[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-small-cell-lung-cancer-stage-iv\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-small-cell-lung-cancer-stage-iv":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,48,116,139,163,194,219,245],{"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":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":47},"100600987","phase-2-pulmonary-rehabilitation-in-advanced-lung-cancer-survivors-100600987","NCT07104630","Pulmonary Rehabilitation in Advanced Lung Cancer Survivors","Inclusion Criteria:\n\n* Participants must have histologically confirmed NSCLC, Stages III or IV treated with palliative intent\n* Adults ≥ 18 years of age\n* ECOG performance status ≤ 3\n* Clinical stability: defined as no clinical\u002Fradiographic progression within the last three months\n* Self-reported dyspnea, defined as score ≥ 2 on the modified Medical Research Council (mMRC) Dyspnea Scale\n* Participants must be fluent in written and spoken English\n\nExclusion Criteria:\n\n* Participants being treated with curative intent for locally advanced NSCLC or oligometastatic NSCLC with concurrent chemotherapy and radiation will be excluded\n* Participants have evidence of clinical and\u002For radiographic progression\n* Mental impairment leading to inability to complete study requirements\n* High risk of fracture or spine instability (Mirels score ≥7 or SINS ≥7)\n* Any of the following cardiac exclusion criteria:\n\n  * Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system\n  * History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty or stenting within the past 6 months prior to the start of radiation therapy\n  * Uncontrolled arrhythmias; individuals with rate-controlled atrial fibrillation for \\> 1 month prior to start of radiation therapy may be eligible\n  * Syncope\n  * Acute myocarditis, pericarditis, or endocarditis\n  * Acute pulmonary embolus or pulmonary infarction within the last 3 months\n  * Acute thrombosis of lower extremities within the last 3 months\n  * Suspected dissecting aneurysm\n  * Pulmonary edema\n  * Respiratory failure\n  * Acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise",{"count":123,"type":21},85,[25],"This study is for people who have previously been diagnosed with advanced stage non-small cell lung cancer (NSCLC). Many people with advanced stage NSCLC have trouble breathing and feel tired. People may be eligible for this study if they have advanced stage NSCLC and feel short of breath some of the time. NSCLC survivors may also experience things like fatigue and a lower quality of life. Pulmonary rehabilitation is a type of supportive treatment that may improve these symptoms.\n\nThis study has two parts. The first part is a randomized trial where half of the participants receive eight weeks of pulmonary rehabilitation. The other half of participants do not do pulmonary rehabilitation and instead receive the treatment that their doctors would normally recommend. The purpose of this part of the research study is to understand if pulmonary rehabilitation can help people with advanced stage NSCLC have better functioning and less shortness of breath.\n\nThe other part of the research study is an interview study. The purpose of doing interviews is to understand any challenges or obstacles that people with advanced stage NSCLC may have regarding pulmonary rehabilitation, as well as oncology care providers have with their participants going to pulmonary rehabilitation.",[66,28,65,127],"Lung Cancer",[129],"Pulmonary Rehabilitation","2026-04-09",{"date":132,"type":39},"2026-04-13",{"date":134,"type":39},"2026-03-16",{"date":136,"type":21},"2028-12",{"name":138,"class":46},"Case Comprehensive Cancer Center",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":147,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":47},"100612199","phase-2-risk-adapted-proteomic-guided-systemic-therapy-for-previously-untreated-advanced-non-small-cell-lung-cancer-100612199","NCT07250477","Risk-adapted, Proteomic-guided Systemic Therapy for Previously Untreated Advanced Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Participants must have histologically confirmed non-small cell lung cancer that is metastatic or unresectable (stage IIIC or IV), deemed appropriate to receive standard of care immune checkpoint inhibitor-based therapy given with palliative intent.\n* Age ≥18 years at the time of consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥50%).\n* Ability to understand and willingness to sign the informed consent form (ICF).\n* Stated ability and willingness to adhere to all protocol requirements while on study\n\nExclusion Criteria:\n\n* Tumor with known sensitizing alteration in ALK, EGFR, HER2, MET exon 14, NTRK, RET, or ROS1.\n* Medical comorbidities precluding immune checkpoint inhibitor-based therapy per treating investgator's discretion.\n* Previous systemic therapy for metastatic Stage IIIC or IV NSCLC. Patients who previously completed systemic therapy for early stage or locally advanced NSCLC ≥ 80 days prior to trial registration are eligible for inclusion.\n* Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on study",{"count":146,"type":21},56,[25],"This is a phase 2, pragmatic, 1:1 randomized, open-label study that evaluates risk-adapted, proteomic-guided systemic therapy to improve 12-month progression free survival (PFS) among patients with previously untreated advanced non-small cell lung cancer.",[150,28,151,152,153],"Non-small Cell Lung Cancer Stage IIIC","Non Small Cell Lung Cancer","Non-small Cell Lung Cancer Metastatic","Non-small Cell Lung Cancer Unresectable","2026-02-04",{"date":156,"type":39},"2026-02-09",{"date":158,"type":39},"2026-01-30",{"date":160,"type":21},"2036-12",{"name":162,"class":46},"University of California, Davis",{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":22,"phases":172,"briefSummary":174,"conditions":175,"keywords":181,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":189,"completionDateStruct":190,"leadSponsor":192,"locationsCount":47},"100565208","early-phase-1-177lulu-akir001-first-in-human-study-100565208","NCT06639191","[177Lu]Lu-AKIR001 First-in-human Study","A Phase 1 Prospective, Open-label, First-in-human Study to Evaluate the Safety, Tolerability and Biodistribution of [177Lu]Lu-AKIR001 and Its Anti-tumour Effect in Adult Patients With CD44v6 Expressing Solid Tumours","AKIR001","Inclusion Criteria:\n\n1. Participant must be 18 years of age or older\n2. Willing and able to provide written informed consent\n3. Participant has one of the following histologically confirmed metastatic or locally advanced irresectable CD44v6 expressing (confirmed in pre-screening according to the pathology manual (Appendix III) solid malignancy in one of the following groups, with documented disease progression in the last 8 weeks during\u002Fafter available standard of care treatment options as mentioned below:\n\n   * For anaplastic, poorly differentiated and radioiodine refractory differentiated thyroid cancer (ATC, PDTC, RAI-R DTC):\n\n     * For BRAFv600E mutated tumours: BRAF\u002FMEK inhibitors.\n     * For BRAF-wildtype tumours at least one of the following: anthracycline- or taxane containing chemotherapy\u002F chemoradiotherapy, or other targeted therapies including vascular endothelial growth factor (VEGF) tyrosine kinase inhibitors (TKI), targeted therapies aimed at specific moleculo-pathological features (e.g., targeting NTRK, RET, ALK, PD-L1)\n     * For PDTC or RAI-R DTC: Radio-iodine refractory disease as deemed by treating physician and disease progression after at least one line of systemic targeted therapy (including VEGF, TKI, NTRK, RET, BRAF inhibitors)\n   * For HNSCC:\n\n     \\- At least one prior treatment with combination chemotherapy (either platinum based + 5-Fluorouracil or platinum based + taxane) together with PD1-inhibitor pembrolizumab if combined positive score (CPS) ≥1 or EGFR-inhibitor if CPS \\\u003C1 (or if immunotherapy is contraindicated)\n   * For NSCLC\n\n     \\- Treatment with at least two lines of systemic therapy, including checkpoint inhibitor based on PD-L1 status and chemotherapy with a platinum-based regimen.\n   * For vulvar SCC:\n\n     \\- After treatment with first line platinum\u002Fpaclitaxel+\u002F-bevacizumab +\u002F- pembrolizumab (the latter in case of PD-L1 positivity), and second line with weekly paclitaxel\n   * For cervical SCC:\n\n     * After treatment with first line systemic therapy with platinum\u002Fpaclitaxel+\u002F-pembrolizumab (the latter in case of PD-L1 positivity)\n4. Measurable disease per Response Criteria for Solid Tumours (RECIST) v1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n6. Life expectancy of at least three months as estimated by the investigator.\n7. Adequate organ and bone marrow function within eight days before the first \\[177Lu\\]Lu-AKIR001 infusion:\n\n   * Peripheral white blood cells (WBC) ≥3.0 x 109\u002FL\n   * Absolute neutrophil count (ANC) ≥ 2,000\u002Fmm3\n   * Platelet \\> 100 x 109\u002FL\n   * Hemoglobin \\> 100 g\u002FL.\n   * Serum creatinine of ≤ 1.5x ULN or calculated creatinine clearance of ≥ 60 mL\u002Fmin\u002F1.73 m2 by Cockcroft- Gault\n   * Total serum bilirubin ≤ 1.5x ULN (unless due to Gilbert's syndrome, in which case direct bilirubin must be normal)\n   * Serum AST and ALT ≤1.5x ULN (or ≤ 5x ULN if participant has liver metastases)\n   * Left Ventricular Ejection Fraction \\>50% on echocardiography\n8. Contraceptives\n\n   * Females of child-bearing potential must agree to use adequate contraception prior to study entry, for the duration of study treatment Phase and for six months after the last dose of study drug. Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone- releasing intrauterine devices (IUDs), and copper IUDs. Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception. Women must refrain from donating eggs during this same period. Should a female become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately. If a female participant is of child-bearing potential (females are considered not of childbearing potential if they are at least one year postmenopausal and\u002For surgically sterile), she must have a documented negative serum pregnancy test before any \\[177Lu\\]Lu-AKIR001 infusion.\n   * Male participant must agree to practice effective barrier contraception (condom) during the entire study treatment period and through four months after the last dose of study drug or agree to completely abstain from heterosexual intercourse.\n\nExclusion Criteria:\n\n1. Symptomatic brain metastases that are not previously treated and\u002For that require ongoing steroid-treatment\n2. Other malignancy diagnosed within the last five years, except for radically treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix\n3. Chemo-, targeted or radiotherapy within the last 4 weeks before enrolment in the study.\n4. Ongoing toxicities graded according to the Common Terminology Criteria for Adverse Events (CTCAE) \\> 1 from previous anti-cancer treatments.\n5. Pregnancy or lactation\n6. Uncontrolled hypertension, heart, liver, or kidney disease or other medical\u002F psychiatric disorders.\n7. Severe skin diseases requiring systemic anti-inflammatory treatment, including plaque psoriasis, Stevens Johnsons syndrome or dermatomyositis.\n8. A known history of Human Immunodeficiency Virus (HIV) infection, hepatitis B (HBsAg reactive) or hepatitis C (HCV RNA detected) infection or active tuberculosis.",{"count":115,"type":21},[173],"EARLY_PHASE1","The goal of this clinical trial is to evaluate the safety and tolerability of increasing doses of \\[177Lu\\]Lu-AKIR001, both in relation to tolerable activity of lutetium-177 and the absorbed protein mass dose of AKIR-001 in patients with irresectable or metastatic CD44v6-expressing solid malignancies for whom no reasonable systemic treatment options are be available. The main question it aims to answer is:\n\n• What is the toxicity profile of the study drug \\[177Lu\\]Lu-AKIR001 according to the rate of Dose Limiting Toxicities and (Severe) Adverse Events? Participants will receive one \\[177Lu\\]Lu-AKIR001 infusion followed by a 6-week safety follow-up period, which can be extended up to 12 weeks. Possible additional infusions of the trial drug, up to a maximum number of four, can be given when clinical benefit is noted and toxicity is deemed acceptable.",[176,177,178,179,180,28],"Thyroid Gland Anaplastic Carcinoma","Poorly Differentiated Thyroid Carcinoma","Cancer Head and Neck","Cervix Carcinoma","Vulvar Cancer, Stage IV",[182,183,184,185,186],"Radiopharmaceutical","first-in-human","CD44v6","Lutetium-177","177Lu-AKIR001","2026-01-28",{"date":158,"type":39},{"date":187,"type":39},{"date":191,"type":21},"2028-11-01",{"name":193,"class":46},"Karolinska University Hospital",{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":201,"enrollmentInfo":202,"targetDuration":4,"studyType":22,"phases":204,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"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":203,"type":21},100,[205],"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.",[208,29,209,28,152],"Non-Small Cell Lung Cancer","Non-small Cell Lung Cancer Stage IIIB","2025-02-23",{"date":212,"type":39},"2025-02-27",{"date":214,"type":21},"2025-03-10",{"date":216,"type":21},"2028-01-31",{"name":218,"class":46},"Jiangxi Provincial People's Hopital",{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":226,"enrollmentInfo":227,"targetDuration":4,"studyType":22,"phases":229,"briefSummary":230,"conditions":231,"keywords":234,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":4},"100549601","phase-2-osimertinib-and-etoposide-as-first-line-treatment-in-osimertinib-resistant-advanced-egfr-mutant-nsclc-100549601","NCT06436144","Osimertinib and Etoposide as First-Line Treatment in Osimertinib-Resistant Advanced EGFR-Mutant NSCLC","A Single-Center, Prospective, Single-Arm, Observational Study Evaluating the Efficacy and Safety of Osimertinib Combined With Etoposide as First-Line Treatment in Patients With Osimertinib-Resistant or -Insensitive, Advanced EGFR-Mutant Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Age 18 to 79 years.\n2. Locally advanced (stage IIIB) or metastatic (stage IV) EGFR-mutant NSCLC.\n3. Harboring an EGFR sensitizing mutation (Exon 19 deletion or L858R).\n4. Received at least two cycles of first-line osimertinib treatment, with a best response of stable disease or slow progression.\n5. Life expectancy greater than 3 months.\n6. At least one measurable tumor lesion meeting the following criteria:\n\n1.No prior radiation therapy; 2.Measurable by chest CT or PET-CT, with a longest diameter ≥ 10 mm at baseline (short axis ≥ 15 mm for lymph nodes); 3.Amenable to accurate repeated measurements.\n\nExclusion Criteria:\n\n1. Currently receiving or planning to receive other anti-cancer therapies.\n2. Having contraindications to osimertinib or etoposide.\n3. Harboring known targetable osimertinib resistance mechanisms.","80 Years",{"count":228,"type":21},93,[25],"Osimertinib, though a standard first-line treatment for EGFR-mutant advanced NSCLC, shows primary resistance in 10-30% of patients, leading to disease progression within 3-4 months. This resistance is linked to co-mutations in genes like TP53, RB1, and PIK3CA, among others. Studies indicate that Topo II inhibitor Etoposide (VP-16) can reduce cell survival, enhance DNA damage, and delay resistance in Osimertinib-resistant cells, suggesting a potential combination therapy to manage resistance.This study is a single-center, prospective, single-arm study evaluating the efficacy and safety of osimertinib combined with etoposide as a first-line treatment in patients with osimertinib-resistant or -insensitive advanced non-small cell lung cancer (NSCLC). The study focuses on patients with advanced NSCLC (stage IIIB or IV) with EGFR-sensitive mutations who developed slow resistance to osimertinib and for whom secondary biopsy after resistance did not identify any therapeutic targets.",[151,232,233,28],"EGFR Gene Mutation","Non Small Cell Lung Cancer Stage IIIB",[151,232,235],"Primary drug resistance of oxitinib","2024-05-28",{"date":238,"type":39},"2024-05-30",{"date":240,"type":21},"2024-06",{"date":242,"type":21},"2029-12",{"name":244,"class":46},"Daping Hospital and the Research Institute of Surgery of the Third Military Medical University",{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":254,"phases":4,"briefSummary":255,"conditions":256,"keywords":258,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":4},"100525123","the-efficacy-of-double-dose-furmonertinib-in-the-treatment-of-patients-with-slow-osimertinib-resistant-nsclc-100525123","NCT06117644","The Efficacy of Double-dose Furmonertinib in the Treatment of Patients With Slow Osimertinib-resistant NSCLC","A Single-center, Prospective Study of the Efficacy of Double-dose Furmonertinib in the Treatment of Patients With Slow Osimertinib-resistant Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. Age ≥ 18 years old;\n2. EGFRm NSCLC of local progression (IIIB stage) or metastasis (IV stage);\n3. previously confirmed to have EGFR (Ex19del or L858R) mutation, or T790M, received Osimertinib treatment. According to Recist 1.1 imaging findings, the focus progressed slowly and there was no systemic explosive progress (definition of slow progress: disease control \\> 6 months, slightly increased tumor load and symptom score ≤ 1);\n4. patients who intend to use Furmonertinib (double dose, 160mg) anticancer therapy;\n5. At least one tumor lesion in the patient can meet the following requirements: it has not been irradiated in the past and can be accurately measured, the longest diameter of the baseline phase is ≥ 10mm (in the case of lymph nodes, short axis ≥ 15mm is required), and the measurement method can be chest CT or PET-CT, as long as repeated measurements can be completed accurately;\n6. No treatable target was found in the second biopsy after drug resistance;\n7. The survival time was more than 3 months;\n\nExclusion Criteria:\n\n1. Patients who have been treated with Furmonertinib;\n2. Patients who intend to use anticancer therapy other than Furmonertinib recently;\n3. Contraindications for the use of Furmonertinib;",{"count":253,"type":21},30,"OBSERVATIONAL","This study is a single-center, prospective, single-arm study of the efficacy of double-dose Furmonertinib in the treatment of patients with slow Osimertinib-resistant non-small cell lung cancer, mainly in patients with advanced non-small cell lung cancer with EGFR-sensitive mutations in stage IIIB or IV, slow drug resistance after treatment with Osimertinib, and no therapeutic target was found by secondary biopsy after drug resistance.",[151,232,257,28],"Non Small Cell Lung Cancer Stage IIIA",[151,232,259,260],"Furmonertinib","Drug Resistance","2023-10-31",{"date":263,"type":39},"2023-11-07",{"date":265,"type":21},"2023-11-01",{"date":267,"type":21},"2026-10-01",{"name":244,"class":46}]