[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"smarca4-deficient-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:smarca4-deficient-tumor":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,84],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100559250","phase-1-a-study-of-ly4050784-in-participants-with-advanced-or-metastatic-solid-tumors-100559250",false,"NCT06561685","A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors","An Open-label, Multicenter Study of LY4050784, a Selective SMARCA2\u002FBRM Inhibitor, in Advanced Solid Tumor Malignancies With SMARCA4\u002FBRG1 Alterations","Inclusion Criteria:\n\n* Have one of the following locally advanced or metastatic solid tumor malignancy with SMARCA4 (BRG1) alteration:\n\n  * Phase 1a dose escalation: Presence of any alteration in SMARCA4 (BRG1)\n  * Phase 1b expansion: Part A: Non-small Cell Lung Cancer (NSCLC) that is locally advanced and not suitable for definitive locoregional therapy, or metastatic with presence of a known or likely loss of function alteration in SMARCA4 (BRG1) or loss of protein expression.\n  * Phase 1b expansion: Part B: Any tumor type (other than NSCLC) that has the presence of a known or likely loss of function alteration in SMARCA4 (BRG1) or loss of protein expression.\n  * Phase 1b expansion: Part C: Non-small Cell Lung Cancer (NSCLC) that is locally advanced and not suitable for definitive locoregional therapy, or metastatic with presence of a known or likely loss of function alteration in SMARCA4 (BRG1) or loss of protein expression.\n* Prior Systemic Therapy Criteria:\n\n  * Phase 1a dose escalation and Phase 1b (Part B): Participants who received all standard therapies for which the individual was deemed to be an appropriate candidate by the treating Investigator; or the individual is refusing the remaining most appropriate standard of care treatment; or there is no standard therapy available for the disease.\n  * Phase 1b expansion (Part A): Participants must have received at least one line of therapy for advanced or metastatic disease.\n  * Phase 1b expansion (Part C): Participants may be treatment naïve or have received therapy for advanced or metastatic disease\n* Measurability of disease\n\n  * Phase 1a dose escalation (excluding backfill): measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)\n  * Phase 1a backfill and Phase 1b expansion: Measurable disease required as defined by RECIST v1.1\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n\nExclusion Criteria:\n\n* Participants with known or likely loss of function alteration of SMARCA2 (BRM) or malignancy with known association with SMARCA2 (BRM) alterations\n* Prior exposure to SMARCA2 (BRM) inhibitor(s) and\u002For degrader(s) (prior exposure may be permitted for dose escalation)\n* Participants with known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement\n* Participants with history of increased risk of prolonged QT or significant arrythmia\n* Significant cardiovascular disease\n* Participants with active and\u002For treated for an additional primary malignancy within 2 years prior to enrolment\n* Participants who are pregnant, breastfeeding or plan to breastfeed or expecting to conceive or father children during study or within 6 months after the last dose of study intervention\n* Participants with history of active autoimmune diseases, history of allogenic stem cell\u002Forgan transplant or compromised immune system within past 2 years (Part C only)","ALL","18 Years",{"count":19,"type":20},340,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The main purpose of this study is to find out whether the study drug, LY4050784, is safe, tolerable and effective in participants alone or in combination with other anticancer agents. In addition, with locally advanced or metastatic solid tumors with a BRG1 (Brahma-related gene 1, also known as SMARCA4) alteration who have previously received, do not qualify for, or are refusing standard of care treatments, or there is no standard therapy available for the disease. The study is conducted in two parts - phase Ia (dose-escalation) and phase Ib (dose-optimization, dose-expansion). The study will last up to approximately 4 years.",[26,27,28,29],"Metastatic Solid Tumor","Advanced Solid Tumor","Non-small Cell Lung Cancer","SMARCA4-Deficient Tumor",[31,32,33,34,35,36,37,38],"SMARCA2","SMARCA4","Lung cancer","BRM","BRG1","Adenocarcinoma","Squamous cell carcinoma","Targeted therapy","RECRUITING","2026-04-17",{"date":42,"type":43},"2026-04-20","ACTUAL",{"date":45,"type":43},"2024-09-19",{"date":47,"type":20},"2027-10",{"name":49,"class":50},"Eli Lilly and Company","INDUSTRY",33,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100616579","phase-2-a-phase-ii-study-of-anlotinib-and-platinum-based-chemotherapy-in-patients-with-smarca4-deficient-locally-advanced-or-metastatic-lung-cancer-100616579","NCT07307443","A Phase II Study of Anlotinib and Platinum-Based Chemotherapy in Patients With SMARCA4-Deficient, Locally Advanced or Metastatic Lung Cancer.","A Phase II Clinical Trial of Anlotinib in Combination With Platinum-based Chemotherapy in Patients With SMARCA4-Deficient, Locally Advanced or Metastatic Lung Cancer.","Inclusion Criteria:\n\nPatients must meet ALL the following criteria to be eligible for trial participation:\n\n1. Voluntary participation and provision of written informed consent.\n2. Age ≥ 18 years.\n3. Life expectancy ≥ 3 months.\n4. Diagnosed with unresectable, locally advanced (Stage IIIB) or metastatic (Stage IV) lung cancer not amenable to curative radiotherapy.\n5. Tumor confirmed by immunohistochemistry (IHC) to be deficient in the BRG1 protein (encoded by the SMARCA4 gene).\n6. No prior systemic anti-cancer therapy.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n8. Willing and able to provide archival or fresh tumor tissue samples from primary or metastatic sites for biomarker analysis. Enrollment may be considered after investigator assessment if tissue is unavailable, provided all other criteria are met.\n9. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n10. Adequate organ and bone marrow function as defined by the following laboratory values (within screening period):\n\n10.1. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL. 10.2. Platelet count ≥ 100 × 10⁹\u002FL. 10.3. Hemoglobin ≥ 90 g\u002FL (without blood transfusion within 14 days). 10.4. Serum creatinine ≤ 1 × Upper Limit of Normal (ULN) OR estimated creatinine clearance \\> 50 mL\u002Fmin (Cockcroft-Gault formula).\n\n10.5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN if liver metastases are present).\n\n10.6. Total bilirubin ≤ 1.5 × ULN (For subjects with Gilbert's syndrome, total bilirubin must be \\\u003C 51.3 µmol\u002FL).\n\n10.7. Prothrombin time (PT), activated partial thromboplastin time (APTT), and International Normalized Ratio (INR) ≤ 1.5 × ULN (for subjects not receiving anticoagulant therapy).\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria will be excluded from the trial:\n\n1. Pathological diagnosis containing a small cell carcinoma component.\n2. Symptomatic brain metastases.\n3. Leptomeningeal carcinomatosis.\n4. Failure to recover from acute toxicities of prior anti-cancer therapy to ≤ Grade 1 per NCI CTCAE v5.0 or to baseline levels specified in the inclusion criteria (excluding alopecia or fatigue) within 4 weeks prior to the first dose.\n5. Conditions that compromise intravenous access or oral drug administration (e.g., inability to swallow, chronic diarrhea, intestinal obstruction); OR unwillingness or inability to undergo a repeat biopsy or provide sufficient tissue samples for comprehensive analysis (whole-exome sequencing, transcriptome sequencing, multiplex fluorescence immunohistochemistry).\n6. Failure to recover from adverse reactions of prior therapies to ≤ Grade 1 per CTCAE v5.0, except for toxicities deemed by the investigator to pose no safety risk (e.g., Grade 2 alopecia, Grade 2 peripheral neuropathy, Grade 2 anemia, non-clinically significant and asymptomatic laboratory abnormalities, or stable hypothyroidism on hormone replacement therapy).\n7. Major surgical procedure, significant traumatic injury within 4 weeks prior to the first dose, or anticipated need for major surgery during the study treatment period (unless specified in the protocol); OR presence of non-healing wounds or fractures. (Major surgery is defined as Grade 3 or higher according to the National Surgery Classification Catalog 2022 edition).\n8. Any arterial or venous thromboembolic event (e.g., cerebrovascular accident, transient ischemic attack, deep vein thrombosis, pulmonary embolism) within 6 months prior to the first dose; OR any bleeding or hemorrhagic event ≥ Grade 3 per CTCAE v5.0 within 4 weeks prior to the first dose.\n9. Poorly controlled active viral hepatitis. Eligible subjects meeting the following criteria may be screened:\n\n   9.1 HBsAg-positive subjects must have HBV DNA \\\u003C 2000 IU\u002FmL (or 1×10⁴ copies\u002FmL) OR have received at least 1 week of anti-HBV therapy prior to study initiation with at least a 10-fold (1-log) reduction in viral load, AND agree to receive continuous anti-HBV therapy throughout the study.\n\n   9.2 HCV-infected subjects (HCV Ab or HCV RNA positive) must be in a stable condition as judged by the investigator OR be receiving approved antiviral therapy at enrollment and willing to continue it during the study.\n10. History of psychotropic substance abuse with inability to abstain, or presence of psychiatric disorders.\n11. Prior or planned allogeneic bone marrow transplantation or solid organ transplantation.\n12. History of hepatic encephalopathy.\n13. Significant cardiovascular disease, including any of the following:\n\n    13.1 Cardiac insufficiency ≥ Class II per New York Heart Association (NYHA) criteria OR left ventricular ejection fraction (LVEF) \\\u003C 50% on echocardiography.\n\n    13.2 History of clinically significant ventricular arrhythmia (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) OR arrhythmia requiring ongoing antiarrhythmic medication.\n\n    13.3 Unstable angina. 13.4 Myocardial infarction within the past 12 months. 13.5 QTcF interval \\> 450 msec for males or \\> 470 msec for females (if abnormal, the average of three consecutive readings taken at least 2 minutes apart).\n\n    13.6 Personal or family history of congenital long QT syndrome. 13.7 History of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolism within 3 months prior to randomization (thrombosis related to implanted ports\u002Fcatheters or superficial thrombophlebitis are not considered \"severe\").\n\n    13.8 Current use or recent use (within 7 days prior to treatment initiation) of aspirin (\\>325 mg\u002Fday), dipyridamole, ticlopidine, clopidogrel, or cilostazol.\n14. Poorly controlled concurrent illnesses, such as:\n\n    14.1 Serious infection within 4 weeks prior to treatment initiation requiring hospitalization; OR therapeutic oral\u002Fintravenous antibiotics within 2 weeks prior to treatment initiation (prophylactic antibiotic use is permitted, e.g., for urinary tract infection or COPD).\n\n    14.2 Symptomatic congestive heart failure (NYHA Class II-IV) OR symptomatic\u002Fpoorly controlled arrhythmia.\n\n    14.3 Other active malignancy diagnosed within the past 5 years, except for curatively treated non-melanoma skin cancer, basal\u002Fsquamous cell carcinoma, or carcinoma in situ (e.g., breast, cervix, bladder) with no evidence of recurrence.\n\n    14.4 Suspected or confirmed acute promyelocytic leukemia (for patients with acute myeloid leukemia).\n\n    14.5 Current carcinomatous meningitis or spinal cord compression. 14.6 Poorly controlled hypertension. 14.7 Symptomatic intrinsic lung disease. 14.8 Any arterial thromboembolic event within 6 months prior to enrollment, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack.\n\n    14.9 Significant malnutrition requiring intravenous nutritional support, unless corrected and stable for ≥ 4 weeks prior to the first dose.\n\n    14.10 Tumor invasion of adjacent vital organs or major blood vessels (e.g., mediastinal great vessels, superior vena cava, trachea, esophagus), or risk of esophageal-tracheal or esophageal-pleural fistula.\n\n    14.11 History of esophageal or tracheal stent implantation. 14.12 Any other acute\u002Fchronic illness or laboratory abnormality that, in the investigator's judgment, increases risk associated with study participation or drug administration, OR interferes with the interpretation of study results.\n\n    14.13 History of gastrointestinal perforation and\u002For fistula within 6 months prior to enrollment.\n\n    14.14 Uncontrolled third-space effusions requiring repeated drainage (e.g., pleural, peritoneal, pericardial effusion). Subjects not requiring drainage or stable for 3 days after stopping drainage may be eligible.\n15. Active gastrointestinal diseases or other conditions that may significantly affect drug absorption, metabolism, or excretion, including but not limited to: malabsorption syndrome, inflammatory bowel disease, partial or complete intestinal obstruction, gastrectomy, or small bowel resection.\n16. Severe underlying pulmonary disease or history thereof, such as moderate to severe chronic obstructive pulmonary disease (COPD), history of interstitial lung disease (ILD), drug-induced ILD, acute or chronic infectious pneumonia, or lung transplantation.\n17. Pregnant or lactating women.\n18. Concurrent participation in another interventional clinical trial, or an observational (non-interventional) clinical study, or being in the follow-up phase of an interventional study.\n19. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n20. Major surgical procedure (as defined by the investigator, e.g., craniotomy, thoracotomy, laparotomy, vascular intervention) within 4 weeks prior to the first study drug dose, OR presence of unhealed wounds, ulcers, or fractures. Note: Palliative local surgery for isolated lesions is acceptable.\n21. HIV infection (HIV 1\u002F2 antibody positive).\n22. Known active syphilis infection or active tuberculosis.\n23. Documented history of psychiatric disorder requiring medication.\n24. History of drug abuse or substance addiction.\n25. Any other condition that, in the judgment of the investigator, may affect study results, interfere with the subject's participation in the entire study process, or render the subject unsuitable for participation, including but not limited to existing or past medical conditions, treatments, laboratory abnormalities, or unwillingness to comply with study procedures and requirements.\n26. Use of any other investigational drug or therapy within 4 weeks prior to the first study dose.\n27. Use of any Chinese herbal medicine with anti-tumor activity within 2 weeks prior to initiation of study treatment.\n28. History of other malignancies (excluding non-melanoma skin cancer and carcinoma in situ of the bladder, stomach, colon, endometrium, cervix\u002Fdysplasia, melanoma, or breast), unless the subject has been in complete remission for at least 2 years prior to enrollment and requires no other treatment during the study.\n29. Planned administration or administration of a live vaccine within 28 days prior to the first study dose.\n30. Known hypersensitivity or intolerance to the study drug(s) or any of their excipients.\n31. Any other condition that, in the investigator's opinion, makes the subject unsuitable for participation in this clinical trial.",{"count":60,"type":20},28,[62],"PHASE2","The goal of this clinical trial is to evaluate the efficacy and safety of combining Anlotinib with platinum-based chemotherapy for treating locally advanced or advanced lung cancer in patients whose tumors are characterized by SMARCA4 deficiency, as evidenced by the loss of BRG1 protein via immunohistochemistry (IHC). It will also learn about the safety of this combination treatment.\n\nThe main questions it aims to answer are:\n\n1. How long can this treatment delay the worsening of the cancer (Progression-Free Survival, PFS)?\n2. What side effects or medical problems do participants have when taking this combination? This is a single-arm study, meaning all participants will receive the same investigational combination therapy. Researchers will monitor how well the cancer responds and compare the results to historical data from similar patients who received other treatments.\n\nParticipants will:\n\n1. Receive treatment in 21-day cycles: take Anlotinib pills on days 1-14 of each cycle and receive platinum-based chemotherapy by intravenous infusion on day 1 (or days 1 and 8).\n2. Undergo regular clinic visits for imaging scans (like CT scans), blood tests, and physical examinations to check the cancer's status and their overall health.\n3. Complete questionnaires about their quality of life.\n4. Provide tumor tissue and blood samples for exploratory research to understand which patients might benefit most from this treatment.\n\nTreatment will continue until the cancer worsens, side effects become intolerable, the participant decides to withdraw, or the study ends.",[29,65],"Locally Advanced or Metastatic Lung Cancer",[67,68,69,70,71],"SMARCA4-Deficient Locally advanced or Metastatic Lung Cancer","first line therapy","combination therapy","Anlotinib","Platinum-based chemotherapy","NOT_YET_RECRUITING","2025-12-14",{"date":75,"type":43},"2025-12-29",{"date":77,"type":20},"2026-02-01",{"date":79,"type":20},"2028-01-01",{"name":81,"class":82},"Zhijie Wang","OTHER",1,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":83},"100608391","phase-2-a-phase-ii-study-of-ql1706-and-platinum-based-chemotherapy-in-patients-with-smarca4-deficient-locally-advanced-or-metastatic-non-small-cell-lung-cancer-100608391","NCT07200947","A Phase II Study of QL1706 and Platinum-Based Chemotherapy in Patients With SMARCA4-Deficient, Locally Advanced or Metastatic Non-Small Cell Lung Cancer.","A Phase II Clinical Trial of Iparomlimab and Tuvonralimab in Combination With Platinum-based Chemotherapy in Patients With SMARCA4-Deficient, Locally Advanced or Metastatic Non-Small Cell Lung Cancer.","QL1706","Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be eligible for the study:\n\n1. Voluntary participation and provision of signed written informed consent.\n2. Age ≥ 18 years.\n3. Life expectancy ≥ 3 months.\n4. Histologically or cytologically confirmed diagnosis of Stage IIIB-IV lung cancer that is not amenable to curative surgery or radiotherapy.\n5. Tumor demonstrates loss of BRG1 protein (encoded by the SMARCA4 gene) as confirmed by immunohistochemistry (IHC).\n6. No prior systemic anti-cancer therapy for advanced disease.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n8. Willingness to provide archived or fresh tumor tissue samples from primary or metastatic lesions. If unavailable, enrollment may be permitted following investigator assessment.\n9. At least one measurable lesion as defined by RECIST v1.1.\n10. Adequate organ function within the screening period, as evidenced by:\n\n10.1 Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL 10.2 Platelet count ≥ 100 × 10\\^9\u002FL 10.3 Hemoglobin ≥ 90 g\u002FL (without transfusion within 14 days) 10.4 Serum creatinine ≤ 1 × ULN OR Creatinine clearance \\> 50 mL\u002Fmin (calculated by Cockcroft-Gault formula) 10.5 AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases) 10.6 Total bilirubin ≤ 1.5 × ULN (except for participants with Gilbert's syndrome) 10.7 TSH, FT3, and FT4 within normal limits (±10%)\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded from the study:\n\n1. Pathological diagnosis containing a small cell component.\n2. Symptomatic brain metastases.\n3. Leptomeningeal metastases.\n4. Recurrence within 6 months after completing prior adjuvant therapy (if applicable).\n5. Active, known, or suspected autoimmune disease (with specific exceptions, e.g., vitiligo, type I diabetes, hypothyroidism managed with hormone replacement only).\n6. Active tuberculosis (TB) infection or history of active TB within the past year.\n7. Comorbidities requiring immunosuppressive medications, including systemic corticosteroids at immunosuppressive doses.\n8. Pregnancy or lactation in female participants.\n9. Symptomatic interstitial lung disease that could interfere with the detection or management of suspected drug-related pulmonary toxicity.\n10. Known HIV infection, active Hepatitis B (HBsAg positive with HBV-DNA \\> 10\\^3 copies\u002FmL), or active Hepatitis C (HCV antibody positive with detectable HCV-RNA).\n11. Significant history of neurological or psychiatric disorders.\n12. Treatment with any investigational drug within 4 weeks prior to the first dose of study treatment.\n13. Use of Chinese herbal medicines with anti-tumor activity within 2 weeks prior to study treatment initiation.\n14. History of another active malignancy within the past 2 years (with specific exceptions for certain early-stage cancers).\n15. Significant cardiovascular or cerebrovascular disease history.\n16. Uncontrolled thrombotic events within 6 months prior to screening.\n17. Administration of a live vaccine within 28 days prior to the first study dose.\n18. Major surgery or significant trauma within 4 weeks prior to the first study dose.\n19. Conditions that may impair oral drug absorption.\n20. Uncontrolled active infection requiring systemic therapy.\n21. Known hypersensitivity to any of the study drug components.\n22. Any other condition that, in the investigator's judgment, would make the participant unsuitable for participation in the study.",{"count":60,"type":20},[62],"This single-arm, open-label, Phase II study assesses first-line QL1706 (iparomlimab and tuvonralimab, an anti-PD-1\u002FCTLA-4 bispecific antibody) combined with platinum-based chemotherapy to treat patients with treatment-naïve, locally advanced or metastatic, SMARCA4-deficient non-small cell lung cancer (NSCLC).\n\nThe main questions it aims to answer are:Evaluate the efficacy and safety of this combination regimen in this specific patient population. Explore correlations between tumor molecular characteristics, the immune microenvironment, and treatment efficacy or toxicity.\n\nParticipants must:\n\nHave histologically or cytologically confirmed, treatment-naïve, locally advanced or metastatic non-small cell lung cancer (NSCLC) with SMARCA4 deficiency. Be willing to provide archived or fresh tumor tissue samples. If unavailable, enrollment may proceed per investigator assessment. Have at least one measurable lesion per RECIST v1.1.",[29,96],"Locally Advanced or Metastatic Non-Small Cell Lung Cancer",[90,69,68,98],"SMARCA4-Deficient Locally advanced or Metastatic Non-Small Cell Lung Cancer","2025-09-23",{"date":101,"type":43},"2025-10-01",{"date":103,"type":20},"2025-12-01",{"date":105,"type":20},"2028-02-01",{"name":81,"class":82}]