[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-4-nsclc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-4-nsclc":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,74],{"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":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100643785","phase-2-universal-immunization-to-fortify-immunotherapy-efficacy-and-response-100643785",false,"NCT07597070","Universal Immunization to Fortify Immunotherapy Efficacy and Response","Universal Immunization to Fortify Immunotherapy Efficacy and Response (UNIFIER)","UNIFIER","Inclusion Criteria:\n\n* Adults ≥ 18 years of age.\n* Histologically or cytologically confirmed stage IV non-small cell lung cancer (NSCLC), defined as: adenocarcinoma, squamous cell carcinoma, large cell carcinoma, and NSCLC not otherwise specified; with clinical disposition to front-line therapy, with pembrolizumab and chemotherapy\n* ECOG Performance Status of 0 to 2.\n* Willing to receive Pfizer-BioNTech mRNA COVID-19 vaccine (for vaccine arms).\n* Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.\n* Subjects must not have more than one active malignancy at the time of enrollment (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen or primary endpoint \\[as determined by the treating physician or approved by the PI\\] are eligible for this trial).\n* Women of childbearing potential (WOCBP) will be given a pregnancy test (blood or urine) prior to the start of treatment and must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 5 months after the last dose of study treatment to minimize the risk of pregnancy. Prior to study enrollment, subjects of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.\n\nAdequate contraception methods for WOCBP include:\n\n* Barrier methods\n\n  * Male and female condoms\n  * Vaginal diaphragm\n  * Cervical cap\n  * Vaginal sponge\n* Hormonal medication and devices\n\n  * Birth control implant (i.e. Nexplanon)\n  * Intrauterine device (IUD, made of copper or progestin)\n  * Hormonal contraception\n  * Birth control pills (combined (estrogen and progestogen containing))\n  * Contraceptive vaginal ring (i.e. NuvaRing)\n  * Patch (i.e. Xulane)\n  * Progestin only pill (mini pill)\n  * Depo-Provera (birth control shot or Depo)\n* Abstinence\n* Vasectomized male partner\n\nWOCBP includes any subject who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who is not post-menopausal. Post-menopause is defined as:\n\n* Amenorrhea that has lasted for ≥ 12 consecutive months without another cause, or\n* For subjects with irregular menstrual periods who are taking hormone replacement therapy (HRT), a documented serum follicle-stimulating hormone (FSH) level of greater than 35 mIU\u002FmL.\n\n  * Subjects with partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 5 months following the last dose of study treatment.\n\nExclusion Criteria:\n\n* Dispositioned to targeted therapy (e.g., EGFR, ALK, ROS1).\n* Determination by the treating physician that treatment with pembrolizumab with chemotherapy is not an appropriate intervention for the participant.\n* Known hypersensitivity or allergy to any component of the mRNA COVID-19 vaccines (Pfizer-BioNTech or Moderna), including polyethylene glycol (PEG) or polysorbate\n* Administration of a vaccine containing live virus within 30 days prior to the first dose of trial treatment. Note: Most flu vaccines are killed viruses, with the exception of the intra-nasal vainer (Flu-Mist) which is an attenuated live virus and therefore prohibited for 30 days prior to first dose.\n* Receipt of any other COVID-19 vaccine or investigational vaccine within 60 days prior to enrollment.\n* Uncontrolled or unstable comorbid conditions (e.g., active infection, unstable cardiovascular disease, history of vaccine-related myocarditis, or uncontrolled autoimmune disease) that, in the opinion of the investigator, could interfere with study participation or pose additional risk.\n* History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.\n* Subjects who are confirmed to be pregnant or breastfeeding.\n* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.","ALL","18 Years",{"count":20,"type":21},500,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Although immune checkpoint inhibitors (ICIs) have substantially extended survival in many patients, most patients do not achieve durable responses on these treatments. There is a substantial unmet need for methods to sensitize more patients to ICIs. Studies have shown that personalized mRNA lipid nanoparticle vaccines enhance antitumor immunity in combination with PD1 inhibition, under the assumption that these vaccines generate T cells reactive against the targets encoded by the mRNA in the vaccines. However, it was recently found that mRNA vaccines targeting non-tumor antigens are also powerful adjuvants to immune checkpoint blockade.\n\nRetrospective clinical data strongly suggests that receipt of COVID mRNA vaccines with ICIs is responsible for significant improvements in three-year overall survival in multiple large cohorts of patients with non-small cell lung cancer (NSCLC). Patients treated with these vaccines also have increased expression of programmed death ligand 1 (PD-L1) on their tumors.\n\nThis trial is designed to evaluate whether the Pfizer-BioNTech COVID mRNA vaccine improves responses to ICIs in patients with stage IV non-small cell lung cancer.",[27],"Stage 4 NSCLC",[29,30,31,32,33],"COVID","immune checkpoint inhibitor","non-small cell lung cancer","mRNA vaccine","stage 4","NOT_YET_RECRUITING","2026-06-04",{"date":37,"type":38},"2026-06-08","ACTUAL",{"date":40,"type":21},"2026-09",{"date":42,"type":21},"2035-03",{"name":44,"class":45},"University of Florida","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":69,"leadSponsor":71,"locationsCount":5},"100621030","phase-2-a-safety-and-efficacy-study-of-eik1001-in-combination-with-pembrolizumab-and-chemotherapy-in-participants-with-stage-4-non-small-cell-lung-cancer-100621030","NCT07365319","A Safety and Efficacy Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer.","A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2\u002F3 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer (TeLuRide-008).","TeLuRide-008","Key Inclusion Criteria:\n\n1. Participant must be ≥ 18 years old at the time of signing the informed consent.\n2. Participant has a life expectancy of at least 3 months.\n3. Participant has histologically or cytologically confirmed Stage 4 NSCLC predominately squamous or non-squamous) and is considered a candidate for standard therapy with pembrolizumab and chemotherapy. Participants with NSCLC-NOS (not otherwise specified) will be considered as non-squamous NSCLC.\n4. Participant must have documented evidence that mutation-directed therapy is not indicated, based on the absence of tumor-activating mutations or fusions (e.g., but not limited to EGFR, ALK, RET, ROS1, BRAF) for which approved first-line targeted therapies are available to the participant in their respective country.\n5. Participant has at least 1 lesion with measurable disease at Baseline according to RECIST 1.1 as determined locally. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.\n6. Participant has not received prior systemic therapy for advanced\u002Fmetastatic NSCLC.\n\n   Note: Participants who received adjuvant or neoadjuvant treatment (after surgery and\u002For radiation therapy) and developed recurrent or metastatic disease more than 1 year after completing therapy are eligible.\n7. Participant has an ECOG Performance Status of 0 to 1 assessed no more than 10 days before start of the treatment.\n8. Participant has tumor tissue available for PD-L1 testing from a site that was not radiated prior to biopsy, and was obtained, ideally, after diagnosis of metastatic disease. Biopsies obtained prior to receipt of adjuvant\u002Fneoadjuvant chemotherapy will be permitted if recent biopsy is not feasible (provided the specimen is \\\u003C 3yrs old).\n\nKey Exclusion Criteria:\n\n1. has small cell elements present histologically and\u002For the tumors are not predominantly non-squamous or squamous NSCLC.\n2. is currently actively enrolled in or has recently participated in a study of an investigational agent and received investigational therapy within 4 weeks or 5 half-lives (whichever is longer) of administration of EIK1001 or placebo.\n3. has had major surgery (\\\u003C 3 weeks prior to the first dose of study intervention administration).\n4. has received a live-virus vaccination within 30 days of the start of study intervention initiation.\n5. has received radiation therapy within 7 days of the first dose of study intervention administration.\n6. has completed palliative radiotherapy within 7 days of the first dose of study intervention administration.",{"count":55,"type":21},750,[24,57],"PHASE3","This is a study to evaluate the safety and efficacy of EIK1001 administered intravenously in combination with pembrolizumab and histologically appropriate chemotherapy for patients with stage 4 NSCLC.",[60,27],"Non Small Cell Lung Cancer (Squamous or Non Squamous)",[62,63],"Non Small Cell Lung Cancer","EIK1001","RECRUITING","2026-05-18",{"date":67,"type":38},"2026-05-20",{"date":65,"type":21},{"date":70,"type":21},"2040-12-31",{"name":72,"class":73},"Eikon Therapeutics","INDUSTRY",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"100536245","phase-2-thoracic-radiotherapy-for-patients-with-metastatic-stage-iv-non-small-cell-lung-cancer-at-high-risk-of-symptomatic-progression-within-the-thorax-100536245","NCT06262321","Thoracic Radiotherapy for Patients With Metastatic (Stage IV) Non-Small Cell Lung Cancer at High Risk of Symptomatic Progression Within the Thorax","Phase II Trial of Thoracic Radiotherapy for Patients With Metastatic (Stage IV) Non-Small Cell Lung Cancer at High Risk of Symptomatic Progression Within the Thorax","DRO2301","Inclusion Criteria:\n\n* Pathologic diagnosis of Non-Small Cell Lung Cancer (NSCLC) without targetable\u002Foncogene driven mutations (i.e., EGFR mutations, ALK-rearrangement, ROS1 rearrangement).\n* T1-4(or Tx)N0-3M1a-c, Stage IV disease (using the 8th edition of the AJCC staging manual) or metastatic recurrence of primary Stage I-III NSCLC that had been treated with curative intent therapy, without prior thoracic radiotherapy.\n* Thoracic lung and\u002For nodal lesion(s) amenable to palliative chest radiotherapy.\n* All subjects are required to have one or more of the following high-risk features: a) a non-central primary lung lesion ≥5 cm in size (at least T3 by criteria); b) bulky (≥2 cm) parenchymal lung lesions and\u002For nodal lesions abutting (within 1 cm) any of the following: Proximal bronchial tree, Esophagus, Vertebra, Heart, brachial plexus or subclavian vessels (if brachial plexus not well visualized), Superior vena cava\n* Prior systemic therapy is allowed. Subjects must be enrolled within 6 months of first cycle of systemic therapy for Stage IV disease.\n* Systemic therapy following the thoracic radiotherapy (on protocol) is allowed.\n* Prior palliative surgical treatment (including airway debridement) is allowed.\n* Concurrent chemotherapy (chemotherapy delivered from ≤2 days of before through ≤2 days after radiotherapy) is NOT allowed.\n* Concurrent immunotherapy therapy is allowed.\n* Subjects may undergo (or may have undergone) standard extrathoracic radiotherapy off protocol, including (but not limited to): Palliation of symptomatic bone metastases, prophylactic palliation of high-risk bone metastases, cranial radiosurgery (with controlled intracranial metastases if performed prior to enrollment), Ablative or non-ablative definitive radiotherapy for oligometastases.\n* Subjects may undergo concurrent palliative thoracic radiotherapy (per study) and palliative radiotherapy for thoracic bone metastases (i.e., painful spine or rib metastases). It is anticipated that the study will be open at multiple sites within the Wilmot Cancer Institute network. Among these sites, subjects may be consulted and consented at any site, simulated and planned at any site, and treated at any site (even if different from the site(s) at which the subject was consulted and simulated).\n\nExclusion Criteria:\n\n* Prior radiation therapy to the thoracic region.\n* Active systemic lupus or Sjogren's disease.\n* NSCLC (primary, nodal sites or metastases) causing severe symptoms requiring thoracic palliative radiotherapy for indications other than bone pain. These symptoms include superior vena cava syndrome, active and large volume (\\>100 ml per day) hemoptysis, airway obstruction (stridor, post-obstructive pneumonia, progressive dyspnea not attributed to other causes), compression of the spinal cord or spinal nerve roots, vertebral compression fracture, brachial plexopathy (from compression).\n* Baseline ECOG performance status of 3-4. For the purposes of eligibility, Karnofsky Performance Score (KPS) will be converted to ECOG\u002FZubrod performance score, per ECOG guidelines.\n* Brain metastases not amenable to immunotherapy alone, resection or stereotactic radiosurgery (i.e., brain metastases requiring whole brain radiotherapy).\n* Malignant pleural effusion attributable to grossly apparent pleural disease. Subjects with malignant pleural effusion amenable to therapeutic thoracenteses and without radiographic evidence of pleural disease (i.e., studding or masses) are potentially eligible.",{"count":83,"type":21},48,[24],"Patients with metastatic non small cell lung cancer with high risk location or size are treated with prophylactic radiation therapy in conjunction with standard of care systemic therapy.",[27,87],"Radiotherapy","2025-09-04",{"date":90,"type":38},"2025-09-08",{"date":92,"type":38},"2024-05-15",{"date":94,"type":21},"2029-02-01",{"name":96,"class":45},"University of Rochester",1]