[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Wen-zhao ZHONG\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":173},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,46,80,100,122,148],{"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":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100638468","evaluating-the-efficacy-and-safety-of-ai-localization-models-in-multidisciplinary-team-care-for-nsclc-100638468",false,"NCT07626736","Evaluating the Efficacy and Safety of AI Localization Models in Multidisciplinary Team Care for NSCLC","Evaluating the Efficacy and Safety of AI Localization Models in Multidisciplinary Team Care for NSCLC: a Prospective, Controlled Clinical Trial Protocol","Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. MDT (Multidisciplinary Team) discussion deems a systemic treatment plan necessary;\n3. Complete clinical, imaging, and molecular pathological data.\n\nExclusion Criteria:\n\n1. Stage I patients;\n2. Diagnosed with a thoracic tumor other than NSCLC;\n3. Lack of detailed medical data, or missing data;","ALL","18 Years",{"count":19,"type":20},300,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this clinical trial is to evaluate the effectiveness and safety of a locally deployed artificial intelligence (AI) decision-support model in the multidisciplinary team (MDT) process for patients with non-small cell lung cancer (NSCLC).\n\nThe main questions it aims to answer :\n\nWhat is the level of agreement between treatment recommendations generated by the AI model and those made by a traditional MDT? How often do clinicians modify their final treatment decision after reviewing the AI model's recommendation? Researchers will compare treatment plans from the traditional MDT (Arm 1), the AI model (Arm 2), and the clinician's final decision after reviewing the AI output (Arm 3) to assess consistency, decision modification rates, and clinical efficiency.\n\nParticipants will:\n\nHave their clinical, imaging, and molecular data submitted to both the traditional MDT and the AI model for independent treatment recommendations Receive a final treatment plan determined by clinicians after reviewing both recommendations, with follow-up for safety and survival outcomes",[26],"Nonsmall Cell Lung Cancer",[28,29,30,31,32],"Non-Small Cell Lung Cancer","Multidisciplinary Team","Locally Deployed AI Model","Large Language Model","Treatment Decision-Making","RECRUITING","2026-05-31",{"date":36,"type":37},"2026-06-04","ACTUAL",{"date":39,"type":37},"2025-12-01",{"date":41,"type":20},"2028-12-31",{"name":43,"class":44},"Wen-zhao ZHONG","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":45},"100640512","phase-3-selective-mediastinal-lymph-node-sampling-versus-systematic-mediastinal-lymph-node-dissection-after-neoadjuvant-chemoimmunotherapy-for-non-small-cell-lung-cancer-science-study-100640512","NCT07617389","Selective Mediastinal Lymph Node Sampling Versus Systematic medIastinal Lymph Node Dissection After Neoadjuvant Chemoimmunotherapy for Non-small Cell Lung Cancer (SCIENCE Study)","Selective Mediastinal Lymph Node Sampling Versus Systematic medIastinal Lymph Node Dissection After Neoadjuvant Chemotherapy Combined With Immunotherapy for the Treatment of Clinical Stage IIA-IIIB (N2) Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. Voluntary participation with a signed written informed consent form.\n2. Aged ≥ 18 and \\\u003C 75 years, of either gender.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Anticipated life expectancy of ≥ 12 months.\n5. Histologically or pathologically confirmed peripheral non-small cell lung cancer (NSCLC), with clinical tumor, node, metastasis(TNM) stage IIA-IIIB, which according to the International Association for the Study of Lung Cancer(IASLC) 9th edition, and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.\n6. Absence of satellite nodules involving different lung lobes.\n7. No history of prior ipsilateral thoracotomy.\n8. Completion of neoadjuvant therapy prior to enrollment, consisting of a PD-1 inhibitor combined with platinum-based doublet chemotherapy.\n9. Adequate organ function.\n10. Cardiopulmonary function assessed by the investigator as meeting surgical standards, specifically: forced expiratory volume in one second (FEV1) \\> 1.0 L or diffusing capacity of the lung for carbon monoxide (DLCO) \\> 40% of the predicted value; and no other cardiopulmonary impairments that, in the investigator's judgment, would preclude surgery.\n11. Evaluation by a multidisciplinary team (MDT) or an evaluation committee\\* confirming that R0 resection can be achieved via anatomical lobectomy.\n\n    * Evaluation Committee: Composed of multidisciplinary experts with at least 10 years of clinical experience. Each participant's eligibility is discussed and evaluated by at least two experts to reach a consensus; in the event of a disagreement, a third expert will be invited for assessment.\n\nExclusion Criteria:\n\n1. Anticipated inability to tolerate an anatomical lobectomy;\n2. Anticipated requirement for sleeve resection, pneumonectomy, or pulmonary autotransplantation to remove the affected lobe;\n3. Prior thoracic radiotherapy before the initiation of surgical treatment;\n4. History of allogeneic tissue or solid organ transplantation;\n5. Diagnosis of an autoimmune disease within 3 months prior to surgery, or currently receiving long-term systemic corticosteroid therapy (at a dose \\>10 mg\u002Fday of prednisone or equivalent) or any other form of immunosuppressive therapy;\n6. History of or current non-infectious interstitial lung disease requiring corticosteroid therapy;\n7. Presence of viral infectious diseases during the screening period:\n\n   1. Seropositivity for human immunodeficiency virus (HIV);\n   2. Active hepatitis B: positive for hepatitis B surface antigen (HBsAg) with an HBV-DNA viral load \\>500 IU\u002FmL or \\>2000 copies\u002FmL;\n   3. Active hepatitis C: positive for hepatitis C virus (HCV) antibody with an HCV-RNA viral load above the upper limit of normal (ULN);\n8. Poorly controlled hypertension despite medical therapy, defined as systolic blood pressure \\>150 mmHg or diastolic blood pressure \\>90 mmHg (adjustment of antihypertensive medications is permitted prior to study initiation, provided that the average of the last three consecutive blood pressure readings taken prior to enrollment is ≤150\u002F90 mmHg, with at least a 2-minute interval between each measurement);\n9. Active infection requiring intravenous anti-infective therapy at the time of screening;\n10. History of another malignancy within 3 years prior to providing informed consent, excluding cured basal cell carcinoma of the skin, carcinoma in situ of the cervix or breast, superficial bladder cancer, and localized prostate cancer. Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, PSA \\\u003C10 ng\u002FmL) are eligible to enroll if they have received radical treatment or are under active surveillance with stable disease, regardless of prior treatment status;\n11. Any condition that, in the investigator's judgment, might interfere with the interpretation of study results, compromise the participant's ability to complete the study, or render study participation contrary to the participant's best interests;\n12. Pregnant, lactating, or planning to become pregnant; or having a positive serum pregnancy test within 7 days prior to the first study treatment;\n13. Poor compliance, or unwilling or unable to adhere to the protocol-specified procedures.","75 Years",{"count":55,"type":20},358,[57],"PHASE3","The SCIENCE trial is a multicenter, open-label, randomized, parallel, noninferiority investigator-initiated trial (IIT). This study aims to evaluate the prognostic differences between selective mediastinal lymph node sampling and systematic mediastinal lymph node dissection in patients with node-negative stage IIA to IIIB (N2) non-small-cell lung cancer (NSCLC) undergoing anatomical lobectomy following neoadjuvant chemoimmunotherapy.",[60,61,62],"Stage IIA-IIIB NSCLC","Selective Mediastinal Lymph Node Sampling","Systematic medIastinal Lymph Node Dissection",[64,65,66,67,68,69,70],"NSCLC","stage IIA-IIIB NSCLC","neoadjuvant","chemoimmunotherapy","selective mediastinal lymph node sampling","systematic medIastinal lymph node dissection","toripalimab","NOT_YET_RECRUITING","2026-05-24",{"date":74,"type":37},"2026-06-01",{"date":76,"type":20},"2026-05-20",{"date":78,"type":20},"2030-06-01",{"name":43,"class":44},{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":89,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":45},"100637958","sub-lobectomy-vs-lobectomy-in-iia-iiib-nsclc-after-neoadjuvant-iochemo-100637958","NCT07612722","Sub-lobectomy vs Lobectomy in IIA-IIIB NSCLC After Neoadjuvant IO+Chemo","Sub-lobectomy Versus Lobectomy in IIA-IIIB Non-small-cell Lung Cancer After Neoadjuvant Immunochemotherapy: a Multicentre, Open-label, Randomised, Controlled, Non-inferiority Trial","Inclusion Criteria:\n\n* Voluntarily participate in the research and sign an informed consent form;\n* Age ≥ 18 years old,\\\u003C75 years old, both male and female;\n* The physical fitness status score of the Eastern Cooperative Oncology Group (ECOG) in the United States is 0 or 1;\n* Expected survival period ≥ 12 months;\n* Peripheral non-small cell lung cancer (NSCLC) confirmed by histology\u002Fpathology, with TNM staging of IIA\\~IIIB before neoadjuvant therapy (IASLC 9th edition), without known EGFR mutations\u002FALK rearrangements;\n* No solid lesions involving different lung lobes;\n* No history of ipsilateral open chest surgery;\n* Prior to enrollment, the patient has received 2-4 cycles of neoadjuvant therapy, which includes PD-1\u002FPD-L1 inhibitors and platinum based dual drug chemotherapy;\n* Having sufficient organ function\n* According to the researcher's assessment, the cardiovascular and pulmonary function meets the criteria for accepting surgery; The forced expiratory volume in the first second (FEV1) of the lung function test should be at least 1.5 L or the diffusion volume of carbon monoxide (DLCO) in the lungs should be at least 40%; The researchers determined that there was no other impact on the heart and lung function impairment during the surgery;\n* Based on preoperative CT diagnosis, the distance between the tumor and the bronchial opening is greater than 2cm;\n* After evaluation by the evaluation committee, the lesion can be treated with sub lobe R0 resection after neoadjuvant therapy.\n\nExclusion Criteria:\n\n* Expected intolerance to lobectomy;\n* Received chest radiation therapy before starting surgical treatment;\n* Have undergone allogeneic tissue\u002Fsolid organ transplantation;\n* Diagnosed with autoimmune disease or undergoing long-term systemic steroid therapy (prednisone or equivalent dosage exceeding 10 mg\u002Fday) or any other form of immunosuppressive therapy within 3 months prior to surgery;\n* There is a history of interstitial lung disease (non infectious) that requires steroid treatment or currently has interstitial lung disease that requires steroid treatment;\n* Viral infectious disease in screening period:\n\nPositive for human immunodeficiency virus (HIV) serum reaction; Active hepatitis B: Hepatitis B virus surface antigen (HBsAg) positive and HBV-DNA quantitative detection\\>500 IU\u002FmL or\\>2000 copies\u002FmL; Active hepatitis C: Hepatitis C (HCV) antibody positive and HCV-RNA quantitative detection above the upper limit of normal;\n\n* Hypertension participants with poor drug treatment control are defined as systolic blood pressure\\>150 mmHg or diastolic blood pressure\\>90 mmHg (it is allowed to adjust the treatment of hypertension drugs before the start of the study, but the average value of the latest three consecutive blood pressure records before enrollment in the study should be ≤ 150\u002F90 mmHg) (each measurement should be at least 2 minutes apart);\n* During screening, there are still active infections that require intravenous anti infective treatment;\n* Other malignant tumors, excluding cured skin basal cell cancer, cervical or breast cancer in situ, superficial bladder cancer cancer, localized prostate cancer, etc., within 3 years before signing the informed consent; Participants with low-risk early prostate cancer (T1-T2a stage, Gleason score ≤ 6, PSA\\\u003C10 ng\u002FmL) who have received curative treatment or are under active monitoring with stable condition, regardless of whether they have received treatment, are allowed to be enrolled;\n* There are situations that may interfere with the interpretation of research results or may affect participants' ability to complete the entire research process, or based on the judgment of the treatment researcher, participation in the research is not in the best interests of the participants;\n* Pregnancy, lactation, or planned pregnancy; Positive blood pregnancy test within 7 days prior to the first study treatment;\n* Participants have poor compliance and are unwilling or unable to follow the research protocol.",{"count":88,"type":20},585,[23],"This study is a prospective, randomized controlled multicenter clinical trial. The study population consisted of non-small cell lung cancer（NSCLC） patients in stage IIA-IIIB (IASLC 9th edition) who received immunotherapy combined with platinum based dual drug chemotherapy before neoadjuvant therapy and were evaluated by the committee to be feasible for sub lobectomy R0 resection. After entering the study, they were randomly divided into a sub lobectomy group (study group) and a lobectomy group (control group). Follow up will be conducted after surgery.\n\nThe study includes screening\u002Fbaseline period, perioperative period, and follow-up period.\n\nScreening\u002FBaseline Period: The screening period is 28 days prior to receiving surgery. After the patient signs the informed consent form (ICF), the inclusion and exclusion criteria are reviewed during the screening\u002Fbaseline period to include patients who meet the inclusion and exclusion criteria, with specific reference to the inclusion and exclusion criteria. During the screening period of this study, if laboratory and imaging tests that do not meet the inclusion criteria are found during the first screening, patients are allowed to undergo re examination and re screening. When re screening, informed consent must be signed and a new participant screening number must be obtained through re registration.\n\nPerioperative period: During the perioperative period, patients were randomized into a sub lobectomy group (study group) and a lobectomy group (control group). The research group used thin-layer CT imaging and 3D reconstruction to accurately plan the surgical resection range before surgery, and underwent subpulmonary lobectomy+hilar\u002Fmediastinal lymph node dissection; The control group patients underwent direct lobectomy and lymph node dissection of the pulmonary hilum\u002Fmediastinum.\n\nFollow up period: The follow-up period includes a safety follow-up period and a survival follow-up period. Safety follow-up will be conducted 30 days (+5 days) after surgery or before receiving the first postoperative adjuvant therapy medication. Survival follow-up will be conducted every 3 months (± 14 days) in the first year after surgery and every 6 months (± 14 days) in the second year after surgery. Participants' chest CT scan results, survival status, follow-up anti-tumor treatment, and drug-related SAEs (including lung function tests at 6 months, 12 months, and 3 years after surgery) will be collected until the 3-year follow-up time\u002F(participant death, loss to follow-up, voluntary withdrawal from clinical study, or end of study) (whichever occurs first). The research plan can be found in the research flowchart.\n\nMain objective:\n\nEvaluate the prognostic differences between sub lobectomy and lobectomy in NSCLC patients after neoadjuvant immunotherapy and chemotherapy;\n\nSecondary objective:\n\n1\\. Evaluate the lung function preservation of NSCLC patients after neoadjuvant immunotherapy and chemotherapy with sub lobectomy compared to lobectomy; Evaluate the safety of sub lobectomy compared to lobectomy in NSCLC patients after neoadjuvant immunotherapy and chemotherapy, including postoperative complications, length of hospital stay, etc; Evaluate the postoperative quality of life of NSCLC patients after neoadjuvant immunotherapy and chemotherapy with sub lobectomy compared to lobectomy.",[64],"2026-05-23",{"date":94,"type":37},"2026-05-29",{"date":96,"type":20},"2026-05-18",{"date":98,"type":20},"2034-05-31",{"name":43,"class":44},{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":21,"phases":109,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":4},"100637054","phase-2-multidisciplinary-treatment-of-stage-iii-alk-nsclc-with-neoadjuvant-alectinib-and-chemotherapy-100637054","NCT07573696","Multidisciplinary Treatment of Stage III ALK+ NSCLC With Neoadjuvant Alectinib and Chemotherapy","A Multicenter, Phase 2 Non-Randomized Study of Unresectable Stage III ALK+ NSCLC Treated With Neoadjuvant Alectinib Plus Chemotherapy Followed by Multidisciplinary Approach for Optimal Local Treatment","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n* Signed Informed Consent Form\n* Age ≥ 18 years at time of signing Informed Consent Form\n* Ability to comply with the study protocol\n* Eligible to receive a platinum-based chemotherapy according to local labels or guidelines\n* Cytologically and\u002For histologically documented locally advanced, unresectable Stage III NSCLC\n\n  * Staging should be based on Version 8 of the American Joint Committee on Cancer\u002FUnion for International Cancer Control NSCLC staging system.\n  * Participants with T4 primary NSCLC with a separate nodule in a different ipsilateral lobe are not eligible.\n* Documented ALK fusion positivity by an eligible result from:\n\n  ○ Previously obtained local test results as ordered by a healthcare provider from a high-quality and appropriately validated ALK fusion test on tumor tissue performed in a Clinical Laboratory Improvement Amendments Certified or equivalent laboratory. Acceptable local test methods include the following\n  * Next-generation sequencing; immunohistochemistry; fluorescence in situ hybridization; reverse transcription-polymerase chain reaction; NanoString.\n  * Only National Medical Products Administration (NMPA)-approved tests for ALK fusions are acceptable.\n  * Identification of a specific gene fusion partner is required (exceptions: ALK immunohistochemistry and certain PCR tests for which the gene fusion partner is not pre-specified as part of the test design). The use of positional 5\u002F3 imbalance probe gene expression is not acceptable.\n* Eastern Cooperative Oncology Group Performance Status of 0, or 1\n* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n* Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study drug (i.e., Day 1 of Cycle 1):\n\n  * ANC ≥1.5 \\* 109\u002FL (≥1500\u002FL), without granulocyte colony-stimulating factor support\n  * Platelet count ≥100\\* 109\u002FL ( 100,000\u002FL), without the need for transfusion\n  * Hemoglobin ≥ 90 g\u002FL (≥9.0 g\u002FdL)\n  * Participants may be transfused or receive erythropoietic treatment as per local SOC to meet this criterion.\n  * AST, ALT, and ALP ≤ 2.5 \\*upper limit of normal (ULN)\n  * Bilirubin≤1.5\\*ULN with the following exception: Participants with known Gilbert disease: bilirubin level ≤ 3\\* ULN\n  * Creatinine clearance (CrCl) ≥ 60 mL\u002Fmin, calculated using the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of CrCl\n  * Albumin ≥ 25 g\u002FL (≥ 2.5 g\u002FdL)\n  * For participants not receiving therapeutic anticoagulation: INR and aPTT≤1.5 \\* ULN\n  * For participants receiving therapeutic anticoagulation: stable anticoagulant regimen\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs, as defined below:\n\n  * Women must remain abstinent or use contraceptive methods with a failure rate of \\\u003C1% per year during the treatment period and for at least 90 days after the final dose of alectinib. While additionally adhering to the local label for alectinib and chemotherapy. Women must refrain from donating eggs during this same period.\n  * A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and\u002For uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis).\n  * Examples of contraceptive methods with a failure rate of\\\u003C1% per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The use of oral contraceptives should be supplemented with a barrier method (preferably a male condom).\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the cohort and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not adequate methods of contraception.\n  * Women should seek advice on fertility preservation before treatment with pemetrexed, cisplatin and carboplatin\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm, as defined below:\n\n  * With a female partner of childbearing potential who is not pregnant, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of 1% per year during the treatment period and for at least 90 days after the final dose of alectinib. Men must refrain from donating sperm during this same period.\n  * With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 90 days after the last final dose of alectinib to avoid exposing the embryo. The reliability of sexual abstinence should be evaluated in relation to the duration of the cohort and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not adequate methods of preventing drug exposure.\n  * Men should seek advice on fertility preservation before treatment with pemetrexed, cisplatin, and carboplatin.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Any exclusion criteria based on local labels or guidelines for chemotherapy\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 90 days after the final dose of alectinib or or according to local labels or guidelines for chemotherapy longer), whichever is longer.\n\n  ○ Women of childbearing potential must have a negative serum pregnancy test result prior to enrollment and within 7 days prior to the first dose of alectinib.\n* Any history of previous NSCLC and\u002For any history of prior treatment for NSCLC (participants must be newly diagnosed with unresectable Stage III disease)\n* Any evidence of Stage IV disease, including, but not limited to, the following:\n\n  * Pleural effusion\n  * Pericardial effusion\n  * Brain metastases\n  * History of intracranial hemorrhage or spinal cord hemorrhage\n  * Bone metastases\n  * Distant metastases\n* If a pleural effusion is present, the following criteria must be met to exclude malignant involvement (T4 disease):\n\n  ○ When pleural fluid is visible on both the CT scan and chest X-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative.\n  * Participants with exudative pleural effusions are excluded regardless of cytology.\n  * Participants with effusions that are minimal (i.e., not visible on chest X-ray) that are too small to safely tap are eligible.\n* NSCLC known to have one or more of the following ALK point mutations: I1171X (where X is any other amino acid), V1180L, G1202R\n* NSCLC known to have a known or likely oncogenic-driver mutation in the EGFR gene\n* Liver disease, characterized by any of the following:\n\n  ○ Impaired excretory function (e.g., hyperbilirubinemia), synthetic function, or other conditions of decompensated liver disease, such as coagulopathy, hepatic encephalopathy, hypoalbuminemia, ascites, and bleeding from esophageal varices or Active viral or active autoimmune, alcoholic, or other types of acute hepatitis\n* Positive hepatitis B surface antigen (HBsAg) test at screening\n\n  ○ Participants with a previous hepatitis B virus (HBV) infection or resolved HBV infection (hepatitis B core antibody \\[HBcAb\\] positive, but negative HBsAg are eligible only if the HBV DNA test is negative.\n* Participants known to be positive for hepatitis C virus (HCV) antibody (Ab) are excluded with the following exception:\n\n  ○ Participants who are HCV Ab positive but HCV RNA negative due to prior treatment or natural resolution are eligible.\n* HIV infection, participants are excluded if they meet any of the following:\n\n  * CD4+ T-cell (CD4+) counts\\\u003C350 cells\u002FL\n  * On established antiretroviral therapy\\\u003C4 weeks\n  * Have a detectable HIV viral load at screening\n  * History of AIDS-defining opportunistic infections within the past 12 months.\n* Known active tuberculosis\n* Symptomatic bradycardia\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina\n\n  ○ Participants with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction 50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate.\n* Any gastrointestinal (GI) disorder that may affect absorption of oral medications, such as malabsorption syndrome or status post-major bowel resection\n* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the participant at high risk from treatment complications\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest CT scan\n* History of malignancy other than NSCLC within 5 years prior to enrollment, with the exception of malignancies with a negligible risk of metastasis or death , such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal breast carcinoma in situ, or Stage I uterine cancer\n* Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer\n\n  ○ Note: Local treatment of isolated lesions, excluding target lesions, with palliative intent is acceptable (e.g., by local surgery or radiotherapy).\n* Major surgical procedure, within 4 weeks prior to initiation of study treatment\n* Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment\n* Prior treatment with ALK inhibitors\n* Known sensitivity to any component of alectinib and chemotherapy\n\n  ○ This includes, but is not limited to, participants with galactose intolerance, a congenital lactase deficiency, or glucose-galactose malabsorption.\n* Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study\n* Any condition that, in the opinion of the investigator, would interfere with the evaluation of the study drug or interpretation of participant safety or study results.",{"count":108,"type":20},50,[110],"PHASE2","This is a multicenter, phase 2 non-randomized study to investigate the clinical feasibility and therapeutic efficacy of employing a MDT-based strategy in unresectable stage III ALK positive NSCLC following neoadjuvant alectinib in combination with platinum-based chemotherapy. Participants in this study must not have received any previous systemic anticancer therapy before enrollment.\n\nThe study will consist of a 42-day screening period, a neoadjuvant treatment period, a local radical treatment period, a post-local treatment period, a safety follow-up visit occurring 28 days after the final dose of alectinib, and a survival follow-up period.\n\nIn the neoadjuvant treatment period, participants will be provided with alectinib (600mg PO BID for 3 cycles) plus platinum-based chemotherapy for a maximum of 3 cycles (each cycle is 21 days).\n\nFollowing the completion of neoadjuvant therapy, all participants who are reassessed by MDT to be resectable after neoadjuvant treatment and have adequate lung functions would be provided with definite surgery. Otherwise, patients would be provided with radical radiotherapy through MDT discussion.\n\nFor the surgery cohort, participants meet both the R0 resection, the pathological assessment criteria of pCR and have two consecutive landmark ctDNA tests that are negative will receive surveillance after surgery. Participants who do not meet all the above conditions will receive alectinib after surgery, adjuvant treatment should be initiated ideally 4-12 weeks after surgery, or according to local standard of care, treatment will continue until completion of treatment period (24 months), disease recurrence, unacceptable toxicity, death, or withdrawal from the study, whichever occurs first.\n\nFor the radical radiotherapy cohort, participants will receive alectinib after radiotherapy, adjuvant treatment should be initiated ideally 4-12 weeks after surgery, or according to local standard of care, the treatment will continue until completion of treatment period (24 months), disease progression, unacceptable toxicity, death, or withdrawal from the study, whichever occurs first.",[113],"Nonsmall Cell Lung Cancer Stage III","2026-05-01",{"date":116,"type":37},"2026-05-07",{"date":118,"type":20},"2026-06-15",{"date":120,"type":20},"2030-08-07",{"name":43,"class":44},{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":129,"targetDuration":4,"studyType":21,"phases":131,"briefSummary":132,"conditions":133,"keywords":136,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":45},"100595992","phase-2-toripalimab-combined-with-chemotherapy-as-adjuvant-therapy-for-non-small-cell-lung-cancer-with-or-without-prior-neoadjuvant-therapy-100595992","NCT07039656","Toripalimab Combined With Chemotherapy as Adjuvant Therapy for Non-small Cell Lung Cancer With or Without Prior Neoadjuvant Therapy","Toripalimab Combined With Chemotherapy as Postoperative Adjuvant Therapy for Non-Small Cell Lung Cancer With or Without Prior Neoadjuvant Therapy: A Two-Cohort, Multicenter Phase II Trial","Inclusion Criteria:\n\n1. Signed Informed Consent Form\n2. Patient with age ≥ 18 and ≤75 years old, gender is not limited.\n3. Cohort 1: Histological diagnosis of Stage IB -IIIB NSCLC without anti-cancer treatment; Cohort 2: Histological diagnosis of Stage IIB-III NSCLC with non-MPR or MPR but lymph node positivity after neoadjuvant chemoimmunotherapy; (per American Joint Committee on Cancer staging system (AJCC) staging system, 8th edition)\n4. Participants must have had complete resection of NSCLC 60 days\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1\n6. Adequate organ function performed within 10 days of treatment initiation\n7. Male or female patients of childbearing potential will voluntarily use an effective method of contraception, e.g., double-barrier contraception, condoms, oral or injectable contraceptives, IUDs, etc., during the study period and for the last 6 months of study drug use. All female patients will be considered of childbearing potential unless the female patient is naturally menopausal, artificially menopausal or sterilised (e.g. hysterectomy, bilateral adnexectomy or radiation ovarian irradiation).\n\nExclusion Criteria:\n\n1. Pathological histology confirmed the diagnosis of small cell lung cancer pathological type;\n2. Treatment with prior systemic chemotherapy at any time\n3. Confirmed EGFR or ALK mutations\n4. Patient has a history of active autoimmune disease or autoimmune disease that may recur\n5. Active hepatitis B and C patients will need to be on relevant antiviral therapy, have HBV-DNA \\\u003C2000 IU\u002Fml (\\\u003C104 copies\u002Fml) and have received anti-HBV therapy for at least 14 days prior to study participation, and continue therapy for the duration of the treatment period; HCV RNA-positive patients must be on antiviral therapy and have a liver function that is within the elevated CTCAE grade 1;\n6. Known allergy to chemotherapy drugs including cisplatin, paclitaxel, albumin-paclitaxel and pemetrexed;\n7. History of allergy to monoclonal antibody drugs\n8. Patients with previous allogeneic stem cell or parenchymal organ transplantation\n9. Having a mental illness or any other condition that renders treatment non-compliant\n10. Patients unable or unwilling to sign the informed consent form\n11. The investigator considered that the patient's condition may affect compliance with the protocol or make participation in this study unsuitable.",{"count":130,"type":20},211,[110],"This is a two-cohort, multicenter, Phase II study to evaluate the efficacy and safety of 3-4 cycles of toripalimab (JS001) plus chemotherapy followed by toripalimab maintenance treatment up to one year in participants with completely resected non-small cell lung cancer (NSCLC) stratified by prior neoadjuvant treatment status, as measured by disease-free survival (DFS) and overall survival (OS).\n\nResearchers will compare outcomes between two cohorts:\n\n1. Cohort 1: Stage IB-IIIB participants following completely resection without neoadjuvant therapy;\n2. Cohort 2: Stage IIB-III participants with non-MPR or MPR but lymph node positivity after neoadjuvant therapy.",[134,135],"Stage IB-IIIB NSCLC","Stage IIB-III NSCLC",[137,138,139],"Toripalimab","MRD","Adjuvant therapy","2025-08-03",{"date":142,"type":37},"2025-08-07",{"date":144,"type":37},"2025-01-01",{"date":146,"type":20},"2030-12-31",{"name":43,"class":44},{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":155,"targetDuration":4,"studyType":21,"phases":157,"briefSummary":158,"conditions":159,"keywords":161,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":5},"100595900","phase-2-a-multicenter-phase-ii-randomized-trial-of-limertinib-followed-by-sintilimab-and-chemotherapy-vs-limertinib-followed-by-limertinib-and-chemotherapy-as-neoadjuvant-therapy-in-resectable-stage-ii-iiib-egfr-mutant-nsclc-100595900","NCT07038460","A Multicenter Phase II Randomized Trial of Limertinib Followed by Sintilimab and Chemotherapy vs. Limertinib Followed by Limertinib and Chemotherapy as Neoadjuvant Therapy in Resectable Stage II-IIIB EGFR-Mutant NSCLC","NEO-LISI","Inclusion Criteria:\n\n1. Signed written informed consent form\n2. Age: 18-75 years.\n3. Cytologically\u002Fhistologically confirmed (via percutaneous lung puncture, bronchoscopy, mediastinoscopy, etc.), previously untreated stage II-IIIB (IASLC 8th Edition Thoracic Tumor Classification) lung adenocarcinoma.\n4. Tumor tissue or blood samples confirmed as EGFR-sensitive or rare mutation-positive by laboratory testing\n5. Must provide archived tumor tissue or newly resected tumor biopsy samples for PD-L1 IHC testing during screening.\n6. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.\n7. Measurable lesions per RECIST v1.1.\n8. Surgically evaluated as eligible for local surgical resection (adequate pulmonary\u002Forgan function).Surgically evaluated as eligible for local surgical resection (adequate pulmonary\u002Forgan function).\n9. Adequate organ and bone marrow function (within 7 days prior to enrollment; no corrective therapies within 14 days prior to testing): • Hematology: ANC ≥1.5×10⁹\u002FL, platelets ≥100×10⁹\u002FL, hemoglobin ≥100 g\u002FL. • Hepatic: Total bilirubin ≤1.5×ULN; AST\u002FALT ≤2.5×ULN; albumin ≥35 g\u002FL. • Renal: Serum creatinine ≤1.5×ULN; CrCl ≥60 mL\u002Fmin (Cockcroft-Gault formula); urine protein \\\u003C2+ or 24-hour urine protein \\\u003C1 g. Cockcroft-Gault formula: • Female: CrCl = \\[(140 - age) × weight (kg) × 0.85\\] \u002F \\[72 × serum creatinine (mg\u002FdL)\\]. • Male: CrCl = \\[(140 - age) × weight (kg)\\] \u002F \\[72 × serum creatinine (mg\u002FdL)\\]. • Coagulation: INR ≤1.5×ULN; PT\u002FAPTT ≤1.5×ULN.\n10. For women of childbearing potential: Negative urine\u002Fserum pregnancy test within 7 days prior to first dose. Confirmatory blood test required if urine test is positive.\n\nExclusion Criteria:\n\n1. Patients with stage I or IV NSCLC who have previously received systemic anti-tumor therapies (e.g., ICIs, targeted therapy, chemotherapy).\n2. Active known or suspected autoimmune diseases (exceptions: type I diabetes, hypothyroidism requiring hormone replacement only, non-progressive skin conditions like vitiligo\u002Fpsoriasis\u002Falopecia).\n3. Active hepatitis B (HBsAg-positive) or hepatitis C (HCV RNA-positive). Patients with resolved HBV infection (HBsAg-negative, HBcAb-positive) must provide HBV DNA-negative results. HCV antibody-positive patients require negative HCV RNA PCR.\n4. HIV-positive or AIDS history.\n5. Arterial thrombosis within 6 months, or deep vein thrombosis\u002Fpulmonary embolism within 3 months.\n6. Uncontrolled angina, arrhythmias, or congestive heart failure.\n7. Active malignancies within 5 years (except cured cervical\u002Fcutaneous carcinoma in situ, superficial bladder\u002Fprostate\u002Fbreast cancer).\n8. Contraindications to local therapies (surgery, radiotherapy, or intervention) per investigator judgment.\n9. Hypersensitivity to sintilimab, limertinib, chemotherapy agents, or excipients.\n10. Unwillingness to sign informed consent or comply with follow-up.\n11. Any condition compromising trial integrity or patient safety, as judged by the investigator.",{"count":156,"type":20},134,[110],"This clinical trial aims to evaluate the efficacy and safety of neoadjuvant therapy with Limertinib Followed by Sintilimab and Chemotherapy in resectable Stage II-IIIB EGFR-Mutant NSCLC. Untreated stage II-IIIB NSCLC (AJCC 8th edition) patients assessed as surgically resectable by investigators will be randomized 1:1 into the experimental or control group after signing informed consent and meeting eligibility criteria. All patients receive Limertinib for 6 weeks. Within 7 days thereafter, imaging assessment will be performed. If no progression is observed, experimental group patients discontinue therapy for 1 week, then receive Sintilimab + Carboplatin\u002FCisplatin + Pemetrexed every 3 weeks for 3 cycles; control group patients receive Limertinib for 9 weeks and Carboplatin\u002FCisplatin + Pemetrexed every 3 weeks for 3 cycles. Preoperative tumor assessment is required. Surgery will be performed 2-6 weeks (±7 days) after the first dose of the final cycle. Then patients will recieve 2-year adjuvant Osimertinib starting 1 month post-surgery. If imaging assessment after 6 weeks of limertinib treatment shows lesion enlargement but remains confined to stage II-IIIB, the investigator will decide whether the patient continues study treatment or not; if progression occurs to unresectable stage III or advanced disease, the patient must discontinue. The primary endpoint is pathological complete response (pCR) rate.",[160],"Resectable Non-small Cell Lung Cancer",[64,162,163,164],"EGFRmut","Limertinib","Sintilimab","2025-06-18",{"date":167,"type":37},"2025-06-26",{"date":169,"type":20},"2025-07",{"date":171,"type":20},"2029-12",{"name":43,"class":44},""]