjects, if enrolled, should not receive live vaccine whilst receiving study treatment and up to 30 days after the last dose of study treatment.\n10. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n11. Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).\n12. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen, per investigator discretion.\n13. History of leptomeningeal carcinomatosis.\n14. History of allogeneic organ transplantation.\n15. Treatment with any investigational drug within 28 days prior to registration or concurrent enrolment in another clinical study, unless observational in nature.\n16. Current or prior use of immunosuppressive medication within 7 days before the first dose of monalizumab and durvalumab (applicable to 'on study' durvalumab for MOZART-ES cohort who may have received prior one dose of durvalumab). The following are exceptions to this criterion:\n\n    * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)\n    * Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent\n    * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication), and for prevention of chemotherapy induced nausea\u002Fvomiting per institutional standards.\n17. Specific for MOZART-ES cohort: Patients who have received prior one dose of durvalumab along with chemotherapy:\n\n    * Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.\n    * Must not have experienced a ≥Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy. NOTE: Patients with endocrine AE of ≤ Grade 2 are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.\n    * Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE and not currently require maintenance doses of \\> 10 mg prednisone or equivalent per day.",{"count":138,"type":21},84,[106],"This study has 2 cohorts: MOZART-ES cohort (for extensive-stage SCLC) and MOZART-LS cohort (for limited-stage SCLC).\n\nMOZART-ES cohort: Study treatment will consist of a platinum drug (carboplatin or cisplatin per investigator's choice) plus etoposide plus durvalumab plus monalizumab every 3 weeks for 4 cycles. After 4 cycles, subjects will continue maintenance treatment with durvalumab plus monalizumab every 4 weeks until disease progression, unacceptable toxicity, decision to stop study treatment, or withdrawal of consent. Patients who have received one prior cycle of treatment before enrolling on the study will receive a total of 4 cycles with monalizumab, durvalumab, and chemotherapy. There will be a safety lead-in phase, including 6 to 12 patients, to confirm the safety of the proposed dose of monalizumab to use in combination with chemotherapy and durvalumab.\n\nMOZART-LS cohort: Study treatment will consist of durvalumab and monalizumab following standard of care chemo-radiation consisting of a platinum drug (carboplatin or cisplatin per investigator's choice) plus etoposide for 3-4 cycles and standard dose radiation. Radiation therapy should have started before completion of cycle 2 of chemotherapy. NOTE: Subjects who have non-progressive disease and meet the eligibility criteria can start study treatment up to 56 days from completion of chemo-radiation. Durvalumab and monalizumab will be administered every 4 weeks for up to 2 years (26 cycles), disease progression, unacceptable toxicity, decision to stop study treatment, or withdrawal consent, whichever occurs first.",[83,27,142,25],"Extensive Stage Small Cell Lung Cancer",[144,145,146,118,147],"Small cell lung cancer","First-line therapy","Chemoimmunotherapy","Monalizumab","2026-04-24",{"date":119,"type":32},{"date":151,"type":32},"2023-09-26",{"date":153,"type":21},"2030-10-31",{"name":155,"class":94},"Hirva Mamdani",4,{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":50,"phases":167,"briefSummary":168,"conditions":169,"keywords":170,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":196},"100575563","phase-2-bms-986489-atigotatug--nivolumab-vs-durvalumab-in-limited-stage-small-cell-lung-cancer-tigos-ls-100575563","NCT06773910","BMS-986489 (Atigotatug + Nivolumab) vs Durvalumab in Limited-stage Small-cell Lung Cancer (TIGOS-LS)","An Open-label, Randomized Study of BMS-986489 (Atigotatug + Nivolumab Fixed-dose Combination) vs Durvalumab as Consolidation Therapy Following Chemoradiotherapy in Limited-stage Small-cell Lung Cancer (TIGOS-LS)","TIGOS-LS","Inclusion Criteria:\n\n* At least 18 years-of-age at the time of signature of the Informed Consent Form (ICF)\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (Appendix A)\n* Histologically or cytologically confirmed pulmonary SCLC, evaluable by RECIST v1.1\n* Limited-stage (LS) disease as determined by positron emission tomography (PET) scan prior to initiation of chemotherapy and radiation therapy\n* Completed concurrent chemotherapy and radiotherapy for LS-SCLC without progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (computed tomography \\[CT\\] scan chest\u002Fabdomen\u002Fpelvis; Appendix B) within 42 days before date of randomization and first dose of study treatment\n\n  * Chemotherapy should consist of a platinum and IV etoposide. Participants who received at least 3 cycles of chemotherapy will be eligible to participate.\n  * Radiotherapy should be administered per institutional guidelines\n* Prophylactic cranial irradiation (PCI) may be delivered at the discretion of the Investigator and institutional guidelines. PCI, if applicable, must be conducted after the end of chemoradiotherapy and completed between 14 and 42 days before date of randomization and first dose of study treatment.\n* Adequate hematologic and organ function\n* Willingness to abide by protocol defined contraceptive requirements for the duration of the study.\n\nExclusion Criteria:\n\n* Small-cell cancer not pulmonary in origin\n* Large cell neuroendocrine carcinoma\n* ES-SCLC\n* Mixed SCLC and NSCLC histologic features; diagnosis of NSCLC; or EGFR-activating, mutation-positive NSCLC that has transformed to SCLC\n* History of severe hypersensitivity reaction to monoclonal antibodies\n* Known hypersensitivity to any excipients of atigotatug, nivolumab, or durvalumab\n* Grade ≥2 peripheral neuropathy by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0\n* Active, prior, or suspected autoimmune disease, including autoimmune neurologic disorders such as paraneoplastic syndrome involving the CNS, peripheral sensory\u002Fmotor nerves, or neuromuscular junction. Exceptions to this criterion include:\n\n  * Type 1 diabetes mellitus\n  * Hypothyroidism requiring only hormone replacement\n  * Skin disorders not requiring systemic treatment\n  * Autoimmune conditions not expected to recur during the study\n* Diseases or conditions requiring chronic systemic corticosteroids (\\>10 mg daily prednisone or equivalent) or other immunosuppressive therapy within 14 days of starting study treatment. Limited-course (\\\u003C2 weeks' duration) oral steroids (10 mg prednisone or equivalent) are permitted. Bronchodilators, inhaled or topical steroids, and adrenal replacement steroid doses \\>10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.\n* History of solid organ or bone marrow transplantation\n* History of Grade ≥2 pneumonitis (excepting resolved infective pneumonitis)\n* Any of the following cardiac criteria, currently or within the last 3 months:\n\n  * Any clinically important abnormalities (as assessed by the Investigator) in rhythm, conduction, or morphology of resting electrocardiograms (ECGs), e.g., complete left bundle branch block, third-degree heart block, atrial fibrillation not rate controlled. Certain conditions may be considered through discussion with the Medical Monitor.\n  * Congestive heart failure (New York Heart Association \\[NYHA\\] \\> Grade 2) or classified as Class 3 or 4 by the NYHA Functional Classification (Appendix D)\n  * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, uncontrolled hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age, or any concomitant medication known to prolong the QT interval (Appendix E). Certain conditions may be considered through discussion with the Medical Monitor.\n  * Participants with a left ventricular ejection fraction \\\u003C55% or the lower limit of normal of the institutional standard\n  * Uncontrolled hypertension, defined as systolic blood pressure \\>150 mmHg or diastolic blood pressure \\>90 mmHg despite optimal medical management\n  * Active coronary artery disease, including unstable or newly diagnosed angina\n  * Myocardial infarction\n  * History of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes)\n  * History or current diagnosis of myocarditis\n* As judged by the Investigator, participants with serious or uncontrolled medical disorders\n* Presence of other active invasive cancers. Participants with a previously treated malignancy will be eligible to participate if treatment of that malignancy was completed at least 2 years before date of screening and the participants has no evidence of disease. Exceptions to this criterion include appropriately treated basal cell carcinoma of the skin; in situ carcinoma of uterine cervix; localized prostate cancer that has been definitively treated; or other local tumors considered cured by local treatment.\n* Received sequential chemotherapy and radiotherapy as a definitive treatment for LS-SCLC\n* Treatment with any of the following:\n\n  * Any systemic anticancer chemotherapy, small molecule, biologic, or hormonal agent from a previous treatment regimen or clinical study within 21 days or 5 half-lives (whichever is longer) prior to the first dose of study treatment\n  * Wide-field radiotherapy (including therapeutic radioisotopes such as strontium-89) administered ≤28 days or limited field radiation for palliation ≤7 days prior to starting study treatment or has not recovered from side effects of such therapy\n  * Prior systemic treatment for LS-SCLC, with the exception of chemoradiotherapy and PCI\n  * Prior treatment with an anti-PD-1, anti-PD-L1, anti-programmed cell death ligand 2 (anti-PD-L2), anti-CD137, anti-cytotoxic T-lymphocyte associated protein 4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways\n  * Prior treatment with fuc-GM-1 vaccine or targeted agent or similar vaccine targeting ganglioside antigens\n  * Current treatment with immunosuppressive medications\n  * Live attenuated vaccine within 100 days before first dose of study treatment\n* Major surgery (excluding placement of vascular access) within 4 weeks of date of screening\n* With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment. Note: Participants with chronic Grade 2 toxicities who are asymptomatic or adequately managed with stable medication may be eligible with approval by the Medical Monitor or Principal Investigator.\n* Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and\u002For follow-up procedures outlined in the protocol",{"count":166,"type":21},250,[106],"This is an open-label, randomized study of BMS-986489 (atigotatug + nivolumab fixed-dose combination) vs durvalumab in limited-stage (LS)-small-cell lung cancer (SCLC) participants.\n\nThe main goals of this study are to:\n\n* Evaluate the efficacy of BMS-986489 vs durvalumab\n* Evaluate the safety profile of BMS-986489",[55],[171,172,173,174,175,176,177,178,179,180,181,81,182,183,184,185,186],"limited stage small cell lung cancer","limited stage small cell lung carcinoma","LS-SCLC","Limited-stage SCLC","Nivolumab","Opdivo","fucosyl-monosialoganglioside-1","fuc-GM1","programmed cell death protein 1","PD-1 inhibitor","anti-PD-1 antibody","Imfinzi","PD-L1 inhibitor","Anti-PD-L1 antibody","Limited-stage (LS)-small-cell lung cancer (SCLC)","BMS-986489","2026-04-17",{"date":189,"type":32},"2026-04-22",{"date":191,"type":32},"2025-03-11",{"date":193,"type":21},"2032-09",{"name":195,"class":94},"SCRI Development Innovations, LLC",33,{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":204,"enrollmentInfo":205,"targetDuration":4,"studyType":50,"phases":207,"briefSummary":208,"conditions":209,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":65},"100588579","phase-2-study-of-probiotics-combined-with-concurrent-hyperfractionated-chemoradiotherapy-and-adebrelimab-immunomaintenance-in-the-treatment-of-limited-stage-small-cell-lung-cancer-ls-sclc-100588579","NCT06943235","Study of Probiotics Combined With Concurrent Hyperfractionated ChemoRadiotherapy and Adebrelimab Immunomaintenance in the Treatment of Limited-stage Small Cell Lung Cancer (LS-SCLC)","A Prospective, Multicenter, Randomized Controlled, Phase II Study of Probiotics Combined With Concurrent Hyperfractionated ChemoRadiotherapy and Adebrelimab Immunomaintenance in the Treatment of Limited-stage Small Cell Lung Cancer (LS-SCLC)","Inclusion Criteria:\n\n1. Sign written informed consent before implementing any experimental procedures;\n2. Age range: 18-80 years old;\n3. Pathological diagnosis of small cell lung cancer;\n4. Limited stage;\n5. ECOG PS 0-1；\n6. Receive ≤ 2 rounds of chemotherapy or chemotherapy plus immunotherapy;\n7. Expected survival time\\>3 months;\n\nExclusion Criteria:\n\n1. Progress after 2 induction treatments;\n2. Severe emphysema, interstitial changes in the lungs, COPD patients;\n3. Resting blood oxygen\\\u003C93;\n4. Have a history of other malignant tumors and have received chemotherapy in the past 3 years;\n5. History of chest radiotherapy;","80 Years",{"count":206,"type":21},60,[106],"ADRIATIC study explored the benefits of immune maintenance therapy after LS-SCLC radiotherapy and chemotherapy. In the presence of immunotherapy, is it necessary to increase the dosage of radiotherapy and can it further improve the efficacy? This study aims to explore the efficacy and safety of simultaneous integrated boost hyperfractionation radiotherapy combined with probiotics and Adalberg monoclonal antibody consolidation therapy for small cell lung cancer.",[55],"2026-02-08",{"date":212,"type":32},"2026-02-11",{"date":214,"type":32},"2025-04-25",{"date":216,"type":21},"2027-12-30",{"name":218,"class":94},"Fudan University",{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":226,"enrollmentInfo":227,"targetDuration":4,"studyType":50,"phases":229,"briefSummary":230,"conditions":231,"keywords":233,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":240,"leadSponsor":242,"locationsCount":65},"100608330","phase-2-adebrelimab-plus-chemoradiotherapy-followed-by-adebrelimab-maintenance-in-limited-stage-sclc-100608330","NCT07200154","Adebrelimab Plus Chemoradiotherapy Followed by Adebrelimab Maintenance in Limited-Stage SCLC","A Single-arm、Exploratory Study of Adebrelimab in Combination With Chemoradiotherapy Followed by Adebrelimab Maintenance in Patients With Limited-stage Small-cell Lung Cancer","Inclusion Criteria:\n\n* Age 18-75 years, either sex. Histologically or cytologically confirmed limited-stage small-cell lung cancer (LS-SCLC) defined by Veterans Administration Lung Group (VALG) two-stage system.\n\nAvailability of either an archival tumour-tissue block\u002Fslides or a newly obtained biopsy from a lesion that has not previously been irradiated.\n\n≤ 2 prior cycles of chemotherapy or chemotherapy-naïve. ECOG performance-status 0 or 1. At least one measurable lesion per RECIST 1.1: ≥ 10 mm in longest diameter for non-nodal lesions or ≥ 15 mm in short axis for lymph-node lesions on CT scan.\n\nEstimated life expectancy ≥ 3 months. Adequate pulmonary function (as judged by the investigator).\n\nAdequate major organ function defined as:\n\nHaematology: Hb ≥ 90 g\u002FL; ANC ≥ 1.5 × 10⁹\u002FL; PLT ≥ 100 × 10⁹\u002FL. Biochemistry: serum albumin ≥ 30 g\u002FL; ALT and AST \\\u003C 3 × ULN; total bilirubin ≤ 1.5 × ULN; serum creatinine ≤ 1.5 × ULN.\n\nWomen of child-bearing potential must have a negative serum or urine pregnancy test within 14 days before enrolment and must use effective contraception from screening until ≥ 8 weeks after the last study-dose; men must be surgically sterile or agree to use effective contraception during the same period.\n\nVoluntary informed consent signed; willing and able to comply with study procedures and follow-up.\n\nExclusion Criteria:\n\n* Prior solid-organ, allogeneic stem-cell or planned transplantation. Immunosuppressive therapy ≤ 14 days before first adebrelimab dose (except intranasal\u002Finhaled corticosteroids or physiological systemic doses equivalent to ≤ 10 mg\u002Fday prednisolone).\n\nKnown hypersensitivity to etoposide, cisplatin, adebrelimab, their excipients, or severe allergic reaction to any other monoclonal antibody.\n\nLive-attenuated vaccine within 4 weeks before first dose or intent to receive one during the study.\n\nActive autoimmune disease or history of autoimmune disease (e.g., autoimmune hepatitis, interstitial pneumonitis, uveitis, colitis, hypophysitis, vasculitis, nephritis, hyper-\u002Fhypothyroidism).\n\nUncontrolled asthma requiring bronchodilators or other systemic therapy (childhood asthma fully resolved and requiring no intervention in adulthood is allowed).\n\nUrinalysis ≥ ++ protein or 24-h urine protein ≥ 1.0 g. Prior malignancy except adequately treated basal-cell or squamous-cell skin carcinoma or cervical carcinoma in situ.\n\nHIV infection or known AIDS. Within 6 months before enrolment: myocardial infarction, severe\u002Funstable angina, NYHA class ≥ II heart failure, poorly controlled arrhythmia (including QTcF \\> 450 ms \\[men\\] or \\> 470 ms \\[women\\] by Fridericia), symptomatic congestive heart failure.\n\nSystemic anti-infective therapy (IV antibiotics, antifungals, or antivirals) within 4 weeks before first dose, or unexplained fever \\> 38.5 °C during screening or before first dose.\n\nActive hepatitis B (HBV DNA ≥ 500 IU\u002FmL), hepatitis C (anti-HCV positive and HCV-RNA detectable), or HBV\u002FHCV co-infection.\n\nParticipation in another interventional clinical trial within 4 weeks before first dose.\n\nKnown history of substance abuse or recreational drug use. Any severe medical, psychiatric, or laboratory abnormality that, in the investigator's opinion, could increase study-related risk or interfere with results.","75 Years",{"count":228,"type":21},30,[106],"This is a single-arm, open-label, single-center phase II trial that will enroll 30 patients with limited-stage small-cell lung cancer to evaluate the safety and efficacy of adebrelimab combined with chemoradiotherapy followed by adebrelimab maintenance.",[109,232],"Concurrent Chemoradiation Therapy",[234,235,232],"limited-stage small-cell lung cancer","Immune checkpoint inhibitors","2025-09-22",{"date":238,"type":32},"2025-09-30",{"date":238,"type":21},{"date":241,"type":21},"2028-09",{"name":243,"class":94},"Peking University Cancer Hospital & Institute",{"id":245,"slug":246,"hasResults":11,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":4,"eligibilityCriteria":250,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":226,"enrollmentInfo":251,"targetDuration":4,"studyType":50,"phases":253,"briefSummary":254,"conditions":255,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":4},"100591263","phase-2-this-is-a-two-cohort-exploratory-clinical-study-assessing-the-activity-of-benmelstobart-combined-with-chemotherapy-with-or-without-anlotinib-in-resectable-limited-stage-small-cell-lung-cancer-100591263","NCT06978153","This is a Two-cohort, Exploratory Clinical Study Assessing the Activity of Benmelstobart Combined With Chemotherapy With or Without Anlotinib in Resectable Limited-Stage Small Cell Lung Cancer","Perioperative Treatment With Benmelstobart Combined With Chemotherapy With or Without Anlotinib in Resectable Limited-Stage Small Cell Lung Cancer: A Randomized, Two-Cohort, Multicenter, Phase II Clinical Study","Inclusion Criteria:\n\n* Patients voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up.\n* Aged 18 to 75 years (inclusive) at the time of signing informed consent, regardless of gender.\n* Histologically confirmed small cell lung cancer (SCLC).\n* Confirmed as stage I-IIIB SCLC (T1-3N0-2M0) per AJCC 9th Edition.\n* Patients who have received 1 cycle of chemotherapy are eligible; no other prior treatments are permitted.\n* ECOG Performance Status (PS) 0 or 1.\n* Assessed by the investigator as having no surgical contraindications.\n* At least one measurable lesion per RECIST 1.1 criteria.\n* Expected survival ≥8 weeks.\n* Women of childbearing potential (aged 15-49) must have a negative serum pregnancy test within 7 days before treatment initiation and agree to use reliable contraception during the study until 8 weeks after discontinuation. Normal function of major organs meeting the following criteria:\n* Hematologic tests (no blood transfusion, blood products, G-CSF, or hematopoietic stimulants within 14 days): Hemoglobin (Hb) ≥90 g\u002FL; Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL; Platelets (PLT) ≥80×10⁹\u002FL.\n* Biochemical tests meeting: Total bilirubin (TBIL) ≤1.5×ULN; ALT\u002FAST ≤2.5×ULN; Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr) ≥60 mL\u002Fmin.\n* Urine protein \\\u003C2+; for patients not on anticoagulation: INR ≤1.5, APTT ≤1.5×ULN. Patients on full-dose or parenteral anticoagulants may enroll if dosing has been stable for ≥2 weeks and coagulation tests are within therapeutic ranges.\n\nExclusion Criteria:\n\n* Histologically confirmed mixed-type SCLC.\n* Extensive-stage SCLC.\n* ECOG PS \\>1.\n* Active or untreated CNS metastases confirmed by CT\u002FMRI during screening\u002Fprior imaging.\n* Uncontrolled tumor-related pain.\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage (≥1×\u002Fmonth).\n* Uncontrolled\u002Fsymptomatic hypercalcemia (ionized calcium \\>1.5 mmol\u002FL, calcium \\>12 mg\u002FdL, or corrected serum calcium \\>ULN).\n* Systemic immunostimulants (e.g., IFN-α, IL-2, TNF) within 4 weeks prior to enrollment (cancer vaccines allowed if prior).\n* Systemic corticosteroids (\\>10 mg prednisone\u002Fday or equivalent) or immunosuppressants within 14 days, except: Replacement therapy (≤10 mg prednisone\u002Fday); Topical\u002Focular\u002Fintra-articular\u002Fnasal\u002Finhaled steroids with minimal systemic absorption; Short-term (≤7 days) prophylactic use (e.g., contrast allergy) or for non-autoimmune conditions.\n* Imaging-confirmed tumor invasion of major vessels or high risk of fatal hemorrhage per investigator; or cavitary\u002Fnecrotic lung tumors.\n* Other malignancies within 5 years except: cervical CIS, cured basal cell carcinoma, Ta\u002FTis bladder tumors.\n* Prior use of anlotinib or other antiangiogenic agents.\n* Prior anti-PD-1\u002FPD-L1\u002FCTLA-4 antibodies or other T-cell co-stimulation\u002Fcheckpoint pathway therapies (e.g., ICOS, CD40\u002FCD137\u002FGITR\u002FOX40 agonists).\n* Hypersensitivity to anlotinib or benmelstobart components.\n* Factors impairing oral drug intake (e.g., dysphagia, chronic diarrhea, intestinal obstruction).\n* Uncontrolled comorbidities including:\n\n  1. Poorly controlled hypertension (SBP ≥150 mmHg, DBP ≥100 mmHg);\n  2. Grade ≥1 myocardial ischemia\u002Finfarction, arrhythmias (QTc ≥480 ms), or ≥NYHA Class II heart failure;\n  3. Abnormal coagulation (INR \\>1.5, PT \\>ULN+4s, APTT \\>1.5×ULN), bleeding tendency, or thrombolytic\u002Fanticoagulant therapy (prophylactic low-dose heparin \\[6,000-12,000 U\u002Fday\\] or aspirin \\[≤100 mg\u002Fday\\] allowed if INR ≤1.5);\n  4. Active\u002Fsevere uncontrolled infections;\n  5. Cirrhosis, decompensated liver disease, active\u002Fchronic hepatitis requiring antivirals;\n  6. Renal failure requiring dialysis;\n  7. Immunodeficiency (HIV+, congenital\u002Facquired immunodeficiency) or organ transplant history;\n  8. Poorly controlled diabetes (FBG \\>10 mmol\u002FL);\n  9. Urine protein ≥++ or 24-h urine protein \\>1.0 g;\n  10. Epilepsy requiring treatment;\n  11. Non-healing wounds\u002Ffractures.\n* Significant hemoptysis (\\>50 mL\u002Fday within 2 weeks) or clinically significant bleeding (e.g., GI bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ≥++).\n* Interstitial lung disease (ILD), drug-induced ILD, steroid-requiring radiation pneumonitis, or active ILD.\n* Arterial\u002Fvenous thromboembolism within 6 months (e.g., stroke \\[including TIA\\], DVT, PE).\n* Grade ≥2 peripheral neuropathy (excluding trauma-related).\n* Major surgery\u002Fsevere trauma with residual effects within 14 days.\n* Concurrent clinical trials or \\\u003C4 weeks from prior trial treatment.\n* Live\u002Fattenuated vaccination within 30 days before benmelstobart or planned during study.\n* History of severe hypersensitivity to monoclonal antibodies.\n* Pregnant\u002Flactating women.\n* Uncontrolled psychiatric\u002Fneurological disorders affecting compliance.\n* Other factors per investigator judgment that may lead to study termination (e.g., severe illness, lab abnormalities, or social\u002Ffamily constraints compromising safety\u002Fdata collection).",{"count":252,"type":21},66,[106],"A total of 66 patients were enrolled in this exploratory study and randomly assigned to cohort 1 and cohort 2, with 33 patients in each group. Cohort 1: Neoadjuvant therapy (benmelstobart combined with chemotherapy and anlotinib, 3 cycles, every 21 days is a cycle). Surgery was performed 4-6 weeks after the final administration of benmelstobart as assessed by the investigator. Adjuvant therapy was evaluated by the investigator 4-6 weeks after surgery. Patients who achieved R0 resection received adjuvant therapy (benmelstobart combined with anlotinib, 12 cycles, every 21 days is a cycle). Cohort 2: Neoadjuvant therapy (benmelstobart combined with chemotherapy, 3 cycles, every 21 days is a cycle). Surgery was performed 4-6 weeks after the final administration of benmelstobart as assessed by the investigator. Adjuvant therapy was evaluated by the investigator 4-6 weeks after surgery. Patients who achieved R0 resection received adjuvant therapy (benmelstobart, every 21 days is a cycle) .",[55],"2025-05-10",{"date":258,"type":32},"2025-05-18",{"date":260,"type":21},"2025-05-20",{"date":262,"type":21},"2027-11-01",{"name":264,"class":94},"Tang-Du Hospital",{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":50,"phases":274,"briefSummary":275,"conditions":276,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":4},"100556555","phase-3-a-study-of-hs-20093-vs-active-surveillance-in-limited-stage-small-cell-lung-cancer-100556555","NCT06526624","A Study of HS-20093 vs Active Surveillance in Limited-Stage Small Cell Lung Cancer","ARTEMIS-009: A Phase 3, Randomized, Controlled, Multi-center, Open-label Study of HS-20093 Versus Active Surveillance As Consolidation Therapy After Chemoradiotherapy in Subjects With Limited-Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Have signed Informed Consent Form.\n2. Males or females ≥18 years old.\n3. Patients with limited-stage SCLC who are deemed unsuitable for surgery or decline surgery.\n4. ECOG performance status of 0-1.\n5. Patients who have received CRT and have not progressed.\n6. Minimum life expectancy \\> 12 weeks.\n7. Males or Females should be using adequate contraceptive measures throughout the study.\n8. Females must not be pregnant at screening or have evidence of non-childbearing potential.\n\nExclusion Criteria:\n\n1. Patients with mixed SCLC or NSCLC or sarcoma-like carcinoma, or large cell neuroendocrine carcinoma.\n2. Patients with extensive-stage SCLC.\n3. Disease progression during CRT or before randomization.\n4. Received or are receiving the following treatments:\n\n   1. For LS-SCLC, prior treatment with or current use of other chemotherapy regimens other than platinum plus etoposide\n   2. Received any other anti-cancer treatment.\n   3. Previous or current treatment with B7-H3 target therapy.\n   4. Traditional Chinese medicine indicated for tumors within 2 weeks prior to the first dose of study drug.\n   5. Major surgery within 4 weeks prior to the first dose of study drug.\n5. Interstitial lung disease (ILD)\u002Fnon-infectious pneumonitis.\n6. History of other primary malignancies.\n7. Inadequate bone marrow reserve or organ functions.\n8. Severe, uncontrolled or active cardiovascular disorders.\n9. Severe or uncontrolled diabetes.\n10. Serious or poorly controlled hypertension.\n11. Severe bleeding symptoms or bleeding tendencies within 1 month prior to randomization.\n12. Severe arteriovenous thrombosis occurred within 3 months prior to randomization.\n13. Serious infection within 4 weeks prior to randomization.\n14. Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.\n15. Having serious neurological or mental disorders.\n16. History of hypersensitivity to any component of HS-200093 or its similar drugs.\n17. Participants with any condition that compromises the safety of the participant or interferes with the assessment of the study, as judged by the investigator.",{"count":273,"type":21},406,[52],"This study will evaluate the efficacy, safety and tolerability of HS-20093 compared with active surveillance as consolidation therapy after chemoradiotherapy in participants with limited-stage small cell lung cancer.",[109],"2024-07-25",{"date":279,"type":32},"2024-07-30",{"date":281,"type":21},"2024-09-30",{"date":283,"type":21},"2029-01-31",{"name":285,"class":39},"Hansoh BioMedical R&D Company",{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":50,"phases":294,"briefSummary":295,"conditions":296,"keywords":297,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":65},"100535777","phase-2-neoadjuvant-therapy-with-toripalimab-and-js004-combined-with-etoposide-and-platinum-chemotherapy-for-limited-stage-small-cell-lung-cancer--a-phase-2-trial-100535777","NCT06256237","Neoadjuvant Therapy With Toripalimab and JS004 Combined With Etoposide and Platinum Chemotherapy for Limited-stage Small Cell Lung Cancer : A Phase 2 Trial","Neoadjuvant Therapy With Toripalimab and JS004 Combined With Etoposide and Platinum Chemotherapy for Limited-stage Small Cell Lung Cancer : A Single-arm, Phase 2 Trial","Inclusion Criteria:\n\n1. The patient shall sign the Informed Consent Form.\n2. Aged 18 ≥ years.\n3. Histological or cytological diagnosis of SCLC by needle biopsy, and limited stage confirmed by imageological examinations (CT, PET-CT or EBUS).\n4. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.\n5. Life expectancy is at least 12 weeks.\n6. At least 1 measurable lesion according to RECIST 1.1.\n7. Patients with good function of other main organs (liver, kidney, blood system, etc.)\n8. Without systematic metastasis (including M1a, M1b and M1c);\n9. Expected to be completely resected\n10. Patients with lung function can tolerate surgery\n11. Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of toripalimab (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.\n12. Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of toripalimab (whichever is later).\n\nExclusion Criteria:\n\n1. Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment;\n2. Patients with a malignancy other than SCLC within five years prior to the start of this trial;\n3. Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (\\>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases;\n4. With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;\n5. Participants who are allergic to the test drug or any auxiliary materials;\n6. Participants with Interstitial lung disease currently;\n7. Participants with active hepatitis B, hepatitis C or HIV;\n8. Pregnant or lactating women;\n9. Any malabsorption;\n10. Participants suffering from nervous system diseases or mental diseases that cannot cooperate\n11. Other factors that researchers think it is not suitable for enrollment.",{"count":228,"type":21},[106],"For limited-stage small cell lung cancer (SCLC), neoadjuvant chemotherapy plus PD-1 antibody is recommended. However, most patients cannot achieve a complete pathological response (CPR). A new immunotherapeutic strategy is needed to achieve a higher CPR rate. JS004 is a new antibody targeting B and T lymphocyte attenuator (BTLA), which restrains immune cells\\' function and leads to immune escape of tumor cells. The combination of PD-1 and BTLA antibodies has shown a good therapeutic effect in solid tumors. This trial aims to investigate the efficacy and safety of the therapeutic regimen of toripalimab and JS004 plus etoposide and platinum Chemotherapy in limited-stage SCLC.",[55],[298,299,300,301],"small cell lung cancer","Toripalimab","JS004","Limited Stage","2024-05-26",{"date":304,"type":32},"2024-05-29",{"date":306,"type":32},"2024-04-01",{"date":308,"type":21},"2032-01-31",{"name":310,"class":94},"Shanghai Pulmonary Hospital, Shanghai, China",{"id":312,"slug":313,"hasResults":11,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":317,"eligibilityCriteria":318,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":226,"enrollmentInfo":319,"targetDuration":4,"studyType":50,"phases":320,"briefSummary":321,"conditions":322,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":4},"100544916","phase-2-pd-l1pd-1-inhibitors-plus-chemotherapy-versus-chemotherapy-alone-for-the-neoadjuvant-treatment-of-limited-stage-sclc-100544916","NCT06375109","PD-L1\u002FPD-1 Inhibitors Plus Chemotherapy Versus Chemotherapy Alone for the Neoadjuvant Treatment of Limited-stage SCLC","PD-L1\u002FPD-1 Inhibitors Plus Chemotherapy Versus Chemotherapy Alone for the Neoadjuvant Treatment of Limited-stage Small Cell Lung Cancer: an Open-label, Non-randomized Controlled, Phase II, Single-center Study","NeoSCLC-001","Inclusion Criteria:\n\n1. Patients voluntarily participated in this study, signed an informed consent form, and demonstrated good compliance.\n2. They were histologically or cytologically confirmed with limited-stage small-cell lung cancer (TNM stage; T1-3N0-2M0).\n3. The age range was 18 to 75 years, with no gender restriction.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score: 0-2.\n5. Life expectancy was estimated to be at least 3 months.\n6. No previous anti-tumor treatment specifically for SCLC was administered.\n7. According to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, there must be at least one measurable lesion.\n8. Patients' organ functions must be adequately sufficient, with the following requirements to be met before the first study treatment:\n\n   1. Hematological parameters: ANC ≥1.5×10\\^9\u002FL, platelets ≥100×10\\^9\u002FL, hemoglobin ≥90g\u002FL.\n   2. Renal function: serum creatinine ≤1.5 times the upper limit, or creatinine clearance ≥50 mL\u002Fmin.\n   3. Liver function: ALT\u002FAST ≤2.5 times the upper limit, total serum bilirubin ≤2 times the upper limit.\n   4. Coagulation: INR should be ≤ 1.5 times the upper limit.\n9. Patients of childbearing potential must agree to use contraception.\n10. Patients must be able to tolerate chemotherapy, immunotherapy, and surgery.\n\nExclusion Criteria:\n\n1. Patients who have received anti-tumor treatment for SCLC (including but not limited to chemotherapy and radiation therapy at the site of the lesion).\n2. Patients who have previously used immune checkpoint inhibitors such as PD-1\u002FPD-L1 inhibitors for treatment.\n3. Patients with a history of interstitial lung disease, non-infectious pneumonia, or uncontrollable systemic diseases, including pulmonary fibrosis and acute lung disease.\n4. Patients requiring systemic anti-bacterial, anti-fungal, or anti-viral treatment for severe chronic or active infections, including tuberculosis.\n5. Patients known to have HIV.\n6. Patients with active hepatitis B or hepatitis C.\n7. Patients with active autoimmune diseases or a history of autoimmune diseases that may recur.\n8. Patients with diseases requiring systemic corticosteroid treatment or other immunosuppressive therapy.\n9. Patients deemed by the investigator to have concomitant diseases that pose a serious risk to patient safety or could affect the patient's ability to complete the study.\n10. Patients who have undergone major surgery within 4 weeks prior to treatment initiation, or those with significant trauma or fractures, or those with unhealed wounds at the time of treatment.\n11. Patients with severe cardiac diseases, such as NYHA class III or higher congestive heart failure, CCS class III or higher angina, a history of myocardial infarction in the past 6 months, or arrhythmias requiring medication.\n12. Patients with comorbidities that make them unsuitable for surgery.\n13. Patients who have had an allergic reaction to the study drug or excipients in the medication.",{"count":206,"type":21},[106],"This is an open-label, non-randomized, controlled, single-center, phase II study to compare the efficacy and safety of neoadjuvant PD-L1\u002FPD-1 inhibitor + chemotherapy (carboplatin\u002Fcisplatin + etoposide) with chemotherapy (carboplatin\u002Fcisplatin + etoposide) alone followed by radical surgery and adjuvant treatment as perioperative therapy in patients with limited-stage SCLC.",[109],"2024-04-17",{"date":325,"type":32},"2024-04-19",{"date":327,"type":21},"2024-04-16",{"date":329,"type":21},"2029-04-15",{"name":331,"class":94},"Beijing Chest Hospital, Capital Medical University",{"id":333,"slug":334,"hasResults":11,"nctId":335,"briefTitle":336,"officialTitle":336,"acronym":337,"eligibilityCriteria":338,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":50,"phases":341,"briefSummary":343,"conditions":344,"keywords":346,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":359},"100423161","prophylactic-cerebral-irradiation-or-active-magnetic-resonance-imaging-surveillance-in-small-cell-lung-cancer-patients-primalung-study-100423161","NCT04790253","PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)","PRIMALung","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histologically\u002Fcytologically proven diagnosis of SCLC\n* Limited and extensive stage\n* LS SCLC: Stage I-III (T any, N any, M0, according to UICC TNM staging v8.0) that can be safely treated with definitive radiation doses. Excludes T3-4 due to multiple lung nodules that are too extensive or have tumour\u002Fnodal volume that is too large to be encompassed in a tolerable radiation plan.\n* ES SCLC: Stage IV (T any, N any, M 1a\u002Fb), or T3-4 due to multiple lung nodules that are too extensive or have tumour\u002Fnodal volume that is too large to be encompassed in a tolerable radiation plan.\n* Completed standard therapy prior to randomization:\n* For patients with LS-SCLC, this includes a combination of 4-6 cycles of platinum-based doublet chemotherapy and either definitive thoracic radiotherapy (including SBRT for early-stage T1-2 N0 M0 disease who do not undergo surgery) or definitive surgical resection; thoracic radiation in addition to definitive surgical resection is allowed at the discretion of the treating physician, but is not mandated.\n* For patients with ES-SCLC, this includes 4-6 cycles of platinum-based doublet chemotherapy either with or without thoracic radiotherapy\n\n  o Immunotherapy concurrent with and\u002For adjuvant to standard therapy is allowed at the discretion of the treating physician.\n* Absence of progressive disease after completed standard therapy on systemic imaging (computed tomography (CT) or magnetic resonance imaging (MRI) of Chest\u002FAbdomen\u002FPelvis and brain MRI), 28 days before randomization.\n* Absence of brain metastases or leptomeningeal disease after completed standard therapy on systemic imaging (computed tomography (CT) or magnetic resonance imaging (MRI) of Chest\u002FAbdomen\u002FPelvis and brain MRI), within 28 days before randomization.\n* Interval from day 1 of last cycle of chemotherapy to randomization of ≤8 weeks\n* ECOG PS ≤ 2\n* Estimated creatinine clearance ≥ 30 mL\u002Fmin as calculated using the MDRD formula\n* Women of child bearing potential (WOCBP) must have a negative serum pregnancy test within 3 days prior to randomization.\n\nNote: women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e. females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy). However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antioestrogens, low body weight, ovarian suppression or other reasons.\n\n* Patients Women of childbearing \u002F reproductive potential should use adequate birth control measures, as defined by the investigator, during the entire period of the radiotherapy treatment study participation and for at least 30 days after the last dose of radiotherapy. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Such methods include:\n* Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)\n* Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)\n* Intrauterine device (IUD)\n* Intrauterine hormone-releasing system (IUS)\n* Bilateral tubal occlusion\n* Vasectomized partner\n* Sexual abstinence (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)\n* Female subjects who are breast feeding should discontinue nursing prior to the first dose of radiotherapy and during the entire period of the radiotherapy treatmentuntil 30 days after the administration of the last dose of radiotherapy.\n* Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up\n* Before patient registration\u002Frandomization, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations.\n\nExclusion Criteria:\n\n* Prior radiotherapy to the brain or whole brain radiotherapy. Note: Patients who have undergone prior stereotactic radiosurgery for benign tumours or conditions (e.g., acoustic neuroma, grade I meningioma, trigeminal neuralgia) may be considered on a case-by-case basis. Discussion with EORTC Headquarters is mandatory, before the randomization.\n* Known contraindication to imaging tracer or any product of contrast media, such as allergy or insufficient renal function. Known contraindication to MRI, such as implanted metal devices or foreign bodies.\n* Other active hematologic or solid tumour malignancy requiring current active treatment.\n* Any unresolved toxicities from prior therapy (e.g., chemotherapy, radiotherapy) greater than CTCAE grade 2 (according to CTCAE v5.0) at the time of randomization.\n* Patient with severe active comorbidities, defined as follows:\n* Unstable angina and\u002For congestive heart failure requiring hospitalization within 6 months prior to randomization\n* Transmural myocardial infarction within 6 months prior to randomization\n* Acute infection requiring treatment at the time of randomization\n* Chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy at the time of randomization\n* Severe hepatic disease defined as a diagnosis of Child-Pugh class B or C hepatic disease\n* HIV positive with CD4 count \\\u003C 200 cells\u002Fmicroliter. Note: patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells\u002Fmicroliter within 16 weeks prior to randomization.\n* Any severe comorbidity that in the opinion of the Investigator might hamper the participation to the study and\u002For the treatment administration.\n* Severe neurological (including dementia and epilepsy) or psychiatric disorder requiring active treatment.\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial",{"count":340,"type":21},600,[342],"NA","In this phase III study, the primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population.",[55,345],"Extensive-stage Small-cell Lung Cancer",[347,298,348],"Prophylactic cerebral Irradiation","PCI","2023-11-02",{"date":351,"type":32},"2023-11-03",{"date":353,"type":32},"2022-10-27",{"date":355,"type":21},"2028-04",{"name":357,"class":358},"European Organisation for Research and Treatment of Cancer - EORTC","NETWORK",41,{"id":361,"slug":362,"hasResults":11,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":366,"eligibilityCriteria":367,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":368,"targetDuration":4,"studyType":50,"phases":370,"briefSummary":371,"conditions":372,"keywords":373,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":65},"100487145","phase-2-sugemalimab-as-consolidation-therapy-in-patients-with-ls-sclc-following-ccrt-or-scrt-100487145","NCT05623267","Sugemalimab as Consolidation Therapy in Patients With LS-SCLC Following cCRT or sCRT","A Phase 2\u002F3, Randomized, Double-blind, Placebo-controlled Study of Sugemalimab as Consolidation Therapy in Patients With Limited-stage Small-cell Lung Cancer Who Have Not Progressed Following Concurrent or Sequential Chemoradiotherapy","SURPASS","Inclusion Criteria:\n\n1、18 years or older. 2、Histologically or cytologically confirmed small cell lung cancer. 3、ECOG PS=0-1 at enrollment; 4、Limited-stage SCLC (Stage I-III, by AJCC 8th Edition Cancer Staging), and can be safely treated with definitive radiation doses).\n\n5、Inoperable SCLC, or the patient has contraindications to surgery, or the patient refuses surgery.\n\n6、Completion of 4 cycles of chemotherapy (etoposide + carboplatin\u002Fcisplatin) concurrent or sequential with radiotherapy during the first two cycles of chemotherapy.\n\n7、After the completion of concurrent or sequential chemoradiotherapy, prophylactic intracranial irradiation (PCI) is allowed based on the common practice of individual sites.\n\n8、The start of concurrent radiotherapy should be no later than the last day of the second course of chemotherapy (the first day of the third cycle of chemotherapy). The interval between the end of chemotherapy cycle and beginning of radiotherapy must not exceed 35 days for sequential chemoradiotherapy.\n\n9、Radiotherapy must be either total 60-66Gy over 6 weeks for the standard qd regimen or total 45Gy over 3 weeks for hyperfractionated bid schedules.\n\n10、Absence of progression after concurrent\u002Fsequential chemoradiotherapy (responses should be complete response \\[CR\\], partial response \\[PR\\] and stable disease \\[SD\\]); 11、For patients not receiving PCI, the first dose of sugemalimab shall be administered within 42 days after the completion of chemoradiation therapy. For patients receiving PCI, the first dose of sugemalimab shall be administered within 56 days after the completion of chemoradiation therapy.\n\n12、Life expectancy ≥ 12 weeks. 13、Can provide tumor tissue samples (fresh or archived) for whole exome sequencing; 14、Women of childbearing potential and fertile men must agree to use an effective contraceptive method from signing the master ICF until 180 days after the last dose of investigational product. Women of childbearing potential include premenopausal women and women who became menopausal less than 2 years ago. Women of childbearing potential must have a negative pregnancy test ≤7 days prior to the first dose of investigational product.\n\n15、The subject should have good compliance, who would participate in the research voluntarily, and sign the informed consent.\n\nExclusion Criteria:\n\n1. Histologically or cytologically diagnosed mixed small cell lung cancer or non-small cell lung cancer.\n2. Extensive-stage small cell lung cancer.\n3. Has malignant pleural or pericardial effusion.\n4. Previously received systemic anti-tumor therapy for SCLC or anti-tumor therapy with immune checkpoint inhibitors.\n5. Subjects with active, unstable systemic diseases, such as active infection, uncontrolled hypertension, heart failure (NYHA class \\>= II), unstable angina pectoris, acute coronary syndrome, severe arrythmia, severe liver, kidney or metabolic diseases, HIV infection.\n6. Has history of interstitial lung disease (ILD), drug-induced ILD, or active ILD which required systemic glucocorticoid or immunosuppressive therapy.\n7. History of other malignancies within 5 years (excluding basal cell carcinoma of the skin or other carcinoma in situ that has been resected).\n8. Pregnant or lactating women.\n9. Those who are allergic to the research drug or its components.\n10. Subjects who are deemed unable to comply with the study requirements or complete the study.\n11. Those with insufficient function of bone marrow or other important organs.",{"count":369,"type":21},346,[106,52],"The purpose of this study was to evaluate the efficacy of sugemalimab consolidation therapy versus placebo in patients with LS-SCLC who had not progressed following Concurrent or Sequential Chemoradiotherapy.",[55],[374,375,118],"Limited-stage Small-cell Lung Cancer（LS-SCLC）","Minimal Residual Disease（MRD）","2023-08-04",{"date":378,"type":32},"2023-08-07",{"date":380,"type":32},"2023-07-01",{"date":382,"type":21},"2027-03-31",{"name":384,"class":94},"Sun Yat-sen University",{"id":386,"slug":387,"hasResults":11,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":392,"enrollmentInfo":393,"targetDuration":4,"studyType":50,"phases":395,"briefSummary":396,"conditions":397,"keywords":398,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":65},"100477376","phase-3-the-efficiency-of-surgery-and-radiotherapy-after-shr-1316-adebrelimab-and-platinum-containing-doublet-induction-therapy-for-limited-stage-small-cell-lung-cancer-100477376","NCT05496166","The Efficiency of Surgery and Radiotherapy After SHR-1316 (Adebrelimab) and Platinum-containing Doublet Induction Therapy for Limited-stage Small Cell Lung Cancer","Comparing the Efficiency Between Surgery and Radiotherapy After SHR-1316 (Adebrelimab) and Platinum-containing Doublet Induction Therapy for Limited-stage Small Cell Lung Cancer: a Randomized, Controlled, Open-label, Single-center Phase III Clinical Trial","Inclusion Criteria:\n\n* after signing informed consent;\n* Aged 18-70;\n* Histologically or cytologically confirmed SCLC, imaging examination and other confirmed limited-stage small cell lung cancer, and without previous treatment;\n* For clinical stage IIB-III, all patients should have clear lymph node pathology by EBUS to exclud occult lymph node metastasis.\n* Two thoracic surgeons assessed thar it would be able to achieve radical surgery or R0 resection after 4 cycles of treatment. Surgical approaches include lobectomy, sleeve resection and pneumonectomy\n* ECOG performance status score 0-1 points;\n* With a life expectancy of at least 12 weeks;\n* At least one measurable tumor\n* With normal Other major organs (liver, kidney, blood system, etc.) function:\n\nAbsolute neutrophil count (ANC) ≥1.5×109\u002FL, platelets ≥100×109\u002FL, hemoglobin ≥90 g\u002FL. Note: Patients should not receive blood transfusion or growth factor support within ≤ 14 days before blood collection during the screening period;\n\n\\- International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × upper limit of normal (ULN); Activated partial thromboplastin time (APTT) ≤ 1.5×ULN; Serum total bilirubin ≤ 1.5×ULN (total bilirubin in patients with Gilbert syndrome must be \\\u003C3×ULN); Aspartate and alanine aminotransferase (AST and ALT) ≤2.5×ULN, or AST and ALT ≤5×ULN in patients with liver metastases\n\n* Female patients of childbearing potential must voluntarily use highly effective contraception during the study period until ≥ 120 days after the last dose of chemotherapy or SHR-1316, whichever is later, and have ≤ 7 days of urine or Serum pregnancy test results are negative;\n* Unsterilized male patients must voluntarily use highly effective contraception during the study period until ≥120 days after the last dose of chemotherapy or SHR-1316, whichever is later.\n\nExclusion Criteria:\n\n* Received any systemic anticancer therapy, including surgery, local radiotherapy, cytotoxic drug therapy, targeted drug therapy, and experimental therapy;\n* Patients with other malignancies within five years prior to the start of the trial;\n* Combined with unstable systemic diseases, such as uncontrolled hypertension, severe arrhythmia, etc;\n* With active, known or suspected autoimmune disease, or autoimmune paraneoplastic syndrome requiring systemic therapy;\n* Allergy to the test drug;\n* Have or currently have interstitial lung disease;\n* Coexisting with HIV infection or active hepatitis;\n* Patients who have undergone other major surgery or severe trauma within 2 months before the start of the trial;\n* Pregnant or breastfeeding women;\n* Those who suffer from neurological diseases or mental illnesses who cannot cooperate;\n* Other reasons that investigators deem inappropriate for enrollment.","70 Years",{"count":394,"type":21},348,[52],"To compare the efficiency between surgery and radiotherapy after SHR-1316 (Adebrelimab)and platinum-containing doublet induction therapy for limited-stage small cell lung cancer",[55],[399,400,401,402],"LD-SCLC","surgery","radiotherapy","neoadjuvant chemoimmunotherapy","2023-05-15",{"date":405,"type":32},"2023-05-17",{"date":407,"type":21},"2023-08-01",{"date":409,"type":21},"2030-08-01",{"name":310,"class":94},{"id":412,"slug":413,"hasResults":11,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":4,"eligibilityCriteria":417,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":226,"enrollmentInfo":418,"targetDuration":4,"studyType":50,"phases":420,"briefSummary":421,"conditions":422,"keywords":423,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":435},"100426185","phase-3-efficacy-and-safety-of-prophylactic-cranial-irradiation-versus-mri-surveillance-in-patients-with-limited-stage-small-cell-lung-cancer-who-achieved-remission-after-first-line-chemoradiotherapy-100426185","NCT04829708","Efficacy and Safety of Prophylactic Cranial Irradiation Versus MRI Surveillance in Patients With Limited-stage Small Cell Lung Cancer Who Achieved Remission After First-line Chemoradiotherapy","Efficacy and Safety of Prophylactic Cranial Irradiation Versus MRI Surveillance in Patients With Limited-stage Small Cell Lung Cancer Who Achieved Remission After First-line Chemoradiotherapy: a Multicenter Randomized Controlled Phase III Clinical Trial","Inclusion Criteria:\n\n1. Histological or cytological confirmation of LS-SCLC before first-line chemoradiotherapy (according to the staging system of the Veterans' Affairs Lung Study Group (VALSG), Appendix 2)；\n2. Remission is achieved after first-line chemoradiotherapy (CR or PR determined by RECIST v1.1)；\n3. Brain MRI examination should be performed to exclude metastatic lesions of brain parenchyma and meninges within four weeks before enrollment；\n4. The ECOG PS score was 0\\~2；\n5. The interval between the end of the last treatment cycle and the randomized grouping should be no more than 8 weeks；\n6. Estimated survival time ≥ 12 weeks；\n7. Patients must agree to participate in the study, comply with the research plan and follow-up process. Written informed consent must obtained.\n8. Male or female aged≥18 and≤75 years old;\n9. For fertile women and man: Subjects are required to agree to maintain abstinence (no heterosexual intercourse) or use contraception with an annual failure rate of less than 1% during the study treatment period and within at least 6 months after the end of the study treatment period.\n10. Hematological indexes: absolute neutrophil count≥1.5×109\u002F L, platelet count≥75×109 \u002FL, haemoglobin≥9.0g\u002FdL, serum albumin≥3g\u002FdL；\n11. Liver function: serum total bilirubin level≤1.5 times normal upper limit (ULN), glutamic pyruvic transaminase, glutamic oxaloacetic transaminase and alkaline phosphatase≤2.5 times ULN；\n12. Renal function: defined as serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance ≥ 15ml\u002Fmin (Cockcroft-Gault formula, Appendix 4); urinary protein negative or less than 2g in routine urine examination, or 24-hour urinary protein \\\u003C 1g；\n13. Good clotting function, defined as international standardized ratio (INR) or prothrombin time (PT) ≤ 1.5x ULN;. If the subject is receiving anticoagulant therapy, as long as PT is within the range of anticoagulant use；\n14. Women of childbearing age must undergo a urinary pregnancy test within 7 days before the start of treatment and the results are negative and are not breastfeeding.\n\nExclusion Criteria:\n\n1. Patients with extensive SCLC (Appendix 2)；\n2. The subjects are confirmed to have brain or meningeal metastasis before they are randomly divided into groups；\n3. During the 5 years before the start of the study, patients with malignant tumors other than SCLC, diseases with negligible risk of metastasis or death (such as expected 5-year OS \\> 90%) and malignant tumors expected to be cured (such as fully treated cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer treated by curable surgery, ductal carcinoma in situ treated by curable surgery)；\n4. Previous head and neck radiation fields overlapped with PCI field；\n5. MRI examination contraindicated\n6. There is evidence that significantly uncontrolled concomitant disease may affect the compliance of the study program, including severe liver disease (such as liver cirrhosis), uncontrollable major seizures or superior vena cava syndrome；\n7. Major cardiovascular diseases, myocardial infarction or cerebrovascular events within 3 months before randomization, unstable arrhythmias, or unstable angina pectoris；\n\n   --Patients with known coronary artery disease, congestive heart failure that do not meet the above criteria, or left ventricular ejection fraction ((LVEF)) \\\u003C 50% must receive a stable treatment plan and optimize it according to the advice of the attending physician, and consult a cardiologist if necessary。\n8. Stroke (including hemorrhagic and ischemic) or transient ischemic attack occurred within 6 months before enrollment；\n9. There were clinically significant bleeding symptoms or obvious bleeding tendency within 1 month before entering the group, such as gastrointestinal bleeding, gastric ulcer bleeding, active hemoptysis or vasculitis；\n10. Serious arteriovenous thrombosis events occurred within 3 months before enrollment, such as deep venous thrombosis, pulmonary embolism, etc. (except for implantable venous infusion port, catheter-derived thrombosis or superficial venous thrombosis, these conditions are not considered \"severe\" thromboembolism);\n11. Diabetic ketoacidosis or hyperglycemia and hyperosmosis occurred in the past 6 months;\n12. There was a history of hypertensive crisis and hypertensive encephalopathy;\n13. Any other disease, metabolic disorder, abnormal result of physical examination or laboratory examination, and there is reason to suspect that it may affect the reliability of the results of the study or put the patient at high risk of treatment complications；\n14. The results of HIV test is positive\n\n    --All patients must be tested for HIV; patients with positive results of HIV will be excluded.\n15. Major surgery has been performed within 28 days before the start of the study treatment, or major surgery is expected to be performed during the study period (except those for diagnostic purposes)；\n16. Severe infections occur at the beginning of the study, including, but not limited to, infectious complications requiring hospitalization, bacteremia, or severe pneumonia；\n17. Pregnant or lactating women；\n18. Previous history of severe neurological or mental disorders, including epilepsy, dementia or severe depression that interfere with assessment;\n19. The researchers believe that some conditions of the patients may affect the evaluation of the efficacy of this study, as well as the compliance of patients with this study.",{"count":419,"type":21},534,[52],"This is a prospective, open,multicenter, randomized controlled phase III clinical trial. In patients with LS-SCLC who achieve remission after first-line chemoradiotherapy, the efficacy and safety of PCI or MRI surveillance is evaluated and analyzed. PCI is performed in hopes of preventing spread of cancer into the brain. The use of brain MRI alone may reduce side effects of receiving PCI and prolong patients' lifespan. MRI surveillance alone (delaying radiation until the actual brain metastasis) may be not inferior to PCI.",[55],[424,425],"prophylactic cranial irradiation (PCI)","MRI surveillance","2021-04-28",{"date":428,"type":32},"2021-04-29",{"date":430,"type":21},"2021-04-26",{"date":432,"type":21},"2028-04-15",{"name":434,"class":94},"Shandong Cancer Hospital and Institute",2]