[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572548":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":46,"centralContacts":51,"locations":59,"responsibleParty":78,"collaborators":32,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":32,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":32,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":103,"overallStatus":62,"whyStopped":32,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,16,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Study group A","EXPERIMENTAL","Patients will receive neoadjuvant chemo-immunotherapy, hypo-RT and concurrent chemotherapy, followed by consolidative immunotherapy for a maximum duration of 12 months.",[13,14,15],"Drug: Neoadjuvant therapy","Radiation: Hypo-RT and concurrent chemotherapy","Drug: Consolidative immunotherapy",{"label":17,"type":10,"description":18,"interventionNames":19},"Study group B","Patients will receive neoadjuvant chemo-immunotherapy, CFRT and concurrent chemotherapy, followed by consolidative immunotherapy for a maximum duration of 12 months.",[13,20,15],"Radiation: CFRT and concurrent chemotherapy",{"label":22,"type":23,"description":24,"interventionNames":25},"Control group","ACTIVE_COMPARATOR","CFRT and concurrent chemotherapy, followed by consolidative immunotherapy for a maximum duration of 12 months.",[20,15],[27,33,38,42],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Neoadjuvant therapy","The neoadjuvant regimen prior to radiotherapy consists of albumin-bound paclitaxel 260 mg\u002Fm², cisplatin 75 mg\u002Fm², and tislelizumab 200 mg, administered every 3 weeks.",[9,17],null,{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":32},"RADIATION","Hypo-RT and concurrent chemotherapy","Definitive dose of hypofractionated thoracic radiotherapy with concurrent chemotherapy",[9],{"type":34,"name":39,"description":40,"armGroupLabels":41,"otherNames":32},"CFRT and concurrent chemotherapy","Definitive dose of conventionally fractionated thoracic radiotherapy with concurrent chemotherapy",[22,17],{"type":28,"name":43,"description":44,"armGroupLabels":45,"otherNames":32},"Consolidative immunotherapy","Following the completion of chemoradiotherapy, Tislelizumab consolidation therapy will be administered based on treatment efficacy and the patient's physical condition, for a total duration of 1 year, starting 1-2 months after chemoradiotherapy.",[22,9,17],[47],{"name":48,"affiliation":49,"role":50},"Hui Liu, Professor","Sun yat-sen universtiy cancer center","PRINCIPAL_INVESTIGATOR",[52,57],{"name":53,"role":54,"phone":55,"phoneExt":32,"email":56},"Bo Qiu, Professor","CONTACT","02087343031","qiubo@sysucc.org.cn",{"name":48,"role":54,"phone":55,"phoneExt":32,"email":58},"liuhui@sysucc.org.cn",[60],{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Sun yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510060","China","CN",{"type":69,"coordinates":70},"Point",[71,72],113.25,23.11667,{"lat":72,"lon":71},[75],{"name":76,"role":54,"phone":55,"phoneExt":32,"email":77},"Hui Liu, MD","liuhuisysucc@126.com",{"type":50,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Hui Liu","Professor","100572548","phase-3-neoadjuvant-immunotherapy-plus-chemotherapy-followed-by-concurrent-chemoradiotherapy-and-consolidative-immunotherapy-for-locally-advanced-non-small-cell-lung-cancer-100572548",false,"NCT06734702","Neoadjuvant Immunotherapy Plus Chemotherapy Followed by Concurrent Chemoradiotherapy and Consolidative Immunotherapy for Locally Advanced Non-small Cell Lung Cancer","Neoadjuvant Immunotherapy Plus Chemotherapy Followed by Concurrent Chemoradiotherapy and Consolidative Immunotherapy Compared With Concurrent Chemoradiotherapy and 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: Patients must not have received prior chemotherapy, radiotherapy, surgery, targeted therapy, or 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* 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* Prior treatment with anti-PD-1 or anti-PD-L1 antibodies.\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":92,"type":93},497,"ESTIMATED","INTERVENTIONAL",[96],"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), leading to a 5-year survival rate of over 40%. The optimal timing of radiotherapy combined with immunotherapy still requires further exploration. This phase III, randomized controlled clinical trial is to investigate the efficacy and safety of neoadjuvant immuno-chemotherapy followed by concurrent chemoradiotherapy and consolidative immunotherapy, compared with concurrent chemoradiotherapy and consolidative immunotherapy in LANSCLC patients.",[99,100,101,102],"Neoadjuvant Therapy","Concurrent Chemoradiotherapy","Immunotherapy","Locally Advanced Non-Small Cell Lung Cancer",[29,100,101,102],"2025-07-19",{"date":106,"type":107},"2025-07-24","ACTUAL",{"date":109,"type":107},"2024-11-30",{"date":111,"type":93},"2028-11-29",{"name":5,"class":6},1]