[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sclcextensive-stage\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sclcextensive-stage":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,49,76,105,126,154],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":34,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100638863","phase-3-evaluate-bl-m14d1-plus-atezolizumab-vs-standard-of-care-in-first-line-extensive-stage-small-cell-lung-cancer-100638863",false,"NCT07625644","Evaluate BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer","A Phase 3 Open-Label, Randomized Controlled Trial of BL-M14D1 and Atezolizumab vs. Standard-of-Care Therapy in Patients With First-Line Extensive-Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed first-line (1L), extensive-stage (ES) small cell lung cancer (SCLC)\n* Must be eligible to receive a platinum-based chemotherapy regimen in combination with an anti-PD-L1 inhibitor.\n* At least one measurable lesion based on RECIST v1.1 per investigator assessment.\n* An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1.\n* Adequate organ function\n\nExclusion Criteria:\n\n* Received any kind of platinum or etoposide treatment for limited stage (LS) SCLC within 6 months prior to enrollment.\n* Participants who have received prior topoisomerase inhibitor-based ADC therapy.\n* Participants with history of severe heart disease\n* Participants with active autoimmune diseases and inflammatory diseases,\n* Participants with other prior or concurrent malignancies except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin and\u002For carcinoma in situ after adequate resection, or other malignancy treated with curative intent with a disease-free interval of at least 3 years\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.","ALL","18 Years",{"count":19,"type":20},550,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The objective of the study is to evaluate the efficacy and safety of BL-M14D1 in combination with Atezolizumab compared to Standard-of-Care Therapy in adult participants with previously untreated extensive-stage small cell lung cancer (ES-SCLC).",[26,27,28,29,30,31,32,33],"Small Cell Lung Cancer Extensive Stage","Small-cell Lung Cancer","Small Cell Carcinoma","Sclc","SCLC,Extensive Stage","Lung Cancer","Lung Cancer Metastatic","Lung Cancer Stage IV",[35,36],"DLL3","First Line","NOT_YET_RECRUITING","2026-05-28",{"date":40,"type":41},"2026-06-04","ACTUAL",{"date":43,"type":20},"2026-06",{"date":45,"type":20},"2031-06",{"name":47,"class":48},"SystImmune Inc.","INDUSTRY",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100494449","phase-2-niraparib-added-to-anti-pd-l1-antibody-maintenance-in-slfn11-positive-extensive-disease-sclc-100494449","NCT05718323","Niraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease SCLC","A Single-arm Phase II Trial of the Addition of Niraparib to Anti-PD-L1 Antibody Maintenance in Patients With SLFN11-positive, Extensive-disease Small Cell Lung Cancer.","RAISE","Inclusion Criteria:\n\nInclusion criteria for SLFN11-expression testing\n\n* Written IC part 1: for SLFN11-screening must be signed and dated by the patient and the investigator prior to sending any tumour material to the central laboratory.\n* Histologically or cytologically confirmed ED-SCLC (stage IV according to the 8th TNM classification).\n* Availability of FFPE tumour tissue for screening.\n\nInclusion criteria for trial participation\n\n* Written IC part 2: for trial participation must be signed and dated by the patient and the investigator prior to any trial-related intervention.\n* High SLFN11-expression on FFPE tumour material:\n\nSLFN11-expression is determined at the central screening laboratory in Basel. Overexpression is defined as detectable protein expression by IHC in ≥20% of tumour cells.\n\n* Patients must have received standard first-line chemo-immunotherapy, consisting of 4 cycles of platinum-etoposide chemotherapy in combination with an anti-PD-L1 antibody (atezolizumab or durvalumab). Patients who started the immunotherapy at chemotherapy cycle 2 are eligible.\n* ED-SCLC must not have progressed during or after standard chemo-immunotherapy (as per RECIST v1.1).\n* Patients must be candidates for ongoing maintenance treatment with immune-checkpoint inhibition.\n* Adequate haematological function:\n* Adequate renal function:\n* Adequate liver function:\n* ECOG PS 0-2\n* Age ≥18 years\n* Women of childbearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test within 4 weeks before enrolment and within 3 days before treatment start.\n\nExclusion Criteria:\n\n* Symptomatic brain metastases\n* Any clinically active cancer, other than SCLC Exception: malignancies with negligible risk of metastases or death (e.g. 5-year OS rate of \\>90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localised prostate cancer, ductal carcinoma in situ, or stage I uterine cancer. Hormonal therapy for non-metastatic prostate or ductal carcinoma in situ is allowed.\n\nConsolidating thoracic radiotherapy. Palliative radiotherapy to the brain or to bones is allowed.\n\n* History of idiopathic pulmonary fibrosis, organising pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.\n* Any lung disease requiring systemic steroids in doses of \\>10 mg prednisolone (or equivalent dose of other steroid).\n* Any serious concomitant systemic disorders (for example active infection, unstable cardiovascular disease) which in the opinion of the investigator would compromise the patient's ability to complete the trial or interfere with the evaluation of the efficacy and safety of the protocol treatment.\n* Inadequately controlled hypertension, defined as systolic blood pressure \\>150 mmHg and\u002For diastolic blood pressure \\>95 mmHg.\n\nThe patient must be considered stable and hypertension medically controlled.\n\n* History of myelodysplastic syndrome\u002Facute myeloid leukemia (MDS\u002FAML).\n* Prior Reversible Encephalopathy Syndrome (PRES)\n* Severe renal or hepatic impairment.\n* Any clinically significant gastrointestinal (GI) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and\u002For bowels.\n* Treated with live vaccine within 30 days before enrolment.\n* Hypersensitivity to niraparib or any of its excipients (e.g., tartrazine).\n* Women who are pregnant or in the period of lactation.\n* Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the trial and within the required timelines after last dose of niraparib treatment.\n* Judgment by the investigator that the patient is unlikely to comply with trial procedures, restrictions and requirements.",{"count":58,"type":20},44,[60],"PHASE2","RAISE is an international, multicentre, single-arm phase II trial. The trial treatment consists of the addition of niraparib, 200 mg orally once daily to anti-PD-L1 antibody maintenance. The primary objective of this trial is to assess the clinical efficacy of the addition of niraparib to anti-PD-L1 monoclonal antibody maintenance treatment in patients with SLFN11-positive ED-SCLC which has not progressed following standard first-line chemo-immunotherapy.",[30,63],"SLFN11-positive","RECRUITING","2026-05-27",{"date":67,"type":41},"2026-05-29",{"date":69,"type":41},"2023-12-20",{"date":71,"type":20},"2027-06",{"name":73,"class":74},"ETOP IBCSG Partners Foundation","NETWORK",18,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":104},"100603803","phase-2-adebrelimab-combine-with-etoposide-capsules-in-es-sclc-maintenance-therapy-100603803","NCT07141264","Adebrelimab Combine With Etoposide Capsules in ES-SCLC Maintenance Therapy","A Single-Arm, Exploratory Study of Adebrelimab Combined With Etoposide Capsules as Maintenance Therapy in Extensive-Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Voluntary participation with signed informed consent and good compliance for follow-up.\n2. Age between 18 and 75 years old.\n3. Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) according to the AJCC 8th edition or VALG phase II staging criteria.\n4. ECOG performance status score: 0 to 2.\n5. Absence of disease progression after receiving 4-6 cycles of platinum-based chemotherapy combined with Adebrelimab induction therapy.\n6. Recovery of non-hematologic adverse reactions to grade 1 (except for alopecia, skin pigment changes, or as determined by the investigator) following induction therapy.\n7. Time from the end of induction treatment (last dose) to initiation of maintenance treatment ≤ 6 weeks.\n8. At least one measurable lesion assessed by the investigator according to RECIST 1.1.\n9. Normal function of major organs, meeting the following criteria:\n\n(1)Bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5×10\\^9\u002FL (grade 1 according to CTCAE 5.0); platelets ≥ 100×10\\^9\u002FL; hemoglobin \\> 80g\u002FL.\n\n(2)Renal function: Creatinine ≤ 1.5 times the upper limit of normal (ULN), grade 1 according to CTCAE. Note: If creatinine is greater than 1.5 times the ULN, creatinine clearance must be \\> 50ml\u002Fmin.\n\n(3)Liver function: Bilirubin ≤ 1.5 times ULN (grade 1 according to CTCAE), patients with Gilbert's syndrome bilirubin ≤ 3.0 times ULN; AST and ALT ≤ 3.0×ULN.\n\n(4)Coagulation indicators: International normalized ratio (INR) ≤ 1.55 (if the patient is receiving a stable dose of therapeutic warfarin or low molecular weight heparin, INR is usually between 2 and 3), PTT \\\u003C 1.2 times ULN.\n\n10.Women of childbearing potential must agree to use contraception during the study and for 6 months after the end of the study (such as an intrauterine device, contraceptive pills, or condoms); serum or urine pregnancy test must be negative within 1 week before enrollment, and must be non-lactating patients; men must agree to use contraception during the study and for 6 months after the end of the study.\n\nExclusion Criteria:\n\n1. Limited-stage small cell lung cancer (SCLC);\n2. Histologically or cytologically confirmed mixed histology SCLC;\n3. Prior treatment with anti-angiogenic agents;\n4. Conditions that may affect oral drug intake, such as inability to swallow, chronic diarrhea, or intestinal obstruction;\n5. Major surgery, open biopsy, or significant traumatic injury within 4 weeks prior to enrollment;\n6. Participation in another investigational drug clinical trial within 4 weeks prior to enrollment;\n7. Relevant medical history:\n\n(1)Untreated or symptomatic brain metastases or spinal cord compression; (2)Concurrent active malignancy requiring treatment; (3)Active autoimmune disease or immunodeficiency, or a history of such conditions, including but not limited to autoimmune hepatitis, interstitial lung disease, uveitis, rheumatoid arthritis, inflammatory bowel disease, hypophysitis, vasculitis, or nephritis.Exceptions include: patients with stable disease not requiring systemic immunosuppressive therapy, such as type I diabetes mellitus, hypothyroidism controlled with hormone replacement therapy, or skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia), or those with no external triggering factors and a low risk of recurrence; (4)History of psychiatric or substance abuse disorders that would interfere with study compliance; 8.Presence of any severe and\u002For uncontrolled comorbid conditions, including but not limited to:\n\n1. Uncontrolled hypertension (systolic BP ≥150 mmHg or diastolic BP ≥100 mmHg);\n2. Myocardial ischemia or infarction of grade I or higher, arrhythmias (including QTc ≥450 ms in males, ≥470 ms in females), congestive heart failure of NYHA class ≥2, or left ventricular ejection fraction (LVEF) \\\u003C50% on echocardiogram;\n3. Decompensated diabetes mellitus or other contraindications requiring high-dose corticosteroids;\n4. Exacerbation of chronic obstructive pulmonary disease (COPD) or other serious respiratory disorders requiring hospitalization;\n5. Active or uncontrolled severe infection (≥CTCAE grade 2);\n6. Uncontrolled pleural, pericardial, or peritoneal effusion requiring repeated drainage;\n7. Liver cirrhosis, decompensated liver disease, active hepatitis, or chronic hepatitis requiring antiviral treatment;\n8. Renal insufficiency: urine protein ≥++ on routine urinalysis and 24-hour urine protein \\>1.0 g confirmed; 9.Severe infection within 4 weeks before the first dose, including but not limited to infectious complications, bacteremia, severe pneumonia requiring hospitalization, or infections requiring intravenous antibiotics, antifungals, or antivirals; or unexplained fever \\>38.5°C during screening or prior to first dose; 10.Grade III-IV immune-related adverse events (irAEs) during the induction phase with PD-L1 inhibitors; 11.Active brain or leptomeningeal metastases at enrollment; Exception: patients who received prior treatment (e.g., radiotherapy) for brain or leptomeningeal metastases during or before induction and had stable disease on imaging for at least 4 weeks prior to enrollment, discontinued systemic steroid therapy (≤10 mg\u002Fday prednisone or equivalent) for more than 4 weeks, and are asymptomatic, may be eligible; 12.Patients deemed by the investigator to be unable or unlikely to comply with the study protocol, restrictions, or requirements.","75 Years",{"count":85,"type":20},32,[60],"This prospective clinical study aims to evaluate and observe the efficacy and safety of adebrelimab combined with etoposide capsules in maintenance therapy for extensive-stage small cell lung cancer using a single-arm trial design.\n\nThe study is planned to be conducted in Shaanxi Province, China, with an initial target enrollment of 32 patients. The study commenced in August 2025, and recruitment is expected to conclude around December 2026, with the trial anticipated to end by December 2027. Assuming no occurrences such as withdrawal of informed consent by subjects, intolerable adverse drug reactions, or investigator-assessed unsuitability for further participation, each participant's estimated duration of study treatment will continue until radiographically confirmed tumor progression.",[30],[90,91,92,93],"SCLC","Adebrelimab","Etoposide Capsules","Maintenance Therapy","2025-12-22",{"date":96,"type":41},"2025-12-30",{"date":98,"type":41},"2025-08-25",{"date":100,"type":20},"2027-12-30",{"name":102,"class":103},"Tang-Du Hospital","OTHER",1,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":83,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":114,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":4},"100615164","phase-2-a-prospective-single-arm-exploratory-study-of-ibi363-in-es-sclc-patients-after-immunotherapy-progression-100615164","NCT07289048","A Prospective, Single-Arm, Exploratory Study of IBI363 in ES-SCLC Patients After Immunotherapy Progression","A Prospective, Single-Arm, Exploratory Clinical Study of IBI363 in Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC) Following Progression on Immunotherapy","Inclusion Criteria:\n\n1. Age 18 to 75 years (inclusive), male or female.\n2. Histologically confirmed small cell lung cancer (SCLC).\n3. Extensive-stage SCLC refractory to 2 to 3 prior lines of systemic anti-tumor therapy, which must have included PD-1\u002FPD-L1 immunotherapy.\n4. At least one measurable target lesion as per RECIST 1.1 criteria. The target lesion must be measurable (longest diameter ≥10 mm at baseline, or for lymph nodes, short-axis diameter ≥15 mm) and not have been previously irradiated, or have demonstrated clear progression after local therapy. Lesions solely within the brain are not acceptable as target lesions.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Life expectancy ≥ 3 months.\n7. Adequate organ function,\n8. Fertile patients (male and female) must agree to use highly effective contraception (e.g., hormonal, barrier methods, or abstinence) with their partner during the trial and for at least 6 months after the last dose. A serum pregnancy test for women of childbearing potential must be negative within 7 days prior to the first study dose.\n9. Subjects must provide written informed consent before initiating any study-specific procedures.\n\nExclusion Criteria:\n\n1. Histological diagnosis of combined small cell lung cancer (e.g., mixed SCLC and NSCLC), transformed non-small cell lung cancer (e.g., SCLC transformed from NSCLC), or transformed SCLC (e.g., NSCLC transformed to SCLC).\n2. Known history of hypersensitivity (≥ Grade 3 per CTCAE v5.0) to any antibody-based therapeutic agent, or known hypersensitivity to the active substance or inactive excipients of the investigational product.\n3. Major surgical procedure (excluding needle biopsy) or significant trauma within 4 weeks prior to the first dose of study treatment, or anticipation of the need for elective surgery during the study period.\n4. Systemic corticosteroid therapy (\\>10 mg\u002Fday prednisone or equivalent) within 14 days prior to the first dose of study treatment, with the following exceptions: topical, ocular, intra-articular, intranasal, or inhaled corticosteroids; short-term prophylactic use (e.g., for contrast media allergy); or treatment with other immunosuppressive agents within 4 weeks.\n5. Use of immunomodulatory drugs (e.g., thymosin, interleukin-2, interferon) within 14 days prior to the first dose of study treatment.\n6. Administration of a live attenuated vaccine within 4 weeks prior to the first dose of study treatment.\n7. Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation.\n8. Adverse events from prior anti-tumor therapy have not recovered to ≤ Grade 1 per CTCAE v5.0 or the levels specified in the inclusion criteria (with the exception of toxicities deemed not to pose a safety risk by the investigator, such as alopecia, Grade 2 peripheral neuropathy, or hypothyroidism stable on hormone replacement therapy).\n9. Untreated brain metastases (subjects with treated brain metastases are eligible if clinically stable for ≥4 weeks prior to the first dose, off steroid therapy for ≥2 weeks, and without significant peritumoral edema on imaging); leptomeningeal metastasis or brainstem metastasis; spinal cord compression (radiologically identified, regardless of symptoms).\n10. Active infection requiring intravenous anti-infective therapy at the time of screening.\n11. History of immunodeficiency, including a positive test for human immunodeficiency virus (HIV).\n12. Active hepatitis B (HBsAg positive and HBV-DNA ≥1000 IU\u002FmL or copies\u002FmL) or active hepatitis C (HCV antibody positive and HCV RNA above the upper limit of normal).\n13. Interstitial lung disease (except for radiation-induced fibrosis not requiring corticosteroid therapy).\n14. Significant cardiovascular and cerebrovascular disease history\n15. Active autoimmune disease, or history of autoimmune disease with potential for recurrence (exceptions include well-controlled autoimmune thyroiditis, type I diabetes, vitiligo, childhood atopic dermatitis resolved, psoriasis not requiring systemic therapy in the past 2 years, etc.).\n16. Prior history of ≥ Grade 3 immune-related adverse event (irAE) or ≥ Grade 2 immune-related myocarditis associated with prior immunotherapy.\n17. History of other malignancies, except for those cured for ≥2 years, such as non-melanoma skin cancer, localized prostate cancer, or carcinoma in situ (e.g., cervical carcinoma in situ).\n18. Pleural effusion or ascites requiring therapeutic intervention (subjects with stable effusion not requiring drainage or stable for ≥1 week after drainage may be eligible); pericardial effusion (asymptomatic, minimal effusion not requiring intervention per investigator's assessment is allowed). If intra-cavitary anti-tumor agents were used during drainage, a washout period of at least 5 half-lives or 21 days (whichever is shorter) must be completed prior to the first dose.\n19. Known history of alcohol or drug dependence.\n20. History of psychiatric disorders or anticipated poor compliance.\n21. Pregnancy or lactation.\n22. Any other condition deemed by the investigator to potentially compromise the subject's safety or compliance, or make the subject unsuitable for the study.",{"count":113,"type":20},35,[60],"This study is a prospective, single-arm, exploratory clinical trial designed to evaluate the efficacy and safety of IBI363 in patients with extensive-stage small cell lung cancer (ES-SCLC) who have progressed after at least two prior lines of standard therapy, including PD-1\u002FPD-L1 inhibitor-based immunotherapy. A total of 35 patients were enrolled. The primary endpoint is the objective response rate (ORR), as assessed by investigators according to RECIST 1.1 criteria. Following a screening period of up to 28 days, patients will receive IBI363 treatment until disease progression, onset of intolerable toxicity, withdrawal of informed consent, completion of 24 months of therapy, discontinuation due to other protocol-specified reasons, or early termination of the study.",[30],"2025-12-05",{"date":119,"type":41},"2025-12-17",{"date":121,"type":20},"2025-12-20",{"date":123,"type":20},"2028-12-30",{"name":125,"class":103},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":21,"phases":136,"briefSummary":137,"conditions":138,"keywords":139,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":153},"100487149","phase-2-pembrolizumab-and-olaparib-treatment-of-extensive-small-cell-lung-cancer-es-sclc-100487149","NCT05623319","Pembrolizumab and Olaparib Treatment of Extensive Small Cell Lung Cancer (ES-SCLC)","Phase 2 Trial of Translational Approach to First Line cHemoimmunotherapy Followed by Maintenance With pembrOlizumab and Olaparib in Extensive-Stage Small-Cell Lung CanceR.","THOR","The Inclusion Criteria:\n\n1. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n2. Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent.\n3. Cytologically\u002Fhistologically confirmed diagnosis of SCLC per the Veterans Administration Lung Study Group (VALG) staging system will be enrolled in this study. Patients must have extensive stage (ES) SCLC defined as Stage IV (T any, N any, M 1a\u002Fb\u002Fc) by the American Joint Committee on Cancer, Eighth Edition.\n4. Possibility of obtaining tissue sample, via a biopsy of the primary tumour or metastatic tumour tissue, within the 6 weeks prior to study entry. An archival biopsy is acceptable as long as there has been no intervening anticancer treatment since the time the biopsy was obtained to enrolment in this clinical study and as long as it was within 6 weeks of study entry. Tissue sample would consist of formalin-fixed, paraffin-embedded tumour tissue blocks, or, from formalin-fixed paraffin-embedded tumor tissue block, at least five re-cut, unstained sections of 5 μM thickness for immunohistochemical analysis and five unstained sections of 10 μM thickness for NGS, presented on slides or cell-block.\n5. No prior systemic treatment for ES-SCLC. Patients who have received prior chemo-radiotherapy for limited-stage SCLC must have been treated with curative intent and experienced a treatment free interval of at least 6 months since the last chemotherapy, radiotherapy, or chemoradiotherapy cycle from diagnosis of ES-SCLC.\n6. Patients with thoracic radiotherapy clinically indicated (e.g. mediastinal syndrome) could be enrolled providing they receive radiotherapy not before 15 days since the start of the experimental treatment. Patients who received radiation therapy to the lung fields that is \\> 30 Gy within 6 months of the first dose of trial treatment, will be excluded.\n7. Presence of target lesions by RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n8. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the date of registration .\n9. Patients with paraneoplastic syndromes can be enrolled if an autoimmune origin can be excluded. Autoimmune origin will be defined according to local practice.\n10. Life expectancy ≥12 weeks.\n11. Capacity to swallow.\n12. Ability to comply with the study protocol, in the investigator's judgment.\n13. Have adequate organ function. Specimens must be collected within 10 days prior to the registration day.\n14. Negative human immunodeficiency virus (HIV) test at screening.\n15. Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening. The HBV DNA test will be performed only for patients who have a positive total HBcAb test.\n16. Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody test.\n17. Male participants: Male patients must use a condom during treatment and for 3 months after the last dose of olaparib when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception.\n18. Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n    1. Not a woman of childbearing potential (WOCBP) as defined in Appendix F, or\n    2. A WOCBP who agrees to follow the contraceptive guidance in Appendix F during the treatment period and for at least 120 days after the last dose of study treatment.\n\nExclusion Criteria:\n\n1. Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.\n2. Active or history of autoimmune disease or immune deficiency which has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs), including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:\n\n   * Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study.\n   * Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n   * Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n     * Rash must cover less than 10% of body surface area;\n     * Disease is well controlled at baseline and requires only low-potency topical corticosteroids;\n     * No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months;\n     * Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n3. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computerized tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n4. Prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n5. Live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n6. Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, corrected QT interval by Fredericia (QTcF) prolongation \\>500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome. In case of significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident), acute events must happen not before than 3 months prior to initiation of study treatment.\n7. Major surgical procedure within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study.\n8. History of malignancy other than SCLC within 3 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\>90%), such as, adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, Stage I uterine cancer or non-muscle-invasive urothelial carcinoma (Ta - Tis - T1).\n9. History of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n10. Active infection requiring systemic therapy.\n11. Known history of active Bacillus Tuberculosis (TB).\n12. Treatment with investigational therapy within 28 days prior to initiation of study treatment.\n13. Patient who has received prior therapy with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, anti-Cytotoxic T-Lymphocyte Associated Protein 4 (CTLA-4), anti-OX40, anti-Cluster of Differentiation 137 (CD137), anti-CD27).\n14. Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin-2 (IL-2)) within 4 weeks or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment.\n15. Any previous treatment with a PARP inhibitor, including Olaparib.\n16. Concomitant use of known strong Cytochrome P450, family 3, subfamily A (CYP3A) inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.\n17. Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort ) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for phenobarbital and 3 weeks for other agents.\n18. Has severe hypersensitivity (≥Grade 3) to pembrolizumab, olaparib and\u002For any of their excipients.\n19. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.\n20. Known allergy or hypersensitivity to carboplatin or etoposide.\n21. 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.\n22. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n23. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n24. Has had an allogenic tissue\u002Fsolid organ transplant.\n25. A WOCBP who has a positive urine pregnancy test within 72 hours prior to registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.",{"count":135,"type":20},60,[60],"This is an open-label, single arm, phase 2 trial enrolling patients with untreated Extensive-Stage Small-Cell Lung Cancer (ES SCLC), with a strong translational attitude.",[30],[30,140,141,142,143],"Translational","Liquid Biopsy","Pembrolizumab","Olaparib","2025-06-18",{"date":146,"type":41},"2025-06-24",{"date":148,"type":41},"2023-03-27",{"date":150,"type":20},"2027-07",{"name":152,"class":103},"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS",12,{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":21,"phases":163,"briefSummary":165,"conditions":166,"keywords":168,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":104},"100534759","phase-1-wbrt-with-hippocampal-avoidance-technique-followed-by-srt-for-extensive-stage-sclc-with-baseline-brain-metastases-100534759","NCT06243003","WBRT With Hippocampal-avoidance Technique Followed by SRT for Extensive-stage SCLC With Baseline Brain Metastases","A Phase I\u002FII Study to Evaluate the Safety and Efficacy of Hippocampal-avoidance Whole Brain Radiotherapy Followed by Stereotactic Radiotherapy for Extensive-stage Small Cell Lung Cancer With Baseline Brain Metastases","Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group(ECOG) performance status score 0-2;\n2. Small cell lung cancer confirmed by histopathology or cytology;\n3. Complete baseline imaging data (including brain enhanced MRI\u002FCT, positron emission tomography(PET\u002FCT) or chest enhanced CT+ bone scan + neck and abdomen B ultrasound \u002FCT) should be obtained before first-line treatment;\n4. Patients with initial diagnosis of ES-SCLC with brain metastases who planned to receive at least 4 cycles of standard platinum-based doublet chemotherapy combined with immunotherapy (PD-1 or PD-L1 monoclonal antibody) as first-line treatment, and who met the organ function requirements as judged by the investigator;\n5. Brain metastases assessed by contrast-enhanced MRI met the criteria for SRS (less than or equal to 10 brain metastases, maximum tumor volume less than 10ml, maximum tumor diameter less than 3cm, total tumor volume less than 15ml, and no evidence of leptomeningeal metastasis).\n6. No history of other malignant tumors;\n7. Male\u002Ffemale of childbearing age agreed to use contraception (surgical ligation or oral contraceptive\u002Fintrauterine device + condom) during the trial;\n8. Life expectancy ≥3 months\n9. Patients must be able to understand and voluntarily sign informed consent.\n\nExclusion Criteria:\n\n1. Patients with non-small cell lung cancer (NSCLC) components on baseline pathological examination;\n2. Patients who had received any antitumor therapy prior to ES-SCLC diagnosis;\n3. Patients with imaging evidence of leptomeningeal metastasis or suspected leptomeningeal metastasis with symptoms and signs;\n4. patients unable to undergo contrast-enhanced MRI;\n5. Patients with severe symptoms of brain metastases requiring emergency surgery to reduce intracranial pressure;\n6. Patients who could not complete immobilization for radiotherapy or tolerate radiotherapy;\n7. Symptomatic interstitial lung disease or active infectious\u002Fnoninfectious pneumonia;\n8. Patients requiring long-term corticosteroid or immunosuppressive therapy;\n9. Patients who are allergic to PD-1 or PD-L1 monoclonal antibody immunotherapy or unable to receive immune maintenance therapy for other reasons;\n10. Lactating or pregnant women;\n11. The patient had severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granulomatosis), etc.\n12. Medical examination or clinical findings or other uncontrollable conditions that the investigator considers may interfere with the results or increase the risk of treatment complications for the patient;\n13. Patients with mental illness, substance abuse, or social problems that could affect adherence were excluded from enrollment after physician review.",{"count":162,"type":20},56,[164,60],"PHASE1","This study aims to evaluate the safety and efficacy of hippocampal-sparing WBRT combined with SRS as first-line treatment for SCLC patients with brain metastases.",[30,167],"Brain Metastases",[169,170],"whole brain radiotherapy (WBRT)","stereotactic body radiotherapy (SBRT)","2024-02-04",{"date":173,"type":41},"2024-02-07",{"date":175,"type":41},"2024-01-15",{"date":177,"type":20},"2026-12",{"name":179,"class":103},"Fudan University"]