[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-or-metastatic-non-small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-or-metastatic-non-small-cell-lung-cancer":187},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,45,86,111,133,162],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100409050","phase-2-study-of-pf-07248144-in-advanced-or-metastatic-solid-tumors-100409050",false,"NCT04606446","Study of PF-07248144 in Advanced or Metastatic Solid Tumors","A PHASE 1\u002F2A DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC, AND ANTI-TUMOR ACTIVITY OF PF-07248144 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS","KAT6","Inclusion Criteria:\n\n* Disease Characteristics - Breast, Prostate, and Lung Cancer\n* Part 1A (Monotherapy Dose Escalation) Histological or cytological diagnosis of locally advanced or metastatic ER+HER2- breast cancer, CRPC, or NSCLC that is intolerant or resistant to standard therapy or for which no standard therapy is available.\n* Part 1B, Part 1C, Part 1D and Part 1E (Combination Dose Escalation) Histological or cytological diagnosis of locally advanced or metastatic ER+HER2- breast cancer. Participants must have progressed after at least 1 prior line of treatment with an endocrine therapy and CDK4\u002F6 inhibitor in the advanced or metastatic setting.\n* Part 2A (ER+HER2- breast cancer 2L+, monotherapy) Histological or cytological diagnosis of locally advanced or metastatic ER+HER2- breast cancer. Participants must have progressed after at least 1 prior line of CDK4\u002F6 inhibitor and 1 line of endocrine therapy.\n* Part 2B (ER+HER2- breast cancer 2-4L, combination with fulvestrant) Histological or cytological diagnosis of advanced or metastatic ER+HER2- breast cancer. Participants must have progressive disease after at least 1 prior line of a CDK4\u002F6 inhibitor and at least 1 prior line of endocrine therapy.. Participants must not have received more than 3 prior lines of systemic therapies including up to 1 line of cytotoxic chemotherapy for visceral disease in advanced or metastatic setting; Participants may have but are not required to have prior treatment with fulvestrant.\n* Part 2D (ER+HER2- breast cancer 2-4L, combination with PF-07220060 (CDK4i) and fulvestrant):\n\nHistological or cytological diagnosis of advanced or metastatic ER+HER2- breast cancer. Participants must have progressive disease after at least 1 prior line of a CDK4\u002F6 inhibitor and at least 1 prior line of endocrine therapy.\n\n* Participants must have not received more than 3 lines of systemic therapies including up to 1 line of cytotoxic chemotherapy for visceral disease in advanced or metastatic setting; Participants may have but are not required to have prior treatment with fulvestrant.\n* Part 2E (ER+HER2- breast cancer 2-4L, combination with vepdegestrant): Histological or cytological diagnosis of advanced or metastatic ER+HER2- breast cancer. Participants must have progressive disease after at least 1 prior line of a CDK4\u002F6 inhibitor and at least 1 prior line of endocrine therapy; Participants must have not received more than 3 lines of systemic therapies including up to 1 line of cytotoxic chemotherapy for visceral disease in advanced or metastatic setting; Participants may have received fulvestrant\n* Participants with ER+HER2- advanced or metastatic breast cancer must have documentation of ER-positive tumor (≥1% positive stained cells) based on most recent tumor biopsy utilizing an assay consistent with local standards.\n* Participants with ER+HER2- advanced or metastatic breast cancer must have documentation of HER2-negative tumor: HER2-negative tumor is determined as immunohistochemistry score 0\u002F1+ or negative by in situ hybridization (FISH\u002FCISH\u002FSISH\u002FDISH) defined as a HER2\u002FCEP17 ratio \\\u003C2 or for single probe assessment a HER2 copy number \\\u003C4.\n* Female participants with ER+HER2- advanced or metastatic breast cancer considered to be of childbearing potential (or have tubal ligations only) must be willing to undergo medically induced menopause by treatment with the approved LHRH agonist such as goserelin, leuprolide or equivalent agents to induce chemical menopause.\n* Female participants with ER+HER2- advanced or metastatic breast cancer of nonchildbearing potential must meet at least 1 criteria of achieving postmenopausal status.\n* Participants must have at least 1 measurable lesion as defined by RECIST version 1.1 that has not been previously irradiated.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status PS 0 or 1\n* Female or male patients aged ≥ 18 years (Japan ≥ 20 years) (South Korea ≥ 19 years).\n* Adequate renal, liver, and bone marrow function.\n* Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1 except for adverse events (AEs) not constituting a safety risk by investigator judgment.\n\nExclusion Criteria:\n\n* Unmanageable ascites (limited medical treatment to control ascites is permitted, but all participants with ascites require review by sponsor's medical monitor).\n* Participants with any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.\n* Major surgery, radiation therapy, or systemic anti-cancer therapy within 3 weeks prior to study entry.\n* Prior irradiation to \\>25% of the bone marrow.\n* ECG clinically relevant abnormalities (eg, QTc \\>470 msec, complete LBBB, second\u002Fthird degree AV block, ST elevation or EKG changes suggesting myocardial infarction or active myocardia ischemia).\n* Therapeutic anticoagulation. However, low molecular weight heparin is allowed. Vitamin K antagonists or factor Xa inhibitors may be allowed following discussion with the Sponsor.\n* Known or suspected hypersensitivity or severe allergy to active ingredient\u002Fexcipients of PF-07248144.\n* Active inflammatory GI disease, refractory and unresolved chronic diarrhea or previous gastric resection, lap band surgery or other GI conditions and surgeries that may significantly alter the absorption of PF-07248144 tablets. Gastroesophageal reflux disease under treatment is allowed.\n* Pregnant or breastfeeding female participants.","ALL","18 Years",{"count":20,"type":21},320,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is an open-label, multi center study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-07248144 and early signs of clinical efficacy of PF-07248144 as a single agent and in combination with other agents",[27,28,29],"Locally Advanced or Metastatic ER+ HER2- Breast Cancer","Locally Advanced or Metastatic Castration-resistant Prostate Cancer","Locally Advanced or Metastatic Non-small Cell Lung Cancer",[31],"Solid tumors","RECRUITING","2026-04-15",{"date":35,"type":36},"2026-04-16","ACTUAL",{"date":38,"type":36},"2020-11-16",{"date":40,"type":21},"2029-08-10",{"name":42,"class":43},"Pfizer","INDUSTRY",44,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100415182","phase-1-phase-ib-study-of-the-safety-of-t-dxd-and-immunotherapy-agents-with-and-without-chemotherapy-in-advanced-or-metastatic-her2-non-squamous-nsclc-100415182","NCT04686305","Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLC","A Phase Ib Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Immunotherapy Agents With and Without Chemotherapy Agents in First-line Treatment of Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 (HER2) Overexpression (OE) (DESTINY-Lung03)","DL03","Inclusion criteria:\n\n* Histologically documented unresectable locally advanced\u002Fmetastatic non-squamous NSCLC\n* Part 1: Progression after 1 or 2 lines of systemic therapy for recurrent or metastatic setting.\n* Part 3, Part 4 and Part 5: Patients must have tumors that do not harbor known genomic alterations or actionable driver kinases, for which approved therapies are available are allowed.\n* Part 3, Part 4 and Part 5: Patient must be treatment-naïve for advanced or metastatic NSCLC. Patients who have received prior adjuvant, or neoadjuvant chemotherapy, or definitive chemoradiation for advanced disease are eligible, provided that progression has occurred \\> 6 months from end of last therapy\n* HER2overexpression status as determined by central review of tumor tissue\n* WHO \u002F ECOG performance status of 0 or 1\n* Measurable target disease assessed by the investigator using RECIST 1.1\n* Has protocol defined adequate organ and bone marrow function\n* Part 3, Part 4 and Part 5: Minimum body weight of 35 kg.\n\nExclusion criteria:\n\n* HER2 mutation if previously known\n* Has a history of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening\n* Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder and prior pneumonectomy\n* Active primary immunodeficiency known HIV infection, or active chronic and resolved hepatitis B (positive hepatitis B virus surface antigen \\[HBsAg+ve\\] or hepatitis B virus core antibody (anti-HBc +ve) regardless of HBV DNA level)) or hepatitis C infection. Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Patients should be tested for HIV prior to treatment assignment if required by local regulations or IRB\u002FEC\n* Active infection including tuberculosis and uncontrolled infection requiring IV antibiotics, antivirals, or antifungals\n* Spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms\n* Medical history of myocardial infarction within 6 months before treatment assignment, symptomatic CHF (New York Heart Association Class II to IV), clinically important cardiac arrhythmias, or a recent (\\\u003C 6 months) cardiovascular event including stroke\n* For Part 3, Part 4 and Part 5: Cardiomyopathy of any etiology, symptomatic CHF (as defined by New York Heart Association Class \\> II), unstable angina pectoris, history of MI within the past 12 months, or cardiac arrhythmia are to be excluded. Patients with troponin levels above ULN at screening (as defined by the manufacturer), and without any myocardial related symptoms, should have a cardiologic consultation before treatment assignment to rule out acute cardiopulmonary events.\n* Ascites or pericardial effusion that requires drainage, peritoneal shunt, Pleuroperitoneal shunt or CART (Concentrated Ascites Reinfusion Therapy)\n* For Part 3, Part 4 and Part 5: Active non-infectious skin disease (including any grade rash, urticarial, dermatitis, ulceration, or psoriasis) requiring systemic treatment, active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.\n* Unresolved toxicities not yet resolved to Grade ≤ 1 or baseline from previous anticancer therapy OR prior discontinuation of any planned study therapy due to toxicity.\n* must not have any medical contraindication to platinum-based chemotherapy.\n* Part 3, Part 4 and Part 5 patients must not have had prior exposure to anti-PD-1, anti-PD-L1, anti-CTLA-4, anti-TIGIT or any other experimental immunotherapy in any setting.\n* For Part 3, Part 4 and Part 5: History of substance abuse or any other medical or psychological conditions that may, in the opinion of the Investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results\n* For Part 3, Part 4 and Part 5: History of thromboembolic events within 3 months before the first dose of IP (limited to pulmonary embolism, deep vein thrombosis, or cerebral venous sinus thrombosis).",{"count":54,"type":21},304,[56],"PHASE1","DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.",[59],"Locally Advanced or Metastatic Non-Small Cell Lung Cancer",[61,62,63,64,65,66,67,68,69,70,71,72,73,74,75],"HER2+","HER2 expression","DS-8201a","T-DXd","Trastuzumab Deruxtecan","Volrustomig (MEDI5752)","Antibody - drug conjugate","bispecific antibody","Volrustomig","Rilvegostomig","Carboplatin","First line","Locally advanced and unresectable non-squamous NSCLC","Metastatic non-squamous NSCLC","Non-small cell lung cancer","2026-04-08",{"date":78,"type":36},"2026-04-13",{"date":80,"type":36},"2021-03-09",{"date":82,"type":21},"2027-06-30",{"name":84,"class":43},"AstraZeneca",91,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":96,"conditions":97,"keywords":98,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100589559","phase-1-a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-efficacy-of-ast2303-tablets-abk3376-tablets-in-patients-with-advanced-or-metastatic-non-small-cell-lung-cancer-100589559","NCT06955988","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AST2303 Tablets (ABK3376 Tablets) in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AST2303 Tablets (ABK3376 Tablets) in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Have fully understood this test and voluntarily sign the informed consent\n2. Age ≥ 18 at the time of signing the informed consent, regardless of gender\n3. Patients with non-small cell lung cancer confirmed by tissue \u002F cytology.\n4. According to recist1.1 criteria, the presence of at least one target lesion without local treatment was assessed by the investigator\n5. Agree to provide blood samples and \u002F or tumor tissue samples (fresh tissue or paraffin embedded tissue) for genetic testing\n6. The subject's bone marrow and organ functions are good (no blood transfusion or hematopoietic growth factor treatment within 2 weeks before the first administration)\n7. The ECoG physical status score is 0 or 1\n8. Expected survival time ≥ 12 weeks\n9. Have normal swallowing function\n10. Female subjects with fertility must have a serum pregnancy test within 7 days before the first administration, and the result is negative, and must be non lactating. For female subjects with fertility and male subjects with reproductive potential, effective contraceptive measures were taken from the signing of informed consent to 6 months after the last Administration\n\nExclusion Criteria:\n\n1. Previously received antitumor therapy targeting the c797s mutation\n2. Carry any other known driver gene alterations\n3. Have received any systemic anti-tumor treatment (including anti-tumor drugs in clinical research stage) within 2 weeks before the first administration or within 5 half lives of the drug (whichever is longer); Or receiving anti-tumor drugs with long half-life, such as immune checkpoint inhibitors, within 4 weeks before the first administration; Or received cytotoxic drugs with significant delayed toxicity, such as mitomycin C, within 6 weeks before the first administration;\n4. Have received non-specific immunomodulatory agents, traditional Chinese medicine or traditional Chinese medicine preparations with approved anti-tumor indications within 2 weeks before the first administration\n5. Strong inhibitors of CYP3A, P-gp or BCRP were used within 7 days before the first administration, or strong inducers of CYP3A, P-gp or BCRP were used within 3 weeks\n6. Local (non bone lesions) radiotherapy within 4 weeks before the first dose, or bone radiotherapy within 2 weeks before the first dose;\n7. Other malignant tumors besides the primary tumor\n8. Subjects known to have meningeal metastasis, brainstem metastasis, spinal cord metastasis and \u002F or compression, active brain metastasis. For brain metastasis subjects who have received local treatment in the past, if they are clinically stable for at least 4 weeks before the first administration of study treatment and do not need to use glucocorticoids or anticonvulsants for at least 14 days before the first administration of study treatment, they can participate in the study\n9. The tumor invades the surrounding important organs and blood vessels or has the risk of esophago tracheal fistula or esophago pleural fistula\n10. The toxicity of previous anti-tumor treatment has not returned to grade ≤ 1 (NCI CTCAE version 5.0 evaluation), except for grade ≤ 2 alopecia and peripheral neuropathy\n11. Presence of cardiovascular and cerebrovascular disease or cardiovascular and cerebrovascular risk factors\n12. Uncontrollable systemic diseases\n13. There is a history of (non infectious) interstitial lung disease (ILD) or non infectious pneumonia requiring steroid treatment; Currently have ILD or non infectious pneumonia; Suspected ILD or noninfectious pneumonia that could not be excluded by imaging examination was present at screening\n14. Pulmonary complications lead to clinically serious lung damage, including but not limited to the following: A. any underlying lung disease; b. Any autoimmune, connective tissue or inflammatory disease that may involve the lungs; c. Previous unilateral pneumonectomy\n15. Severe acute or chronic infection\n16. Being under long-term systemic corticosteroid treatment with prednisone \\> 10 mg\u002F day or equivalent anti-inflammatory active drugs or any form of immunosuppressive treatment before the first administration. Subjects who need to use bronchodilators, inhaled or topical steroids or local steroid injections for treatment or as preventive medication for hypersensitivity reactions (such as medication before CT examination, etc.) can be included in the study\n17. Subjects who had undergone major surgery within 4 weeks before the first dose or were expected to undergo major surgery during the study period\n18. Bleeding symptoms with significant clinical significance or obvious bleeding tendency within 4 weeks before the first administration, such as gastrointestinal bleeding, gastric ulcer bleeding, active hemoptysis, etc\n19. It is known that there are serious gastrointestinal dysfunction: such as untreated recurrent diarrhea, moderate to severe atrophic gastritis, gastrointestinal obstruction, Crohn's disease, ulcerative colitis, gastrointestinal perforation, etc\n20. Known to have a history of hypersensitivity to the ingredients of the preparation used in the test\n21. Pregnant or lactating women or women planning to become pregnant during the study\n22. In the judgment of the investigator, the subject has other factors that may affect the results of the study or cause the forced termination of the study, such as alcohol abuse, drug abuse, suffering from other serious diseases (including mental diseases) requiring combined treatment, serious abnormal laboratory test values, family or social factors and other conditions that may affect the safety of the subject or the collection of test data, etc",{"count":94,"type":21},120,[56],"This study is a multicenter, single arm, open label, phase I clinical trial, including dose escalation (phase IA) and dose expansion (phase IB). This study aimed to evaluate the safety, tolerability, PK characteristics and preliminary antitumor activity of ast2303 tablets (abk3376 tablets) in subjects with locally advanced or metastatic non-small cell lung cancer. A safety review committee (SRC) was established in this study, which will review the safety, efficacy, pharmacokinetics and other data obtained from the study, and make decisions on key issues such as dose escalation and dose expansion.",[29],[99,100],"EGFR L858R-C797S","Del19-C797S","2026-02-10",{"date":103,"type":36},"2026-02-12",{"date":105,"type":36},"2025-03-04",{"date":107,"type":21},"2027-06",{"name":109,"class":43},"Allist Pharmaceuticals, Inc.",1,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":110},"100606412","phase-2-phase-ii-clinical-study-of-shr2554-tablets-combined-with-other-anti-tumor-treatments-in-non-small-cell-lung-cancer-subjects-100606412","NCT07175220","Phase II Clinical Study of SHR2554 Tablets Combined With Other Anti-tumor Treatments in Non-small Cell Lung Cancer Subjects","A Multicenter, Open Label Phase II Clinical Study on the Safety, Tolerability, and Efficacy of SHR2554 Tablets in Combination With Other Anti-tumor Treatments in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. Age range of 18-75 years old (including both ends), gender not limited;\n2. Patients with locally advanced unresectable or metastatic non-small cell lung cancer diagnosed by pathology\n3. ECOG score is 0 or 1\n4. Expected survival period ≥ 12 weeks\n5. Has a good level of organ function\n6. Patients voluntarily joined the study and signed informed consent\n\nExclusion Criteria:\n\n1. Having difficulty swallowing or malabsorption syndrome or any other uncontrolled gastrointestinal disease (such as nausea, diarrhea, or vomiting), having undergone gastrectomy or gastric banding surgery, etc\n2. Symptomatic or active central nervous system tumor metastasis\n3. Previously or simultaneously suffering from other malignant tumors\n4. Spinal cord compression that cannot be cured by surgery and\u002For radiotherapy\n5. Accompanied by uncontrolled tumor related pain\n6. Plan to receive any other anti-tumor treatment during this trial period\n7. Receive other anti-tumor treatments within 4 weeks before the first medication\n8. Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration\n9. Currently participating in other clinical studies or taking medication for the first time less than 4 weeks after the end of the previous clinical study\n10. Moderate to severe pleural effusion with clinical symptoms\n11. Individuals with active pulmonary tuberculosis infection within one year prior to the first use of medication\n12. Subjects who have experienced severe infections within 30 days prior to their first medication use\n13. Administer attenuated live vaccine within 30 days before the first use of medication.\n14. History of immunodeficiency\n15. Suffering from poorly controlled or severe cardiovascular and cerebrovascular diseases\n16. History of interstitial pneumonia\u002Fnon infectious pneumonia requiring hormone therapy in the past\n17. AE caused by previous anti-tumor treatment has not recovered to CTCAE v5.0 level evaluation ≤ 1\n18. Untreated active hepatitis\n19. Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study period.\n20. There are other serious physical or mental illnesses or laboratory abnormalities present","75 Years",{"count":120,"type":21},200,[24],"Evaluate the safety, tolerability, and objective response rate (ORR) of SHR2554 tablets in combination with other anti-tumor treatments in subjects with locally advanced or metastatic non-small cell lung cancer",[29],"2025-11-16",{"date":126,"type":36},"2025-11-18",{"date":128,"type":36},"2025-10-09",{"date":130,"type":21},"2028-10",{"name":132,"class":43},"Jiangsu HengRui Medicine Co., Ltd.",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":151,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":110},"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":142,"type":21},28,[24],"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.",[146,59],"SMARCA4-Deficient Tumor",[139,148,149,150],"combination therapy","first line therapy","SMARCA4-Deficient Locally advanced or Metastatic Non-Small Cell Lung Cancer","NOT_YET_RECRUITING","2025-09-23",{"date":154,"type":36},"2025-10-01",{"date":156,"type":21},"2025-12-01",{"date":158,"type":21},"2028-02-01",{"name":160,"class":161},"Zhijie Wang","OTHER",{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":22,"phases":171,"briefSummary":172,"conditions":173,"keywords":175,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":185,"locationsCount":110},"100438963","phase-1-a-study-of-xzp-5955-tablets-in-patients-with-ntrk-or-ros1-fusion-positive-locally-advanced-or-metastatic-solid-tumors-100438963","NCT04996121","A Study of XZP-5955 Tablets in Patients With NTRK or ROS1 Fusion Positive Locally Advanced or Metastatic Solid Tumors","The Safety Tolerability Pharmacokinetic Characteristics and Efficacy of XZP-5955 Tablets in Patients With NTRK or ROS1 Gene Fusion Locally Advanced or Metastatic Solid Tumors in a Single-arm Open-label Multi-center Phase I\u002FII Clinical Study","Inclusion Criteria:\n\n1. Male or female subjects aged ≥18 years old;\n2. Phase I dose escalation period: Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor, assessed by investigator that no standard therapy exists, or the tumor has relapsed, progressed or was nonresponsive to available therapies, or intolerance, or not suitable to standard therapy at current stage. Priority will be given to patients who have previously documented NTRK or ROS1 gene fusion confirmed by the central laboratory; Phase I dose expansion and Phase II: Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor, patients can provide a written report of pathological diagnosis of NTRK or ROS1 positive tested by qualified laboratory;\n3. Phase I dose expansion cohort 1 and Phase II cohort 1: locally advanced, or metastatic solid tumor with NTRK gene fusion Phase I dose expansion cohort 2 and Phase II cohort 2： locally advanced, or metastatic NSCLC with ROS1 gene fusion that has progressed to crizotinib and other therapies or was intolerance to crizotinib Phase I dose expansion cohort 3: locally advanced, or metastatic NSCLC with ROS1 gene fusion who have not previously received crizotinib or other therapy.\n4. phase I dose escalation: at least 1 measurable target lesion according to RECIST version 1.1 Phase I dose expansion and Phase II: at least 1 measurable target lesion according to RECIST version 1.1 (Tumor lesions treated with prior radiation or other local treatment are considered measurable if they show definite progression)\n5. ECOG PS 0-1\n6. Life expectancy ≥ 3 months.\n7. Adequate organ function:\n\n   Baseline laboratory values fulfilling the following requirements: Absolute neutrophils count (ANC) ≥1.5 × 109\u002FL; Platelets (PLTs) ≥75 × 109\u002FL; Hemoglobin ≥ 85g\u002FL; Serum creatinine≤ 1.5 × ULN， or creatinine clearance ≥50 mL\u002Fmin\u002F1.73m2(only when serum creatinine\\>1.5 × ULN); Total serum bilirubin ≤1.5 × ULN; Liver transaminases (AST\u002FALT) ≤ 2.5 × ULN，≤3× ULN if liver metastases are present or liver cancer patients; Activated Partial Thromboplastin Time≤1.5× ULN；International Normalized Ratio (INR)≤1.5× ULN；\n8. Eligible patients (male and female) who are fertile must agree to at least use a reliable contraceptive method with partner during the trial and within 90 days from the last dose; Women of childbearing age must have a negative serum pregnancy test within 7 days before the first dose of the trial.\n\nExclusion Criteria:\n\n1. Received anti-tumor therapy such as chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy or other therapy within 4 weeks prior to the first dose of the investigational drug except the following:\n\n   Nitroso ureas or mitomycin C within 6 weeks before the first dose of the drug; Oral fluorouracil and small molecule targeted drugs within 2 weeks prior to the first dose of drug or within 5 half life (whichever is longer);\n2. Received other unmarketed investigational drugs or treatments within 4 weeks prior to the first dose of the investigational drug;\n3. Major organ surgery (except biopsy) or significant trauma within 4 weeks prior to first dose of the investigational drug or required elective surgery during the trial;\n4. Adverse reactions to previous antitumor therapy have not recovered to NCI CTCAE 5.0 ≤ grade 1 (except for alopecia, grade 2 peripheral neurotoxicity, stable hypothyroidism after hormone replacement therapy, etc.);\n5. Inability to swallow drug, or a condition that the investigator judged to severely affect gastrointestinal absorption (eg:Chronic Diarrhea, intestinal obstruction, etc.);\n6. Cerebral or meningeal metastases with clinical symptoms. The below patients were allowed to be included: those who were asymptomatic, stable, and did not require steroid treatment for more than 4 weeks prior to the start of study treatment (if the cerebral metastases had undergone radiotherapy or\u002Fand surgery, radiotherapy and surgery should be at least 1 month prior to the first dose) ;\n7. Known active infections and currently need intravenous anti-infective therapy;\n8. History of immune deficiencies, including positive HIV antibody tests;\n9. Active Hepatitis B (HBsAg and\u002For HBcAb positive with HBV-DNA \\> 500IU\u002Fml) or hepatitis c virus infection (positive test results of anti-HCV with positive HCV-RNA );\n10. Known interstitial lung disease (except for radioactive pulmonary fibrosis that does not require steroid therapy);\n11. History of serious cardiovascular disease;\n12. Pregnant or lactating women.",{"count":170,"type":21},360,[56,24],"A phase I\u002FII study to examine the safety, tolerability, pharmacokinetics and efficacy of XZP-5955 tablets in patients with advanced solid tumors harboring NTRK or ROS1 gene fusion",[174,29],"Locally Advanced or Metastatic Solid Tumors",[176,177,178],"XZP-5955","Safety, tolerability, pharmacokinetics and efficacy","Solid tumors with NTRK or ROS1 gene fusion","2022-08-28",{"date":181,"type":36},"2022-08-30",{"date":183,"type":36},"2021-12-06",{"date":107,"type":21},{"name":186,"class":43},"Xuanzhu Biopharmaceutical Co., Ltd.","Locally Advanced or Metastatic Non Small Cell Lung Cancer"]