[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"patients-with-non-small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:patients-with-non-small-cell-lung-cancer":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":44},"100552373","phase-3-trial-of-therapeutic-cancer-vaccine-ose2101-in-patients-with-non-small-cell-lung-cancer-and-secondary-resistance-to-immune-checkpoint-inhibitor-100552373",false,"NCT06472245","Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor","A Randomised, Open-label, Phase 3 Trial Comparing the Efficacy and Safety of OSE2101 Versus Docetaxel in HLA-A2 Positive Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) With Secondary Resistance to Immune Checkpoint Inhibitor","ARTEMIA","Inclusion Criteria:\n\n1. Male or female, aged ≥ 18 years\n2. Patients expressing HLA-A2 phenotype in blood by pre-screening central laboratory\n3. Patients with histologically or cytologically squamous or non-squamous documented NSCLC, metastatic stage at study entry, not eligible for definite surgery or radiation, without EGFR, ALK and ROS1 gene alterations eligible for targeted therapy; for patients with squamous NSCLC, the molecular tests are not mandatory if age ≥ 50 years old and smoker ≥ 15 pack years; other sensitizing mutations known to be immunosensitive are eligible in case of lack of local access to targeted therapy (i.e.; KRAS G12C and BRAF mutations) after Sponsor' agreement.\n4. Patients with secondary resistance to ICI;\n\nOther inclusion and exclusion criteria will apply per protocol.","ALL","18 Years",{"count":20,"type":21},363,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Multicenter, randomized (2:1), open-label phase 3 study in HLA-A2 positive patients with squamous and non-squamous metastatic NSCLC with ICI secondary resistance.\n\nPatients will be randomized into 2 arms (randomization 2:1): experimental Arm A with OSE2101 monotherapy or control Arm B SoC with docetaxel monotherapy. Stratification factors will be histology (squamous versus non squamous) and ECOG Performance Status (0 versus 1).",[27],"Patients With Non-Small Cell Lung Cancer",[29,30,31],"Immune Checkpoint Inhibitor","Cancer vaccine","Non-Small Cell Lung Cancer","RECRUITING","2026-03-31",{"date":35,"type":36},"2026-04-01","ACTUAL",{"date":38,"type":36},"2024-12-03",{"date":40,"type":21},"2028-12-15",{"name":42,"class":43},"OSE Immunotherapeutics","INDUSTRY",207,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100556717","feasibility-of-primer-shot-radiotherapy-for-non-small-cell-lung-cancer---primer-100556717","NCT06528743","Feasibility of Primer Shot Radiotherapy for Non-small Cell Lung Cancer - PRIMER","PRIMER","Inclusion Criteria:\n\n* Age ≥ 18 years\n* NSCLC (either pathology proven or sufficient clinical suspicion to be treated as NSCLC), referred for palliative radiotherapy of at least the primary tumor site.\n* Stage 2-4\n* WHO performance score 0-2.\n* Provision of signed, written and dated IC prior to any study specific procedures.\n\nExclusion Criteria:\n\n* Interstitial lung disease\n* Treatment with vascular endothelial growth factor receptor (VEGFR) inhibitors\n* Prior thoracic radiotherapy (\\>20 Gy EQD2 a\u002Fb 3) overlapping with the current planning target volume",{"count":53,"type":21},34,[55],"NA","Intro\u002Frationale: Radiotherapy employs uniform, equally spaced weekday fractions that do not account for changes in tumor radiosensitivity. However, radiobiological characteristics evolve during the radiotherapy schedule as reoxygenation increases radiosensitivity. In tumor-response simulations and preclinical experiments, it was superior to prime the tumor with one radiotherapy fraction, followed by a treatment break permitting mitotic cell death and reoxygenation of tumor cells.\n\nObjective: To determine the safety and feasibility of primer shot fractionation for NSCLC.\n\nStudy design: A prospective non-randomized feasibility trial to test the safety of primer shot fractionation in a 3+3 phase with increasing treatment breaks, followed by an expansion cohort.\n\nStudy population: Patients with NSCLC stage 2-4, referred for palliative radiotherapy of the primary tumor and possibly (lymph node) metastases. Patients are allowed to receive systemic treatments, except for VEGFR-inhibitors. The 3+3 phase is followed by an expansion phase of 22 patients.\n\nIntervention: All treatments are 5x6 Gy to all targets. Patients receive an increasing primer shot treatment break. In the 3+3 phase, the break between the first and the second radiotherapy fraction is: 1, 2 and 3 weeks. The maximum tolerated break length will be used for the expansion cohort.\n\nMain study parameters\u002Fendpoints: The main study endpoint is the ability of patients to finish the radiotherapy schedule as planned. Secondary endpoints are tumor response at the end of treatment and 3 months thereafter, and acute toxicity.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: Based on simulations and preclinical data, primer shot treatment breaks increase tumor control. However, the increased overall treatment time could potentially increase the chance a patient drops out before the radiotherapy schedule is finished. Because of the gradually prolonged break, this risk is relatively small and acceptable for this population. Additionally, patients are asked to fill in PRO-CTCAE lung subset questionnaires at the start of treatment and during follow-up. They will also receive 1 additional CT with contrast at fraction 5.",[58],"Patients With Non-small-cell Lung Cancer","2025-01-02",{"date":61,"type":36},"2025-01-06",{"date":63,"type":36},"2024-08-08",{"date":65,"type":21},"2029-08-01",{"name":67,"class":68},"The Netherlands Cancer Institute","OTHER",1,"Patients With Non-small Cell Lung Cancer"]