[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nsclc-stage-iiia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nsclc-stage-iiia":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100563289","phase-2-neoajuvant-tislelizumab-combined-with-chemotherapy-for-initially-unresectable-stage-iiian2-non-small-cell-lung-cancer-100563289",false,"NCT06614231","Neoajuvant Tislelizumab Combined with Chemotherapy for Initially Unresectable Stage IIIA\u002FN2 Non-small Cell Lung Cancer","Prospective Phase II Trial of Neoajuvant Tislelizumab Combined with Chemotherapy for Initially Unresectable Stage IIIA\u002FN2 Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. Patients with initially untreated, unresectable stage III NSCLC (according to the International Association for the Study of Lung Cancer IASLC 8th Thoracic Tumor Stage) with non-small cell lung cancer\n2. All patients received baseline PET\u002FCT (or neck, upper thoracic and abdominal CT+ cranial MR) for clinical staging\n3. Cytology\u002Fhistology (mediastinoscopy or EBUS, etc.) confirmed N2 non-small cell lung cancer\n4. For non-squamous cell carcinoma patients, if EGFR\u002FALK mutation status is unknown, tissue samples should be provided for EGFR\u002FALK gene testing before enrollment; For patients with squamous cell carcinoma, if EGFR\u002FALK mutation status is unknown, testing is not required during screening\n5. ECOG (Performance status, PS) score 0-1\n6. Hematology testings meet the following requirements\n\n   * neutrophil ≥1.5\\*109\u002FL\n   * Platelets ≥100\\*109\u002FL\n   * Hemoglobin \\> 9.0 g\u002FdL\n   * Serum creatinine ≤1.5ULN or creatinine clearance (Ccr) ≥40mL\u002Fmin\n   * AST\u002FALT≤ 3ULN\n   * Total bilirubin ≤1.5ULN\n   * FEV1≥1.2L or \\> 40% of the estimated value\n   * INR\u002FAPTT within normal range\n7. The patient is over 18 years old\n8. Measurable lesions (according to the RECIST 1.1 version)\n9. Subject must understand and voluntarily sign informed consent prior to any study-related evaluation\n\nExclusion Criteria\n\n1. The patient presents with a confirmed or suspected autoimmune disorder.\n\n   * Note: Patients with vitiligo, type I diabetes mellitus, or Hashimoto\\'s thyroiditis who are hypothyroid but require only hormone replacement therapy may be included in the study if there are no obvious signs of relapse\n2. Patients must have undergone systemic corticosteroid treatment (≥10mg prednisolone \\[or equivalent\\]\u002Fday) or received other immunosuppressive medications within 14 days prior to enrollment.\n\n   * Note: Inhaled or topical corticosteroids and adrenal hormone replacement therapy (≥10mg prednisolone \\[or equivalent\\]\u002Fday) can also be accepted for individuals lacking clear evidence of autoimmune disorders\n3. Patients with grade 3 or 4 interstitial lung disease\n4. Have other malignant tumors and need anti-tumor therapy\n5. Patients with previous malignancies (except skin malignancies other than melanoma, and in situ cancers of the following sites (bladder, stomach, colorectal, endometrial, cervix, melanoma, or breast) were not included in the study. Unless the malignancy has been in complete remission for two years or more and no additional antitumor therapy is required during the study period\n6. The investigator believes that the patient is medically, psychologically, or physically incapable of completing this study or of understanding the patient handbook information\n7. Previously received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA, and other drugs targeting T-cell co-stimulation or immune regulatory pathways\n8. Presence of active Hepatitis B or C\n9. HIV-positive or diagnosed with Acquired Immune Deficiency Disease (AIDS)\n10. Allergy to the study drug\n11. Women who are pregnant or breastfeeding","ALL","18 Years",{"count":19,"type":20},48,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","To investigate the efficacy and safety of neoadjuvant treatment with Tislelizumab combined with chemotherapy for initially unresectable N2\u002FIII non-small cell lung cancer.",[26,27],"NSCLC, Stage IIIA","NSCLC (non-small Cell Lung Cancer)",[29,30,31],"Unresectable stage III NSCLC","Tirellizumab","Neoadjuvant treatment","NOT_YET_RECRUITING","2024-09-23",{"date":35,"type":36},"2024-09-26","ACTUAL",{"date":38,"type":20},"2024-09-20",{"date":40,"type":20},"2028-09-08",{"name":42,"class":43},"Sun Yat-sen University","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100428914","phase-2-predicting-response-to-neoadjuvant-atezolizumab-plus-carboplatinnab-paclitaxel-in-resectable-non-squamous-nsclc-100428914","NCT04865250","Predicting Response to Neoadjuvant ATEZOLIZUMAB Plus Carboplatin\u002FNab Paclitaxel in Resectable Non-squamous NSCLC","Exploratory Study Evaluating the Potential of Immune Signature Profiling for Predicting Response in Patients With Resectable Stage II, IIIA and Select IIIB (T3N2 Only) Non-squamous Non-Small Cell Lung Cancer (NSCLC) to Neoadjuvant ATEZOLIZUMAB Plus Carboplatin\u002FNab Paclitaxel","iReP","Inclusion Criteria:\n\n* Informed consent, patients age ≥ 18-year-old including, signed and dated\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Histologically confirmed NSCLC of non-squamous histology, cStage II, IIIA or select IIIB (T3N2 only); for T-status ≤ T3 allowed; for N2 patients only IIIa1-3 Robinson classification allowed\n* Deemed surgically resectable with curative intent by an attending thoracic surgeon after adequate staging including PET-CT (positron emission tomography)\n* Adequate lung and cardiac function for intended lung resection according to German S3 regulation\n* Radiologically measurable disease as defined by response evaluation criteria in solid tumors RECIST v1.1\n* Sufficient availability of the tissue sample from primary tumor before start of neoadjuvant treatment\n* Females of child-bearing potential must agree to use, and be able to comply with, effective contraception (\\\u003C\u002F=1% failure rate annually) without interruption, 28 days prior to starting therapy (including dose interruptions), and while on study medication or for a period of 120 days after the last dose of study medication\n* Females must have a negative serum pregnancy test (β -hCG) result at screening and agree to ongoing pregnancy testing during the course of the study, and after the end of study therapy.\n* Male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following treatment discontinuation, even if he has undergone a successful vasectomy.\n* adequate renal, hepatic, and bone marrow function as defined below\n\n  * Absolute neutrophil count (ANC) \\> 1500\u002Fμl\n  * Platelet count ≥ 100000\u002Fμl\n  * Hemoglobin ≥ 9 g\u002Fdl (can be post-transfusion)\n  * International normalized ratio (INR) ≤ 1.4 in patients not receiving anticoagulation; for patients receiving respective anticoagulation an INR ≤3.0 allowed\n  * Activated partial thromboplastin time (aPTT) ≤ 1.5 times upper limit of normal (ULN) in patients not receiving anticoagulation; for patients receiving respective anticoagulation a PTT ≤2.5 ULN allowed\n  * Bilirubin \\\u003C 1.5 times ULN (for patients with known Gilbert disease Bilirubin ≤ 3 times ULN allowed)\n  * ALT and AST \\\u003C 2.5 times ULN\n  * Creatinine ≤ 1.5 ULN or calculated creatinine clearance \\> 60 ml\u002Fmin for subjects with creatinine levels \\> 1.5 ULN; for patients meeting the criterion of creatinine ≤ 1.5 ULN also a calculated creatinine clearance of \\> 30 ml\u002Fmin is mandatory\n\nExclusion Criteria:\n\n* Illness or condition that may interfere with a patient's capacity to understand, follow, and\u002For comply with study procedures\n* Treatment in any other clinical trial within 30 days before screening.\n* NSCLC Stage cT4\n* NSCLC stage cN3 or cN2 IIIA4 (bulky or fixed multi-station N2 disease) according to Robinson classification\n* NSCLC of squamous cell histology\n* Any prior therapy for lung cancer (including systemic therapy, radiotherapy or major surgery)\n* Malignancies other than NSCLC within 5 years prior to study inclusion with the exception of malignancies with a negligible risk of metastasis or death (5-year OS \\> 90%) like localized prostate cancer, ductal carcinoma in situ, adequately treated carcinoma in situ of the cervix, Stage I uterine cancer or non-melanoma skin carcinoma\n* History of allogeneic tissue \u002F solid organ transplant or allogeneic stem cell transplantation\n* Patients with active hepatitis B or C infections or a history of HIV infection\n* Pregnant or lactating women\n* Active autoimmune disease or history of severe autoimmune disease or immunodeficiency or a syndrome that requires systemic steroids or immunosuppressive agents\n* The following exceptions are granted:\n\n  * patients with vitiligo, eczema, lichen simplex or resolved childhood asthma\u002Fatopy\n  * subjects requiring intermittent use of bronchodilatators or local steroid injections\n  * patients with hypothyroidism stable on hormone replacement\n* Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, and anti-tumor necrosis factor (anti-TNF) agents) within 2 weeks prior to Cycle 1, Day 1 (except low-dose steroids for adrenal failure or emesis prophylaxis)\n* History of idiopathic pulmonary fibrosis, interstitial lung disease, organizing pneumonia, drug-induced pneumonitis, or evidence of active pneumonitis on screening chest Computed Tomography (CT) scan\n* Prior treatment with cluster of differentiation 137 (CD137) agonist or immune checkpoint blockade therapies, anti-programmed-death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibody\n* Live vaccine within 30 days prior to first dose of trial treatment\n* Cerebrovascular accident within the past 6 months\n* Severe infection or significant traumatic injury within the past 4 weeks\n* Clinically significant history of cardiovascular disease, including any of the following:\n\n  * Myocardial infarction or unstable angina within the past 6 months\n  * New York Heart Association class II, III-IV congestive heart failure\n  * Poorly controlled cardiac arrhythmia despite medication, except rate-controlled atrial fibrillation\n* Known allergy or hypersensitivity to any component of the chemotherapy regimen Patients who have been incarcerated or involuntarily institutionalized by court order or by the authorities, as well as patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial",{"count":53,"type":20},20,[23],"Exploratory study evaluating the potential of immune signature profiling for predicting response in patients with resectable Stage II, IIIA and select IIIB (T3N2 only) non-squamous Non-Small Cell Lung Cancer (NSCLC) to neoadjuvant ATEZOLIZUMAB plus Carboplatin\u002Fnab Paclitaxel\n\nAtezolizumab is given as intravenous infusion at a fixed dose of 1200 mg, day 1 of each 21-day cycle (every 3 weeks) for 3 cycles during the neoadjuvant treatment phase, Carboplatin at an initial dose of AUC (area under curve) 5 mg\u002FmL\u002Fmin, intravenously day 1 of each 21-day cycle for 3 cycles during the neoadjuvant treatment Phase, and Nab-Paclitaxel (Abraxane) at 100 mg\u002Fm2, intravenously day 1, 8 and 15 of each 21-day cycle for 3 cycles during the neoadjuvant treatment phase. Surgery after the 3rd cycle Atezolizumab \u002F Carboplatin \u002F Nab-Paclitaxel is standard procedure.",[57,26,58],"NSCLC Stage II","NSCLC Stage IIIB","RECRUITING","2024-05-13",{"date":62,"type":36},"2024-05-16",{"date":64,"type":36},"2021-01-07",{"date":66,"type":20},"2026-12-30",{"name":68,"class":43},"University Hospital Heidelberg",1]