[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-small-cell-lung-cancer-recurrent\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-small-cell-lung-cancer-recurrent":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,116],{"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":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100620252","phase-1-first-line-ipilimumab-plus-nivolumab-and-nogapendekin-alfa-inbakicept-n-803-in-patients-with-stage-iv-or-recurrent-non-small-cell-lung-cancer-100620252",false,"NCT07355205","First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer","A Phase Ib\u002FII, Single-Center, Open-Label Study of First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer (FLINN)","FLINN","Inclusion Criteria:\n\n* Histologically or cytologically confirmed, previously untreated or recurrent metastatic NSCLC.\n* Availability of archival biopsy tissue or willingness to undergo a biopsy prior to C1D1 for biomarker analysis, including PD-L1 by IHC using a CLIA-certified test. Results of the PD-L1 testing are not required for enrollment.\n* Measurable disease per RECIST 1.1.\n* At least 18 years of age.\n* ECOG performance status ≤ 1\n* Adequate organ and marrow function, as defined below:\n\n  * Absolute neutrophil count ≥ 1.5 K\u002Fcumm\n  * Platelets ≥ 100 K\u002Fcumm\n  * Hemoglobin ≥ 9.0 g\u002FdL\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 x IULN without hepatic metastasis and ≤ 5 x IULN with hepatic metastasis\n  * Total bilirubin ≤ 2 x IULN (except participants with Gilbert's syndrome who must have total bilirubin \\\u003C 3.0 mg\u002FdL)\n  * Creatinine clearance \\> 30 mL\u002Fmin by Cockcroft-Gault\n  * INR ≤ 1.5 unless using therapeutic anticoagulation\n  * PTT\u002FaPTT \\\u003C 1.5 x IULN unless using therapeutic anticoagulation\n* Patients with brain metastases are eligible if they have previously treated with surgery or radiation therapy, are neurologically stable after a washout period of at least 2 weeks, and are not receiving corticosteroids at dose higher than 10 mg of prednisone or equivalent on C1D1.\n* The effects of the treatment regimen on the developing human fetus are unknown. For this reason, people of childbearing potential and people able to father a child must agree to use highly effective methods of contraception, according to the protocol, from the time of consent through 6 months after the last dose of study treatment.\n* Ability to understand and willingness to sign an IRB-approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Mixed histology including small cell lung cancer.\n* Tumor harboring any of the following:\n\n  * classic EGFR mutations\n  * HER2 mutation\n  * ALK fusion\n  * ROS1 fusion\n  * RET fusion\n  * NTRK fusion\n  * MET Exon14 skipping mutation\n  * BRAF V600E mutation\n* Use of any live vaccines within 28 days of C1D1.\n* Prior chemotherapy in the adjuvant setting or during concurrent radiation therapy for locally advanced disease within 12 months prior to enrollment. If the interval from the last treatment is 12 months or longer, the patient is eligible.\n* Radiation therapy within 14 days prior to C1D1.\n* History of major surgery within 14 days prior to C1D1.\n* Underlying medical conditions that, in the Investigator's opinion, will make the administration of study treatment hazardous, including but not limited to:\n\n  * History of interstitial lung disease or noninfectious pneumonitis,\n  * Active viral, bacterial or fungal infections requiring parenteral treatment within 14 days of C1D1,\n  * Clinically significant cardiovascular disease,\n  * A condition that may obscure the interpretation of toxicity determination or AEs,\n  * History of prior solid-organ transplantation.\n* Concurrent medical condition requiring the use of supra-physiologic doses of corticosteroids (\\> 10 mg\u002Fday of oral prednisone or equivalent) or immunosuppressive medications (absorbable topical corticosteroids are not excluded).\n* HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.\n* Evidence of chronic hepatitis B (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.\n* History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.\n* Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma\u002Fatopy.\n\n  * Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.\n  * Participants with asthma who require intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections will not be excluded from this study.\n  * Participants on chronic systemic corticosteroids will be excluded from the study.\n* Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.\n* Use of other investigational drugs (drugs not marketed for any indication) within 28 days or 5 half-lives (whichever is longer) of C1D1.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in the study, or known hypersensitivity to recombinant proteins, or any excipient contained in the trial formulations.\n* Pregnant and\u002For breastfeeding. People of childbearing potential must have a negative pregnancy test within 7 days of study entry.","ALL","18 Years",{"count":20,"type":21},26,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a single center, phase Ib\u002FII study combining an anti-PD-1 antibody and an anti-CTLA-4 antibody with IL-15. It is testing the hypothesis that the addition of nogapendekin alfa inbakicept to nivolumab and ipilimumab will augment the clinical activity of those two drugs.",[28,29],"Non-small Cell Lung Cancer Stage IV","Non-small Cell Lung Cancer Recurrent",[31,32,33,34],"Non-small cell lung cancer","Stage IV","Immunotherapy","IL-15 super agnoist","NOT_YET_RECRUITING","2026-06-30",{"date":38,"type":39},"2026-07-02","ACTUAL",{"date":41,"type":21},"2026-07-31",{"date":43,"type":21},"2032-07-31",{"name":45,"class":46},"Washington University School of Medicine","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":67,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":115},"100551713","phase-2-efficacy--safety-of-olvimulogene-nanivacirepvec--platinum-doublet--physicians-choice-of-immune-checkpoint-inhibitor-compared-to-docetaxel-in-nscl-cancer-100551713","NCT06463665","Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's Choice of Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer","A Randomized Phase 2 Study Assessing the Efficacy and Safety of Olvimulogene Nanivacirepvec Followed by Platinum-doublet Chemotherapy + Physician's Choice of Immune Checkpoint Inhibitor Compared With Docetaxel in Patients With NSCL Cancer After First Progression While on Front-line Immune Checkpoint Inhibitor-based Maintenance","VIRO-25","Inclusion Criteria:\n\n* Male or female 18 years or older.\n* ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.\n* Have histologically or cytologically confirmed advanced or metastatic NSCLC.\n* Histologically confirmed Stage III or IV squamous or nonsquamous \\[American Joint Committee on Cancer (AJCC) 8th edition\\].\n* Received at least 2 cycles and maximum of 6 cycles of front-line platinum-based chemotherapy with ICI-based therapy, regardless of PD-L1 expression.\n* Reached first disease progression by radiological assessment while receiving front-line or maintenance ICI.\n* At least one measurable target tumor lesion anywhere except the brain per RECIST 1.1 by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan.\n* Have adequate renal, hepatic, bone marrow function as well as adequate coagulation tests \\[International Normalized Ratio (INR)\\] and adequate immune function by lymphocyte count.\n* Women of child-bearing potential must have a negative serum pregnancy test prior to initiating study dosing.\n* Be willing and able to comply with scheduled visits, the treatment plan, imaging and laboratory tests.\n\nExclusion Criteria:\n\n* Active and untreated urinary tract infection, pneumonia, or other systemic infections.\n* Current symptomatic central nervous system (CNS) metastasis.\n* Any uncontrolled systemic disease, condition or comorbidity that, in the opinion of the Investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.\n* Persistent toxicities \\[Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 3\\] caused by previous anticancer therapy; alopecia and vitiligo are excluded toxicities.\n* Required the use of additional immunosuppression other than corticosteroids for the management of an adverse event or have experienced recurrence of an adverse event if re-challenged, or currently require maintenance doses of \\>10 mg prednisone or equivalent per day.\n* Receiving concurrent antiviral agent active against vaccinia virus (e.g., cidofovir, vaccinia immunoglobulin, imatinib, tecovirimat, or other agents with known anti-vaccinia activities).\n* Underwent major surgery within 4 weeks, or have insufficient recovery from surgical-related trauma or wound healing, prior to the planned first dose of treatment in either Arm.\n* Have received prior virus-based gene therapy or therapy with cytolytic virus of any type.\n* Vaccination against smallpox or monkeypox within 1 year of study therapy.\n* Any non-oncology vaccine therapy used for prevention of infectious diseases, such as seasonal (influenza) vaccinations, corona virus disease (COVID) vaccination or other vaccines, within 2 weeks of the planned first dose of study drug.\n* Clinically significant skin disease as assessed by the Investigator (e.g., severe eczema, psoriasis, or any unresolved skin injury or ulcer).\n* Known hypersensitivity to carboplatin, cisplatin, paclitaxel or nab-paclitaxel, docetaxel, or any of the constituents of Olvi-Vec (i.e., gentamicin).\n* Had severe hypersensitivity (CTCAE Grade ≥ 3) to ICI and\u002For any of its excipients previously.\n* Dementia or altered mental status that would prohibit informed consent, and\u002For psychiatric illness\u002Fsocial situations that might interfere or limit compliance with study requirements.",{"count":57,"type":21},142,[25],"This Phase 2, open-label, randomized study in non-small-cell lung cancer (NSCLC) is designed to evaluate the efficacy and safety of an intravenously delivered oncolytic vaccinia virus, Olvi-Vec, followed by platinum-doublet chemotherapy + Physician's Choice of Immune Checkpoint Inhibitor (ICI) vs. docetaxel for patients with advanced or metastatic NSCLC who have shown first disease progression (i.e., progressive disease not yet confirmed by further scan after initial scan showing progression) while on front-line treatment or maintenance ICI therapy after front-line treatment with platinum-doublet chemotherapy + ICI as standard of care.",[61,62,63,64,65,66,28,29],"Advanced Non-squamous Non-small-cell Lung Cancer","Advanced Squamous Non-Small Cell Lung Carcinoma","Metastatic Non-squamous Non Small Cell Lung Cancer","Metastatic Squamous Non-Small Cell Lung Carcinoma","Non-small Cell Lung Cancer","Non-small Cell Lung Cancer Stage III",[68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103],"Olvi-Vec","virotherapy","viral therapy","immunotherapy","immunochemotherapy","combination therapy","vaccinia virus","platinum-doublet chemotherapy","pembrolizumab","nivolumab","cemiplimab","atezolizumab","durvalumab","anti-PD-1","anti-PD-L1","carboplatin","cisplatin","docetaxel","neoplasms by site","neoplasms","carcinoma","Neoplasms by Histologic type","Antineoplastic Agents, Phytogenic","Antineoplastic Agents","Antimitotic Agents","Molecular Mechanisms of Pharmacological Action","Immune Checkpoint Inhibitors","NSCLC","NSCL cancer","chemoimmunotherapy","ICI","platinum resensitization","platinum resistant","chemoresistance","resensitize","olvimulogene nanivacirepvec","RECRUITING","2026-06-02",{"date":107,"type":39},"2026-06-04",{"date":109,"type":39},"2024-09-26",{"date":111,"type":21},"2029-07",{"name":113,"class":114},"Genelux Corporation","INDUSTRY",15,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":123,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":47},"100581293","xingbai-ji-formula-combined-with-chemotherapy-and-sintilimab-in-metastatic-multi-target-mutation-negative-non-small-cell-lung-cancer-a-clinical-trial-100581293","NCT06848426","Xingbai Ji Formula Combined with Chemotherapy and Sintilimab in Metastatic Multi-Target Mutation-Negative Non-Small Cell Lung Cancer: a Clinical Trial","A Clinical Study of Xingbaiji Formula in Combination with Chemotherapy and Sintilimab As First-Line Treatment for Metastatic Multi-Target Mutation-Negative Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Signed written informed consent.\n2. Age: 18-75 years, regardless of gender.\n3. Histologically or cytologically confirmed non-small cell lung cancer (NSCCC), including adenocarcinoma, squamous cell carcinoma, or large cell carcinoma, with negative EGFR, ALK, and ROS-1 mutations confirmed by next-generation sequencing (NGS). Stage IIIB-IV NSCLC as per AJCC 8th edition staging criteria (required evaluations: neck contrast-enhanced CT or ultrasound, chest contrast-enhanced CT, abdominal contrast-enhanced CT or ultrasound, brain contrast-enhanced MRI, bone scan, or whole-body PET\u002FCT).\n4. ECOG performance status ≤2 and life expectancy ≥3 months.\n5. Histologically or cytologically documented ineligibility for EGFR, ALK, or ROS-1 targeted therapies (written evidence required).\n6. At least one measurable lesion per RECIST v1.1. Lesions within prior radiation fields or post-local treatment may be selected if progression is confirmed.\n7. No prior systemic anti-tumor therapy for advanced disease. Adjuvant chemotherapy is permitted if ≥6 months have elapsed between recurrence and the last dose.\n\nExclusion Criteria:\n\n1. History of or concurrent other malignancies (excluding non-invasive tumors such as cured basal cell carcinoma of the skin, cervical carcinoma in situ, etc.);\n2. Individuals with allergic reactions to the Xingbaiji formula;\n3. Patients with mixed small cell lung cancer or those with a small cell lung cancer component;\n4. Severe mental illness or cognitive impairment that would impede compliance with study protocols or follow-up requirements;\n5. Pregnant or lactating women (a pregnancy test must be performed to exclude pregnancy; women of childbearing age must agree to use effective contraception during the study);\n6. Presence of any major illness or significant laboratory abnormalities that may interfere with receiving Xingbaiji formula, chemotherapy, or immunotherapy; 7Any other conditions deemed by the investigators to render participation in the trial inappropriate.","75 Years",{"count":125,"type":21},100,[127],"NA","Clinical Trial Protocol\n\nPrimary Objective:\n\nTo evaluate the efficacy of the Xingbaiji Formula combined with chemotherapy and Sintilimab as first-line therapy in patients with recurrent or metastatic Stage IIIB-IV EGFR\u002FALK\u002FROS-1 mutation-negative non-small cell lung cancer (NSCLC), using Objective Response Rate (ORR) of tumor lesions as the primary endpoint.\n\nSecondary Objectives:\n\nTo assess secondary endpoints including Progression-Free Survival (PFS), Quality of Life (QoL), immune-related indicators, and safety profile (e.g., incidence of adverse events), and to further evaluate the efficacy and safety of the combination therapy.\n\nRandomized Group Allocation:\n\nParticipants will be randomly assigned to two groups:\n\nControl Group\n\nRegimen for Advanced Non-Squamous NSCLC:\n\nDrugs and Dosage:\n\nSintilimab 200mg + Pemetrexed + Cisplatin\u002FCarboplatin via intravenous infusion, administered every 3 weeks (Q3W) for 4 cycles.\n\nAfter completion of 4 cycles, patients enter the maintenance phase: Sintilimab 200mg Q3W (up to 24 months) + Pemetrexed Q3W until disease progression, intolerable toxicity, death, or voluntary withdrawal.\n\nRegimen for Advanced Squamous NSCLC:\n\nDrugs and Dosage:\n\nSintilimab 200mg + Gemcitabine + Cisplatin\u002FCarboplatin via intravenous infusion, Q3W for 4-6 cycles.\n\nPost-treatment, patients receive Sintilimab 200mg Q3W maintenance until disease progression, intolerability, or completion of 2 years of Sintilimab therapy.\n\nExperimental Group Control Group Regimen + Xingbaiji Formula\n\nXingbaiji Formula Dosage:\n\n1. Granule No. 1: 10g\u002Fbag, dissolved in warm water. Administration: 1 bag orally, twice daily (morning and evening), after meals.\n2. Granule No. 2: 5g\u002Fbag, dissolved in warm water. Administration: 1 bag orally, twice daily (morning and evening), after meals. Treatment Duration: Both granules are taken concurrently with chemotherapy for 6 months, then discontinued.",[130,29,131,28,132],"Non-Small Cell Lung Cancer","Non-small Cell Lung Cancer Stage IIIB","Non-small Cell Lung Cancer Metastatic","2025-02-23",{"date":135,"type":39},"2025-02-27",{"date":137,"type":21},"2025-03-10",{"date":139,"type":21},"2028-01-31",{"name":141,"class":46},"Jiangxi Provincial People's Hopital"]