[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"consolidation-immunotherapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:consolidation-immunotherapy":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100599962","phase-2-a-study-of-ql1706-combined-with-chemotherapy-induction-on-sequential-immunotherapy-consolidation-in-patients-with-limited-stage-small-cell-lung-cancer-after-chemoradiotherapy-100599962",false,"NCT07091305","A Study of QL1706 Combined With Chemotherapy Induction on Sequential Immunotherapy Consolidation in Patients With Limited-Stage Small Cell Lung Cancer After Chemoradiotherapy","A Study of QL1706 Combined With Chemotherapy Induction on Sequential Immunotherapy Consolidation in Patients With Limited-Stage Small Cell Lung Cancer After Chemoradiotherapy：A Phase II Trial","Inclusion Criteria:\n\n1. The patient must be aged between 18 and 75 years (inclusive of boundary values), and both males and females are eligible.\n2. Pathologically confirmed LS-SCLC\n3. Investigator confirmation of at least one measurable lesion, as defined by RECIST v1.1\n4. ECOG performance status of 0 or 1\n5. Forced expiratory volume in one second (FEV₁) \\> 1.0 L\n6. No clinically significant interstitial lung disease on baseline CT or PET\u002FCT.\n7. Adequate organ and bone-marrow function (all tests performed within 7 days prior to first dose; no transfusions, growth factors, albumin, or other corrective therapies within 14 days):Hemoglobin ≥ 90 g\u002FL, ANC ≥ 1.5 × 10⁹\u002FL, PLT ≥ 90 × 10⁹\u002FL,Serum creatinine ≤ 1.5 × ULN, TBIL ≤ 1.5 × ULN, ALT and AST ≤ 3 × ULN, Albumin (ALB) ≥ 25 g\u002FL,INR ≤ 1.5 × ULN, PT and APTT ≤ 1.5 × ULN (subjects on prophylactic anticoagulation must have values within a safe therapeutic range, per investigator)\n8. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment and agree to use reliable contraception from screening until 3 months after the last dose; male subjects must agree to use effective contraception or have undergone surgical sterilization for the same period.\n9. No prior systemic anti-tumor therapy before enrollment.\n10. Estimated life expectancy ≥ 12 weeks.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to QL1706 or any of its excipients\n2. Histologically confirmed non-small cell lung cancer (NSCLC) or mixed tumor containing an NSCLC component.\n3. History of another primary malignancy or previous allogeneic organ transplantation.\n4. Surgery (other than diagnostic biopsy) within 4 weeks before first dose of study drug.\n5. Active substance abuse (e.g., illicit drug use), chronic alcoholism, AIDS, or known HIV infection.\n6. Active autoimmune disease, or history of autoimmune disease likely to recur. Systemic corticosteroid therapy equivalent to \\>10 mg\u002Fday prednisone (or other immunosuppressive therapies) within 14 days before first dose.\n7. Prior therapy with any antibody or agent targeting T-cell co-regulatory proteins (e.g., PD-1, PD-L1, CTLA-4, TIM-3, LAG-3).\n8. Interstitial lung disease (ILD), or history of ILD requiring steroid therapy. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia (e.g., bronchiolitis obliterans), or evidence of active pneumonia on screening chest CT.\n9. Live vaccine administration within 28 days prior to first study drug dose. Any condition or comorbidity contraindicating chemo- or radiotherapy (e.g., active infection, myocardial infarction within 6 months, symptomatic heart disease including unstable angina, congestive heart failure, uncontrolled arrhythmia, ongoing immunosuppressive therapy).\n10. Pregnant or breastfeeding women; women of childbearing potential or men unwilling to use adequate contraception.\n11. Known hereditary bleeding diathesis or coagulation disorder.\n12. Prior malignancy, except adequately treated non-melanoma skin cancer, or in situ carcinoma (e.g., breast, oral, cervical) with expected survival \\>3 years.\n13. Any other medical, psychiatric, or laboratory abnormality that, in the investigator's judgment, could interfere with trial participation or interpretation of results.","ALL","18 Years","75 Years",{"count":20,"type":21},28,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The study is being conducted to evaluation of the Efficacy and Safety of QL1706 Combined with Chemotherapy Induction in Sequential Immunotherapy Consolidation After Concurrent Chemoradiotherapy for Limited-Stage Small Cell Lung Cancer(LS-SCLC), and Exploration of the Correlation Between Biomarkers (PD-L1, TMB, ctDNA, etc.) Related to QL1706 Treatment and Treatment Efficacy and Prognosis.\n\nQL1706 (Iparomlimab and Tuvonralimab) is a single bifunctional MabPair product against PD-1 and CTLA-4. QL1604 is a monoclonal antibody against PD-1.",[27,28,29,30],"Limited-stage Small Cell Lung Cancer (LS-SCLC)","Chemoradiotherapy","Induction Therapy","Consolidation Immunotherapy",[32,33,34,35,36],"Limited-stage small cell lung cancer","QL1706","chemoradiotherapy","induction therapy","consolidation immunotherapy","RECRUITING","2026-06-10",{"date":40,"type":41},"2026-06-11","ACTUAL",{"date":43,"type":41},"2025-10-23",{"date":45,"type":21},"2028-08-01",{"name":47,"class":48},"Shanghai Chest Hospital","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":49},"100497505","phase-2-tislelizumab-consolidation-therapy-after-radiotherapy-or-sequential-chemoradiation-in-locally-advanced-nsclc-patients-100497505","NCT05758116","Tislelizumab Consolidation Therapy After Radiotherapy or Sequential Chemoradiation in Locally Advanced NSCLC Patients","A Prospective, Open-label, Single-arm, Phase II Trial Investigating the Efficacy and Safety of Tislelizumab Consolidation Therapy After Radiotherapy or Sequential Chemoradiation in Locally Advanced NSCLC Patients","Inclusion Criteria:\n\n1. Patients with stage III(AJCC 8th) unresectable NSCLC, or resectable but intolerant or refusing surgery;\n2. Intolerable of concurrent chemoradiation;\n3. No progression after radiotherapy or sequential chemoradiation;\n4. Chemotherapy: standard dose of 2-6 cycles of paclitaxel, pemetrexed or gemcitabine in combination with platinum; Radiotherapy: starting within 3 months after chemotherapy using IMRT or VMAT technique. The target volume includes the primary tumor and regional lymph nodes, and the prescription dose 95% PTV ranges from 50Gy to 66Gy;\n5. ECOG PS0-2;\n6. PD-L1≥1%;\n7. Age≥18 years, and life expectancy\\>3 months;\n8. Adequate Hematologic, biochemistry and organ function (to be confirmed by test results within 7 days prior to the first dose);\n9. Be able to provide written informed consent (ICF) and able to understand and agree to comply with study requirements and assessment schedule.\n\nExclusion Criteria:\n\n1. Patients with EGFR-sensitive mutations and ALK rearrangements;\n2. Any prior use of anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibodies (including Ipilimumab or any other antibody targeting the T-cell co-stimulation or checkpoint pathway);\n3. History of allergy to components of Tislelizumab;\n4. Any active malignancy within 2 years prior to enrollment, except for the specific cancers examined in this study and any locally recurrent cancers that have been eradicated (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, cervical or breast cancer in situ);\n5. History of interstitial lung disease or pneumonia requiring oral or intravenous steroids;\n6. Progression after radiotherapy or sequential chemoradiation;\n7. Unresolved ≥grade2 toxicities from radiotherapy and sequential chemoradiation, (excluding those that the investigator determines do not affect study treatment, such as alopecia);\n8. Grade 2 or severe Pneumonia from radiotherapy or sequential chemoradiation;\n9. Administration of a live vaccine within 30 days prior to treatment start (seasonal influenza vaccine without live vaccine is allowed);\n10. Severe chronic or active infections (including tuberculosis infections, etc.) requiring systemic antibacterial, antifungal or antiviral therapy ≤ 14 days prior to treatment start;\n11. History of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation;\n12. History of active autoimmune disease requiring systemic therapy;\n13. Treatment with long-term systemic immunosuppressive medications (≥10 mg\u002Fd prednisone or equivalent doses of other steroids) or other immunosuppressive medications;\n14. History of uncontrolled cardiovascular disease; or clinically significant QT interval prolongation, or QTc interval \\>480 ms during screening period;\n15. Abnormal liver function \\[total bilirubin \\> 1.5 times of the upper limit of normal value; ALT\u002FAST \\> 2.5 times of the upper limit of normal value in patients without liver metastases and ALT\u002FAST \\> 5 times of the upper limit of normal value in patients with liver metastases\\], abnormal renal function (serum creatinine \\> 1.5 times of the upper limit of normal value);\n16. History of serious concomitant diseases (e.g., severe hypertension, diabetes, thyroid disease, active infection, etc.) ;\n17. History of diagnosed neurological or psychiatric disorders, including epilepsy or dementia;\n18. Unsuitable for participation in this study assessed by investigators;\n19. Patients who were already enrolled in other clinical studies;\n20. Mixed lung cancer with small cell components.",{"count":58,"type":21},20,[24],"The current standard of care for locally advanced non-small cell lung cancer (NSCLC) is concurrent chemoradiation and consolidation immunotherapy. In real world clinical practice, patients who cannot tolerate concurrent chemoradiation generally received radiotherapy alone or sequential chemoradiation. These patients are more likely to develop distant metastases and therefore may require tolerable systemic consolidation regimens. However, there is a lack of evidence from clinical studies on consolidation immunotherapy after radiotherapy alone or sequential chemoradiation. The aim of the study is to explore the efficacy and safety of Tislelizumab consolidation therapy after radiotherapy or sequential chemoradiation in locally advanced NSCLC patients who are intolerable of concurrent concurrent chemoradiation.",[62,30,63],"Non-small Cell Lung Cancer","Radiotherapy or Sequential Chemoradiation","2024-11-22",{"date":66,"type":41},"2024-11-26",{"date":68,"type":41},"2022-07-07",{"date":70,"type":21},"2026-07-07",{"name":72,"class":48},"Peking University Cancer Hospital & Institute"]