[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jun Zhang, MD, PhD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":102},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,71],{"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":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100505273","phase-2-a-study-of-combining-cabozantinib-and-atezolizumab-for-advancedmetastatic-nsclc-cabatezo-1-100505273",false,"NCT05859217","A Study of Combining Cabozantinib and Atezolizumab for Advanced\u002FMetastatic NSCLC (Cabatezo-1)","A Multi-center Phase II Study of Combining Cabozantinib and Atezolizumab as the 1st Line Therapy for PD-L1 Negative Advanced\u002FMetastatic NSCLC (Cabatezo-1)","Cabatezo-1","INCLUSION CRITERIA:\n\n* Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent\n* Males and females age ≥ 18 years\n* ECOG Performance Status 0 - 1\n* Pathologically confirmed advanced\u002Fmetastatic NSCLC, with PD-L1\\\u003C1% based on IHC using 22C3 antibody\n* At least one target lesion that can be assessed by RECIST 1.1\n* For candidates who are not qualified for upfront FDA-approved targeted therapy, must be systemic treatment naïve (local palliative RT more than 4 weeks prior is allowed)\n* For candidates who are qualified for upfront FDA-approved targeted therapy (e.g. having sensitizing mutations in EGFR, ALK and BRAF, etc.), treatment must have failed and received at least one line of ONLY FDA-approved targeted therapy\n* Availability of a representative tumor specimen for correlative research. Optional but highly recommended: willing to undergo tumor tissue biopsy only if deemed safe and feasible by the investigator.\n* Recovery to baseline or ≤ Grade 1 CTCAE v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and\u002For stable on supportive therapy.\n* Women of childbearing potential must have a negative serum pregnancy test 72 hours prior to initiating treatment. Female participants are considered to be of childbearing potential unless one of the following criteria is met: documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\> 45 years-of-age in the absence of other biological or physiological causes. In addition, females \\\u003C 55 years-of-age must have a serum follicle stimulating (FSH) level \\> 40 mIU\u002FmL to confirm menopause). Note: Documentation may include review of medical records, medical examinations, or medical history interview by study site.\n* Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence or to use two forms of adequate contraception (hormonal AND barrier method of birth control) prior to study entry, for the duration of study participation and for 6 months following completion of therapy.\n* Men of child-bearing potential must not father a child or donate sperm while on this study and for 6 months after the last study treatment.\n* Adequate organ function\n* Negative HIV test at screening, with the following exception: patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count \\>200\u002FuL, and have an undetectable viral load. They must agree to continue on such anti-retroviral therapy per local standard treatment guideline\n* Negative HBV and HCV tests at screening, with the following exception:\n\n  * For HBV: DNA must be \\\u003C 500 IU\u002FmL (or must be \\\u003C 2500 copy\u002FmL if copy\u002FmL is the only unit available in the study site; if the normal ranges of the study sites are different, the positive standard must not be met), and have received anti-HBV therapy for at least 14 days prior to the first dose of study treatment (treatment in accordance with local standard of care, e.g., entecavir) and are willing to receive antiviral therapy throughout the study if indicated;\n  * For HCV (with positive HCV RNA): must receive anti-viral therapy in accordance with the local standard treatment guideline and hepatic function resolve to CTCAE Grade ≤1\n\nEXCLUSION CRITERIA:\n\n* Simultaneously enrolled in any therapeutic clinical trial\n* Current or anticipating use of other investigational agents while participating in this study\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment\n* Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements\n* Active Grade 3 (per the NCI CTCAE, Version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment\n* Patients harboring targetable mutations (e.g., EGFR, ALK and BRAF, etc.) who have not had at least one frontline targeted therapy fail, or have received other systemic therapies (e.g. chemotherapy, immunotherapy, etc.)\n* Patients with carcinomatous meningitis (leptomeningeal metastasis)\n* Undergone major surgery within 2 weeks prior to the start of study regimen, or has not achieved complete wound healing\n* Presence of another cancer with disease manifestations or therapy that could adversely affect participant safety or longevity, create the potential for drug-drug interactions, or compromise the interpretation of study results. Otherwise, patients can be considered eligible, for example, locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.\n* Prior treatment with cabozantinib and\u002For atezolizumab.\n* Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.\n* Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment\n* Radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Participants with clinically relevant ongoing complications from prior radiation therapy are not eligible.\n* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks prior to first dose of study treatment after radiotherapy or at least 4 weeks prior to first dose of study treatment after major surgery (e.g., removal or biopsy of brain metastasis). Participants must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Eligible participants must be neurologically asymptomatic and with corticosteroid no more than 10mg prednisone or equivalent at the time of first dose of study treatment.\n* Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following:\n\n  * Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).\n  * Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors such as rivaroxaban, edoxaban, or apixaban in participants without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.\n* Live, attenuated vaccines (e.g., FluMist) are prohibited within 4 weeks prior to initiation of study treatment, during treatment with atezolizumab, and for 5 months after the last dose of atezolizumab.\n* The participant has uncontrolled, significant cardiovascular disorders\n* Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before first dose of study treatment\n* Lesions invading or encasing any major blood vessels.\n* Other clinically significant disorders that would preclude safe study participation\n* Major surgery (e.g., laparoscopic nephrectomy, GI surgery, removal or biopsy of brain metastasis) within 2 weeks before first dose of study treatment. Minor surgeries within 10 days before first dose of study treatment. Participants must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Participants with clinically relevant ongoing complications from prior surgery are not eligible\n* Pregnant or lactating females.\n* Inability to swallow tablets or unwillingness or inability to receive IV administration.\n* Previously identified allergy or hypersensitivity to Chinese hamster ovary cell products, or components of the study treatment formulations or history of severe infusion-related reactions to monoclonal antibodies.\n* Uncontrolled tumor-related pain\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters (e.g., PleurX) are allowed.\n* Uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL or corrected serum calcium \\> ULN)\n* Active or history of autoimmune disease or immune deficiency (see Appendix I), including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis.\n* Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies\n* Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \\[IL-2\\]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment\n* Any serious illness, uncontrolled inter-current illness, psychiatric illness, active or uncontrolled infection, or other medical history, including laboratory results, which, in the Investigator's opinion, would be likely to interfere with the patient's participation in the study, or with the interpretation of the results","ALL","18 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","NSCLC patients with low expression level of PD-L1, esp. those with its level less than 1%, do not derive much benefit from anti-PD-1\u002FL1 therapy (e.g. atezoilzumab). In this study, investigators hypothesize that the combination of cabozantinib (a multi-kinase inhibitor) and atezolizumab will result in better therapeutic value.",[27,28,29,30],"Lung Cancer","NSCLC Stage IV","Metastatic NSCLC - Non-Small Cell Lung Cancer","Advanced NSCLC",[32,33,34],"Cancer immunotherapy","anti-angiogenesis","Investigator-initiated clinical trial","NOT_YET_RECRUITING","2024-05-06",{"date":38,"type":39},"2024-05-08","ACTUAL",{"date":41,"type":21},"2024-12",{"date":43,"type":21},"2028-06",{"name":45,"class":46},"Jun Zhang, MD, PhD","OTHER",4,{"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":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100414727","using-microbiome-to-predict-durvalumab-toxicity-in-post--concurrent-chemoradiation-therapy-ccrt-nsclc-patients-100414727","NCT04680377","Using Microbiome to Predict Durvalumab Toxicity in Post- Concurrent Chemoradiation Therapy (CCRT) NSCLC Patients","Using Microbiome to Predict Durvalumab Toxicity in Post-CCRT NSCLC Patients (Microdurva)","Microdurva","Inclusion Criteria:\n\n* Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent\n* Participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up\n* Life expectancy ≥12 weeks\n* Males and females age ≥ 18 years\n* Allowable type and amount of prior therapy:\n\nParticipants must have received two or more cycles of platinum-based chemotherapy (containing etoposide, vinblastine, vinorelbine, a taxane \\[paclitaxel or docetaxel\\], or pemetrexed) concurrently with definitive radiation therapy (54-66 Gy)\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status = 0 or 1\n* Body weight \\>30 kg (66.14 lbs)\n* Participants must have histologically- or cytologically-documented NSCLC who present with locally advanced, unresectable (Stage III) disease\n* Participants must have not progressed following definitive, platinum-based, concurrent chemoradiation therapy\n* Adequate organ function based on laboratory results\n* Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use an acceptable form of contraception for the duration of study participation, and for the time specified following completion of therapy\n\nExclusion Criteria:\n\n* Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or if the participant is in the follow-up period of an interventional study\n* Participation in another clinical study with an investigational product during the last 4 weeks prior to enrollment on this study\n* Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment\n* Mixed small cell and non-small cell lung cancer histology\n* Participants who receive sequential chemoradiation therapy for locally advanced NSCLC\n* Participants with locally advanced NSCLC who have progressed whilst definitive platinum based, concurrent chemoradiation therapy\n* Receipt of any investigational drug within 4 weeks prior to the first dose of durvalumab; and in the case of monoclonal antibodies (not immunotherapy) 6 weeks prior to the first dose of durvalumab\n* Participants who have received prior anti-programmed death (PD)-1, anti- programmed death ligand (PD-L)1 or anti- cytotoxic T-lymphocyte-associated protein (CTLA)-4\n* Participants who have received prior immunotherapy\n* Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product (IP). Note: Participants, if enrolled, should not receive live vaccine whilst receiving durvalumab and up to 30 days after the last dose of IP\n* Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab\n* Any unresolved toxicity CTCAE ≥ Grade 2 from the prior chemoradiation \u002F anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\n* Any grade pneumonitis from prior chemoradiation therapy\n* Active infection\n* Recent major surgery within 28 days prior to the first dose of study therapy\n* Active or prior documented autoimmune or inflammatory disorders\n* History of primary immunodeficiency\n* History of another primary malignancy\n* History of allogenic organ transplantation\u002Forgan transplant that requires therapeutic immunosuppression\n* History of leptomeningeal carcinomatosis\n* Participants with active ventricular arrhythmia requiring medication\n* Uncontrolled intercurrent illness\n* Participants who have progressed following definitive, platinum-based, concurrent chemoradiation therapy\n* Known allergy or hypersensitivity to durvalumab or any of durvalumab's excipients\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent",{"count":57,"type":21},44,"OBSERVATIONAL","This phase IV study is hoping to determine if examining the microbiome in non-small cell lung cancer participants who will receive durvalumab can predict treatment toxicity.",[61,62],"NSCLC, Stage III","Locally Advanced Lung Carcinoma","RECRUITING",{"date":38,"type":39},{"date":66,"type":39},"2021-04-12",{"date":68,"type":21},"2026-12",{"name":45,"class":46},2,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":70},"100464840","using-ex-vivo-tumoroids-to-predict-immunotherapy-response-in-nsclc-100464840","NCT05332925","Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC","Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC (TUMORIN)","TUMORIN","Inclusion Criteria:\n\n* Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent\n* Patients with advanced\u002Fmetastatic NSCLC\n* Must be immunotherapy naive\n* Males and females age ≥ 18 years\n* ECOG Performance Status 0 - 2\n* Measurable disease by RECIST 1.1\n* Must have a lesion (either primary or metastatic lesion) that can be safely biopsied to have sufficient tissue (at minimum, 3-4 cores using 20g or larger core biopsy) to generate tumoroids\n* Must have at least one target lesion to evaluate treatment response\n* Will be receiving anti-PD-1\u002FL1 with or without anti-CTLA-4 per standard of care Adequate organ function defined per standard of care in this setting.\n* Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception as required\u002Frecommended by each immune checkpoint inhibitor used in the setting of standard of care.\n\nExclusion Criteria:\n\n* Incarcerated\n* Not competent to make medical decision, noncommunicative or noncompliant per investigator's judgement.","110 Years",{"count":81,"type":21},25,"To test whether it is feasible to perform the 3D-EX functional predictive response bioassay in the context of patients with advanced\u002Fmetastatic NSCLC receiving immune checkpoint inhibitors in the standard of care clinical setting.",[27,84,28],"NSCLC",[86,87,88,89,90,91,92,93],"Tumoroids","Organoids","Immunotherapy","Immune check point inhibitor","Anti-PD-1","Anti-CTLA-4","Ex vivo model","3D culture","2024-02-21",{"date":96,"type":39},"2024-02-23",{"date":98,"type":39},"2022-07-21",{"date":100,"type":21},"2027-02",{"name":45,"class":46},""]