[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652730":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":53,"locations":62,"responsibleParty":79,"collaborators":26,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":26,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":26,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":104,"whyStopped":26,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Sichuan Cancer Hospital and Research Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SFRT + Tislelizumab + Chemotherapy","EXPERIMENTAL","Participants receive spatially fractionated radiotherapy (lattice radiation therapy) to the primary lung tumor, with a prescription dose of GTV 20 Gy in 5 fractions and GTV-Lattice 60 Gy in 5 fractions, delivered on Monday, Wednesday, and Friday over one week. Following SFRT, participants receive 2 to 4 cycles (depending on clinical evaluation and per protocol specifications) of tislelizumab 200 mg intravenously on Day 1 of each 21-day cycle (Q3W), combined with platinum-based doublet chemotherapy (carboplatin AUC 5 or cisplatin 75 mg\u002Fm², plus pemetrexed 500 mg\u002Fm² for non-squamous histology or paclitaxel 175 mg\u002Fm² for squamous histology). Definitive radical surgery (lobectomy, bilobectomy, pneumonectomy, or sleeve resection with systematic mediastinal lymph node dissection) is performed 4 to 6 weeks (±7 days) after the last dose of neoadjuvant therapy. The first 6 enrolled patients undergo dose-limiting toxicity (DLT) assessment within 21 days after the first dose of study drugs.",[13,14,15,16,17,18,19],"Radiation: Spatially Fractionated Radiotherapy (SFRT)","Drug: Tislelizumab","Drug: Carboplatin","Drug: Cisplatin","Drug: Pemetrexed","Drug: Paclitaxel","Procedure: Radical Lung Resection Surgery",[21,27,32,36,40,44,48],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"RADIATION","Spatially Fractionated Radiotherapy (SFRT)","Participants receive lattice radiation therapy to the primary lung tumor. The gross tumor volume (GTV) is delineated, and lattice target volumes (GTV-Lattice) are generated using a hexagonal close-packed model within the tumor. Volumetric modulated arc therapy (VMAT) plans are designed. Prescription dose: GTV receives 20 Gy in 5 fractions, and GTV-Lattice receives 60 Gy in 5 fractions. After plan verification, treatment is delivered on 3 non-consecutive working days (e.g., Monday, Wednesday, Friday).",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DRUG","Tislelizumab","200 mg administered via intravenous infusion on Day 1 of each 21-day cycle (Q3W) for 2 to 4 cycles, starting on Day 8-15 following SFRT.",[9],{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":26},"Carboplatin","AUC 5 administered via intravenous infusion on Day 1 of each 21-day cycle (Q3W) for 2 to 4 cycles. Used in combination with either pemetrexed (for non-squamous histology) or paclitaxel (for squamous histology), at the investigator's discretion.",[9],{"type":28,"name":37,"description":38,"armGroupLabels":39,"otherNames":26},"Cisplatin","75 mg\u002Fm² administered via intravenous infusion on Day 1 of each 21-day cycle (Q3W) for 2 to 4 cycles. Used in combination with either pemetrexed (for non-squamous histology) or paclitaxel (for squamous histology), at the investigator's discretion. Adequate hydration and antiemetic prophylaxis are required.",[9],{"type":28,"name":41,"description":42,"armGroupLabels":43,"otherNames":26},"Pemetrexed","500 mg\u002Fm² administered via intravenous infusion on Day 1 of each 21-day cycle (Q3W) for 2 to 4 cycles. Indicated only for patients with non-squamous NSCLC. Vitamin B12 and folic acid supplementation are required per standard practice.",[9],{"type":28,"name":45,"description":46,"armGroupLabels":47,"otherNames":26},"Paclitaxel","175 mg\u002Fm² administered via intravenous infusion on Day 1 of each 21-day cycle (Q3W) for 2 to 4 cycles. Indicated only for patients with squamous NSCLC. Premedication to prevent hypersensitivity is required per standard practice.",[9],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":26},"PROCEDURE","Radical Lung Resection Surgery","Definitive radical surgery is performed 4 to 6 weeks (±7 days) after the last dose of neoadjuvant therapy. Surgical approaches include minimally invasive techniques (video-assisted thoracoscopic surgery \\[VATS\\] or robotic-assisted surgery) or open thoracotomy. Procedures include lobectomy, bilobectomy, pneumonectomy, or sleeve resection, combined with ipsilateral systematic mediastinal lymph node dissection.",[9],[54,59],{"name":55,"role":56,"phone":57,"phoneExt":26,"email":58},"bin hu, PhD","CONTACT","028-85420367","hubin@sczlyy.org.cn",{"name":60,"role":56,"phone":26,"phoneExt":26,"email":61},"peng xu, PhD","xupeng4618@163.com",[63],{"facility":64,"status":26,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Sichuan Cancer Hospital","Chengdu","Sichuan","610041","China","CN",{"type":71,"coordinates":72},"Point",[73,74],104.06667,30.66667,{"lat":74,"lon":73},[77],{"name":78,"role":56,"phone":57,"phoneExt":26,"email":58},"bin hu",{"type":80,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Hu Bin","Deputy Director of Thoracic Surgery and Chief of the Second Ward","100652730","phase-2-spatially-fractionated-radiotherapy-with-tislelizumab-and-chemotherapy-for-bulky-stage-iii-nsclc-a-phase-ii-trial-100652730",false,"NCT07775040","Spatially Fractionated Radiotherapy With Tislelizumab and Chemotherapy for Bulky Stage III NSCLC: A Phase II Trial","A Prospective, Single-arm, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of Spatially Fractionated Radiotherapy Combined With Tislelizumab and Platinum-based Doublet Chemotherapy as Induction\u002FConversion Therapy for Potentially Resectable Stage III Non-small Cell Lung Cancer With Bulky Disease.","Inclusion Criteria:\n\n* Voluntary agreement to participate and signed written informed consent.\n* Cytologically or histologically confirmed (via percutaneous lung biopsy, bronchoscopy, mediastinoscopy, etc.) bulky stage III non-small cell lung cancer (NSCLC) per AJCC 9th edition staging, with primary tumor \\>5 cm (T3-T4), N0-N2, and no prior chemotherapy, radiotherapy, surgery, or immunotherapy.\n* Pulmonary lesion considered potentially resectable by a multidisciplinary team (MDT) including a thoracic surgeon.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n* Adequate hematologic and organ function as demonstrated by:\n\nAbsolute neutrophil count ≥ 1,500 × 10⁹\u002FL.\n\nPlatelet count ≥ 100 × 10⁹\u002FL.\n\nHemoglobin \\> 9.0 g\u002FdL.\n\nSerum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (CrCl) ≥ 40 mL\u002Fmin.\n\nAST\u002FALT ≤ 3 × ULN.\n\nTotal bilirubin ≤ 1.5 × ULN.\n\nFEV1 ≥ 1.2 L or \\> 40% of predicted value.\n\nINR\u002FAPTT within normal limits.\n\n-Age 18 to 75 years (inclusive).\n\nExclusion Criteria:\n\n* Has or is suspected of having an autoimmune disease. Note: patients with vitiligo, type I diabetes mellitus, or hypothyroidism (Hashimoto's thyroiditis) requiring only hormone replacement therapy may be enrolled if no significant signs of recurrence are present.\n* Requires systemic corticosteroid therapy (\\>10 mg prednisone or equivalent per day) or other immunosuppressive agents within 14 days after enrollment. Note: inhaled or topical corticosteroids, or adrenal hormone replacement therapy (\\>10 mg prednisone or equivalent per day) for patients without active autoimmune disease, are permitted.\n* Prior history of thoracic radiotherapy.\n* Active bleeding prior to treatment.\n* Severe cardiac, pulmonary, hepatic, renal, or hematopoietic dysfunction, cachexia, or any condition that would preclude tolerance to radiochemotherapy.\n* History of diabetes mellitus for \\>10 years with poorly controlled blood glucose.\n* History of interstitial lung disease or non-infectious pneumonitis.\n* NSCLC with known EGFR-sensitizing mutations, ALK fusion gene, or ROS1 rearrangement.\n* History of another malignancy (excluding non-melanoma skin cancer and carcinoma in situ of the bladder, stomach, colon, endometrium, cervix, melanoma, or breast) unless the malignancy has been in complete remission for ≥2 years and no additional anti-tumor therapy is required during the study period.\n* In the investigator's opinion, medically, psychologically, or physically unable to complete the study or to understand the patient information.\n* Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or other agents targeting T-cell co-stimulation or immune checkpoint pathways.\n* Active hepatitis B (HBV DNA ≥ 2000 IU\u002FmL or ≥ 10⁴ copies\u002FmL) or hepatitis C (anti-HCV antibody positive and HCV-RNA above the lower limit of detection).\n* HIV-positive or diagnosed with acquired immunodeficiency syndrome (AIDS).\n* Known or suspected allergy to the study drugs or to any agent used in this trial.\n* Pregnant or breastfeeding women.","ALL","18 Years","75 Years",{"count":94,"type":95},43,"ESTIMATED","INTERVENTIONAL",[98],"PHASE2","This is a prospective, single-arm, multicenter phase II clinical study evaluating the efficacy and safety of spatially fractionated radiotherapy (SFRT) combined with tislelizumab and platinum-based doublet chemotherapy as induction\u002Fconversion therapy for patients with potentially resectable stage III non-small cell lung cancer (NSCLC) with bulky disease (primary tumor \\>5 cm).\n\nSFRT, also known as lattice radiation therapy, is a novel radiotherapy technique that creates alternating high-dose and low-dose regions within the tumor. This approach not only reduces tumor burden but also may enhance anti-tumor immune responses, potentially working synergistically with immunotherapy.\n\nStudy participants will receive SFRT to the primary lung tumor (GTV 20 Gy\u002F5 fractions, GTV-Lattice 60 Gy\u002F5 fractions), followed by 2-4 cycles of tislelizumab (200 mg, Q3W) combined with platinum-based doublet chemotherapy. Surgery will be performed 4-6 weeks after the last cycle of neoadjuvant therapy. The first 6 enrolled patients will undergo dose-limiting toxicity (DLT) assessment within 21 days after the first dose of study drug.\n\nThe primary endpoint is major pathological response (MPR) rate, defined as the proportion of patients with ≤10% viable tumor cells in the resected specimen. Secondary endpoints include 1-year event-free survival (EFS), pathological complete response (pCR) rate, objective response rate (ORR), disease control rate (DCR), R0 resection rate, 1-year overall survival (OS), time to distant metastasis (TTDM), and safety.\n\nA total of 44 patients will be enrolled across multiple centers in China. An interim analysis will be conducted after 50% of patients are enrolled.",[101],"Non-Small Cell Lung Cancer",[103],"Non-Small Cell Lung Cancer (Stage III, Bulky Disease, Potentially Resectable)","NOT_YET_RECRUITING","2026-08-15",{"date":107,"type":108},"2026-08-20","ACTUAL",{"date":107,"type":95},{"date":111,"type":95},"2030-06-30",{"name":5,"class":6},1]