[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-small-cell-lung-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-small-cell-lung-carcinoma":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,55,87,101,114,194,223,265,300,327,355,379,402,424,451],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100053417","phase-1-neoadjuvant-inhaled-azacytidine-with-platinum-based-chemotherapy-and-durvalumab-medi4736---a-combined-epigenetic-immunotherapy-aza-aegean-regimen-for-operable-early-stage-non-small-cell-lung-cancer-nsclc-100053417",false,"NCT06694454","Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immunotherapy (AZA-AEGEAN) Regimen for Operable Early-Stage Non-Small Cell Lung Cancer (NSCLC)","Phase I\u002FII Study of Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immunotherapy (AZA-AEGEAN) Regimen for Operable Early-Stage Non-Small Cell Lung Cancer (NSCLC)","* INCLUSION CRITERIA:\n* Histologically or cytologically confirmed, resectable per standard of care stage IB-IIIA non-small cell lung cancer (NSCLC) irrespective of programmed death-ligand 1 (PD-L1) expression. Note: Confirmation is required by NCI Laboratory of Pathology (LP).\n* Willingness to undergo tumor resection surgery per standard of care (SOC) guidelines following induction therapy (platinum chemotherapy and durvalumab).\n* Participants must have disease that can be safely accessed via bronchoscopic, thoracoscopic, or percutaneous biopsy techniques, and be willing to undergo tumor biopsy before treatment.\n* No prior therapy for the NSCLC.\n* Measurable disease per RECIST 1.1\n* Age \\>= 18 years.\n* Body weight \\> 30kg.\n* ECOG Performance Status \\\u003C= 1\n* Participants must have adequate pulmonary reserve evidenced by predicted post-op FEV1 and adjusted DLCO \\>= 40% at screening.\n* Participants must have pCO2 \\\u003C= 45 and pO2 \\>=60 on room air by arterial blood gas (ABG) if O2 sat by pulse oximetry is\\\u003C= 92% on room air at screening.\n* Adequate organ and marrow function as defined below:\n\n  * Leukocytes \\>3,000\u002FmicroL\n  * Absolute neutrophil count \\>1,500\u002FmicroL (without transfusion or cytokine support)\n  * Absolute lymphocyte count \\> 800\u002FmicroL\n  * Platelets \\>100,000\u002FmicroL\n  * Hemoglobin \\>= 9.0 g\u002FdL\n  * Prothrombin time (PT) no more than 2 seconds above the upper limit of normal (ULN)\n  * Total bilirubin OR Direct bilirubin \\\u003C 1.5 X institutional upper limit of normal OR \\\u003C= ULN for participants with total bilirubin \\>= 1.5 ULN\n  * Aspartate aminotransferase (AST) \u002F Alanine aminotransferase (ALT) \\\u003C 2.5 X institutional ULN\n  * Serum albumin \\>= 2.0 mg\u002FdL\n  * Creatinine OR Creatinine clearance (eGFR) \\\u003C= 1.6 mg\u002Fml OR \\>60 mL\u002Fmin\u002F1.73 m\\^2 for participants with creatinine levels above institutional normal\n* Individuals of child-bearing potential (IOCBP) must agree to use a highly effective method of contraception (hormonal, intrauterine device (IUD), surgical sterilization, abstinence) for the duration of the study treatment and up to 6 months after the last dose of the study drug(s). Note: participants who have cisplatin as part of SOC chemo must agree to use a highly effective method of contraception for 14 months.\n\nIndividuals able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to 3 months after the last dose of the study drug(s). Note: participants who have cisplatin as part of SOC chemo must agree to use an effective method of contraception for 11 months. We also will recommend these individuals with partners of childbearing potential to ask partners to be on highly effective birth control (hormonal, intrauterine device (IUD), surgical sterilization).\n\n* Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 3 months after the last dose of the study drug(s).\n* Participants with history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness are included if on appropriate antiretroviral therapy with HIV viral load \\\u003C400 copies\u002FmL.\n* Participants must agree to not donate blood from the study entry and up to 3 months after the last dose of the study drug(s).\n* Participants must be co-enrolled in protocol 06C0014: Prospective Evaluation of Genetic and Epigenetic Alterations in Patients with Thoracic Malignancies .\n* The ability of a participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Medically inoperable because of clinical co-morbidities.\n* Participants with T4 tumors invading the diaphragm, mediastinum, carina, trachea, esophagus, heart, great vessels, recurrent laryngeal nerve, or vertebral body.\n* Participants who experienced serious immune adverse events that required discontinuation of immune checkpoint inhibitor therapy for a prior non-NSCLC malignancy.\n* History of known EGFR or ALK alterations in the tumor.\n* History of active autoimmune disease including colitis, nephritis, hypophysitis, or neuropathy, with the exceptions of:\n\n  --Diabetes type I, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment.\n* History of pneumonitis or interstitial lung disease.\n* Clinically significant cardiovascular\u002Fcerebrovascular disease as follows:\n\n  * cerebral vascular accident\u002Fstroke (within 6 months prior to study treatment initiation)\n  * myocardial infarction (within 6 months prior to study treatment initiation)\n  * unstable angina, congestive heart failure (New York Heart Association Classification Class \\>= II, https:\u002F\u002Fmanual.jointcommission.org\u002Freleases\u002FTJC2016A\u002FDataElem0439.html#:\\~:text=Class%20II%20%2D%20Mild%20symptoms%20(mild,Class%20IV%20%2D%20Severe%20limitations), serious cardiac arrhythmia, clinically significant bleeding or clinically significant pulmonary embolism at screening.\n* Active Hepatitis A (HAV), Hepatitis B (HBV) (HbsAg reactive), or Hepatitis C (HCV) (HCV RNA \\[qualitative\\] is detected) at screening.\n* Other active infections requiring systemic therapy at screening.\n* Positive beta human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test performed in females of childbearing potential at screening.\n* Systemic corticosteroids at doses above physiologic levels (\\> 10 mg of prednisone or equivalent per day), or inhaled corticosteroids within 14 days before study treatment initiation. Administration of steroids through a route known to result in a minimal systemic exposure (i.e., topical, intro-ocular, or intra-articular) is allowed.\n* Major surgical procedure within 28 days prior to the study treatment initiation. Note: Local surgery of isolated lesions for palliative intent is acceptable provided other site(s) of disease is available for response assessment.\n* History of allogenic organ transplantation.\n* History of another primary malignancy except for malignancy treated with curative intent and with no known active disease \\>= 5 years before the study treatment initiation.\n* Administration of live attenuated vaccines within 30 days prior to study treatment initiation. Note: Administration of inactivated vaccines (e.g., inactivated influenza vaccines) is permitted before or during the study.\n* Administration of investigational drug on other clinical trial within 14 days prior to study treatment initiation.\n* History of hypersensitivity to Mannitol.\n* Herbal and natural remedies that may have immune-modulating effects within 7 days prior to study treatment initiation.\n* Uncontrolled intercurrent illness evaluated by history and physical exam or situation that would limit compliance with study requirements.","ALL","18 Years","120 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Background:\n\nLung cancer is the leading cause of cancer-related death worldwide. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Surgery to remove the tumors is the standard treatment for people diagnosed with early stages of NSCLC. Despite complete removal of these tumors, many recur (happen again). An FDA-approved drug combination to treat early-stage NSCLC prior to the surgery is durvalumab plus standard chemotherapy. The FDA approved infusion drug azacytidine \\[AZA\\] is used to treat several diseases because it can rapidly kill dividing cells (including cancer cells) but it is not approved for NSCLC. An inhaled (aerosolized) form of AZA is also not approved for NSCLC. However, researchers want to know if an inhaled version of AZA can help improve treatment of people with NSCLC because inhaled AZA goes directly into the lungs with limited absorption into the bloodstream.\n\nObjective:\n\nTo find the safest and most effective dose of inhaled AZA in participants with early-stage non-small cell lung cancer (NSCLC) that can still be removed by surgery.\n\nEligibility:\n\nAdults aged 18 and older with operable early-stage NSCLC. Participants will be required to also enroll in NIH protocol 06C0014 which allows for pre- and post-treatment biopsies and bloodwork to be obtained for additional research studies.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. Their medical records will be reviewed. They will have imaging scans and tests of their heart and lung functions. Participants will be required to have a tissue sample (biopsy) taken of their tumor prior to receiving study drug and again during surgery after Cycle 3; airway tissue biopsies and collection of collect bronchial (lung) fluid may also be done.\n\nParticipants will receive the study treatment for 3 cycles. Each cycle is 21 days. They will need to come to the NIH Clinical Center (CC) on days 1-4 of Cycles 1-3.\n\nAZA will be given as a drug mist that can be inhaled (like the type of mist in an asthma inhaler) using a nebulizer at the NIH Clinical Center (CC) for 3 days in a row (consecutive days) during the first week of each cycle. The participant will inhale the AZA drug mist for 20 to 30 minutes each time. Participants will also receive durvalumab and a specific 2-drug assigned chemotherapy by intravenous (IV) infusion on day 4 of each cycle.\n\nParticipants will have a follow-up visit 2 weeks after their last dose of study drugs. Then they will have planned surgery to remove the tumors.\n\nParticipants will have additional follow-up visits at the NIH CC about 1 and 3 months after the surgery, and then for every 3 months for up to 3 years.",[28,29,30,31,32],"Non-small Cell Lung Cancer (NSCLC)","Carcinoma, Non-Small Cell Lung","Non-Small Cell Lung Carcinoma","Non Small Cell Lung Cancer","Non Small Cell Lung Carcinoma",[34,35,36,37,38,39,40,41],"immune checkpoint inhibitor (CPI)","pathologic complete response (pCR)","aerosolized drug delivery","immunosuppressive tumor microenvironment (TME)","reversible epigenetic mechanisms","DNA demethylating agents","nebulizer treatment","AZA","RECRUITING","2026-07-10",{"date":45,"type":46},"2026-07-13","ACTUAL",{"date":48,"type":21},"2026-07-16",{"date":50,"type":21},"2034-12-31",{"name":52,"class":53},"National Cancer Institute (NCI)","NIH",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":65,"conditions":66,"keywords":67,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":86},"100053684","phase-1-study-to-evaluate-adverse-events-and-efficacy-of-intravenous-iv-telisotuzumab-adizutecan-in-combination-with-a-pd-1-immune-checkpoint-inhibitor-in-adult-participants-with-advanced-or-metastatic-non-squamous-nsclc-with-no-prior-treatment-for-advanced-disease-and-no-actionable-genomic-alterations-100053684","NCT06772623","Study to Evaluate Adverse Events and Efficacy of Intravenous (IV) Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease, and No Actionable Genomic Alterations","An Open-label Multi-Cohort Phase 1b\u002F2 Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease and No Actionable Genomic Alterations","Inclusion Criteria:\n\n* Must have histologically documented non-squamous (NSq) non small cell lung carcinoma (NSCLC) that is locally advanced or metastatic will be enrolled into the study.\n* Must have measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.\n* For Part 1, participants must have had no more than 1 systemic therapy for advanced disease including platinum-based chemotherapy or an immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy), or appropriate targeted therapy for an actionable gene alteration, if applicable, for epidermal growth factor receptor (EGFR) wild-type (WT) NSq NSCLC.\n* For Part 2, participants must have no prior systemic therapy for advanced disease, no known actionable genomic alteration.\n* Must have documented programmed death ligand 1 (PD-L1) status.\n* For Part 2, participant must have evaluable c-Met immunohistochemistry (IHC) result per central testing prior to randomization.\n* Must have adequate organ function.\n\nExclusion Criteria:\n\n* Known uncontrolled metastases to the central nervous system.\n* History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis on screening chest computed tomography (CT) scan.",{"count":63,"type":21},252,[24,25],"Non small cell lung carcinoma (NSCLC) is the most frequently occurring histologic subtype of lung cancer and is the leading cause of cancer-related deaths worldwide. The purpose of this study is to assess adverse events and change in disease activity when Telisotuzumab Adizutecan (ABBV-400) is given in combination with a programmed cell death receptor 1 (PD1) immune checkpoint inhibitor to adult participants to treat NSCLC.\n\nTelisotuzumab Adizutecan (ABBV-400) and budigalimab are investigational drugs being developed for the treatment of NSCLC. This study will be divided into two stages, with the first stage treating participants with several doses of telisotuzumab adizutecan in combination with budigalimab within the dose escalation regimen until the dose reached is tolerable and expected to be efficacious. In Stage 2 there will be 3 treatment groups. Two groups will receive pembrolizumab with different optimized doses of telisotuzumab adizutecan (to allow for the best dose to be studied in the future). One group will receive the standard of care (SOC) - pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. Approximately 252 adult participants with NSCLC will be enrolled in the study in 132 sites worldwide.\n\nIn the dose escalation stage participants will be treated with increasing intravenous (IV) doses of Telisotuzumab Adizutecan in combination with budigalimab until the dose of Telisotuzumab Adizutecan reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive IV optimized doses of Telisotuzumab Adizutecan in combination with IV pembrolizumab, or IV SOC - pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. The study will run for a duration of approximately 33 months.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.",[32],[32,68,69,70,71,72,73,74,75,76],"Pembrolizumab","Pemetrexed","Carboplatin","Cisplatin","Telisotuzumab Adizutecan","ABBV-400","ABBV-181","Budigalimab","AndroMETa-Lung-536","2026-07-09",{"date":45,"type":46},{"date":80,"type":46},"2025-03-06",{"date":82,"type":21},"2027-11",{"name":84,"class":85},"AbbVie","INDUSTRY",106,{"id":88,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":100,"locationsCount":54},"100569454",{"count":20,"type":21},[24,25],"Background:\n\nLung cancer is the leading cause of cancer-related death worldwide. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Surgery to remove the tumors is the standard treatment for people diagnosed with early stages of NSCLC. Despite complete removal of these tumors, many recur (happen again). An FDA-approved drug combination to treat early-stage NSCLC prior to the surgery is durvalumab plus standard chemotherapy. The FDA approved infusion drug azacytidine \\[AZA\\] is used to treat several diseases because it can rapidly kill dividing cells (including cancer cells) but it is not approved for NSCLC. An inhaled (aerosolized) form of AZA is also not approved for NSCLC. However, researchers want to know if an inhaled version of AZA can help improve treatment of people with NSCLC because inhaled AZA goes directly into the lungs with limited absorption into the bloodstream.\n\nObjective:\n\nTo find the safest and most effective dose of inhaled AZA in participants with early-stage non-small cell lung cancer (NSCLC) that can still be removed by surgery.\n\nEligibility:\n\nAdults aged 18 and older with operable early-stage NSCLC. Participants will be required to also enroll in NIH protocol 06C0014 which allows for pre- and post-treatment biopsies and bloodwork to be obtained for additional research studies.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. Their medical records will be reviewed. They will have imaging scans and tests of their heart and lung functions. Participants will be required to have a tissue sample (biopsy) taken of their tumor prior to receiving study drug and again during surgery after Cycle 3; airway tissue biopsies and collection of collect bronchial (lung) fluid may also be done.\n\nParticipants will receive the study treatment for 3 cycles. Each cycle is 21 days. They will need to come to the NIH Clinical Center (CC) on days 1-4 of Cycles 1-3.\n\nAZA will be given as a drug mist that can be inhaled (like the type of mist in an asthma inhaler) using a nebulizer at the NIH Clinical Center (CC) for 3 days in a row (consecutive days) during the first week of each cycle. The participant will inhale the AZA drug mist for 20 to 30 minutes each time. Participants will also receive durvalumab and a specific 2-drug assigned chemotherapy by intravenous (IV) infusion on day 4 of each cycle.\n\nParticipants will have a follow-up visit 2 weeks after their last dose of study drugs. Then they will have planned surgery to remove the tumors.\n\nParticipants will have additional follow-up visits at the NIH CC about 1 and 3 months after the surgery, and then for every 3 months for up to 3 years.\n\n...",[28,29,30,31,32],[34,35,36,37,38,39,40,41],"2026-07-01",{"date":96,"type":46},"2026-07-02",{"date":98,"type":21},"2026-07-07",{"date":50,"type":21},{"name":52,"class":53},{"id":102,"slug":4,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":65,"conditions":105,"keywords":106,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":111,"leadSponsor":112,"locationsCount":113},"100575464",{"count":63,"type":21},[24,25],[32],[32,68,69,70,71,72,73,74,75,76],"2026-06-26",{"date":109,"type":46},"2026-06-30",{"date":80,"type":46},{"date":82,"type":21},{"name":84,"class":85},103,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":16,"minAge":121,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":125,"conditions":126,"keywords":156,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":193},"100407463","phase-1-the-evaluation-of-pc14586-in-patients-with-advanced-solid-tumors-harboring-a-tp53-y220c-mutation-pynnacle-100407463","NCT04585750","The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","A Phase 1\u002F2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","Inclusion Criteria:\n\n* At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval.\n* Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation\n* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* Previously treated with one or more lines of anticancer therapy and progressive disease\n* Adequate organ function\n* Measurable disease per RECIST v1.1 (Phase 2)\n\nAdditional Criteria for Inclusion in Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Anti-PD-1\u002FPD-L1 naive or must have progressed on treatment\n* Measurable disease\n\nExclusion Criteria:\n\n* Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug\n* Radiotherapy within 14 days of receiving the study drug\n* Primary CNS tumor\n* History of leptomeningeal disease or spinal cord compression\n* Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptoms\n* Stroke or transient ischemic attack within 6 months prior to screening\n* Heart conditions such as unstable angina within 6 months prior to screening, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other rhythm abnormalities\n* Strong CYP3A4 inducers and strong CYP2C9 inhibitors\u002Finducers within 14 days of first dose of rezatapopt\n* History of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication\n* History of prior organ transplant\n* Known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer\n* Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection\n\nAdditional Criteria for Exclusion from Phase 2 (rezatapopt monotherapy)\n\n* Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2)\n\nAdditional Criteria for Exclusion from Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE)\n* Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention\n* Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy within 7 days prior to the first dose of study drug\n* Hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients\n* Active autoimmune disease that has required systemic treatment in past 2 years\n* History of radiation pneumonitis\n* History of (non-infectious) or active pneumonitis \u002F interstitial lung disease that required steroids\n* Active infection requiring systemic therapy\n* Known history of HIV infection\n* Has previously received rezatapopt","12 Years",{"count":123,"type":21},300,[24,25],"The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.",[127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,30,147,148,149,150,151,152,153,154,155],"Advanced Solid Tumor","Advanced Malignant Neoplasm","Metastatic Cancer","Metastatic Solid Tumor","Lung Cancer","Ovarian Cancer","Endometrial Cancer","Prostate Cancer","Colorectal Cancer","Breast Cancer","Other Cancer","Locally Advanced","Head and Neck Cancer","Gall Bladder Cancer","Small Cell Lung Cancer","Small Cell Lung Cancer ( SCLC )","Small Cell Lung Carcinoma","NSCLC","NSCLC (Non-small Cell Lung Cancer)","SCLC","Triple Negative Breast Cancer","TNBC","HER2+ Breast Cancer","Non-Small Cell Lung Cancer","ER\u002FPR Positive Breast Cancer","HER2- Breast Cancer","HER2-positive Breast Cancer","HER2-negative Breast Cancer","ER\u002FPR(+), Her2(-) Breast Cancer",[157,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184],"PC14586","p53","Y220C","Phase 1","Phase 1\u002F2","PMV","PMV Pharma","p53 mutation","TP53","TP53 mutation","p53 mutant","p53 reactivator","pembrolizumab","Keytruda","combination","PD-1","PD-L1","anti-PD-1","Merck","MSD","IgG4","mAb","Phase 1b","NGS","Next Generation Sequencing","precision","Phase 2","Rezatapopt","2026-06-24",{"date":107,"type":46},{"date":188,"type":46},"2020-10-29",{"date":190,"type":21},"2027-12-31",{"name":192,"class":85},"PMV Pharmaceuticals, Inc",77,{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":203,"briefSummary":204,"conditions":205,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":222},"100614791","phase-1-first-in-human-study-of-plx-61639-in-locally-advanced-or-metastatic-solid-tumors-100614791","NCT07284186","First-in-Human Study of PLX-61639 in Locally Advanced or Metastatic Solid Tumors","A Phase 1, First-in-Human Study of the SMARCA2 Degrader, PLX-61639, in Patients With SMARCA4-Mutated Locally Advanced or Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Participants with locally advanced or metastatic, relapsed\u002Frefractory, solid tumors harboring a SMARCA4 loss-of-function mutation that have progressed on, are intolerant of, or not otherwise candidates for available approved therapies\n* Adequate liver bone marrow, coagulation, renal, and cardiopulmonary function\n* Measurable disease per RECIST 1.1\n* ECOG PS of 0 or 1\n\nKey Exclusion Criteria:\n\n* Germline SMARCA4 mutations\n* Known SMARCA2 mutation or loss of expression\n* Symptomatic CNS disease\n* Prior treatment with another SMARCA2-directed therapy\n* History of other malignancies\n* Clinically significant heart disease\n* Uncontrolled hypertension\n* Prolongation of QT interval",{"count":202,"type":21},155,[24],"A multicenter, single-arm, first-in-human study to investigate the safety, pharmacokinetics, and preliminary antitumor activity of PLX-61639 in participants with locally advanced or metastatic, relapsed\u002Frefractory, SMARCA4-deficient solid tumors who are intolerant of or have failed available, approved therapies.\n\nThe study will be conducted in 3 parts: dose escalation (Part 1), dose optimization (Part 2), and cohort expansion (Part 3). Each part of the study will consist of a Screening Phase lasting up to 28 days during which participants will be assessed for eligibility, a Treatment Phase beginning on Cycle 1 Day 1 and consisting of consecutive 28-day cycles, an End of Treatment Visit, and a Post-Treatment Follow-Up Phase.\n\nParticipants will receive their assigned dose of PLX-61639 administered orally, once daily until progression\u002Frelapse, intolerance, death, or withdrawal from study treatment by the Investigator or participant.",[206,207,208,209,130,30,210,211,212,127],"Esophageal Squamous Cell Carcinoma","Gastric Adenocarcinoma","Gastric Squamous Cell Carcinoma","Gastroesophageal Junction (GEJ) Adenocarcinoma","Esophageal Adenocarcinoma","SMARCA4 Mutation","Gastroesophageal Junction Squamous Cell Carcinoma","2026-06-10",{"date":215,"type":46},"2026-06-12",{"date":217,"type":46},"2025-12-01",{"date":219,"type":21},"2030-09",{"name":221,"class":85},"Plexium, Inc.",10,{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":230,"enrollmentInfo":231,"targetDuration":4,"studyType":233,"phases":4,"briefSummary":234,"conditions":235,"keywords":237,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":222},"100493312","a-post-approval-commitment-study-on-tabrecta-capmatinib-in-south-korea-100493312","NCT05703516","A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea","A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea; Open Label, Prospective, Multicenter, Post Approval Surveillance","Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study.\n* Subject who are diagnosed as exon 14 skipping mutated NSCLC from tissue or plasma(ctDNA) sample analysis by treating physician (i.e. Any kind of diagnostic methods the institution currently has. Diagnostic modalities for research purpose would be also allowable.)\n* Subject who plan to receive Tabrecta® (Capmatinib) as per locally approved label\n\nExclusion Criteria:\n\n* Subject with contraindication according to the locally approved label\n* Subject whose medical record is not accessible\n* Subject who are not willing to provide informed consent","100 Years",{"count":232,"type":21},44,"OBSERVATIONAL","This is an open label, prospective, multicenter, non-comparative study to assess the safety and effectiveness of Tabrecta® (Capmatinib) in real world setting. Also, this study is to fulfill the regulatory requirements as part of the RMP (Risk Management Plan) for Tabrecta® (Capmatinib), as requested by Korea Health Authority, MFDS (Ministry of Food and Drug Safety).",[236],"Non-Small-Cell Lung Carcinoma",[238,31,239,144,240,241,242,243,244,245,246,247,248,249,250,251,252,253,254,255],"Non Small Cell Lung","Non-small cell lung cancer","INC280","Non-small cell lung carcinoma (NSCLC)","lung cancer","lung adenocarcinoma","Non small cell lung carcinoma","MET exon 14 deletion","METex14del","MET exon 14 skipping","MET exon 14 mutation","MET mutation","MET amplification","MET inhibitor","MET dysregulation","MET activation","MET signaling","MET pathway","2026-05-28",{"date":258,"type":46},"2026-06-01",{"date":260,"type":46},"2023-06-12",{"date":262,"type":21},"2026-10-31",{"name":264,"class":85},"Novartis Pharmaceuticals",{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":271,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":233,"phases":4,"briefSummary":275,"conditions":276,"keywords":283,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":299},"100636247","observational-multicenter-study-in-patients-receiving-chemotherapy-and-amivantamab-for-metastatic-non-small-cell-lung-cancer-100636247","NCT07563205","Observational Multicenter Study in Patients Receiving Chemotherapy and Amivantamab for Metastatic Non-small Cell Lung Cancer","Observational Multicenter Study in Patients Receiving Chemotherapy and Amivantamab for Metastatic Non-small Cell Lung Cancer as Part of an Early Access Program","OMAE","Inclusion Criteria:\n\n* Patient over 18 years old\n* Cohort A: Patient with metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion treated with amivantamab-platimum based chemotherapy via an early access program in first line setting.\n* Cohort B: Patient with metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 19 or 21 treated with amivantamab-platimum based chemotherapy post osimertinib (with or without chemotherapy) via an early access program.\n* Patient covered by the French National Health Insurance system or by an approved third-party payer\n* Patient who does not object to the collection of their personal data for research purposes (an information sheet will be provided to all living participants; for deceased participants, documented non-opposition in the medical record is not required)\n\nExclusion Criteria:\n\n* Patient placed under legal guardianship or subject to a protective legal measure\n* Patient who explicitly refuses the collection or use of their personal data for research purposes\n* Patient not enrolled, managed, or followed at the investigating site by a qualified site investigator",{"count":274,"type":21},100,"The purpose of this observational study is to understand how well a treatment combining chemotherapy and amivantamab works in real life, and how safe it is, in adults with metastatic non-small cell lung cancer (NSCLC) who have certain EGFR gene mutations.\n\nThe study includes two groups of people:\n\n* Group A: people with an EGFR exon 20 insertion who receive amivantamab together with platinum-based chemotherapy as their first treatment, through an early access program.\n* Group B: people with an EGFR exon 19 or exon 21 mutation who receive amivantamab with platinum-based chemotherapy after having been treated with osimertinib (with or without chemotherapy), also through an early access program.\n\nThe main question the study wants to answer is:\n\nHow long can the combination of amivantamab and chemotherapy keep the cancer from coming back or getting worse in these two groups of people?\n\nPeople already receiving amivantamab and chemotherapy for NSCLC through an early access program may be included. They will continue to be followed by their usual oncologist as part of their normal medical care. The study will simply collect their medical information from March 21, 2024 to October 21, 2025.\n\nNo extra tests or procedures are required. This is an observational study, carried out by the GFPC and partner centers in France.",[150,277,278,32,144,279,280,281,282],"Non Small Cell Lung Cancer Metastatic","Non Small Cell Lung Cancer NSCLC","EGFR","EGFR Exon 20 Insertion Mutation","EGFR Exon 19 Deletion Mutation","EGFR Exon 21 Mutation",[131,284,285,286,287,288,144],"Non Small Cell lung cancer","Metastatic lung cancer","EGFR Exon 20","EGFR Exon 19","EGFR Exon 21","2026-04-24",{"date":291,"type":46},"2026-05-01",{"date":293,"type":46},"2025-11-19",{"date":295,"type":21},"2027-11-19",{"name":297,"class":298},"GFPC Investigation","OTHER",16,{"id":301,"slug":302,"hasResults":11,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":307,"targetDuration":4,"studyType":22,"phases":309,"briefSummary":311,"conditions":312,"keywords":315,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":326},"100604035","phase-3-a-study-to-learn-about-the-study-medicine-called-pf-08046054sgn-pdl1v-versus-docetaxel-in-adult-participants-with-previously-treated-programmed-cell-death-ligand-1-pd-l1-positive-non-small-cell-lung-cancer-nsclc-100604035","NCT07144280","A Study to Learn About the Study Medicine Called PF-08046054\u002FSGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)","PADL1NK-005: A Randomized, Phase 3, Open-Label Study to Evaluate PF-08046054\u002FSGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)","Inclusion Criteria\n\n* Histologically or cytologically confirmed diagnosis of NSCLC with locally advanced, unresectable Stage IIIB or IIIC not eligible for definitive chemoradiotherapy or metastatic (Stage IV: M1a, M1b, or M1c) disease per the American Joint Committee on Cancer (AJCC) Staging Manual, Version 8.0, and the Union for International Cancer Control (UICC) Staging System. Note: Participants with a neuroendocrine component or histology are not eligible.\n* PD-L1 expression on ≥1% of tumor cells based on local immunohistochemistry (IHC) testing with an assay utilizing the anti-PD-L1 monoclonal antibody clones 22C3 or SP263.\n* Participants who have NSCLC with known AGAs are permitted.\n* Able to provide any of the following tumor tissues for biomarker analysis:\n\n  * Archival specimen (preferably collected within 12 months after the last anticancer therapy) (see laboratory manual for details); or\n  * De novo biopsy from a tumor lesion, if medically feasible.\n* Participants must have received the following therapies and progressed during or relapsed after receiving their most recent prior therapy, or have been intolerant to their most recent therapy:\n\nParticipants with no known AGAs must fulfill 1 of the following conditions:\n\n* Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease, and unless contraindicated, a PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy).\n* Experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant, neoadjuvant, or chemoradiotherapy setting and received a PD-(L)1 monoclonal antibody at any time during the course of treatment.\n\nParticipants with known AGAs (eg, EGFR mutations, ALK translocations, or other relevant actionable mutations) must fulfill the following conditions:\n\n* Must have received at least 1 relevant AGA-targeted therapy if locally available and, in the opinion of the investigator, additional AGA-targeted therapy is not in the best interest of the participant\n* Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease, or experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant, neoadjuvant, or chemoradiotherapy setting.\n* May have received PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy).\n\nExclusion Criteria\n\n* History of another malignancy within 3 years before the first dose of PF-08046054, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (eg, 5-year overall survival \\[OS\\] ≥90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.\n* Any central nervous system (CNS) lesions, unless definitively treated with CNS-directed local therapy (surgery and\u002For radiotherapy). Participants with definitively treated brain metastases are eligible if they meet the following criteria:\n\n  * The participant is on a stable dose of ≤10 mg\u002Fday of prednisone or equivalent for at least \\>14 days prior to randomization (if requiring steroid treatment).\n  * No clinical or radiographic progression in the CNS following CNS-directed definitive radiotherapy and\u002For surgery.\n  * Time since CNS-directed treatment is ≥28 days prior to randomization.\n* Participants with a history of leptomeningeal metastasis are excluded.\n* Prior treatment with an anti-PD-L1 agent (where indicated per protocol) within 5 half-lives.\n* Previous receipt of an MMAE-containing agent or prior docetaxel.\n\nThere are additional inclusion and exclusion criteria. The study center will determine if criteria for participations are met.",{"count":308,"type":21},680,[310],"PHASE3","The purpose of this study is to understand if PF-08046054 alone works well compared to standard-of-care docetaxel alone in participants with non-small cell lung cancer (NSCLC) with PD-L1 expression greater than or equal to 1% and had cancer progression during or after treatment with PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted treatment regimen(s) for participants with known actionable genomic alterations (AGAs). Participants in this study must have cancer that has spread through their body or can't be removed with surgery or treated with definitive radiation.\n\nParticipants will randomly (like a flip of the coin) be assigned to either the PF-08046054 treatment group or the docetaxel treatment group. Participants in the PF-08046054 treatment group will receive an IV infusion (injected directly into the veins) twice during each 21-day cycle. Participants in the docetaxel treatment group will receive an IV infusion once during each 21-day cycle. Study participation may be up to 5 years if the participant's NSCLC is responding to treatment. The study team will see how each participant is doing with the study treatment during regular visits at the clinic.",[313,314,30],"Non-small Cell Carcinoma","Non-Small Cell Lung Cancer Metastatic",[316,144],"Non-small cell lung cancer NSCLC","2026-04-20",{"date":319,"type":46},"2026-04-21",{"date":321,"type":46},"2025-09-29",{"date":323,"type":21},"2032-03-10",{"name":325,"class":85},"Pfizer",305,{"id":328,"slug":329,"hasResults":11,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":333,"eligibilityCriteria":334,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":22,"phases":337,"briefSummary":338,"conditions":339,"keywords":341,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":54},"100609822","phase-1-retifanlimab-and-ruxolitinib-in-solid-malignancies-100609822","NCT07219576","Retifanlimab and Ruxolitinib In Solid Malignancies","PRISM: Phase 1b of Retifanlimab and Ruxolitinib In Solid Malignancies Progressing on Prior Checkpoint Inhibition","PRISM","Inclusion Criteria:\n\n1. Advanced or metastatic clear cell renal cell carcinoma or non-small cell lung carcinoma having progressed on prior PD-1\u002FPD-L1 therapy (radiographic progression within 6 months of discontinuing immunotherapy; immunotherapy does not need to be the immediate line of preceding therapy).\n2. Decline standard of care treatment or no available standard of care treatment.\n3. Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1.\n4. Eastern Cooperative Oncology Group performance status of 0 or 1.\n5. Adequate organ and marrow function:\n\n   * Absolute neutrophil count ≥ 1.0×10\\^9\u002FL.\n   * Platelet count ≥ 100×10\\^9\u002FL.\n   * Hemoglobin level ≥ 8.5 g\u002FdL; criteria must be met without erythropoietin dependency and without packed red blood cell transfusion within the last 2 weeks.\n   * Serum creatinine ≤ 2 mg\u002FdL (or estimated creatinine clearance ≥ 30 mL\u002Fminute calculated by the Cockcroft Gault or Modification of Diet in Renal Disease formulas).\n   * Aspartate Aminotransferase and Alanine Aminotransferase ≤ 2.5 x upper limit of normal.\n   * Bilirubin ≤1.5 x upper limit of normal.\n6. Ability to take oral medication and be willing to adhere to the study intervention.\n7. Willingness to comply with all study procedures and availability for the duration of the study.\n\nExclusion Criteria:\n\n1. Pregnancy or lactation.\n2. No prior treatment with Janus kinase inhibitors.\n3. No more than one prior line of PD-1\u002FPD-L1 therapy. No limit on prior lines of systemic therapy. PD-1\u002FPD-L1 therapy does not need to be the most immediate prior line of therapy. Patients with progressive disease as best response to prior PD-1\u002FPD-L1 therapy are not eligible. Need to have either stable disease, partial response, or complete response as best response using RECIST version 1.1 principles to prior PD-1\u002FPD-L1 therapy.\n4. Received systemic anti-cancer therapy within 3 weeks of enrollment or small molecule kinase inhibitors within two weeks or six elimination half-lives of enrollment, whichever is sooner.\n5. Has received prior radiotherapy within one week before enrollment.\n6. Has had history of major surgery less than two weeks before enrollment. Adequate wound healing after major surgery must be assessed clinically.\n7. Failure to recover from any immune related adverse event from prior immunotherapy to Common Terminology Criteria in Adverse Event grade ≤ 1 (participants with grade ≤ 2 sensory neuropathy, endocrinopathies controlled by hormone replacement, or other grade ≤ 2 not constituting a safety risk based on investigator's judgment are eligible).\n8. Known active central nervous system metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate, provided they are clinically stable and without the requirement of steroid treatment for at least 14 days prior to enrollment.\n9. Known active or history of autoimmune disease that requires steroids or immunosuppressive agents. Patients are allowed in the study if they have vitiligo, type 1 diabetes mellitus, controlled asthma; residual hypo- or hyperthyroidism due to an autoimmune condition not requiring immunosuppressive treatment; psoriasis, atopic dermatitis, or another autoimmune skin condition that is managed without steroids or immunosuppressive agents; or arthritis that is managed without systemic therapy beyond oral acetaminophen and non-steroidal anti-inflammatory drugs.\n10. Diagnosis of immunodeficiency or receiving systemic steroid therapy (equivalent of prednisone \\> 10 mg daily) or any other form of immunosuppressive therapy within seven days prior to the first dose of study treatment. The use of physiologic doses of corticosteroids is permitted. Intra-articular, intra-ocular, intra-nasal, inhalation and ocular steroids are permitted.\n11. Active infections requiring systemic antibiotics or antifungal or antiviral treatment within 7 days before first dose of study treatment.\n12. Active tuberculosis.\n13. Active immunodeficiency virus (HIV) infection. To be enrolled, patients with history of HIV must have an undetectable viral load at screening.\n14. Active hepatitis B or hepatitis C virus infections. To be enrolled, patients with a history of these infections must have been treated and cured with undetectable viral load at screening.\n15. Have clinically significant cardiovascular disease defined as:\n\n    * Cerebral vascular accident\u002Fstroke or myocardial infarction (\\\u003C6 months prior to enrollment)\n    * Unstable angina, congestive heart failure exacerbation (New York Heart Association Classification ≥ Class II), or unstable cardiac arrhythmia (\\\u003C 3 months prior to enrollment). Stable cardiac arrhythmia (such as atrial fibrillation, atrial flutter) controlled on or off medications is permitted.\n16. Known additional malignancy that is progressing or has required active treatment within the past 2 years. Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, low grade prostate cancer, carcinoma in situ (e.g., breast carcinoma in situ, bladder carcinoma in situ) that have undergone potentially curative therapy or are on active surveillance are not excluded. Patients with cancer not detectable on imaging, not receiving active treatment, and not expected to impact 5-year life expectancy are eligible to enroll.\n17. Unable to swallow orally administered medication intact or has a history or current evidence of a gastrointestinal disorder (e.g., inflammatory bowel disease, Crohn's disease, ulcerative colitis, gastrectomy, partial bowel obstruction, malabsorption) or impaired liver function or diseases that in the opinion of the investigator may significantly alter the absorption and metabolism of oral medications.\n18. History or evidence of any other clinically unstable\u002Funcontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, renal, metabolic, hematologic, or psychiatric) other than their primary malignancy, that in the opinion of the investigator would pose a risk to patient safety or interfere with study evaluations, procedures, or completion.\n19. Known allergy or hypersensitivity to any component or formulation components of retifanlimab and ruxolitinib.",{"count":336,"type":21},40,[24,25],"The goal of this clinical trial is to learn what dose of ruxolitinib can be given safely together with retifanlimab in patients with metastatic renal cell carcinoma and non-small cell lung carcinoma.\n\nThe main question it aims to answer is:\n\nWhat is the maximum dose of ruxolitinib that can be used safely in patients with metastatic renal cell carcinoma and non-small cell lung carcinoma, and will it work?\n\nParticipants will:\n\nTake drug ruxolitinib twice a day and keep a diary of when they take ruxolitinib at home; visit the clinic for infusions of retifanlimab every 4 weeks; visit the clinic for checkups and tests.",[32,340],"Renal Cell Carcinoma",[342,343,344,345],"programmed death ligand-1 blocker","Janus kinase inhibitor","3+3 dose escalation design","recommended phase 2 dose","2026-01-10",{"date":348,"type":46},"2026-01-13",{"date":350,"type":46},"2026-01-08",{"date":352,"type":21},"2029-12",{"name":354,"class":298},"University of California, San Diego",{"id":356,"slug":357,"hasResults":11,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":22,"phases":364,"briefSummary":365,"conditions":366,"keywords":368,"overallStatus":370,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":375,"leadSponsor":377,"locationsCount":4},"100469488","phase-1-bpi-361175-tablets-in-patients-with-advanced-non-small-cell-lung-cancer-nsclc-100469488","NCT05393466","BPI-361175 Tablets in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)","A Phase I\u002FII, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of BPI-361175 Tablets in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n1. Male or female ≥ 18 years old;\n2. Life expectancy ≥ 12 weeks;\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;\n4. Patients with histologically or cytologically confirmed diagnosis of inoperable locally advanced or recurrent\u002Fmetastatic NSCLC with EGFR mutations. Patients must have progressed from or be intolerant to or be unfit for standard treatment.\n5. For dose escalation: patients with documented EGFR mutation that have progressed on or after third-generation EGFR-TKI. In addition, other lines of therapy may have been given.\n6. For dose expansion and Phase II: patients with EGFR C797S mutation confirmed prior to enrollment on tissue or blood samples with radiological documentation of disease progression from first-generation, second-generation or third-generation EGFR-TKIs. In addition, other lines of therapy may have been given;\n7. For dose expansion and Phase II, patients must have at least one measurable tumor lesion per RECIST v1.1 criteria as per Investigator's assessment;\n8. Adequate bone marrow, liver, and renal function:\n\n   * Blood: Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL (1500\u002Fmm3), platelets count ≥ 100 × 109\u002FL, hemoglobin ≥ 9 g\u002FdL (90 g\u002FL) (must not have received transfusion or granulocyte colony-stimulating factor within 2 weeks of screening tests and procedures);\n   * Liver function: total bilirubin ≤ 1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN; if liver metastases exist, AST and ALT ≤ 5.0 × ULN; for patients with documented Gilbert's syndrome, total bilirubin ≤ 3.0 × ULN;\n   * Renal function: Estimated glomerular filtration rate (eGFR) ≥ 50 mL\u002Fmin (calculated by CKD-EPI);\n9. All acute toxic effects of any prior antitumor therapy or surgery must have resolved to baseline or ≤ CTCAE Grade 1 (with the exception of alopecia);\n10. For women with childbearing potential, serum pregnancy test will be performed within 7 days before dosing, with a negative result, and they must be non-lactating; all patients should take medically recognized contraceptive measures throughout the treatment period and 3 months after the last dose (see section Error! Reference source not found.);\n11. Men with partners of childbearing potential willing to use adequate contraceptive measures during the study and for 90 days after the last dose of study medication.\n12. Patients must have fully understood and voluntarily signed informed consent form (ICF).\n\nExclusion Criteria:\n\n1. Presence of another active primary malignant tumors;\n2. Unstable, symptomatic primary CNS tumors\u002Fmetastasis or leptomeningeal metastases which are not suitable for enrollment, as judged by investigators. A patient can be enrolled if his\u002Fher clinical condition is stable and imaging evidence does not show disease progression within 2 weeks prior to the first dose, and who is off corticosteroid, anticonvulsant or mannitol treatment for longer than 2 weeks prior to the first dose.\n3. Treatment with the most recent therapy (e.g., chemotherapy, immunotherapy, targeted therapy, radiation therapy, investigational therapy\u002Fagent) within 4 weeks or approximately 5 half-lives, whichever is the longer, before the first dose. (If sufficient wash-out time has not occurred due to schedule or PK properties, an alternative appropriate wash-out time based on known duration and time to reversibility of drug related adverse events could be agreed upon by the sponsor and investigators);\n4. Gastrointestinal disorders that would affect oral swallowing or the investigators judge the absorption of the study drug will be interfered;\n5. Use of strong or moderate CYP3A inhibitors or inducers within 7 days prior to the first dose;\n6. Autologous (within 3 months) or allogeneic (within 6 months) organ or stem cell transplantation prior to the first dose; any major surgery or severe trauma (except biopsy sampling) within 4 months prior to the first dose;\n7. Palliative radiation therapy within 2 weeks prior to the first dose;\n8. Patients who have active viral hepatitis B (HBV) infection (exception: HBV DNA ≤ 500 IU\u002FmL and has been stable for longer than 4 weeks);\n9. Patients who have active infections that required systemic therapy within 1 week prior to the first dose;\n10. Any of the following cardiac conditions within the last 6 months:\n\n    Unexplained or cardiovascular cause of presyncope or syncope, tachycardia, ventricular fibrillation, or sudden cardiac arrest. Prolonged corrected QT interval \\[mean resting corrected QT interval QTcF \\> 450 msec for males or \\> 470 msec for females from 3 electrocardiogram (ECG)\\];\n11. Any \\> CTCAE Grade 1 prior to the first dose;\n12. Medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease, any uncontrolled systemic disease, and other serious illnesses;\n13. Patients with deep venous thrombosis, pulmonary embolism or any other serious thromboembolism within 3 months prior to the first dose (implantable venous access-port, catheter-related thrombosis or superficial venous thrombosis is not considered as \"serious\" thromboembolism);\n14. The presence of drug abuse and medical, psychological, or social conditions that do not permit compliance with the protocol or will not be available for protocol-required study visits or procedures.",{"count":363,"type":21},30,[24,25],"This is a three-stage study, consisting of Phase Ia dose-escalation, Phase Ib dose expansion, and a Phase II component.",[367],"Non-small Cell Lung Carcinoma",[369],"non-small cell lung carcinoma","NOT_YET_RECRUITING","2025-10-06",{"date":373,"type":46},"2025-10-07",{"date":94,"type":21},{"date":376,"type":21},"2029-05-31",{"name":378,"class":85},"Xcovery Holdings, Inc.",{"id":380,"slug":381,"hasResults":11,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":387,"enrollmentInfo":388,"targetDuration":4,"studyType":22,"phases":390,"briefSummary":391,"conditions":392,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":54},"100428001","phase-3-to-assess-the-efficacy-and-safety-of-furmonertinib-versus-placebo-in-patients-with-epidermal-growth-factor-receptor-mutation-positive-stage-ii-iiia-non-small-cell-lung-carcinoma-following-complete-tumour-resection-with-or-without-adjuvant-chemotherapy-100428001","NCT04853342","To Assess the Efficacy and Safety of Furmonertinib Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage II-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy","A Phase III, Double-blind, Randomized, Placebo-Controlled Multi-centre, Study to Assess the Efficacy and Safety of Furmonertinib (AST2818) Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage II-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy","FORWARD","Inclusion Criteria:\n\n* Male or female, aged at least 18 years.\n* Histologically confirmed diagnosis of primary non-small lung cancer (NSCLC) on predominantly non-squamous histology.\n* MRI or CT scan of the brain must be done prior to surgery as it is considered standard of care.\n* Patients must be classified post-operatively as Stage IB, II, or IIIA on the basis of pathologic criteria.\n* Confirmation by the central laboratory that the tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M.\n* Complete surgical resection of the primary NSCLC is mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for the tumor.\n* Complete recovery from surgery and standard post-operative therapy (if applicable) at the time of randomization.\n* World Health Organization Performance Status of 0 to 1.\n* Female patients should be using adequate contraceptive measures, should not be breastfeeding, and must have a negative pregnancy test prior to the first dose of the study drug; or female patients must have evidence of non-child-bearing potential.\n\nExclusion Criteria:\n\n* Pre-operative or post-operative or planned radiation therapy for the current lung cancer\n* Pre-operative (neo-adjuvant) platinum-based or other chemotherapy\n* Any prior anticancer therapy\n* Prior treatment with neoadjuvant or adjuvant EGFR-TKI at any time\n* Major surgery (including primary tumor surgery, excluding placement of vascular access) within 4 weeks of the first dose of study drug\n* Patients currently receiving medications or herbal supplements known to be potent inducers of cytochrome P450 (CYP) 3A4\n* Treatment with an investigational drug within five half-lives of the compound or any of its related material.\n* Patients who have had only segmentectomies or wedge resections\n* History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumors curatively treated with no evidence of disease for \\> 5 years following the end of treatment.\n* Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy.\n* Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV).\n* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of AZD9291.\n* Any of the following cardiac criteria:\n* Mean resting corrected QT interval (QTc) \\>470 msec, obtained from 3 ECGs, using the screening clinic ECG Machine-derived QTc value.\n* Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG.\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval.\n* Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.\n* Inadequate bone marrow reserve or organ function.","75 Years",{"count":389,"type":21},318,[310],"This is a phase 3 double-blind, randomized, placebo-controlled, study to assess the efficacy and safety of Furmonertinib (AST2818) versus placebo in patients with stage II-IIIA non-small cell lung cancer (NSCLC) with centrally confirmed, most common sensitising EGFR mutations (Ex19Del and L858R) either alone or in combination with other EGFR mutations as confirmed by a central test, who have had complete tumour resection, with or without postoperative adjuvant chemotherapy.",[367],"2025-04-02",{"date":395,"type":46},"2025-04-04",{"date":397,"type":46},"2021-06-07",{"date":399,"type":21},"2030-01",{"name":401,"class":85},"Allist Pharmaceuticals, Inc.",{"id":403,"slug":404,"hasResults":11,"nctId":405,"briefTitle":406,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":408,"targetDuration":4,"studyType":22,"phases":409,"briefSummary":410,"conditions":411,"keywords":414,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":54},"100533182","phase-2-whole-body-her3-quantification-with-radiolabelled-patritumab-deruxtecan-her3-dxd-petct-100533182","NCT06222489","Whole Body HER3 Quantification With Radiolabelled Patritumab Deruxtecan (HER3-DXd) PET\u002FCT","Inclusion Criteria:\n\n1. Provision of informed consent prior to any study specific procedures.\n2. Have a histologically or cytologically confirmed diagnosis of (locally) advanced stage EGFR mutation positive NSCLC, not amenable for curative intent treatment.\n3. Have measurable disease according to RECIST 1.1.\n4. At least two lesions with a long axis diameter ≥2 cm.\n5. Have received at least one line of EGFR TKI treatment for (locally) advanced stage NSCLC.\n6. In case the tumor is positive for T790M mutation, prior treatment with a third generation EGFR TKI is mandatory.\n7. Patients must be ≥18 years of age.\n8. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1 at the time of Screening.\n9. Has adequate bone marrow reserve and organ function, based on local laboratory data within 14 days prior to Cycle 1, Day 1, defined as:\n\n   * Platelet count ≥100 000\u002Fmm3 or ≥100 × 109\u002FL (platelet transfusions are not allowed up to 14 days prior to Cycle 1 Day 1 to meet eligibility)\n   * Hemoglobin (Hgb) ≥9.0 g\u002FdL or 5.6 mmol\u002FL (transfusion and\u002For growth factor support is allowed)\n   * Absolute neutrophil count (ANC) ≥1500\u002Fmm3 or ≥1.5 × 109\u002FL\n   * Creatinine clearance (CrCl) ≥30 mL\u002Fmin as calculated using the Cockcroft-Gault equation or measured CrCl\n   * Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤3 × ULN (if liver metastases are present, ≤5 ×ULN)\n   * Total bilirubin (TBL) ≤1.5 × ULN if no liver metastases (\\\u003C3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases)\n   * Serum albumin ≥2.5 g\u002FdL or 25 g\u002FL\n   * Prothrombin time (PT) or Prothrombin time- international normalized ratio (PT-INR) and activated partial thromboplastin time (aPTT)\u002Fpartial thromboplastin time (PTT) ≤1.5 × (ULN), except for subjects on coumarin-derivative anticoagulants or other similar anticoagulant therapy, who must have PT-INR within therapeutic range as deemed appropriate by the Investigator\n10. Be willing to provide a qualifying tumor tissue specimen. A pretreatment tumor biopsy (if medically feasible) or otherwise archival tumor tissue is required. Samples must be of sufficient quantity and of adequate tumor tissue content (as defined in the Laboratory Manual).\n\n    1. A Baseline pretreatment tumor biopsy must be of the primary (if intact) and\u002For metastatic lesion(s) not previously irradiated and amenable to core biopsy. Any serious adverse event (SAE) directly related to the new biopsy should be reported as outlined in Section 8.\n    2. If not medically feasible to collect the pretreatment tumor biopsy, archival tumor tissue not previously irradiated must be collected from a biopsy on or after treatment with the most recent EGFR TKI cancer therapy regimen.\n11. If the subject is a female of childbearing potential, she must have a negative serum pregnancy test at screening and must be willing to use a highly effective birth control upon enrollment, during the Treatment Period, and for 7 months, following the last dose of study drug. A female is considered of childbearing potential following menarche and until becoming postmenopausal (no menstrual period for a minimum of 12 months) unless permanently sterile (undergone a hysterectomy, bilateral salpingectomy or bilateral oophorectomy) with surgery at least 1 month before the first dose or confirmed by follicle stimulating hormone (FSH) test.\n12. Female subjects must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study drug administration.\n13. If male, the subject must be surgically sterile or willing to use a highly effective birth control upon enrollment, during the treatment period, and for at least 4 months following the last dose of study drug.\n14. Male subjects must not freeze or donate sperm starting at screening and throughout the study period, and for at least 4 months after the final study drug administration.\n\nExclusion Criteria:\n\n1. Any history of interstitial lung disease (ILD) (including pulmonary fibrosis or radiation pneumonitis), has current ILD, or is suspected to have such disease by imaging during screening.\n2. Clinically severe pulmonary compromise (based on investigator's assessment) resulting from intercurrent pulmonary illnesses including, but not limited to:\n\n   1. any underlying pulmonary disorder (eg, pulmonary emboli, severe asthma, severe chronic obstructive lung disease (COPD), restrictive lung disease, pleural effusion);\n   2. any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement (eg, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis); OR prior pneumonectomy.\n3. Is receiving chronic systemic corticosteroids dosed at \\>10 mg prednisone or equivalent or any form of immunosuppressive therapy prior to Cycle 1 Day 1. Subjects who require use of bronchodilators, inhaled steroids, or local steroid injections may be included in the study.\n4. Evidence of any leptomeningeal disease.\n5. Has clinically significant corneal disease.\n6. Any evidence of severe or uncontrolled systemic diseases (including active bleeding diatheses, active infection, psychiatric illness\u002Fsocial situations, geographical factors, substance abuse, or other factors which in the Investigator's opinion makes it undesirable for the subject to participate in the study or which would jeopardize compliance with the protocol. Screening for chronic conditions is not required.\n7. Evidence of clinically active spinal cord compression or brain metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Subjects with clinically inactive or treated brain metastases who are asymptomatic (ie, without neurologic signs or symptoms and do not require treatment with corticosteroids or anticonvulsants) may be included in the study. Subjects must have a stable neurologic status for at least 2 weeks prior to Cycle 1 Day 1.\n8. Inadequate washout period prior to Cycle 1 Day 1, defined as:\n\n   1. Whole brain radiation therapy \\\u003C14 days or stereotactic brain radiation therapy \\\u003C7 days.\n   2. Any cytotoxic chemotherapy, investigational agents or other anticancer drug(s) from a previous cancer treatment regimen or clinical study (other than Epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI)), \\\u003C14 days or 5 half-lives, whichever is longer.\n   3. Monoclonal antibodies other than immune checkpoint inhibitors, such as bevacizumab (anti-VEGF) and cetuximab (anti-EGFR) \\\u003C28 days.\n   4. Immune checkpoint inhibitor therapy \\\u003C 21 days.\n   5. Major surgery (excluding placement of vascular access) \\\u003C 28 days.\n   6. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation \\\u003C 28 days or palliative radiation therapy \\\u003C 14 days.\n   7. Chloroquine or hydroxychloroquine ≤ 14 days.\n9. Prior treatment with an HER3 antibody and\u002For antibody drug conjugate (ADC) that consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, trastuzumab deruxtecan).\n10. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, grade ≤1 or baseline. Subjects with chronic Grade 2 toxicities may be enrolled at the discretion of the Investigator after consultation with the Sponsor Medical Monitor or designee.\n11. Has known hypersensitivity to either the drug substances or inactive ingredients in the drug product.\n12. Has any primary malignancy other than locally advanced or metastatic NSCLC within 3 years prior to Cycle 1 Day 1, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated.\n13. Uncontrolled or significant cardiovascular disease prior to Cycle 1 Day 1, including:\n\n    1. QT interval corrected by Fridericia's formula (QTcF) prolongation interval of \\>470 ms for females and \\>450 ms for males.\n    2. Left ventricular ejection fraction (LVEF) \\\u003C50% by either echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan.\n    3. Resting systolic blood pressure \\>180 mmHg or diastolic blood pressure \\>110 mmHg.\n    4. Myocardial infarction within 6 months.\n    5. New York Heart Association (NYHA) Classes 2 to 4 within 28 days.\n    6. Uncontrolled angina pectoris within 6 months.\n    7. Cardiac arrhythmia requiring antiarrhythmic treatment.\n14. Active Hepatitis B and\u002For Hepatitis C infection, such as those with serologic evidence of viral infection within 28 days of Cycle 1, Day 1.\n\n    a. Subjects with past or resolved Hepatitis B virus (HBV) infection are eligible if: i. Hepatitis surface antigen (HBsAg) negative and hepatitis B core antibody (anti-HBc) positive; OR ii. HBsAg positive and HBV DNA viral load is documented to be ≤ 2000 IU\u002FmL in the absence of anti-viral therapy and during the previous 12 weeks prior to the viral load evaluation with normal transaminases (in the absence of liver metastasis); OR iii. HBsAg positive and HBV DNA viral load is documented to be ≤ 2000 IU\u002FmL in the absence of anti-viral therapy and during the previous 12 weeks prior to the viral load evaluation with liver metastasis and abnormal transaminases AST\u002FALT \\\u003C 3 ULN.\n\n    b. Subjects with a history of Hepatitis C infection will be eligible for enrollment only if the viral load according to local standards of detection, is documented to be below the level of detection in the absence of anti-viral therapy during the previous 12 weeks (ie, sustained viral response according to the local product label but no less than 12 weeks, whichever is longer).\n15. Female subject who is pregnant or breastfeeding or intends to become pregnant during the study.\n16. Subjects with known human immunodeficiency virus (HIV) infection.\n17. Prior or ongoing clinically relevant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the Investigator's judgment, could affect the safety of the subject; alter the absorption, distribution, metabolism or excretion of the study drug; or confound the assessment of study results.\n18. Live virus vaccination 28 days prior to Cycle 1 Day 1.",{"count":299,"type":21},[25],"Activity of patritumab deruxtecan (U3-1402; HER3-DXd) has been shown in a phase I\u002FII study in patients with HER3 expressing breast cancer as well as in a phase I study in patients with EGFR TKI refractory EGFR mutation positive NSCLC with a preliminary ORR of 25%. HER3 expression can be seen in multiple tumor types and is therefore an attractive target for antibody drug conjugate (ADC) treatment. However, intra- and intertumor heterogeneity of HER3 expression might be substantial, as is seen for HER2, and might contribute to treatment failure or heterogeneous responses. In addition, HER3 expression is dynamic and has been shown to change over time.\n\nIn order to identify patients that may benefit most from treatment with patritumab deruxtecan, better knowledge of the in vivo behaviour of the drug is warranted. One way to visualize this behaviour is positron emission tomography (PET) imaging with radiolabelled antibodies (immune-PET). 89Zr-Patritumab deruxtecan PET\u002FCT can assess HER3 expression non-invasively at a whole body level, including sites that may be difficult to biopsy. It also visualizes and quantifies biodistribution of patritumab deruxtecan, thereby obtaining valuable information for safety and toxicity analyses.",[30,412,413],"Advanced Non-Small Cell Squamous Lung Cancer","EGFR Gene Mutation",[415],"At least one line of systemic treatment","2025-03-04",{"date":80,"type":46},{"date":419,"type":46},"2025-03-03",{"date":421,"type":21},"2028-05-01",{"name":423,"class":298},"The Netherlands Cancer Institute",{"id":425,"slug":426,"hasResults":11,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":430,"eligibilityCriteria":431,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":432,"enrollmentInfo":433,"targetDuration":4,"studyType":22,"phases":435,"briefSummary":436,"conditions":437,"keywords":4,"overallStatus":370,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":4},"100492906","phase-1-clinical-study-to-evaluate-safety-and-dosing-of-ca9hu-1-in-patients-with-advanced-solid-tumours-100492906","NCT05698238","Clinical Study to Evaluate Safety and Dosing of CA9hu-1 in Patients With Advanced Solid Tumours","Phase Ib\u002Fll Clinical Study to Evaluate Safety and Dosing of Humanised Monoclonal Antibody CA9hu-1 to Human Carbonic Anhydrase IX in Patients With Advanced Solid Tumours","CAMP1","Inclusion Criteria:\n\n* Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up\n* Histologically proven solid tumors (Clear Cell Renal Cell Carcinoma Metastatic, Triple-Negative Breast Cancer, Head and Neck Cancer, Non-small-cell Lung Carcinoma, Malignant Mesothelioma) refractory to conventional treatment, or for which no conventional therapy is considered appropriate by the Investigator or is declined by the patient\n* Life expectancy of at least 12 weeks\n* World Health Organization (WHO) performance status of 0 or 1\n* Hematological and biochemical indices within the ranges (hemoglobin ≥9.0 g\u002FdL, absolute neutrophil count ≥1.5 x 109\u002FL, platelet count ≥100 x 109\u002FL, bilirubin ≤1.5 x upper limit of normal, alanine amino-transferase (ALT) and aspartate amino-transferase (AST) ≤ 2.5 x upper limit of normal. These measurements must be performed within one week (Day -7 to Day -1) before the patient receives their first infusion of CA9hi-1.\n* Calculated creatinine clearance or isotope clearance measurement ≥ 50 mL\u002Fmin\n* PT\u002FAPTT ≤1.5 upper limit of normal\n\nExclusion Criteria:\n\n* Ongoing toxic manifestations of previous treatments (Grade 2 or greater according to NCI-CTCAE v4.02) with the exception of alopecia or certain Grade 2 toxicities, which in the opinion of the investigator and CDD should not exclude the patient - these should be discussed on a case by case basis\n* Symptomatic brain metastases or spinal cord compression\n* Patients who have received prior radiotherapy to their lungs will not be eligible for this trial.\n* Female patients who are able to become pregnant (or already pregnant or lactating). However, those patients who have a negative serum or urine pregnancy test before enrolment and agree to use two highly effective forms of contraception (oral; injected or implanted hormonal contraception and condom; have an intra-uterine device and condom; diaphragm with spermicidal gel and condom) effective at the first administration of CA9hu-1, throughout the trial and for six months afterwards are considered eligible. Breast feeding should be discontinued if the mother is treated with CA9hu-1.\n* Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using one form of highly effective contraception \\[condom plus spermicide\\] effective at the first administration of hu-CA91, throughout the trial and for six months afterwards). Men with pregnant or lactating partners must be advised to use barrier method contraception (for example: condom plus spermicidal gel) to prevent exposure to the foetus or neonate.\n* Any major surgical procedure within 4 weeks prior to patients scheduled Cycle 1 Day 1, any major thoracic or abdominal surgery from which the patient has not yet recovered.\n* A serious or non-healing active wound, ulcer, or bone fracture.\n* At high medical risk because of non-malignant systemic disease including active uncontrolled infection.\n* Known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV) or who have an active, ongoing infection or an active, known or suspected autoimmune disease or on systemic steroids.\n* Concurrent congestive heart failure, prior history of class III\u002F IV cardiac disease (New York Heart Association \\[NYHA\\]), prior history of cardiac ischemia or prior history of cardiac arrhythmia.\n* Is a participant or plans to participate in another interventional clinical trial, whilst taking part in this Phase I study of CA9hu-1. Participation in an observational trial or interventional clinical trial which does not involve administration of an IMP and which would not place an unacceptable burden on the patient in the opinion of the Investigator and Medical Advisor would be acceptable.\n* Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.","80 Years",{"count":434,"type":21},50,[24],"Carbonic anhydrase IX (CA IX) has been implicated in the progression of most solid tumours and expression has been demonstrated in clinical samples from a variety of solid cancers. High expression is often associated with high grade or metastatic disease and poor prognosis. CA IX is not expressed in normal tissue, potentially providing a cancer-associated target that would not likely result in significant interruption of normal biologic function in organs not affected by cancer. A humanized monoclonal antibody CA9hu-1 has shown robust activity in a variety of tumour models including models of ovarian, prostate, breast, pancreatic, colon and lung where tumour growth and metastasis are inhibited when CA9hu-1 is used as a monotherapy. Enhancement of chemotherapy has also been demonstrated in several models in combination with CA9hu-1. CA IX is also expressed by tumour-associated cells (angiogenic endothelium, tumour-associated macrophages), which also drive cancer progression. Thus, targeting CA IX with CA9hu-1 in cancer patients is expected to affect multiple pathways and multiple tumour compartments that are important to tumour progression. Taken together, there is strong rationale for developing hu-CA91 for the treatment of advanced cancer. The present study was designed to establish safety and toxicity profile and maximum tolerated dose of CA9hu-1, evaluate pharmacokinetics, investigate the presence of anti-drug antibody, to document anti-tumour activity at a clinically relevant dose, and to document the use of \\[18F\\]FLT-PET as a biomarker for detection of early tumour response at a clinically relevant dose.",[438,439,139,440,441],"Clear Cell Renal Cell Carcinoma Metastatic","TNBC - Triple-Negative Breast Cancer","Non-small-cell Lung Carcinoma","Mesothelioma, Malignant","2023-03-14",{"date":444,"type":46},"2023-03-15",{"date":446,"type":21},"2024-01",{"date":448,"type":21},"2027-01",{"name":450,"class":85},"Mabpro, a.s.",{"id":452,"slug":453,"hasResults":11,"nctId":454,"briefTitle":455,"officialTitle":455,"acronym":456,"eligibilityCriteria":457,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":233,"phases":4,"briefSummary":460,"conditions":461,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":54},"100442164","the-gut-microbiome-and-immune-checkpoint-inhibitor-therapy-in-solid-tumors-100442164","NCT05037825","The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors","PARADIGM","Inclusion Criteria:\n\n1. Men or women ≥18 years of age\n2. Screened negative for COVID-19 symptoms at time of consent, as per institutional policy and as applicable for the duration of the COVID-19 pandemic\n3. Diagnosed with stages I-IV primary NSCLC, MM, TNBC or RCC\n4. Plan to be treated at a partner cancer site with a checkpoint inhibitor (anti-PD-1, anti-PD-L1, or anti-CTLA-4) as a single agent or in combination with another checkpoint inhibitor or other treatment agent or modality (e.g., targeted therapy, chemotherapy, surgery, radiation, etc.) in accordance with FDA-labeled use of the agent\n5. Able to provide informed consent and answer study questionnaires in either English or Spanish\n6. Able to provide stool specimens for research purposes\n\nExclusion Criteria:\n\n1. Mental incapacity\n2. Incarcerated individuals\n3. Pregnancy (by self-report of pregnancy status)\n4. Experiencing active brain metastasis\u002Fmetastases\n5. Treatment with checkpoint inhibitor in off-label capacity or through a clinical\u002Finterventional trial\n6. Active participation in an immuno-oncology clinical\u002Finterventional trial or pharma-sponsored observational study",{"count":459,"type":21},800,"The microbiome has the potential to serve as a robust biomarker of clinical response to immunotherapy. Additionally, microbial manipulation, through diet, exercise, prebiotics, probiotics, or microbially-derived metabolites, may prove to be beneficial in promoting anti-tumor immune responses. However, large prospective studies in humans with longitudinal sample collection and standardized methods are needed to understand how microbiota and their byproducts affect cancer therapies, particularly among patients undergoing identical therapy but experiencing different outcomes. The proposed observational study builds upon these hypotheses by proposing a large cohort design to further assess the associations between the gut microbiota (composition and function), host immune system, and ICI treatment efficacy across multiple cancer types.",[236,462,340,463],"Malignant Melanoma","Triple-Negative Breast Cancer","2022-04-25",{"date":466,"type":46},"2022-04-27",{"date":468,"type":46},"2021-11-22",{"date":470,"type":21},"2028-09-14",{"name":472,"class":85},"VastBiome"]