[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657964":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":51,"studyPopulation":44,"armGroups":52,"interventions":62,"overallOfficials":44,"centralContacts":81,"locations":87,"responsibleParty":104,"collaborators":44,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":108,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":44,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":132,"whyStopped":44,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":44},[9],{"measure":10,"description":11,"timeFrame":12},"Pathological Complete Response (pCR) Rate","The proportion of patients with no residual viable tumor cells in the resected primary tumor and regional lymph nodes, as assessed by pathological review. Patients who do not undergo surgery will be considered as not achieving pCR.","After completion of neoadjuvant therapy and surgery (approximately 4-6 weeks after the last dose of neoadjuvant therapy)",[14,17,21,25,29,32,36,40],{"measure":15,"description":16,"timeFrame":12},"Major Pathological Response (MPR) Rate","The proportion of patients with ≤10% viable tumor cells in the resected specimen.",{"measure":18,"description":19,"timeFrame":20},"R0 Resection Rate","The proportion of patients achieving microscopically margin-negative resection.","At time of surgery",{"measure":22,"description":23,"timeFrame":24},"Objective Response Rate (ORR) per RECIST v1.1","The proportion of patients achieving a confirmed complete or partial response according to RECIST v1.1.","Up to 14 days before surgery",{"measure":26,"description":27,"timeFrame":28},"Event-Free Survival (EFS) and 2-Year EFS Rate","Time from enrollment to disease progression, local recurrence, distant metastasis, or death from any cause.","Up to 60 months after enrollment",{"measure":30,"description":31,"timeFrame":28},"Overall Survival (OS) and 2-Year OS Rate","Time from enrollment to death from any cause.",{"measure":33,"description":34,"timeFrame":35},"Incidence and Severity of Adverse Events (AEs), Serious Adverse Events (SAEs), and Immune-Related Adverse Events (irAEs)","Evaluated according to NCI CTCAE v5.0.","From informed consent to 90 days after the last dose of study treatment",{"measure":37,"description":38,"timeFrame":39},"Feasibility (Completion Rate of Neoadjuvant Therapy and Surgery)","Proportion of patients completing 3 cycles of neoadjuvant therapy and undergoing surgery as planned; surgical delay rate.","Up to 4-6 weeks after the last dose of neoadjuvant therapy",{"measure":41,"description":42,"timeFrame":43},"QS Radiotherapy-Related Toxicity","Incidence and severity of radiation pneumonitis, esophagitis, dermatitis, myelosuppression, and myocarditis, graded according to NCI CTCAE v5.0.","Up to 90 days after the last dose of radiotherapy",null,{"allocation":46,"interventionModel":47,"interventionModelDescription":44,"primaryPurpose":48,"observationalModel":44,"timePerspective":44,"maskingInfo":49},"NA","SINGLE_GROUP","TREATMENT",{"masking":50,"maskingDescription":44,"whoMasked":44},"NONE","Background:\n\nNeoadjuvant immune checkpoint inhibitor (ICI) combined with platinum-based chemotherapy has become a standard of care for resectable stage II-III NSCLC, as demonstrated by phase III trials such as CheckMate-816, KEYNOTE-671, and RATIONALE-315. However, a significant proportion of patients still fail to achieve deep pathological responses due to mechanisms such as poor antigen release, impaired antigen presentation, and an immunosuppressive tumor microenvironment (TME).\n\nRadiotherapy possesses immunomodulatory properties, inducing immunogenic cell death and promoting antigen release. However, traditional continuous fractionated radiotherapy may deplete circulating lymphocytes and cause normal tissue damage. The \"Quad Shot\" (QS) regimen is a cyclical hypofractionated radiotherapy approach (14-14.8 Gy in 4 fractions over 2 days) that has shown low toxicity in palliative settings. Its cyclical, pulsatile nature may provide repeated immune stimulation and TME remodeling, making it a promising partner for immunotherapy.\n\nStudy Design:\n\nThis is a single-arm, prospective, exploratory phase II clinical study. Patients with histologically or cytologically confirmed, untreated, resectable stage II-IIIB NSCLC (including T3-4N2 IIIB, AJCC 9th edition) will be enrolled.\n\nPatients will receive 3 cycles of neoadjuvant treatment (every 3 weeks):\n\nQuad Shot radiotherapy (14-14.8 Gy\u002F4 fractions, Day 1-2) Tislelizumab (200 mg, Day 3) Platinum-based doublet chemotherapy (Day 3): Carboplatin (AUC 5) or Cisplatin (75 mg\u002Fm²) combined with Pemetrexed (500 mg\u002Fm², for non-squamous) or Paclitaxel (175 mg\u002Fm², for squamous).\n\nFollowing 3 cycles of neoadjuvant therapy, patients will undergo surgery 4-6 weeks (±7 days) after the last dose. Postoperative adjuvant therapy will be administered at the investigator's discretion according to NCCN and CSCO guidelines.\n\nObjectives and Endpoints:\n\nThe primary objective is to evaluate the antitumor efficacy of this regimen, with the primary endpoint being the pathological complete response (pCR) rate. Secondary endpoints include major pathological response (MPR) rate, R0 resection rate, objective response rate (ORR) per RECIST v1.1, event-free survival (EFS), overall survival (OS), safety (NCI CTCAE v5.0), feasibility, surgical complications (Clavien-Dindo classification), and QS radiotherapy-related toxicities.\n\nSample Size:\n\nA total of 12 patients will be enrolled, with at least 10 evaluable patients included in the primary endpoint analysis to account for an estimated 2 dropouts.\n\nStudy Duration:\n\nThe estimated enrollment period is 6-12 months, with an anticipated study completion date of December 2031.",[53],{"label":54,"type":55,"description":56,"interventionNames":57},"Neoadjuvant Quad Shot Radiotherapy + Tislelizumab + Chemotherapy","EXPERIMENTAL","Patients receive 3 cycles of neoadjuvant therapy (every 21 days). Each cycle consists of:\n\n* Quad Shot radiotherapy (14-14.8 Gy\u002F4 fractions on Day 1-2)\n* Tislelizumab (200 mg, Day 3)\n* Platinum-based doublet chemotherapy (Day 3): Carboplatin (AUC 5) or Cisplatin (75 mg\u002Fm²), combined with Pemetrexed (500 mg\u002Fm² for non-squamous) or Paclitaxel (175 mg\u002Fm² for squamous).\n\nSurgery is performed 4-6 weeks (±7 days) after the third cycle. Postoperative adjuvant therapy is administered at the investigator's discretion according to NCCN and CSCO guidelines.",[58,59,60,61],"Radiation: Quad Shot Radiotherapy","Drug: Tislelizumab","Drug: Carboplatin or cisplatin","Drug: Pemetrexed or Paclitaxel",[63,68,73,77],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":44},"RADIATION","Quad Shot Radiotherapy","3.7 Gy per fraction, twice daily (with an interval of at least 6 hours), for 4 fractions over 2 consecutive days (Days 1-2 of each cycle). Total dose of 14.8 Gy per cycle, repeated every 3 weeks for 3 cycles (cumulative dose 44.4 Gy). Delivered using IMRT or VMAT.",[54],{"type":69,"name":70,"description":71,"armGroupLabels":72,"otherNames":44},"DRUG","Tislelizumab","200 mg administered via intravenous infusion on Day 3 of each 21-day cycle for 3 cycles.",[54],{"type":69,"name":74,"description":75,"armGroupLabels":76,"otherNames":44},"Carboplatin or cisplatin","Carboplatin (AUC 5) or Cisplatin (75 mg\u002Fm²) administered intravenously on Day 3 of each 21-day cycle for 3 cycles.",[54],{"type":69,"name":78,"description":79,"armGroupLabels":80,"otherNames":44},"Pemetrexed or Paclitaxel","Pemetrexed (500 mg\u002Fm²) for non-squamous NSCLC or Paclitaxel (175 mg\u002Fm²) for squamous NSCLC, administered intravenously on Day 3 of each 21-day cycle for 3 cycles.",[54],[82],{"name":83,"role":84,"phone":85,"phoneExt":44,"email":86},"Kunyu Yang, MD","CONTACT","0086-13995595360","yangkunyu@hust.edu.cn",[88],{"facility":89,"status":44,"city":90,"state":91,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"Wuhan Union Hospital","Wuhan","Hubei","430022","China","CN",{"type":96,"coordinates":97},"Point",[98,99],114.26667,30.58333,{"lat":99,"lon":98},[102],{"name":83,"role":84,"phone":103,"phoneExt":44,"email":86},"13995595360",{"type":105,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100657964","phase-2-quad-shot-radiotherapy-combined-with-tislelizumab-and-platinum-based-chemotherapy-before-surgery-for-stage-ii-iii-non-small-cell-lung-cancer-100657964",false,"NCT07845916","Quad Shot Radiotherapy Combined With Tislelizumab and Platinum-Based Chemotherapy Before Surgery for Stage II-III Non-Small Cell Lung Cancer","A Single-Arm, Prospective, Exploratory Phase II Clinical Study of Quad Shot Radiotherapy Combined With Tislelizumab and Platinum-Based Doublet Chemotherapy as Neoadjuvant Treatment for Stage II-III Non-Small Cell Lung Cancer","QS-NSCLC","Inclusion Criteria:\n\n1. Age 18-75 years, either gender.\n2. Histologically or cytologically confirmed, untreated stage II-IIIB non-small cell lung cancer (NSCLC) (including T3-4N2 IIIB, AJCC 9th edition). Baseline staging must include PET\u002FCT (or chest + upper abdomen contrast-enhanced CT + whole body bone scan) + brain MRI. Stage III patients will be further subdivided into IIIA and IIIB per AJCC 9th edition for separate recording, evaluation, and analysis.\n3. Evaluated as resectable by a multidisciplinary team including thoracic surgeons.\n4. At least one evaluable target lesion per RECIST v1.1.\n5. ECOG Performance Status 0-1.\n6. Adequate major organ function: Neutrophils ≥ 1.5×10\\^9\u002FL; Platelets ≥ 100×10\\^9\u002FL; Hemoglobin \\> 9.0 g\u002FdL; Serum creatinine ≤ 1.5×ULN or Creatinine Clearance (CrCl) ≥ 40 mL\u002Fmin; AST\u002FALT ≤ 3×ULN; Total bilirubin ≤ 1.5×ULN; INR\u002FAPTT within normal range; FEV1 ≥ 1.2L or \\> 40% predicted.\n7. Signed written informed consent prior to any study-related procedures.\n8. Investigator judges that the patient is able to comply with the study protocol, willing and able to follow visit schedules, treatment plans, laboratory tests, and other study procedures.\n9. Negative pregnancy test at screening (for women of childbearing potential). Subjects of childbearing potential (male and female) must agree to use effective contraception from screening until 180 days after the last dose.\n\nExclusion Criteria:\n\n1. Known or suspected autoimmune disease (except vitiligo, Type I diabetes, or hypothyroidism requiring only hormone replacement therapy with no signs of recurrence).\n2. Requires systemic corticosteroid therapy (\\>10 mg\u002Fday prednisolone or equivalent) or other immunosuppressive drugs within 14 days prior to enrollment (inhaled or topical steroids, and physiological replacement doses of adrenal corticosteroids are allowed).\n3. History of thoracic radiotherapy.\n4. Active bleeding before treatment.\n5. Severe heart, lung, liver, or kidney dysfunction, hematopoietic system disease, cachexia, or other conditions that make the patient unable to tolerate chemoradiotherapy.\n6. History of diabetes for more than 10 years with unsatisfactory blood glucose control.\n7. History of interstitial lung disease or non-infectious pneumonitis.\n8. NSCLC patients with EGFR sensitizing mutations or ALK fusion genes.\n9. Prior or concurrent other malignancies (except cured non-melanoma skin cancer and carcinoma in situ; or malignancies in complete remission for ≥ 2 years without requiring additional anti-tumor therapy during the study period).\n10. Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or other drugs targeting T-cell costimulatory or immune regulatory pathways.\n11. Active hepatitis B (HBV DNA ≥ 2000 IU\u002FmL or 10\\^4 copies\u002FmL) or hepatitis C (HCV antibody positive and HCV-RNA above the lower limit of detection).\n12. HIV positive or diagnosed with acquired immunodeficiency syndrome (AIDS).\n13. Received live vaccine within 4 weeks prior to the start of study treatment.\n14. Known or suspected allergy to the study drugs or any related drugs in this trial.\n15. Pregnant or breastfeeding women.\n16. Investigator considers that the patient has other factors that may prevent completion of the study or affect subject safety or data collection.","ALL","18 Years","75 Years",{"count":118,"type":119},12,"ESTIMATED","INTERVENTIONAL",[122],"PHASE2","This study aims to evaluate a new pre-surgery (neoadjuvant) treatment for patients with stage II-III non-small cell lung cancer (NSCLC). Currently, standard pre-surgery treatment involves immunotherapy combined with chemotherapy. While effective, many patients still have residual tumor cells after this standard treatment.\n\nRadiation therapy can not only kill tumor cells but also help the immune system recognize and fight cancer. The type of radiation used in this study is called \"Quad Shot\" (QS) radiotherapy. It is a short, high-dose, cyclical treatment designed to boost the effects of immunotherapy with less toxicity than standard daily radiation.\n\nPatients in this study will receive 3 cycles of QS radiotherapy combined with Tislelizumab (an immunotherapy drug) and standard platinum-based chemotherapy before surgery. The main goal of this study is to see if this combined approach can make the tumor completely disappear under a microscope (called pathological complete response, or pCR). Researchers will also monitor the safety of the treatment, side effects, and how well patients tolerate the treatment before undergoing surgery. Approximately 12 patients will be enrolled in this study.",[125],"Non-Small Cell Lung Cancer",[127,128,65,70,129,130,131],"NSCLC","Neoadjuvant Therapy","Platinum-based Chemotherapy","Immunotherapy","Pathological Complete Response","NOT_YET_RECRUITING","2026-09-27",{"date":135,"type":136},"2026-09-29","ACTUAL",{"date":138,"type":119},"2026-10-10",{"date":140,"type":119},"2031-12-31",{"name":5,"class":6},1]