[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596991":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":47,"centralContacts":52,"locations":60,"responsibleParty":107,"collaborators":29,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":29,"eligibilityCriteria":116,"healthyVolunteers":112,"sex":117,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":29,"studyType":123,"phases":124,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":63,"whyStopped":29,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Hypofractionated CCRT","EXPERIMENTAL","All patients will receive hypofractionated concurrent chemoradiotherapy, followed by consolidative immunotherapy for a maximum duration of 12 months.",[13,14,15],"Radiation: Hypofractionated Radiation Therapy","Drug: Concurrent Chemotherapy","Drug: Consolidative immunotherapy",{"label":17,"type":18,"description":19,"interventionNames":20},"Conventional fractionated CCRT","ACTIVE_COMPARATOR","All patients will receive conventional fractionated concurrent chemoradiotherapy, followed by consolidative immunotherapy for a maximum duration of 12 months.",[21,22,15],"Radiation: Conventionally Fractionated Radiation Therapy","Drug: concurrent chemotherapy",[24,30,34,39,43],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"RADIATION","Hypofractionated Radiation Therapy","All patients will receive split-course hypofractionated radiotherapy. First course of radiotherapy: Total dose of 4000 cGy in 10 daily fractions (400 cGy per fraction) or 3000 cGy in 6 daily fractions (500 cGy per fraction). Three weeks after the completion of the first course of hypofractionated radiotherapy, tumor response and toxicity will be evaluated. For patients who achieve a partial response and without grade 2 or higher respiratory toxicity, a second course of radiotherapy will be planned for the residue disease at a total dose of 2000 \\~2400 cGy in 5\\~6 fractions (400 cGy per fraction). The interval between the two courses of radiotherapy will be 28 days.",[9],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Conventionally Fractionated Radiation Therapy","Patients in this group will receive a total dose of 6000- 6400 cGy in 30- 32 fractions, with 200 cGy per fraction.",[17],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":29},"DRUG","Concurrent Chemotherapy","Paclitaxel plus platinum-based chemotherapy.",[9],{"type":35,"name":40,"description":41,"armGroupLabels":42,"otherNames":29},"concurrent chemotherapy","Paclitaxel plus platinum-based chemotherapy or pemetrexed plus platinum-based chemotherapy.",[17],{"type":35,"name":44,"description":45,"armGroupLabels":46,"otherNames":29},"Consolidative immunotherapy","Following the completion of chemoradiotherapy, PD-1\u002FPD-L1 immune checkpoint inhibitor consolidation therapy will be administered for up to 12 months.",[17,9],[48],{"name":49,"affiliation":50,"role":51},"Hui Liu, Professor","Sun yat-sen universtiy cancer center","PRINCIPAL_INVESTIGATOR",[53,58],{"name":54,"role":55,"phone":56,"phoneExt":29,"email":57},"Bo Qiu, Professor","CONTACT","02087343031","qiubo@sysucc.org.cn",{"name":49,"role":55,"phone":56,"phoneExt":29,"email":59},"liuhui@sysucc.org.cn",[61,79,93],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"The First Affiliated Hospital of Chongqing Medical University","RECRUITING","Chongqing","Chongqing Municipality","400016","China","CN",{"type":70,"coordinates":71},"Point",[72,73],106.55771,29.56026,{"lat":73,"lon":72},[76],{"name":77,"role":55,"phone":29,"phoneExt":29,"email":78},"Tao Zhang, MD","tumorzzt@163.com",{"facility":80,"status":63,"city":81,"state":82,"zip":83,"country":67,"countryCode":68,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Gansu Provincial Cancer Hospital","Lanzhou","Gansu","730050",{"type":70,"coordinates":85},[86,87],103.83987,36.05701,{"lat":87,"lon":86},[90],{"name":91,"role":55,"phone":29,"phoneExt":29,"email":92},"Shihong Wei, M.Med","taonayongheng@126.com",{"facility":94,"status":63,"city":95,"state":96,"zip":97,"country":67,"countryCode":68,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Sun yat-sen University Cancer Center","Guangzhou","Guangdong","510060",{"type":70,"coordinates":99},[100,101],113.25,23.11667,{"lat":101,"lon":100},[104],{"name":105,"role":55,"phone":56,"phoneExt":29,"email":106},"Hui Liu, MD","liuhuisysucc@126.com",{"type":51,"investigatorFullName":108,"investigatorTitle":109,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Hui Liu","Professor","100596991","phase-3-hypofractionated-versus-conventional-chemoradiotherapy-followed-by-consolidative-immunotherapy-in-locally-advanced-nsclc-100596991",false,"NCT07052669","Hypofractionated Versus Conventional Chemoradiotherapy Followed by Consolidative Immunotherapy in Locally Advanced NSCLC","Hypofractionated Chemoradiotherapy Followed by Consolidative Immunotherapy Versus Conventional Fractionated Chemoradiotherapy Followed by Consolidative Immunotherapy in Locally Advanced Non-small Cell Lung Cancer: A Randomized, Phase III Controlled Study","Inclusion Criteria:\n\n* Signed and Dated Informed Consent: Written informed consent must be provided prior to any study procedures, with the consent form signed and dated by the participant.\n* Age Range: Male or female patients aged 18 to 75 years.\n* Diagnosis: Patients must have locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC), with histological or cytological confirmation of the diagnosis.\n* Previous Treatment: Treatment-naïve or previously treated with induction chemotherapy ± immunotherapy.\n* Tumor Sample Requirement: Tumor tissue samples must be provided, and they should be sufficient for analysis. The samples must be unstained and archived.\n* Driver gene testing: EGFR wild-type, ALK rearrangement-negative.\n* Life Expectancy: Patients must have an expected survival of at least 12 weeks.\n* Performance Status (PS): The patient's WHO Performance Status (PS) must be 0 or 1.\n* Pregnancy Testing: Postmenopausal women, or women who have had a negative urine or serum pregnancy test within 14 days before the study medication (HCG sensitivity ≥ 25 IU\u002FL or equivalent).\n* Breastfeeding: Women must not be breastfeeding.\n* Women of childbearing potential (WOCBP) must agree to use contraception during the study treatment period and for 5 months after the last dose of the investigational drug (i.e., 30 days \\[ovulation cycle\\] + approximately 5 half-lives of the study drug).\n* Men who have sexual relations with WOCBP must agree to use contraception during the study treatment period and for 7 months after the last dose of the investigational drug (i.e., 90 days \\[sperm renewal cycle\\] + approximately 5 half-lives of the study drug).\n* Males with no sperm production are exempt from contraception requirements. WOCBP who are not sexually active are exempt from contraception but must still undergo pregnancy testing as outlined above.\n* Organ and Bone Marrow Function: The following laboratory parameters must be met:\n\nForced expiratory volume in 1 second (FEV1) ≥ 800 mL Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL Platelets ≥ 100 × 10⁹\u002FL Hemoglobin ≥ 9.0 g\u002FdL Calculated creatinine clearance using the Cockcroft-Gault formula ≥ 50 mL\u002Fmin Serum bilirubin ≤ 1.5 × upper limit of normal (ULN) AST and ALT ≤ 2.5 × ULN\n\nExclusion Criteria:\n\n* Patients meeting any of the following criteria should not be enrolled in the study:\n* Concurrent participation in another clinical trial, except for observational (non-interventional) studies.\n* Histological subtype of mixed small-cell and non-small-cell lung cancer. Use of immunosuppressive drugs within 28 days before treatment, except for intranasal or inhaled corticosteroids at physiological doses or systemic corticosteroids ≤10 mg\u002Fday of prednisone or equivalent.\n* Major surgery within 4 weeks prior to enrollment (excluding procedures for vascular access).\n* History or active autoimmune diseases within the past two years.\n* Active or a history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).\n* History of primary immunodeficiency.\n* History of organ transplantation requiring immunosuppressive therapy.\n* Average corrected QT interval (QTc) ≥470 ms calculated from three ECG cycles using the Bazett formula.\n* Uncontrolled comorbidities, including but not limited to: Persistent or active infections. Symptomatic congestive heart failure. Poorly controlled hypertension. Unstable angina. Cardiac arrhythmias. Active peptic ulcer disease or gastritis. Active bleeding disorders. Hepatitis C or HIV infection. HBsAg-positive patients with HBV DNA \\>500 IU\u002FmL. Mental or social conditions that may limit adherence to study requirements or compromise the ability to provide informed consent.\n* Known history of tuberculosis.\n* Receipt of a live attenuated vaccine within 30 days before study initiation or planned during the study period.\n* History of another primary malignancy within the past 5 years, except for adequately treated basal or squamous cell carcinoma of the skin or in situ cervical cancer.\n* Pregnancy, breastfeeding, or not using effective contraception (for men and women of reproductive potential).\n\nPatients in the experimental group should not proceed to concurrent chemoradiotherapy if any of the following criteria are met:\n\n* Presence of distant metastases.\n* Locoregional progression making definitive concurrent chemoradiotherapy unfeasible due to normal tissue dose constraints (assessed by the radiation oncologist).\n* WHO performance status score of 2-4.\n* Impaired organ or bone marrow function, including:\n\nForced expiratory volume in 1 second (FEV1) \\\u003C800 mL. Absolute neutrophil count (ANC) \\\u003C1.5 × 10⁹\u002FL. Platelets \\\u003C100 × 10⁹\u002FL. Hemoglobin \\\u003C9.0 g\u002FdL. Creatinine clearance (Cockcroft-Gault formula) \\\u003C50 mL\u002Fmin. Serum bilirubin \\>1.5 × upper limit of normal (ULN). AST and ALT \\>2.5 × ULN.\n\n\\- Patient withdrawal from the study.\n\nPatients should not proceed to consolidation immunotherapy if any of the following criteria are met:\n\n* Disease progression during concurrent chemoradiotherapy.\n* Use of immunosuppressive drugs within 28 days before the first dose of tislelizumab, except for physiological doses of intranasal or inhaled corticosteroids or systemic corticosteroids ≤10 mg\u002Fday of prednisone or equivalent. Use of corticosteroids to manage chemoradiotherapy-related toxicity is permitted.\n* Persistent unresolved CTCAE grade \\>2 toxicities from prior chemoradiotherapy.\n* Grade ≥2 pneumonitis resulting from prior chemoradiotherapy.\n* Any prior grade ≥3 immune-related adverse event (irAE) or unresolved irAE \\> grade 1.","ALL","18 Years","75 Years",{"count":121,"type":122},311,"ESTIMATED","INTERVENTIONAL",[125],"PHASE3","Consolidative immunotherapy following concurrent chemoradiotherapy, based on the PACIFIC trial, has become the standard treatment for locally advanced non-small cell lung cancer (LANSCLC). Radiotherapy strategies for maximizing efficacy and local control require further investigation. This phase III, randomized controlled clinical trial is to investigate the efficacy and safety of hypofractionated chemoradiotherapy followed by consolidative immunotherapy versus conventional fractionated chemoradiotherapy followed by consolidative immunotherapy in LANSCLC patients.",[128],"Locally Advanced Non-Small Cell Lung Cancer",[130,131,132,44],"Hypofractionated radiotherapy","Conventionally fractionated radiotherapy","Concurrent Chemoradiotherapy","2025-07-19",{"date":135,"type":136},"2025-07-23","ACTUAL",{"date":138,"type":136},"2025-07-01",{"date":140,"type":122},"2029-06-30",{"name":5,"class":6},3]