[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-iii-non-small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-iii-non-small-cell-lung-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,44,112,139,170,197,220,247],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100641953","phase-2-in-vivo-fluorescence-molecular-bronchoscopy-of-dur-valumab-680lt-in-patients-with-unresectable-stage-iii-nsclc-after-chemoradiation-100641953",false,"NCT07653438","In-vivo Fluorescence Molecular Bronchoscopy of Dur-valumab-680LT in Patients With Unresectable Stage III NSCLC After Chemoradiation","In-vivo Fluorescence Molecular Bronchoscopy of Dur-valumab-680LT in Patients With Unresectable Stage III NSCLC After Chemoradiation - PulmoPrint","PulmoPrint","Inclusion Criteria:\n\n* Signed informed consent prior to participation in the study.\n* Age ≥ 18 years.\n* Histologically or cytologically confirmed unresectable stage III NSCLC.\n* Completion of concurrent platinum-based CRT\n* Eligibility for adjuvant durvalumab per standard of care.\n* At least one tumor lesion or involved lymph node accessible by bronchoscopy or endoscop-ic\u002Fendobronchial ultrasound, suitable for biopsy\u002FFNA and fluorescence measurement.\n* ECOG performance status 0-2.\n* Patient is considered fit to undergo a research bronchoscopy (with or without addition of endobronchial ultrasound; including propofol sedation or general anesthesia if either is indicated).\n\nExclusion Criteria:\n\n* Known history of infusion reactions to durvalumab, other anti-PD-L1 antibodies, or other monoclonal antibodies, according to the patient's medical history.\n* Contraindication for bronchoscopy or endoscopic\u002Fendobronchial ultrasound (if applicable), including severe uncorrectable coagulopathy, pre-existing severe respiratory insufficiency, or any other clinical reason as judged by the investigator.\n* Medical or psychiatric conditions compromising the patient's ability to provide informed consent, according to the treating physician.\n* Pregnancy or breastfeeding. A negative pregnancy test must be available for women of childbearing potential on the day of tracer administration.\n* Use of an investigational medicinal product within 30 days prior to tracer administration.","ALL","18 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","PulmoPrint is a clinical study at UMCG that investigates why some patients with unresectable stage III lung cancer stop responding to immunotherapy after chemoradiation. To do this, a small dose of a fluorescently labeled version of the immunotherapy drug durvalumab is given via an IV drip, after which a camera bronchoscopy is performed to visualize where and how much of the drug actually reaches the tumor and lymph nodes - before the actual durvalumab treatment starts.",[27],"Stage III Non-small Cell Lung Cancer",[29,30,31],"Fluorescence molecular bronchoscopy","Durvalumab-680LT","Near-infrared fluorescence imaging","NOT_YET_RECRUITING","2026-06-11",{"date":35,"type":36},"2026-06-17","ACTUAL",{"date":38,"type":21},"2026-09-01",{"date":40,"type":21},"2031-03-01",{"name":42,"class":43},"University Medical Center Groningen","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":111},"100467009","phase-1-a-study-to-investigate-the-efficacy-and-safety-of-an-infusion-of-iov-4001-in-adult-participants-with-unresectable-or-metastatic-melanoma-or-stage-iii-or-iv-non-small-cell-lung-cancer-100467009","NCT05361174","A Study to Investigate the Efficacy and Safety of an Infusion of IOV-4001 in Adult Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer","A Phase 1\u002F2, Open-label Study of PD-1 Knockout Tumor-infiltrating Lymphocytes (IOV-4001) in Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer","Inclusion Criteria:\n\n1. Participants must have a confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma or Stage III or IV NSCLC.\n2. Participants who have received the following previous therapy:\n\n   1. Cohort 1 (Melanoma): Participants who have progressed within 12 weeks of last dose of anti-PD-1\u002FPD-L1 blocking antibody and received BRAF\u002FMEK inhibitor in those with BRAF mutations.\n   2. Cohort 2 (NSCLC): Participants who should have received no more than 3 prior lines of therapy and:\n\n      * those without oncogene-driven tumors: Have progressed within 12 weeks after last dose of anti-PD-1\u002FPD-L1 blocking antibody\n      * those with oncogene-driven tumors: Have progressed during\u002Fafter ≥1 targeted therapy AND either:\n\n        * platinum doublet chemotherapy\n        * Or within 12 weeks after last dose of anti-PD-1\u002FPD-L1 blocking antibody\n3. Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Participants who is assessed as having at least one resectable lesion.\n5. Participants who have at least one measurable lesion, following resection of the lesion for IOV-4001 generation.\n6. Participants who have adequate organ function.\n7. Cardiac function test required.\n8. Pulmonary function test may be required.\n9. Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months.\n10. Participants who are \\>70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.\n\nExclusion Criteria:\n\n1. Participants who have melanoma of uveal\u002Focular origin.\n2. Participants who have symptomatic untreated brain metastases.\n3. Participants who have had a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years.\n4. Participants who require systemic steroid therapy 10 mg\u002Fday prednisone or another steroid equivalent dose.\n5. Participants who have any form of primary immunodeficiency.\n6. Participants who have another primary malignancy within the previous 3 years.\n7. Participants who have received or will receive a live or attenuated vaccination within 28 days prior to the start of the NMA-LD.","70 Years",{"count":53,"type":21},53,[55,24],"PHASE1","This is a study to investigate the efficacy and safety of an infusion of IOV-4001 in adult participants with unresectable or metastatic melanoma or advanced non-small-cell lung cancer (NSCLC).",[58,59,27,60],"Unresectable Melanoma","Metastatic Melanoma","Stage IV Non-small Cell Lung Cancer",[62,63,58,59,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100],"Tumor Infiltrating Lymphocytes","TIL","Stage III Non-small-cell lung cancer","Stage IV Non-small-cell lung cancer","PD-1 Knockout","Cell Therapy","Autologous Adoptive Cell Therapy","Cellular Immuno-therapy","IL-2","Non Small Cell Lung Cancer","NSCLC","Second line Lung Cancer","Bronchial Neoplasms","Carcinoma","Lung Disease","Metastatic Lung Cancer","Metastatic Non Small Cell Lung Cancer","Lung Carcinoma","PD-L1","Stage IV Cancer","Stage IV Lung Cancer","Stage IV NSCLC","Systemic Therapy","2nd line therapy","Second line therapy","CPI","Check point inhibitor","Metastatic NSCLC","NSCLC Recurrent","Recurrent Lung Cancer","Recurrent Lung Carcinoma","Autologous Adoptive Cell Transfer","Melanoma","Lifileucel","Stage III Melanoma","Stage IV Melanoma","Skin cancer","Skin cancer types","Malignant melanoma","RECRUITING","2026-06-10",{"date":33,"type":36},{"date":105,"type":36},"2022-07-20",{"date":107,"type":21},"2029-09",{"name":109,"class":110},"Iovance Biotherapeutics, Inc.","INDUSTRY",11,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":126,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":111},"100523926","phase-2-paccelio---fdg-pet-based-small-volume-accelerated-immuno-chemoradiotherapy-in-locally-advanced-nsclc-100523926","NCT06102057","PACCELIO - FDG-PET Based Small Volume Accelerated Immuno Chemoradiotherapy in Locally Advanced NSCLC","PACCELIO","Inclusion Criteria:\n\n* Written informed consent\n* Patients irrespective of sex and gender, aged 18 years or older at the time of signing the ICF\n* Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study as determined by the investigator\n* Patients with histologically or cytologically documented NSCLC who present with locally advanced, unresectable (Stage III) disease (according to version 8 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology (IASLC Staging Manual in Thoracic Oncology 2016))\n* Patients fit for simultaneous chemoradiotherapy and consolidation immunotherapy according to interdisciplinary consensus\n* Histologically proven PD-L1-expression of ≥ 1% (tumor proportion score; TPS) in tumor sample as assessed in routine staging using a validated test such as Ventana SP236 assay\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrolment\n* Tumor assessment by FDG-PET CT within 21 days prior to start of chemoradiotherapy.\n* Adequate pulmonary function test results\n\n  * Pre- or post-bronchodilator forced expiratory volume 1 of 1.0 L or \\>40% of predicted AND\n  * Diffusing capacity of the lung for carbon monoxide (DLCO) \\>30% of predicted\n* Adequate bone marrow and organ function at enrolment\n\n  * Hemoglobin ≥9.0 g\u002FdL\n  * Absolute neutrophil count \\>1.5 × 109\u002FL\n  * Platelet count \\>100 × 109\u002FL\n  * Serum bilirubin ≤1.5 × upper limit of normal (ULN)\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN\n  * Measured creatinine clearance (CrCl) \\>40 mL\u002Fmin or calculated CL \\>40 mL\u002Fmin as determined by Cockcroft-Gault (using actual body weight)\n* Body weight of \\>30 kg at enrolment\n* Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they are amenorrhoic for 12 months or more without an alternative medical cause. The following age-specific requirements apply:\n\n  * Women \\\u003C50 years old would be considered post-menopausal if they have been amenorrhoic for 12 months or more following cessation of exogenous hormonal treatments with luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution\n  * Women ≥50 years old would be considered post-menopausal if they have been amenorrhoic for 12 months or more following cessation of all exogenous hormonal treatments, radiation-induced oophorectomy with last menses \\>1 year ago, chemotherapy-induced menopause with \\>1 year interval since last menses, or surgical sterilization (bilateral oophorectomy or hysterectomy)\n* Women of childbearing potential (WOCBP) and male patients with partners of childbearing potential must agree to always use a highly effective form of contraception according to the Clinical Trials Facilitation and Coordination Group during the treatment phase of this study and for at least 90 days after the last dose durvalumab or 6 months after the last dose of chemotherapy, whichever occurs last\n\nExclusion Criteria:\n\n* Mixed small cell and NSCLC histology\n* Neuroendocrine tumor\n* Distant metastases\n* Malignant pleural effusion or pericardial effusion\n* Acute superior vena cava obstruction\n* Receipt of prior or current cancer treatment for NSCLC, including but not limited to, surgical resection, radiation therapy, investigational agents, chemotherapy, and monoclonal antibodies (mAbs). Exception: Prior surgical resection of limited metachronous NSCLC (i.e., stage I or II) is permitted.\n* Receipt of live attenuated vaccine within 30 days prior to the start of therapy. Note: Patients, if enrolled, should not receive live vaccine during treatment phase and up to 30 days end of treatment\n* Major surgical procedure (as defined by the Investigator) within 28 days prior start of treatment.\n* Prior exposure to immune-mediated therapy, including but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1 (including durvalumab), and anti-PD-L2 antibodies, including therapeutic anticancer vaccines\n* Current use of ongoing long-term immunosuppressive medication. The following are exceptions to this criterion\n\n  * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)\n  * Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent\n  * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n* History of allogeneic organ transplantation\n* Active or prior documented autoimmune or inflammatory disorders including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\\]). The following are exceptions to this criterion:\n\n  * Patients with vitiligo or alopecia\n  * Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\n  * Any chronic skin condition that does not require systemic therapy\n  * Patients without active disease in the last 5 years at randomization may be included but only after consultation with the local study physician\n  * Patients with celiac disease controlled by diet alone\n* Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, ILD, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent\n* Patients with oxygen dependence\n* Acute inflammation of mediastinal lymph nodes\u002Fmediastinal lymphadenopathy in the context of active pneumoconiosis, sarcoidosis or tuberculosis\n* History of another primary malignancy, except for\n\n  * Basal cell carcinoma of the skin\n  * Second malignancy diagnosed \\> 2 years prior to NSCLC diagnosis if after curative treatment without persistence or progression at baseline. Patients with a previous history of radiation therapy are eligible provided field overlap is minimal and the risk of toxicity to tissues in the overlapping region(s) is deemed to be acceptable by treating radiation oncologist.\n  * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n  * Adequately treated carcinoma in situ without evidence of disease\n* History of leptomeningeal carcinomatosis\n* Positive diagnostic test for hepatitis B (hepatitis B surface antigen) or hepatitis C (hepatitis C antibody or hepatitis C RNA)\n* Known active infection of tuberculosis or human immunodeficiency virus\n* Known allergy or hypersensitivity to concomitant chemotherapy and durvalumab or any of the excipients\n* Any medical contraindication to treatment with platinum-based doublet chemotherapy as listed in the applying SmPCs\n* Patients who have disease considered for surgical treatment as part of their care plan, such as Pancoast or superior sulcus tumors.\n* Concurrent enrolment in another clinical study, unless it is an observational (noninterventional) clinical study or the follow-up period of an interventional study\n* Participation in another clinical study with an investigational product during the 4 weeks prior to enrolment\n* Pregnancy or breast-feeding",{"count":120,"type":21},110,[24],"Multinational, randomized, controlled, open-label, multicenter phase II trial. Eligible patients will be randomized in a ratio of 1:1 to Experimental Arm (FDG-PET-based small volume accelerated radiotherapy with concurrent standard of care chemotherapy) or Conventional Arm (standard FDG-PET-based radiotherapy with concurrent standard of care chemotherapy). Patients showing complete response, partial response, or stable disease following chemoradiotherapy will receive standard of care consolidation therapy with durvalumab (fixed dose of 1500 mg q4w) for up to 12 months or until progression of disease, unacceptable toxicity, patient´s wish, or investigator´s decision, whichever comes first.\n\nAfter end of durvalumab therapy, patients will undergo safety follow up for 90 (+7) days followed by survival follow up until overall end of study. Overall end of study will be reached 24 months after the last patient has started durvalumab therapy. Patients showing PD following chemoradiotherapy will be treated according to investigator´s decision but will be followed up until overall end of study.",[27,124,125],"Locally Advanced","Unresectable",[127,128,129],"chemoradiotherapy","immunotherapy","small volume accelerated chemoradiotherapy","2025-12-09",{"date":132,"type":36},"2025-12-17",{"date":134,"type":36},"2024-07-01",{"date":136,"type":21},"2028-06",{"name":138,"class":43},"TheraOp",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":149,"briefSummary":150,"conditions":151,"keywords":156,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":20},"100586607","phase-2-palace-cemiplimab-trial-according-to-ctdna-levels-100586607","NCT06917573","PALACE: Cemiplimab Trial According to ctDNA Levels","Phase II Clinical Trial With an Adaptive Design According to Response to Cemiplimab Monotherapy Using ctDNA and Subsequent Treatment With Chemotherapy (CT) and Cemiplimab or Cemiplimab Monotherapy in First Line Advanced NSCLC Patients","PALACE","Inclusion Criteria:\n\n* Histologically confirmed stage IV or stage IIIB\u002FC not candidates for definitive chemo\u002Fradiotherapy or surgical resection non-small cell lung cancer (NSCLC) per the 8th edition TNM with no prior systemic anti-cancer therapy\n* PDL1 ≥50%\n* ECOG performance status 0-1\n* Patients aged ≥ 18 years\n* Prior adjuvant or neoadjuvant chemotherapy for early stage is permitted if completed at least 6 months prior to enrolment\n* Presence of at least one measurable lesion by CT-scan per RECIST version 1.1\n* Anticipated life expectancy \\>12 weeks\n* Correct hematological, hepatic and renal function\n* Patient consent must be obtained in the appropriate manner as established in the applicable local and regulatory requirements\n* Patients must be accessible for treatment and follow-up\n* Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 3 days before enrolment.\n* All sexually active men and women of childbearing potential must use a highly effective contraceptive method during the study treatment and for a period of at least 4 months following the last administration of trial drugs\n\nExclusion Criteria:\n\n* Patients whose tumors harbor an activating mutation in EGFR, ALK translocation, or ROS Proto-Oncogene 1 (ROS1) rearrangements sensitive to available targeted inhibitor therapy\n* Patients with grade ≥2 neuropathy\n* Pregnant or breastfeeding women\n* Patients with a weight loss \\>10% within the previous 3 months\n* Patients with carcinomatous meningitis\n* Patients with a history of other malignant diseases within the past 3 years\n* Patients must have recovered from a major surgery at least 14 days prior to enrolment\n* Patients with active or uncontrolled infections or with serious medical conditions or disorders that may not allow patient management as established in the protocol\n* Prior treatment with antineoplasic drugs or thoracic radiotherapy for any reason different from the ones specific in the inclusion criteria\n* Patients who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, or chemo-radiotherapy with curative intent for non-metastatic disease less than 6 months before enrollment since the last chemotherapy, radiotherapy, or chemo-radiotherapy\n* Patients with a combination of small cell lung cancer and non-small cell lung cancer, a carcinoid lung tumor or large cell neuroendocrine carcinoma\n* Has known allergy or hypersensitivity to components of study drug\n* Significant comorbidities that preclude the administration of chemotherapy according to the investigator's criteria\n* Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments\n* Untreated brain metastasis(es) that may be considered active\n* Immunosuppressive corticosteroid doses within 4 weeks prior to the first dose of cemiplimab\n* Uncontrolled infection with hepatitis B or hepatitis C or human immunodeficiency virus; or diagnosis of immunodeficiency\n* History of interstitial lung disease or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management.\n* History of documented allergic reactions or acute hypersensitivity reactions attributed to antibody treatments\n* Patients with a history of solid organ transplant\n* Receipt of live vaccines within 30 days of first study treatment\n* Women of childbearing potential, or sexually active men, who are unwilling to practice highly effective contraception prior to the initial dose\u002Fstart of the first treatment prior to the start of the first treatment, during the study, and for at least 4 months after the last dose.",{"count":148,"type":21},63,[24],"This is an open-label, non-randomised, phase II, multicenter clinical trial. 63 stage IV or stage IIIB\u002FC not candidates for definitive chemo\u002Fradiotherapy or surgical resection non-small cell lung cancer (NSCLC) per the 8th edition TNM with no prior systemic anti-cancer therapy will be enrolled in this trial to determine whether therapy decision making based on ctDNA analysis improves overall survival.",[152,153,60,27,154,155],"Non Small Cell Lung Cancer Metastatic","Lung Diseases","Respiratory Tract Neoplasms","Thoracic Neoplasms",[157,158,159,160],"Cemiplimab","ctDNA levels","Chemotherapy","Non-resectable non-small cell lung cancer","2025-11-17",{"date":163,"type":36},"2025-11-19",{"date":165,"type":36},"2025-07-29",{"date":167,"type":21},"2031-12-30",{"name":169,"class":43},"Fundación GECP",{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":180,"briefSummary":182,"conditions":183,"keywords":184,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":196},"100522428","the-beneficial-value-of-petct-in-the-follow-up-of-stage-iii-non-small-cell-lung-cancer-patients-100522428","NCT06082492","The Beneficial Value of PET\u002FCT in the Follow-up of Stage III Non-small Cell Lung Cancer Patients","The Beneficial Value of 18F FDG PET\u002FCT in the Follow-up of Stage III Non-small Cell Lung Cancer Patients: the NVALT31-PET Study","NVALT31-PET","Eligible for this study are patients with stage III NSCLC (8th edition TNM Classification) who (are about to) start(ed) follow-up care (which may include adjuvant treatment) at a participating hospital. Patients may already be included during their curative intent treatment. Patients enter a screening period that runs until their randomization.\n\nInclusion Criteria:\n\nTo be eligible to participate in this study, a subject must meet all of the following criteria at the timing of randomization:\n\n* Cytological or histologically proven stage III non-small cell lung cancer before start of curative intent treatment\n* Treated with curative intent and started follow-up care\n* All adjuvant treatments are permitted as co-intervention during follow-up care\n* Age 18 years or older\n* ECOG Performance Status classification 0-2 at moment of inclusion\n* Written and signed informed consent by the patient or patient's representative (with the understanding that consent may be withdrawn by the patient or patient's representative at any time without consequences to future medical care)\n\nExclusion Criteria:\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n* Life expectancy shorter than 6 months at the end of curative intent treatment\n* Evidence of recurrence after end of curative intent treatment and before randomization (4 months follow-up)\n* Any condition that, in the opinion of the investigator, would interfere with evaluation of the intervention or interpretation of HRQOL or other study results.",{"count":179,"type":21},690,[181],"NA","The primary objective of this study is to compare the 3-year overall survival of stage III NSCLC patients during follow-up surveillance with 18F-Fluorodeoxyglucose Positron Emission Tomography\u002F Computerized Tomography (18F FDG PET\u002FCT) versus follow-up with conventional CT surveillance.\n\nParticipants will receive usual care until 3 years of follow-up (control group) with additional whole-body 18F FDG PET\u002FCT scans during follow-up visits at 6 months, 12 months, 18 months, 24 months, and 36 months of follow-up in the intervention group.\n\nOther tasks include:\n\n* filling in quality of life (QOL) questionnaires at every time point;\n* participating in an interview evaluating the addition of the 18F FDG PET\u002FCT scans (optional);\n* collecting blood at the follow-up time points for our secondary endpoint (optional).\n\nResearchers will compare the usual care control group with the intervention group to see if the additional 18F FDG PET\u002FCT scans are (cost-)effective.",[27],[185,186],"18F FDG PET\u002FCT scans","Follow-up care","2025-02-04",{"date":189,"type":36},"2025-02-05",{"date":191,"type":36},"2024-03-19",{"date":193,"type":21},"2029-06",{"name":195,"class":43},"Radboud University Medical Center",27,{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":204,"enrollmentInfo":205,"targetDuration":4,"studyType":22,"phases":207,"briefSummary":208,"conditions":209,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":219},"100475232","phase-2-study-of-tislelizumab-for-locally-advanced-non-small-cell-lung-cancer-following-neoadjuvant-chemotherapy-plus-tislelizumab--bevacizumab-and-definitive-concurrent-chemoradiation-therapy-100475232","NCT05468242","Study of Tislelizumab for Locally Advanced Non-Small Cell Lung Cancer Following Neoadjuvant Chemotherapy Plus Tislelizumab ± Bevacizumab and Definitive Concurrent Chemoradiation Therapy","A Phase II Trial of Tislelizumab as Consolidation Therapy in Patients With Locally Advanced Non-Small Cell Lung Cancer Who Have Not Progressed Following Neoadjuvant Chemotherapy Plus Tislelizumab ± Bevacizumab and Definitive Concurrent Chemoradiation Therapy","Inclusion Criteria:\n\n* For inclusion in neoadjuvant therapy, patients should fulfil the following criteria:\n\n  * Provision of signed, written and dated informed consent prior to any study specific procedures;\n  * Male or female aged 18\\~75 years old;\n  * Patients must have histologically- or cytologically-documented NSCLC who present with locally advanced (Stage III) disease;\n  * Without prior chemotherapy, radiotherapy, surgery, targeted therapy or immunotherapy;\n  * A recent tumour biopsy (taken following completion of the most recent therapy) is an optional requirement, provided that a biopsy procedure is technically feasible and the procedure is not associated with unacceptable clinical risk;\n  * Life expectancy ≥12 weeks;\n  * World Health Organization (WHO) Performance Status of 0 or 1;\n  * Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients within 14 days before the use of study drug (HCG has a minimum sensitivity of 25 IU\u002FL or equivalent);\n  * Women must be non-breastfeeding\n  * Forced expiratory volume in 1 second (FEV1) ≥800ml\n  * Absolute neutrophil count \\>1.5 x 109\u002FL (1500 per mm3)\n  * Platelets \\>100 x 109\u002FL (100,000 per mm3)\n  * Haemoglobin≥9.0 g\u002FdL (5.59 mmol\u002FL)\n  * Serum creatinine clearance(CL) \\>50 mL\u002Fmin by the Cockcroft-Gault formula (Cockcroft and -Gault 1976)\n  * Serum bilirubin ≤1.5 x upper limit of normal (ULN). Aspartate Transaminase(AST) and Alanine Transaminase(ALT) ≤2.5 x ULN\n\nExclusion Criteria:\n\n* Exclusion criteria for enrolment for neoadjuvant therapy Patients should not enter the study if any of the following exclusion criteria are fulfilled:\n\n  * Concurrent enrolment in another clinical study, unless it is an observational(non-interventional) clinical study;\n  * Mixed small cell and non-small cell lung cancer histology;\n  * Current or prior use of immunosuppressive medication within 28 days before the first dose of Tislelizumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg\u002Fday of prednisone, or an equivalent corticosteroid. Systemic steroid administration required to manage toxicities arising from radiation therapy delivered as part of the chemoradiation therapy for NSCLC is allowed.\n  * Prior exposure to any anti-programmed cell death protein(PD)-1 or anti-PD-L1 antibody;\n  * Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access) that would prevent administration of Tislelizumab;\n  * Active or prior documented autoimmune disease within the past 2 years;\n  * Active or prior documented inflammatory bowel disease (eg. Crohn's disease, ulcerative colitis);\n  * History of primary immunodeficiency;\n  * History of organ transplant that requires therapeutic immunosuppression;\n  * The tumor has completely approached, encircled, or invaded the intravascular space of the great vessels (e.g., the pulmonary artery or the superior vena cava)\n  * Bleeding tendency or coagulation disorder\n  * Hypertensive crisis, hypertensive encephalopathy, symptomatic heart failure (New York class II or above), active cerebrovascular disease or cardiovascular disease occurred within 6 months\n  * Uncontrolled hypertension (systolic \\> 150mmHg and\u002For diastolic \\> 100mmHg)\n  * Major surgery within 28 days or minor surgery or needle biopsy within 48 hours\n  * Urine protein 3-4+, or 24h urine protein quantitative \\>1g\n  * Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Bazett's Correction;\n  * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent;\n  * Known history of tuberculosis;\n  * Receipt of live attenuated vaccination within 30 days prior to study entry or within30 days of receiving Tislelizumab;\n  * History of another primary malignancy within 5 years prior to starting Tislelizumab, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study;\n  * Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control;\n  * Any condition that, in the opinion of the investigator, would interfere with evaluation of the Tislelizumab or interpretation of patient safety or study results.\n* Exclusion criteria for concurrent chemoradiation following neoadjuvant therapy\n\nPatients should not enter the concurrent chemoradiation phase if any of the following exclusion criteria are fulfilled:\n\n* Patients who develop disease progression and the irradiation dose of normal tissue will exceed the limit as defined in Section 7.\n* World Health Organization (WHO) Performance Status of 2-4;\n* Inadequate organ and marrow function as defined below:\n* Forced expiratory volume in 1 second (FEV1) \\\u003C800ml\n* Absolute neutrophil count \\\u003C1.5 x 109\u002FL (1500 per mm3)\n* Platelets \\\u003C100 x 109\u002FL (100,000 per mm3)\n* Haemoglobin\\\u003C9.0 g\u002FdL (5.59 mmol\u002FL)\n* Serum creatinine CL \\\u003C50 mL\u002Fmin by the Cockcroft-Gault formula (Cockcroft and Gault 1976)\n* Serum bilirubin \\>1.5 x upper limit of normal (ULN).\n* Aspartate Transaminase(AST) and Alanine Transaminase(ALT) \\>2.5 x ULN\n\n  * Further exclusion criteria for Tislelizumab consolidation:\n\nPatients should not enter the Tislelizumab consolidation if any of the following exclusion criteria are fulfilled:\n\n* Patients who have progressed whilst definitive platinum based, concurrent chemoradiation therapy;\n* Current or prior use of immunosuppressive medication within 28 days before the first dose of Tislelizumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg\u002Fday of prednisone, or an equivalent corticosteroid. Systemic steroid administration required to manage toxicities arising from radiation therapy delivered as part of the chemoradiation therapy for locally advanced NSCLC is allowed.\n* Any unresolved toxicity CTCAE \\>Grade 2 from the prior chemoradiation therapy will be excluded from randomization;\n* Patients with Grade ≥2 pneumonitis from prior chemoradiation therapy will be excluded from randomization; Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE\\>Grade 1.","75 Years",{"count":206,"type":21},116,[24],"The phase II Study is to explore the efficacy and safety of Tislelizumab as consolidation therapy in patients with locally advanced non-small cell lung cancer who have not progressed following neoadjuvant chemotherapy plus Tislelizumab ± Bevacizumab and definitive concurrent chemoradiation therapy.",[27],"2024-10-27",{"date":212,"type":36},"2024-10-30",{"date":214,"type":36},"2022-01-01",{"date":216,"type":21},"2024-12-30",{"name":218,"class":43},"Sun Yat-sen University",1,{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":22,"phases":229,"briefSummary":230,"conditions":231,"keywords":234,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":219},"100342750","heterogeneously-hypofractionated-radiotherapy-for-locally-advanced-nsclc-100342750","NCT03742687","Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC","HERAN-Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC","Inclusion Criteria:\n\n* Histologically or cytological confirmed locally advanced, inoperable NSCLC.\n* Age ≥18 years.\n* Signed informed consent.\n* Performance status 0-2.\n* Able to comply with study and follow-up procedures.\n* Fertile women must have a negative pregnancy test. Fertile men and women must use effective contraception. Fertile women included in the study must use the pill, spiral, depot injection of gestagen, subdermal implantation, hormonal vaginal ring or transdermal patch for the duration of study treatment and one month thereafter.\n\nExclusion Criteria:\n\n* Prior radiotherapy to the thorax, unless there is no significant overlap of current treatment volumes with previous treatment fields.\n* Dose plan conforming to protocol planning criteria not possible.\n* Uncontrolled metastatic disease.\n* Other active malignant disease.",{"count":228,"type":21},151,[181],"The options for patients with locally advanced non-small cell lung cancer (NSCLC) who are not candidates for a standard definitive chemoradiotherapy regime are meagre. These are patients who are not fit for a chemoradiotherapy schedule of 66 Gy in 2 Gy fractions due to either tumour extent, resulting in excessive dose to the healthy tissue in the thorax, or with performance status not supporting seven weeks of intensive treatment.\n\nThe aim is to study the efficiency as well as the safety of a new treatment option of heterogeneously hypofractionated radiotherapy for patients with locally advanced NSCLC who are not candidates for standard, high-dose chemoradiotherapy, either due to excessive irradiation of normal tissue (defined as category A patients) or due to fragility of the patient (category B patients).",[232,60,233],"Stage III Non-small-cell Lung Cancer","Radiotherapy Side Effect",[235,236,237],"Locally advanced NSCLC","Radiotherapy","Hypofractionation","2023-09-08",{"date":240,"type":36},"2023-09-11",{"date":242,"type":36},"2018-11-22",{"date":244,"type":21},"2026-12-30",{"name":246,"class":43},"Danish Lung Cancer Group",{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":22,"phases":255,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":4},"100507722","phase-2-neoadjuvant-therapy-with-toripalimab-and-js004-combined-with-platinum-based-doublet-chemotherapy-for-resectable-or-potentially-resectable-stage-iii-non-small-cell-lung-cancer-a-randomised-controlled-open-label-phase-2-trial-100507722","NCT05891080","Neoadjuvant Therapy With Toripalimab and JS004 Combined With Platinum-based Doublet Chemotherapy for Resectable or Potentially Resectable Stage III Non-small Cell Lung Cancer: A Randomised Controlled, Open-label, Phase 2 Trial","Inclusion Criteria:\n\n1. The patient shall sign the Informed Consent Form.\n2. Aged 18 ≥ years.\n3. Histological or cytological diagnosis of NSCLC by needle biopsy, and stage IIIB-IIIC confirmed by imageological examinations (CT, PET-CT or EBUS).\n4. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.\n5. Life expectancy is at least 12 weeks.\n6. At least 1 measurable lesion according to RECIST 1.1.\n7. Patients with good function of other main organs (liver, kidney, blood system, etc.)\n8. Patients with lung function can tolerate surgery;\n9. Without systematic metastasis (including M1a, M1b and M1c);\n10. Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of toripalimab (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.\n11. Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of toripalimab (whichever is later).\n\nExclusion Criteria:\n\n1. Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment;\n2. Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (\\>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases;\n3. With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;\n4. Participants who are allergic to the test drug or any auxiliary materials;\n5. Participants with Interstitial lung disease currently;\n6. Participants with active hepatitis B, hepatitis C or HIV;\n7. Pregnant or lactating women;\n8. Participants suffering from nervous system diseases or mental diseases that cannot cooperate;\n9. Participated in another therapeutic clinical study;\n10. Other factors that researchers think it is not suitable for enrollment.",{"count":254,"type":21},124,[24],"For stage III non-small cell lung cancer (NSCLC), neoadjuvant chemotherapy plus PD-1 antibody is recommended. However, most patients could not achieve complete pathological response (CPR). New immunotherapeutic strategy is needed to achieve higher CPR rate. JS004 is a new antibody targeting B and T lymphocyte attenuator (BTLA) which restrains the function of immune cells and leads to immune escape of tumor cells. The combination of PD-1 antibody and BTLA antibody has shown good therapeutic effect in solid tumors. This trial aims to investigate the efficacy and safety of the therapeutic regimen of toripalimab and JS004 plus chemotherapy in stage III NSCLC.",[27],"2023-06-03",{"date":260,"type":36},"2023-06-06",{"date":262,"type":21},"2023-07-01",{"date":264,"type":21},"2030-07-01",{"name":266,"class":43},"Shanghai Pulmonary Hospital, Shanghai, China"]