[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"small-cell-lung-cancer--sclc-\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:small-cell-lung-cancer--sclc-":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,48,130,160,182,208,234,264,289,322,353,415,439,469,493,517],{"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":25,"conditions":26,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100645163","dll3-targeted-petct-in-small-cell-lung-cancer-100645163",false,"NCT07677787","DLL3-Targeted PET\u002FCT in Small Cell Lung Cancer","Delta-like Protein 3 (DLL3)- Targeted PET Imaging in Small Cell Lung Cancer","Inclusion Criteria:\n\n* Adult patients (aged 18 years or older);\n* Patients with suspected, newly diagnosed, and previously treated small cell lung cancer(supporting evidence may include imaging findings and pathology report);\n* Serum ProGRP or NSE level ≥ 3 times the upper limit of normal;\n* Patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.\n* Estimated life expectancy of more than 3 months, as assessed by the investigator, and ability to comply with study procedures and scheduled visits;\n\nExclusion Criteria:\n\n* The inability or unwillingness of the research participant or legal representative to provide written informed consent.\n* Inability to complete PET\u002FCT imaging.","ALL","18 Years","80 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","The objective of the study is to evaluate the diagnostic value of DLL3-targeted PET\u002FCT in patients with suspected or histologically confirmed small cell lung cancer, and to compare with conventional imaging modalities.",[27,28,29,30],"PET\u002FCT","Small Cell Lung Cancer ( SCLC )","DLL3-targeted PET\u002FCT","Delta-like Protein 3",[29,27,32,33,34],"Small Cell Lung Cancer","SCLC","Delta-like protein 3","RECRUITING","2026-06-25",{"date":38,"type":39},"2026-07-01","ACTUAL",{"date":41,"type":39},"2026-05-09",{"date":43,"type":21},"2028-05-31",{"name":45,"class":46},"The First Affiliated Hospital of Xiamen University","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":61,"conditions":62,"keywords":90,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":129},"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":57,"type":21},300,[59,60],"PHASE1","PHASE2","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.",[63,64,65,66,67,68,69,70,71,72,73,74,75,76,32,28,77,78,79,33,80,81,82,83,84,85,86,87,88,89],"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 Carcinoma","NSCLC","NSCLC (Non-small Cell Lung Cancer)","Non-Small Cell Lung Carcinoma","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",[91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118],"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":121,"type":39},"2026-06-26",{"date":123,"type":39},"2020-10-29",{"date":125,"type":21},"2027-12-31",{"name":127,"class":128},"PMV Pharmaceuticals, Inc","INDUSTRY",77,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":139,"briefSummary":140,"conditions":141,"keywords":144,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":158,"locationsCount":47},"100632066","phase-1-68ga-pfd3-pet-imaging-for-the-diagnosis-and-evaluation-of-small-cell-lung-cancer-100632066","NCT07508852","68Ga-PFD3 PET Imaging for the Diagnosis and Evaluation of Small Cell Lung Cancer","Targeting Delta-like Ligand 3 (DLL3) With 68Ga-PFD3 PET\u002FCT for the Diagnosis and Assessment of Small Cell Lung Cancer (SCLC)","Inclusion Criteria:\n\n* Adults.\n* Histologically confirmed small cell lung cancer (SCLC).\n* At least one measurable lesion ≥1 cm in diameter (primary tumor, metastatic lesion, or involved lymph node) confirmed by standard imaging modalities.\n* Laboratory tests (complete blood count and biochemical analysis) completed within 4 weeks prior to enrollment.\n\nExclusion Criteria:\n\n* Pregnancy.\n* Breastfeeding.\n* Acute psychiatric disorders.\n* Inability to undergo PET scanning (e.g., due to claustrophobia, weight limits, or other medical contraindications).\n* Inability to complete the study procedures as anticipated.\n* Prior therapy targeting DLL3.",{"count":138,"type":21},30,[59,60],"This study aims to investigate and evaluate the safety and performance of a novel probe, PFD3, for the diagnosis and assessment of patients with small cell lung cancer (SCLC).",[33,142,143,32,28],"SCLC, Extensive Stage","SCLC, Limited Stage",[33,145,27,146,147,148,149,150,151],"small cell lung cancer","PET","DLL3","Delta-like ligand 3","imaging","diagnosis","evaluation","2026-06-16",{"date":154,"type":39},"2026-06-18",{"date":156,"type":39},"2025-10-22",{"date":125,"type":21},{"name":159,"class":46},"Peking University First Hospital",{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":22,"phases":169,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":175,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":47},"100604710","phase-1-lurbinectedin-with-osimertinib-in-transformed-small-cell-lung-cancer-100604710","NCT07153055","Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer","Phase I\u002FII Trial of Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer","LOTS","Inclusion Criteria\n\n1. ≥ 18 years old at the time of informed consent.\n2. Ability to provide written informed consent and HIPAA authorization.\n3. Must have a histologically or cytologically confirmed transformation to small cell lung carcinoma\u002Fcancer.\n4. Must have an initial diagnosis of EGFR altered (EGFR-mutated) non-small cell lung cancer and received EGFR targeted therapy (TKI) osimertinib, and does not demonstrate evidence of acquired molecular underpinnings (i.e., presence of a MET amplification \\>6 copies or EGFR C797S) resulting in progression on osimertinib, aside from histologic transformation to small cell lung cancer. Interruptions of osimertinib prior to enrollment on study is permitted.\n\n   Note: Tissue specimens from archival tissue are encouraged but not required for enrollment.\n5. Patients who have received platinum (cisplatin or carboplatin)\u002Fetoposide after histologic transformation are permitted on study. Receipt of last cycle of therapy should be at least 3 weeks prior to initiation of treatment on study. Last exposure to immunotherapy such as anti-PD-L1 should be at least four weeks from treatment to initiation of treatment on study. Patients who decline to receive platinum\u002Fetoposide after SCLC transformation, for personal preferences or considered medical ineligible for this regimen, may be considered for this study, subject to investigator discretion.\n6. Must have measurable disease per RECIST (version 1.1).\n7. ECOG performance status ≤ 2.\n8. Adequate laboratory functions on baseline testing within 21 days of enrollment, as defined as:\n\n   a. Hematologic parameters: i. Absolute neutrophil count (ANC) ≥ 1.5x109\u002FL ii. Platelet count (Plt) ≥ 100x109\u002FL b. Hepatic parameters: i. Total bilirubin ≤ 1.5x upper limit of normal (ULN); for patients with suspected\u002Fdocumented Gilbert's syndrome, total bilirubin ≤ 3x ULN.\n\n   ii. AST ≤ 3x ULN. iii. ALT ≤ 3x ULN. c. Renal parameters: i. Creatinine clearance (CrCl) or estimated glomerular filtration rate (eGFR, calculated per institutional standards) should be \\> 30 mL\u002Fmin.\n9. Women of childbearing potential must have a negative pregnancy test within 21 days of protocol registration. Women are considered to have childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) unless they meet one of the following criteria:\n\n   i. Has achieved menarche at some point; or ii. Has not undergone a hysterectomy or bilateral oophorectomy; or iii. Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n10. Women of childbearing potential and men with any partners of child-bearing potential must agree to use 2 forms of effective contraception throughout the study and for 6 months after the last study treatment.\n\n    Note: Acceptable methods of birth control include abstinence, partner with previous vasectomy, placement of an intrauterine device (IUD), condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository, diaphragm or cervical vault cap, or hormonal birth control (pills or injections).\n11. Male subjects must agree to refrain from donating sperm during the study and for 6 months after the last study treatment. Female subjects must agree to refrain from donating eggs during the study and for 6 months after the last study treatment.\n\nExclusion Criteria\n\n1. Patients who have tumors harboring EGFR exon 20 insertion alterations, EGFR C797S, or known mechanisms of resistance to osimertinib (i.e., MET amplification) aside from histologic transformation to SCLC.\n2. Patients who are pregnant (treatment can cause fetal harm) and\u002For breastfeeding.\n3. Symptomatic or unstable brain metastases, requiring \\> 2 mg dexamethasone orally daily, or received palliative radiation to the CNS within 2 weeks of enrollment.\n4. Patients with known history of interstitial lung disease (ILD) or pneumonitis (\\> grade 1) or ILD\u002Fpneumonitis (\\> grade 1) related to antineoplastic drug treatment.\n5. Prior history of documented Stephen Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), erythema multiforme major (EMM), or aplastic anemia on osimertinib.\n6. History of congenital long QTc syndrome or mean resting QTc \\>500 msec at screening with two replicated EKGs at baseline screening for the study.\n7. History of ongoing unstable or uncontrolled cardiac conditions, including documented cardiomyopathy or symptomatic congestive heart failure (defined as New York Heart Association (NYHA) class III or IV).\n8. Prior history of documented severe allergic or anaphylactic reaction to osimertinib.\n9. Prior history of documented aplastic anemia with osimertinib.\n10. Prior history of documented allergic or anaphylactic reactions to inactive ingredients of lurbinectedin, including sucrose, lactic acid, and sodium hydroxide.",{"count":5,"type":21},[59,60],"This open-label, Phase I\u002FII trial is studying the safety and effectiveness of an experimental drug combination, lurbinectedin with osimertinib, against a rare type of cancer known as transformed small cell lung cancer (SCLC).",[28,172],"Transformed Small Cell Lung Cancer",[174],"EGFR mutations",{"date":154,"type":39},{"date":177,"type":21},"2026-08",{"date":179,"type":21},"2029-10",{"name":181,"class":46},"Misty Shields",{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":22,"phases":191,"briefSummary":192,"conditions":193,"keywords":197,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":207},"100629562","phase-2-symbiotic-lung-14-a-study-to-learn-about-the-study-medicine-called-pf08634404-in-combination-with-chemotherapy-in-adult-participants-with-transformed-small-cell-lung-cancer-100629562","NCT07476287","Symbiotic-Lung-14: A Study to Learn About the Study Medicine Called PF08634404 in Combination With Chemotherapy in Adult Participants With Transformed Small Cell Lung Cancer","A PHASE 2 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH PREVIOUSLY UNTREATED TRANSFORMED SMALL CELL LUNG CANCER","Inclusion Criteria:\n\n* Male or female participants aged ≥18 years at the time of informed consent.\n* Histologically or cytologically confirmed T-SCLC. Participant must have had a prior diagnosis of NSCLC with EGFR mutation which transformed to SCLC following the treatment with TKI(s).\n* Participants have not received systemic therapy for T-SCLC.\n* Have at least one measurable lesion as the target lesion based on RECIST v1.1.\n* Have sufficient tumor tissue from the diagnosis of transformed SCLC available.\n* Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Have a minimum life expectancy of \\>12 weeks.\n* Clinical laboratory values at screening within acceptable limits, as defined in the protocol, including: 1) Hematology, 2) Liver function and 3) Renal function.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Active or untreated CNS disease, including brain, brainstem, spinal cord, or meningeal metastases. Participants with definitively treated, clinically stable brain metastases may be eligible per protocol criteria. Participants with untreated asymptomatic brain metastases of longest diameter \\\u003C1 cm are permitted if all of the following criteria are met: absence of neurological symptoms, no need for corticosteroids, and brain metastasis has no evidence of edema or hemorrhagic features.\n* Leptomeningeal disease\n* Clinically significant risk of hemorrhage or fistula, including tumor necrosis\u002Fcavitation, invasion or compression of major blood vessels, airways, or critical organs, or risk of tracheoesophageal or pleuroesophageal fistula\n* History of another malignancy (other than NSCLC) within 3 years prior to first dose, except for malignancies with negligible risk of metastasis or death (eg, adequately treated carcinoma in situ, nonmelanoma skin cancer)\n* Unresolved toxicity from prior anti-tumor therapy that has not recovered to Grade ≤1 per NCI CTCAE v5.0 (except alopecia or irreversible toxicities deemed stable)\n* History of allogeneic organ or hematopoietic stem cell transplantation\n* Active autoimmune disease requiring systemic treatment within the past 2 years (Stable replacement therapy and selected low-risk autoimmune conditions are permitted per protocol)\n* Interstitial lung disease (ILD), pneumonitis, or significant pulmonary disease, including:\n\n  * Prior or current non-infectious pneumonitis requiring systemic therapy\n  * DLCO \\\u003C50% predicted\n  * Severe asthma, COPD, pulmonary embolism, or autoimmune lung involvement\n* Uncontrolled or clinically significant cardiovascular, cerebrovascular, metabolic, hepatic, or renal disease within 6 months prior to first dose\n* Baseline QTcF \\>480 msec\n* Major surgery or severe trauma within 4 weeks prior to first dose, or planned major surgery during the study\n* Clinically significant pleural effusion, pericardial effusion, or ascites requiring repeated drainage\n* History of significant bleeding disorders or recent major bleeding events\n* Clinically significant gastrointestinal conditions, including recent perforation, fistula, obstruction, or active bleeding\n* Active, uncontrolled, or symptomatic infection, including:\n\n  * Active TB\n  * Active hepatitis B or C\n  * Uncontrolled HIV infection\n* History of immunodeficiency\n* Severe hypersensitivity or allergic reactions to study intervention components or monoclonal antibodies\n* Psychiatric illness or medical condition, including recent suicidal ideation or behavior, that may increase risk or interfere with study participation\n* Prior anti-angiogenic therapy or other prohibited anti-tumor or immunomodulatory therapies per protocol-specified washout periods\n* Use of prohibited concomitant medications, including high-dose systemic corticosteroids, certain anticoagulants, or live vaccines within protocol-specified timeframes\n* Recent participation in another investigational study (within 30 days or 5 half-lives, whichever is longer)\n* Pregnant or breastfeeding participants, or unwillingness to comply with contraception requirements",{"count":190,"type":21},40,[60],"This study is being done to learn more about a new medicine called PF-08634404. The study team wants to understand how well PF-08634404 works when given alone or with chemotherapy . Chemotherapy is a type of cancer treatment that uses medicines to destroy cancer cells or stop them from growing. The study is for adults with Transformed Small Cell Lung Cancer (T-SCLC ). T SCLC is a rare lung cancer that happens when one type of lung cancer changes into a more aggressive type after treatment stops working.\n\nTo join the study, participants must meet the following conditions:\n\n* Are aged 18 years or older\n* Diagnosed with T-SCLC and have not received treatment for this type of lung cancer (a single cycle of chemotherapy may be permitted)\n* Prior diagnosis of epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer treated with tyrosine kinase inhibitors (TKIs)\n* Have healthy organs based on medical tests and are in good physical condition\n\nAfter joining the study, adults will be given chemotherapy in addition to the study medicine. After this combination treatment is finished, the study medicine will be continued alone. Adults will receive the treatment through IV infusions (medicine given directly into a vein). All treatments will be done at clinical study sites, where a trained medical team will monitor adults during and after each visit.",[32,28,172,194,195,196],"Lung Neoplasms","Carcinoma, Small Cell Lung","Small Cell Cancer Of The Lung",[172,32],"2026-06-03",{"date":200,"type":39},"2026-06-04",{"date":202,"type":21},"2026-05-15",{"date":204,"type":21},"2031-03-19",{"name":206,"class":128},"Pfizer",12,{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":214,"targetDuration":216,"studyType":217,"phases":4,"briefSummary":218,"conditions":219,"keywords":223,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":47},"100636426","establishment-of-a-prospective-clinical-cohort-of-small-cell-lung-cancer-patients-receiving-radiotherapy-involved-comprehensive-treatment-100636426","NCT07565532","Establishment of a Prospective Clinical Cohort of Small Cell Lung Cancer Patients Receiving Radiotherapy-Involved Comprehensive Treatment","Inclusion Criteria:\n\nInclusion Criteria for Limited-Stage Small Cell Lung Cancer (LS-SCLC):\n\n1\\. Voluntary signed informed consent according to clinical routine practice. 2. Histologically and radiologically confirmed, previously untreated limited-stage SCLC (according to the Veterans Administration Lung Study Group staging system).\n\n3\\. Age ≥ 18 years. 4. Life expectancy ≥ 8 weeks. 5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. 6. At least one documented efficacy assessment. 7. At least one measurable lesion as confirmed by the investigator according to RECIST (iRECIST 2017) criteria.\n\n8\\. Adequate organ and bone marrow function, with laboratory tests performed within 7 days prior to the first dose meeting the following criteria (without receiving any blood components, hematopoietic growth factors, albumin, or other corrective therapies considered by the investigator within 14 days prior to laboratory assessments):\n\n1. Hematology: Hemoglobin (Hb) ≥ 90 g\u002FL, absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL, platelet count (PLT) ≥ 90 × 10⁹\u002FL.\n2. Biochemistry: Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN); serum total bilirubin (TBIL) ≤ 1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN in patients without liver metastases, or ≤ 5.0 × ULN in patients with liver metastases; serum albumin (ALB) ≥ 25 g\u002FL.\n3. Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN; prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (for patients receiving prophylactic anticoagulation, the INR and APTT values should be judged by the treating physician or investigator to be within a safe and effective therapeutic range).\n\n9\\. Pulmonary function test showing FEV₁ \\> 0.75 L. 10. No evidence of severe interstitial lung disease confirmed by CT or PET\u002FCT prior to treatment.\n\n11\\. No prior or concurrent primary malignancy at other sites. 12. No requirement for PD-L1 expression level.\n\nInclusion Criteria for Extensive-Stage Small Cell Lung Cancer (ES-SCLC):\n\n1\\. Voluntary signed informed consent according to clinical routine practice. 2. Histologically confirmed SCLC with complete staging workup showing extensive-stage disease (according to the Veterans Administration Lung Study Group staging system).\n\n3\\. Age ≥ 18 years. 4. Life expectancy ≥ 8 weeks. 5. At least one documented efficacy assessment. 6. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2. 7. Adequate organ and bone marrow function, with laboratory tests performed within 7 days prior to the first dose meeting the following criteria (without receiving any blood components, hematopoietic growth factors, albumin, or other corrective therapies considered by the investigator within 14 days prior to laboratory assessments):\n\n1. Hematology: Hemoglobin (Hb) ≥ 90 g\u002FL, absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL, platelet count (PLT) ≥ 90 × 10⁹\u002FL.\n2. Biochemistry: Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN); serum total bilirubin (TBIL) ≤ 1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN in patients without liver metastases, or ≤ 5.0 × ULN in patients with liver metastases; serum albumin (ALB) ≥ 25 g\u002FL.\n3. Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN; prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (for patients receiving prophylactic anticoagulation, the INR and APTT values should be judged by the treating physician or investigator to be within a safe and effective therapeutic range).\n\n8\\. No severe concurrent medical illness. 9. Forced expiratory volume in one second (FEV₁) \\> 0.75 L. 10. For patients with prior radiotherapy to the primary lesion, the current radiotherapy target is limited to metastatic lesions.\n\n11\\. No prior or concurrent primary malignancy at other sites. 12. No requirement for PD-L1 expression level. 13. For patients with limited-stage SCLC who previously received curative-intent treatment, upon recurrence or metastasis, if complete staging workup is available and this is their first use of immunotherapy, they may still be considered for inclusion in the extensive-stage cohort.\n\nExclusion Criteria:\n\nExclusion Criteria for Limited-Stage Small Cell Lung Cancer (LS-SCLC):\n\n1. Histologically confirmed non-small cell lung cancer (NSCLC).\n2. No efficacy assessment record, or missing efficacy assessment data.\n3. Presence of other primary malignancies; history of allogeneic organ transplantation.\n4. Major surgery (excluding diagnostic biopsy) within 4 weeks prior to the first dose.\n5. History of substance abuse (e.g., drug addiction), long-term alcoholism, or AIDS or HIV carrier.\n6. Active autoimmune disease, or history of autoimmune disease with potential for relapse.\n7. Current systemic corticosteroid therapy (e.g., equivalent to \\>10 mg prednisone daily) or use of any other form of immunosuppressive therapy within 14 days prior to the first dose.\n8. Prior treatment with any antibody\u002Fdrug targeting T-cell co-regulatory proteins (immune checkpoints), including but not limited to PD-1, PD-L1, CTLA-4, TIM-3, and LAG-3.\n9. Interstitial lung disease (ILD) or history of ILD requiring corticosteroid therapy.\n10. History of idiopathic pulmonary fibrosis (IPF), drug-induced pneumonitis, organizing pneumonia (e.g., bronchiolitis obliterans), idiopathic pneumonia, or evidence of active pneumonitis on screening chest CT.\n11. Receipt of live vaccine within 28 days prior to the first dose of study drug.\n12. Any other disease or condition that contraindicates chemoradiotherapy, including but not limited to active infection, within 6 months post-myocardial infarction, symptomatic heart disease (including unstable angina, congestive heart failure, or uncontrolled arrhythmias), and immunosuppressive therapy.\n13. Unresolved toxicity of Grade 2 or higher (according to CTCAE version 5.0).\n14. Pregnant or breastfeeding women; men or women of childbearing potential who are unwilling to use adequate contraceptive measures.\n15. Evidence of inherited bleeding diathesis or coagulation disorders.\n16. Prior history of malignancy (excluding skin cancer, or in situ breast cancer, oral cancer, or cervical cancer with life expectancy \\>3 years).\n\nExclusion Criteria for Extensive-Stage Small Cell Lung Cancer (ES-SCLC):\n\n1. Pulmonary carcinoid or non-small cell lung cancer, unless transformed SCLC is ruled out.\n2. No efficacy assessment record, or missing efficacy assessment data.\n3. History of severe anaphylactic\u002Fallergic reaction to humanized antibodies or fusion proteins.\n4. Acute exacerbation of chronic obstructive pulmonary disease (COPD) or other pulmonary diseases requiring hospitalization.\n5. Active or prior autoimmune disease (within the past 2 years) or history of primary immunodeficiency.\n6. Progression after immunotherapy; prior or concurrent diagnosis of any other malignancy, excluding non-melanoma skin cancer or carcinoma in situ of the cervix.\n7. Any other disease or condition that contraindicates chemoradiotherapy, including but not limited to active infection, within 6 months post-myocardial infarction, symptomatic heart disease (including unstable angina, congestive heart failure, or uncontrolled arrhythmias), or immunosuppressive therapy.\n8. Unresolved toxicity of Grade 2 or higher (according to CTCAE version 5.0).\n9. Current or prior history of autoimmune disease or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, and rheumatoid arthritis.\n10. History of idiopathic pulmonary fibrosis (IPF), organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonia; or evidence of active pneumonitis on chest CT scan. Patients with a history of radiation pneumonitis (fibrosis) within the radiation field may be enrolled.\n11. Pregnant or breastfeeding women; men or women of childbearing potential who are unwilling to use adequate contraceptive measures.",{"count":215,"type":21},500,"2 Years","OBSERVATIONAL","By establishing a prospective clinical cohort for small cell lung cancer (SCLC) and systematically collecting high-quality real-world data integrating clinical, imaging, pathological, and molecular dimensions, this study aims to enable personalized treatment for distinct SCLC subtypes. Furthermore, by evaluating the influence of radiotherapy timing, dose and fractionation, and target selection on efficacy and toxicity, we aim to identify the optimal radio-immunotherapy combination regimen that maximizes the synergistic effect in SCLC patients.",[28,220,221,222],"Radiotherapy","Immunotherapy","Personalized Cancer Treatment",[224,220,221,222],"Small Cell Lung Cancer (SCLC)","2026-04-27",{"date":227,"type":39},"2026-05-04",{"date":229,"type":39},"2026-04-01",{"date":231,"type":21},"2030-03-31",{"name":233,"class":46},"Shanghai Chest Hospital",{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":22,"phases":243,"briefSummary":244,"conditions":245,"keywords":247,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":47},"100619010","phase-2-study-of-sacituzumab-govitecan-with-atezolizumabdurvalumab-as-maintenance-therapy-for-extensive-stage-small-cell-lung-cancer-100619010","NCT07339059","Study of Sacituzumab Govitecan With Atezolizumab\u002FDurvalumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer","Phase II Study of Sacituzumab Govitecan With Atezolizumab\u002FDurvalumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the trial.\n* Male or Female aged 18 years or above.\n* Participants must have a histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC) and extensive stage at diagnosis or locally advanced disease and unable to receive curative intent radiation.\n* Participants must have received at least four cycles of platinum plus etoposide and at least 2-3 cycles of atezolizumab\u002F Durvalumab.\n* No evidence of progression on restaging CT CAP following 4-6 cycles of Chemo\u002FIO from the last dose of the chemotherapy cycle.\n* ECOG performance status of 0-2\n* Patients must not have active uncontrolled HIV, HBV, and HCV infections. Well-controlled infections on treatment will be allowed to participate in the trial.\n* Patients with stable and asymptomatic brain metastasis.\n* Adequate organ function - bone marrow, kidney, and liver.\n\nExclusion Criteria:\n\n* Significant renal impairment requiring dialysis or hepatic impairment with end-stage liver disease.\n* Participants with leptomeningeal disease.\n* Participants with a recent diagnosis of heart failure and acute coronary disease within 3 months.\n* Participants who are unable to receive immunotherapy with chemotherapy for induction will be excluded, or those immunotherapy was discontinued to manage immune-related adverse events\n* Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months of enrolment.\n* Patients with prior exposure to anti-PD-1, anti-PD-L1, or anti-PD-L2 agents or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4) within 12 months of the study is not allowed.",{"count":242,"type":21},35,[60],"The goal of this clinical trial is to learn if the combination of sacituzumab govetican (SG) and atezolizumab\u002Fdurvalumab is effective in controlling cancer tumor growth in adults with extensive stage small cell lung cancer. These drugs are FDA approved individually in different cancers. This combination is evaluated in breast cancer and showed promising combination.\n\nThe effectiveness of this treatment combination will be measured by changes in tumor size and appearance of new tumors.\n\nParticipants in the trial will:\n\n* receive treatment SG and immunotherapy every 21 days for up to 2 years or until it is no longer works for the patient.\n* CT scans at 6weeks for first 6 cycles and then every 9-12 weeks and MRI brain every 12 weeks.\n* provide tissue (optional) and blood for additional testing (learn about the cancer).",[28,246],"Extensive Stage Small Cell Lung Cancer (ES-SCLC)",[248,249,250,145,251,252,253,254],"atezolizumab","durvalumab","sactizumab govetican","sclc","es-sclc","lung cancer","extensive stage","2026-04-20",{"date":257,"type":39},"2026-04-23",{"date":259,"type":21},"2026-06-01",{"date":261,"type":21},"2029-12-01",{"name":263,"class":46},"Bindu R Potugari",{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":270,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":22,"phases":274,"briefSummary":275,"conditions":276,"keywords":277,"overallStatus":279,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":4},"100628754","phase-2-a-study-of-alisertib-and-paclitaxel-in-patients-with-small-cell-lung-cancer-sclc-100628754","NCT07465757","A Study of Alisertib and Paclitaxel in Patients With Small Cell Lung Cancer (SCLC)","A Phase 2 Study of Alisertib in Combination With Paclitaxel in Patients With Small Cell Lung Cancer","ALISCA-Lung2","Inclusion Criteria:\n\n* Aged ≥18 years at signing of informed consent\n* Pathologically confirmed SCLC\n* Prior treatment with one platinum-based chemotherapy and an anti-PD-1\u002FPD-L1 immunotherapy. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to 2 prior treatment regimens\n* Measurable disease as defined by RECIST v1.1\n\nExclusion Criteria:\n\n* Prior treatment with an aurora kinase A (AURKA) specific-targeted or pan-Aurora- targeted agent, including alisertib, in any setting\n\nThere are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.",{"count":273,"type":21},50,[60],"The goal of this clinical trial is to determine how well people tolerate treatment with alisertib at different doses when it is used together with paclitaxel to treat people with SCLC. The main question it aims to answer is:\n\n* What percentage of side effects, both mild and serious, do participants experience when being treated with alisertib and paclitaxel based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v.5.0)?\n\nThe study will consist of different groups, called cohorts, in which alisertib will be studied at increasing doses. Participants in the first group, Cohort 1, will take 30 mg of alisertib by mouth 2 times a day. The dose will increase by 10 mg 2 times a day for each new cohort of participants joining the study. Side effects will be checked during the study, and the decision to increase the dose of alisertib will be based on the specific side effects experienced during the first 21 days of treatment for each cohort.\n\nParticipants will:\n\n* take alisertib by mouth on their own 2 times a day from Day 1 through Day 7 of each 21-day cycle and will be given paclitaxel intravenously at a dose of 60 mg\u002Fm2 on Day 1 and Day 8 of each 21-day cycle.\n* be given a preventive treatment to increase their body defenses, called granulocyte-colony stimulating factor (G-CSF). Study staff will give G-CSF after the last dose of alisertib or paclitaxel of each 21-day cycle in which alisertib was given.\n* provide blood samples to evaluate the different levels of alisertib in the blood at different times. Blood samples will be collected on Days 1 and 7 of the first and second 21-day cycles of treatment.\n* be treated with alisertib and paclitaxel until death, worsening of the disease, unacceptable toxicity, unwillingness to continue participating in the trial, or other criteria that requires participants to stop treatment and participation in the study.\n* be contacted every 8 weeks after stopping alisertib and paclitaxel treatment as part of a specific study phase called the long-term follow-up period. This will last until death, unwillingness to continue participating in the trial, or until the end of the study.",[28],[278,33],"alisertib","NOT_YET_RECRUITING","2026-03-06",{"date":282,"type":39},"2026-03-12",{"date":284,"type":21},"2026-09-30",{"date":286,"type":21},"2028-09-30",{"name":288,"class":128},"Puma Biotechnology, Inc.",{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":296,"targetDuration":4,"studyType":22,"phases":298,"briefSummary":299,"conditions":300,"keywords":306,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":321},"100595269","phase-1-study-of-cp-383-in-patients-with-advanced-or-metastatic-solid-tumors-100595269","NCT07030257","Study of CP-383 in Patients With Advanced or Metastatic Solid Tumors","A Multi-Center, Open Label, Phase 1\u002F2 Study of CP-383, in Patients With Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Measurable or non measurable cancer that the research can assess for changes\n* Not eligible or able to take existing standard therapies for cancer\n* Availability of a part of a tumor for laboratory testing or willing to have a safe biopsy taken from a tumor\n* Diagnosed with locally advanced, recurrent or metastatic incurable disease\n* Part 1: any solid tumor (with the exception of brain cancer) that has progressed, standard therapy is no longer or has not helped the cancer, or is too toxic and for whom a clinical trial is an option for continued treatment\n* Part 1: specific advanced, metastatic tumor types will also be enrolled: colorectal cancer, small cell lung cancer, head and neck cancer, non-small cell lung cancer, pancreatic cancer, bladder cancer - some of these will have a specific gene mutation in the cancer\n* Part 1: selected solid tumor cancer types (with the exception of brain cancers) that have a specific gene mutation in the cancer\n* Part 2: specific advanced, metastatic tumor types will also be enrolled: colorectal cancer, small cell lung cancer, head and neck cancer - some of these will have a specific gene mutation in the cancer\n\n  \\_ Part 2: selected solid tumor cancer types (with the exception of brain cancers) that have a specific gene mutation in the cancer\n* Adequate blood and urine lab tests\n* Women and men of childbearing potential with adequate contraception\n* Provides written informed consent\n* Willing to comply with the requirements of the protocol\n\nExclusion Criteria:\n\n* Inability to swallow pills\n* Known history of HIV, HCV, HBV unless cured, controlled with undetectable viral load\n* Active tumor in the brain\n* Clinically significant liver disease\n* Significant gastrointestinal diseases\n* History of other cancer within past 5 years with certain exceptions for cancers that are likely cured\n* Significant cardiac disease\n* Other diseases that are not well controlled that could make taking the drug unsafe\n* pregnant or lactating females\n* Exposure to certain anti-cancer or other drugs within a certain period before the start of study drug",{"count":297,"type":21},150,[59,60],"The goal of this clinical trial is to learn if an investigational drug CP-383 works to treat advanced cancer. It will also learn about the safety of CP-383. The main questions if aims to answer are:\n\n* Does CP-383 slow or stop the growth of cancer in patients with advanced cancer\n* What medical problems do participants have when taking CP-383 Researchers will test CP-383 in all kinds of cancers at various dose levels to determine what the best dose is to study further. Researchers will also see if certain cancers that have gene mutations respond better to CP-383\n\nParticipants will:\n\n* Take CP-383 every day by mouth until the researcher learns whether CP-383 is helping slow or reduce the cancer growth\n* Visit the clinic weekly for the first 6 weeks for checkups and tests\n* Visit the clinic every 3 weeks thereafter for checkups and tests",[301,302,28,303,304,84,305],"Solid Tumor Malignancies","Colorectal Carcinoma","Head and Neck (HNSCC)","Bladder Cancer","Pancreatic Cancer, Advanced or Metastatic",[94,307,308,309,310,311],"Dose Escalation","Dose Expansion","Loss of Function","FAT1","P300","2026-02-17",{"date":314,"type":39},"2026-02-18",{"date":316,"type":39},"2025-08-27",{"date":318,"type":21},"2029-02",{"name":320,"class":128},"Tasca Therapeutics",13,{"id":323,"slug":324,"hasResults":11,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":4,"eligibilityCriteria":328,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":329,"targetDuration":4,"studyType":22,"phases":330,"briefSummary":332,"conditions":333,"keywords":341,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":352},"100539601","early-phase-1-177lu-anti-pd-l1-sdab-in-metastatic-solid-tumors-100539601","NCT06305962","177Lu-anti-PD-L1 sdAb in Metastatic Solid Tumors","Phase 0\u002F1 Study of the Safety and Tolerability of 177Lu-RAD204, a Lutetium-177 Radiolabelled Single Domain Antibody Against Programmed Cell Death-Ligand 1 in Patients With Metastatic Solid Tumours","Inclusion Criteria:\n\n1. Willing and able to provide informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.\n2. Adult participants ≥ 18 years of age.\n3. Participants with a documented history of histopathologically confirmed relapsed\u002Frefractory locally advanced, inoperable or metastatic NSCLC, SCLC, TNBC, cutaneous melanoma, HNSCC, endometrial cancer or any cancer that is known to be MMR deficient or MSI high with documented disease progression during or after their most recent line of anticancer therapy. Participants must be refractory to or have refused standard of care therapy (including PD-1\u002FPD-L1 inhibitors) or have refused or have no standard of care therapy available that is likely to provide clinical benefit.\n4. Participants with PD-L1 positive NSCLC, SCLC, TNBC, cutaneous melanoma, HNSCC, endometrial cancer or any cancer that is known to be MMR deficient or MSI high:\n\n   * If the participant tumour's PD-L1 expression status is unknown, PD-L1 positivity may be determined in a pre-screening step whereby the participant may be approached to provide written informed consent to have their tumour tissue undergo IHC testing as determined by a validated test (tumour tissue may be obtained from archived samples or from a freshly obtained biopsy).\n   * Any number of prior treatment lines are allowed.\n5. Must have at least 1 measurable target lesion according to RECIST version 1.1.\n6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n7. Participants must have a life expectancy of ≥ 4 months in the opinion of the Investigator.\n8. Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin (β-hCG) test and must not be breastfeeding. WOCBP are defined as those who are not surgically sterile or post-menopausal. Female participants will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. Female participants \\\u003C 50 years old who meet the criteria for post-menopausal status without previous surgical sterilisation should be considered for further investigation with luteinising hormone (LH) and follicle stimulating hormone (FSH) levels to confirm serological post-menopausal status.\n9. WOCBP must agree to use a highly effective method of contraception during the study and for 14 days after the last injection of 177Lu-RAD204im and\u002For 6 months after the last dose of 177Lu-RAD204tr, whichever occurs later. Acceptable methods of contraception are described in Section 13.3 of the Protocol.\n10. Male participants who are able to father a child must agree to avoid impregnating a partner and to adhere to a highly effective method of contraception during the study and for 14 days after the last injection of 177Lu-RAD204im and\u002For 6 months after the last dose of 177Lu-RAD204tr, whichever occurs later. All male participants must agree to not donate sperm during the study and for 14 days after the last injection of 177Lu-RAD204im and\u002For 6 months after the last dose of Lu-RAD204tr, whichever occurs later. Acceptable methods of contraception are described in Section 13.3 of the Protocol.\n11. Participants with previously treated brain metastases are eligible to participate if:\n\n    * they are neurologically and radiologically stable (no evidence of progression by imaging; same imaging modality \\[magnetic resonance imaging (MRI) or computed tomography (CT) scan\\] must be used for each assessment) for at least 28 days prior to the first dose of 177Lu-RAD204im,\n    * do not require steroids to treat associated neurological symptoms, and\n    * have no history of leptomeningeal disease or spinal cord compression.\n    * Participants with active brain metastases who have not received brain-directed therapy such as radiotherapy are not eligible to enroll.\n12. For Phase I:\n\n    * Participants must have positive lesion(s) by 177Lu-RAD204im SPECT\u002FCT per central review as described in Image Review Charter, and\n    * Participants without any positive lesion by 177Lu-RAD204im SPECT\u002FCT, e.g. due to poor image quality, may be allowed to enrol on a case-by-case basis at the discretion of the Principal Investigator and in discussion with study Sponsor, provided the participant's tumour is known to express PD-L1.\n\nExclusion Criteria:\n\n1. History of prior organ transplant.\n2. Any other known, active malignancy, except for treated cervical intraepithelial neoplasia or non-melanoma skin cancer. Patients with a history of malignancies of low recurrence potential who have received curative-intent therapy may be approved on a case-by-case basis in discussion with study Sponsor, if it is determined not to put the patient at an increased risk of adverse drug effects and\u002For interfere with the integrity of study outcome.\n3. Have any medical condition that would, in the Investigator's judgment, prevent the participant's full participation in the clinical study due to safety concerns or compliance with clinical study procedures such as participants with severe claustrophobia who are unresponsive to oral anxiolytics, participants with low back pain who cannot lie comfortably on an imaging table, participants who are hyperactive or hyperkinetic such that they cannot tolerate lying still for multiple time point imaging procedures, etc.\n4. Residual toxicity ≥ Grade 2 from prior anti-cancer therapy (except alopecia).\n5. History of uncontrolled allergic reactions and\u002For known or expected hypersensitivity to protein therapeutics, 177Lu-RAD204 or any of its excipients.\n6. Inadequate organ functions as reflected in laboratory parameters:\n\n   * Creatinine clearance or body surface area (BSA) adjusted estimated glomerular filtration rate (eGFR) (calculated using any clinically validated formula, preferably Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), or measured) \\\u003C 60 mL\u002Fmin\n   * Platelet count of \\\u003C 80 × 109\u002FL\n   * Absolute neutrophil count (ANC) \\\u003C 1.5 × 109\u002FL\n   * Haemoglobin \\\u003C 9 g\u002FdL\n   * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 × ULN, or \\> 5 × ULN for patients with known liver metastases\n   * Total bilirubin \\> 1.5 × ULN, except for patients with documented Gilbert's syndrome who are eligible if total bilirubin ≤ 3 × ULN\n   * For participants not taking warfarin or other anticoagulants: international normalized ratio (INR) ≥ 1.5 or prothrombin time (PT) ≥ 1.5 × ULN; and either partial thromboplastin time or activated partial thromboplastin time (PTT or aPTT) ≥1.5 × ULN. Participants taking warfarin must be on a stable dose that results in a stable INR \\\u003C 3.5. Among participants receiving other anticoagulant therapy, PT or aPTT must be within the intended therapeutic range of the anticoagulant.\n7. Patients requiring blood product transfusion within 4 weeks of first dose of 177Lu-RAD204tr are not eligible to participate.\n8. Clinically significant cardiovascular disease including but not limited to:\n\n   * Unstable angina\n   * Acute myocardial infarction within 6 months prior to screening\n   * New York Heart Association (NYHA) Class II or greater congestive heart failure (see Section 20.6)\n   * Clinically significant abnormalities in rhythm, conduction or morphology on resting ECG (e.g. complete left bundle branch block, third degree heart block)\n   * Uncontrolled hypertension\n   * Known LVEF \\\u003C 50%\n   * QT interval corrected for heart rate using Fridericia's formula (QTcF) \\> 470 msec for females and QTcF \\> 450 msec for males on screening electrocardiogram (ECG) or congenital long QT syndrome.\n9. Participation in any other investigational trial at the time of informed consent signature.\n10. Pregnant or lactating women.\n\n    The following exclusion criteria applies to participants in Phase I:\n11. Received anti-cancer therapy, including chemotherapy, immunotherapy, radiation therapy, biologic, herbal therapy, or any investigational therapy or investigational device, within 28 days (or 5 half-lives for biologic\u002Fnon-cytotoxic agents, whichever is shorter), prior to the first dose of 177Lu-RAD204tr.\n12. Has 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 (e.g. CTLA-4, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher immune-mediated AE.\n\n    NOTE: endocrine immune-mediated AEs that are controlled with replacement therapy are allowed.\n13. Has had or is scheduled to have major surgery \\\u003C 28 days prior to the first dose of 177Lu-RAD204tr.Surgical procedures not considered to put participants at higher risk of AEs and\u002For interfere with the integrity of study outcome may be allowed on a case-by-case basis in discussion with the Sponsor.\n14. Positive status for human immunodeficiency virus (HIV).\n15. Active or chronic hepatitis B or C. Chronic hepatitis B or hepatitis C with undetectable viral loads on stable suppression therapy may be allowed on a case-by-case basis in discussion with study Sponsor.\n16. Any medical condition which, in the opinion of the Investigator, places the participant at an unacceptably high risk for toxicities.\n17. Any uncontrolled intercurrent illness or clinically significant uncontrolled condition(s), including but not limited to active bacterial, fungal, or viral infections requiring systemic therapy.",{"count":138,"type":21},[331],"EARLY_PHASE1","This is a Phase 0\u002F1, First-in-Human (FIH), study to evaluate safety, tolerability, biodistribution, radiation dosimetry and preliminary anti-tumour activities of 177Lu-RAD204 in participants with selected solid tumours, to identify the MTDs\u002F recommended doses of 177Lu-RAD204 for future exploration.\n\nThe study will consist of a Pre-screening Period (if applicable for PD-L1 testing), a Screening Period of up to 4 weeks, followed by a Phase 0 (Imaging) Period for imaging and dosimetry to 177Lu-RAD204im and a Phase I (Treatment) Period for 177Lu-RAD204tr dose escalation.",[334,335,28,336,337,338,69,339,340],"PDL1 Gene Mutation","Non Small Cell Lung Cancer","TNBC, Triple Negative Breast Cancer","Cutaneous Melanoma","HNSCC","Mmr Deficiency","MSI-High",[342,335,224,336,337,338,343,339,340],"PDL1 Positive","Endometrial cancer",{"date":345,"type":39},"2026-02-19",{"date":347,"type":39},"2024-06-03",{"date":349,"type":21},"2027-12",{"name":351,"class":128},"Radiopharm Theranostics, Ltd",5,{"id":354,"slug":355,"hasResults":11,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":360,"targetDuration":4,"studyType":22,"phases":362,"briefSummary":363,"conditions":364,"keywords":387,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":414},"100328442","phase-1-vmd-928-monotherapy-and-in-combination-with-pembrolizumab-to-treat-trka-overexpression-driven-solid-tumors-or-lymphoma-100328442","NCT03556228","VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma","A Phase 1\u002F2 Open-Label, Multiple-Dose, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of VMD-928 as Monotherapy and in Combination With Pembrolizumab in Subjects With Solid Tumors or Lymphoma","Key Inclusion Criteria:\n\n#. Histologically or cytologically confirmed diagnosis of any type of solid tumor malignancy or lymphoma:\n\nPhase 1 Dose Escalation only: Subjects with\n\n(A) any advanced solid tumors of\n\n1. Head and Neck Cancers (\"HNC\") (of any types),\n2. Esophageal cancer,\n3. Lung cancers (of any types),\n4. Mesothelioma,\n5. Pancreatic cancers,\n\nOr,\n\n(B) any NTRK1 gene fusion positive (\"NTRK1+\") solid tumors or lymphomas, that is relapsed, refractory or intolerant (R\u002FR\u002FI) to standard of care (SOC) and for which there is no approved or curative therapy. Additionally, patients must not be candidates for or have exhausted regimens known to provide clinical benefit, including hematopoietic stem cell transplantation in lymphoma patients if they are deemed transplant eligible.\n\nPhase 2 Monotherapy and Combination with Pembrolizumab only:\n\nSubjects must have\n\n1. TrkA-driven HNC, Esophageal, Lung, Mesothelioma, Pancreatic cancers; or,\n2. any NTRK1+ solid tumors or lymphoma\\*, that is R\u002FR\u002FI to SOC.\n\nKey Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0 or 1.\n* Able to swallow and retain oral medication.\n* Subjects must either have available archival tumor tissue samples, or consent to tumor tissue sampling prior to the first dose.\n* Adequate organ system function as defined as follows:\n\n  1. Absolute neutrophil count ≥1.5x10\\^9\u002FL\n  2. Hemoglobin ≥9g\u002FdL\n  3. Platelets ≥100x10\\^9\u002FL\n  4. PT\u002FINR, PTT ≤1.5xULN\n  5. Total bilirubin ≤1.5x ULN\n  6. AST, ALT ≤2.5xULN\n  7. Creatinine ≤1.2xULN for age, weight\n  8. Calculated creatinine clearance or 24h urine creatinine clearance ≥60mL\u002Fmin\n\nKey Exclusion Criteria:\n\n* Received chemotherapy having delayed toxicity within the last 14 days (six weeks for prior nitrosourea or mitomycin C).\n* Received anticancer therapy with radiation, immunotherapy, and a biologic, surgery and\u002For tumor embolization within the past 2 weeks.\n* Received an investigational anticancer drug within 14 days or 5 half-lives of the investigational agent, whichever is longer, prior to the first dose of VMD-928. Any exceptions to the above must be approved by the Sponsor Medical Monitor.\n* Unresolved toxicity from previous anticancer therapy \\> CTCAE Grade 1 (except alopecia or anemia) unless agreed to by both the Sponsor Medical Monitor and the Investigator.\n* Known active infections including HIV disease.\n* Currently pregnant, nursing, or planning to become pregnant during the course of the study.\n* QTcF interval ≥ 480 msec.\n* Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.\n* Acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 24 weeks.\n* Unstable or uncompensated respiratory, hepatic, renal, or cardiac disease that would compromise the patient's safety or interfere with assessment of the drug.\n* Psychological, familial, sociological, geographical, or other concurrent conditions that would interfere with safety evaluation, limit the patient's ability to follow the procedures in the protocol or otherwise jeopardize compliance with the protocol. Patients with uncontrolled major depression, bipolar disorder, or severe anxiety disorder are excluded.\n* Patient has had or is currently having other malignant tumors within 3 years.\n* Patients have multiple factors that affect their oral medication.\n* Patients have long-term unhealed wounds or fractures.\n* Patients have uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage.\n* Patients are taking the following drugs and can't stop them during the study:\n\n  * Tylenol or medicine containing acetaminophen (paracetamol).\n  * Antacids (e.g. TUMS, calcium carbonate, or magnesium hydroxide), proton pump inhibitors (e.g. omeprazole), H2 blockers (e.g. famotidine), or buffered vitamins.\n* Epstein-Barr virus (EBV) negative nasopharyngeal carcinoma.\n\nFor Phase 2 only:\n\n* Negative result on TrkA immunohistochemistry (IHC) assay.\n* Have visceral crisis, defined as severe organ dysfunction and rapid progression of the cancer. (It is not about presence of visceral metastasis.)\n\nFor combination therapy with Pembrolizumab only:\n\n* Serious adverse immune related adverse events (grade 3 or 4) with previous PD-1(L1) inhibitor therapy, that were symptomatic and required prolong immunosuppression (\\>6 weeks).\n* Any grade Pneumonitis and Myocarditis related to prior PD-1(L1) inhibitor therapy.\n* For subjects that received PD-1(L1) inhibitors before, there should be a washout period of at least 21 days between the last day of PD-1(L1) inhibitor and first day of study medications.\n* Subjects who relapsed after prior treatment with PD-1(L1) inhibitors. Relapsed is defined as patients having best overall response of CR or PR after treatment with a PD-1(L1) inhibitor.",{"count":361,"type":21},242,[59,60],"This is a multicenter, open-label, Phase 1\u002F2 study of orally administered VMD-928 monotherapy and in combination with pembrolizumab in adult subjects with advanced solid tumors or lymphoma that have progressed or are non responsive to available therapies and for which no standard or available curative therapy exists",[365,366,67,84,367,368,369,370,371,372,373,374,375,376,28,377,378,379,380,381,382,383,384,385,386],"Head and Neck Carcinoma","Adenoid Cystic Carcinoma","Pancreatic Cancer","Mesothelioma","Esophageal Cancer","Any Solid Tumors Progressed After a Prior Immunotherapy","Head and Neck Squamous Cell Carcinoma","Head and Neck Squamous Cell Carcinoma HNSCC","Salivary Gland Carcinomas","Head and Neck Cancers - Salivary Gland","Head and Neck Cancers - Nasopharyngeal","Head and Neck Cancers - Throat","Lung Cancer (Locally Advanced or Metastatic)","Head and Neck Cancers - Tonsils","Head and Neck Cancers Hypopharynx","Head and Neck Cancers Larynx","Head and Neck Cancers Lip","Head and Neck Cancers Nasopharynx","Head and Neck Cancers Oral Cavity","Head and Neck Cancers","Head and Neck Cancers Oropharynx","Head and Neck Cancers Trachea",[388,389,365,366,67,84,78,368,390,391,392,393,33,394,338,384,395,396,397,398,399,400,401,402,403,404],"TrkA","NTRK1","Pancreatic","Progression after anti PD-1\u002FPD-L1 immunotherapy","Progressed after an immunotherapy","Esophageal","ACC","HNC","Salivary Gland Carcinoma","Nasopharyngeal","Throat","Tonsils","Hypopharynx","Larynx","Oral Cavity","Oropharynx","Trachea","2025-12-04",{"date":407,"type":39},"2025-12-11",{"date":409,"type":39},"2018-06-08",{"date":411,"type":21},"2028-06",{"name":413,"class":128},"VM Oncology, LLC",15,{"id":416,"slug":417,"hasResults":11,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":4,"eligibilityCriteria":421,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":422,"enrollmentInfo":423,"targetDuration":4,"studyType":22,"phases":425,"briefSummary":426,"conditions":427,"keywords":429,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":47},"100611878","early-phase-1-tc-d101-cell-therapy-for-patients-with-dll3-positive-sclc-100611878","NCT07246304","TC-D101 Cell Therapy for Patients With DLL3-Positive SCLC","A Preliminary Exploratory Clinical Study of TC-D101 in the Treatment of DLL3-Positive Relapsed\u002FRefractory Primary Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Participants must voluntarily provide written informed consent.\n2. Aged 18-75 years (inclusive).\n3. Life expectancy ≥ 3 months.\n4. ECOG performance status 0-1.\n5. Failed or unsuitable for standard therapy.\n6. At least one measurable lesion per RECIST 1.1.\n7. DLL3-positive r\u002Fr SCLC confirmed by immunohistochemistry.\n8. Adequate organ and bone marrow function.\n9. Effective contraception required for participants of childbearing potential.\n10. Adequate venous access for leukapheresis.\n\nExclusion Criteria:\n\n1. Primary CNS malignancy or uncontrolled CNS metastases.\n2. Other malignancies within 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ).\n3. Active autoimmune disease or history of autoimmune disease.\n4. Immunodeficiency, including HIV positivity.\n5. Bleeding disorders (inherited or acquired).\n6. Clinically significant cardiovascular disease.\n7. Active infection (including tuberculosis, hepatitis B\u002FC, syphilis).\n8. Pregnant or breastfeeding women.\n9. Clinically significant ascites . 10 Uncontrolled pleural effusion or pericardial effusion.\n\n11\\. Prior cell or gene therapy. 12. Severe drug hypersensitivity history. 13. Investigator-assessed unsuitability for trial participation.","75 Years",{"count":424,"type":21},24,[331],"This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of TC-D101 CAR-T cells in patients with DLL3-positive Relapsed\u002FRefractory primary small cell lung cancer(r\u002Fr SCLC) who have progressed after prior therapies. The primary objective is to determine the maximum tolerated dose (MTD), with a secondary aim to assess preliminary clinical efficacy in SCLC.",[28,428],"CAR-T Cell Therapy",[28,428,147],"2025-11-17",{"date":432,"type":39},"2025-11-24",{"date":434,"type":21},"2025-11-30",{"date":436,"type":21},"2028-11-30",{"name":438,"class":128},"TCRCure Biopharma Ltd.",{"id":440,"slug":441,"hasResults":11,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":422,"enrollmentInfo":446,"targetDuration":4,"studyType":22,"phases":448,"briefSummary":449,"conditions":450,"keywords":454,"overallStatus":279,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":47},"100608823","phase-1-penfluridol-for-relapsedrefractory-small-cell-cancers-100608823","NCT07206563","Penfluridol for Relapsed\u002FRefractory Small Cell Cancers","Penfluridol for Relapsed\u002FRefractory Small Cell Lung Carcinoma and Small Cell Cervical Cancer: An Open-Label, Multicenter, Single-Arm Ib\u002FII Trial","Inclusion Criteria:\n\n1. Patients aged 18 to 75 years, inclusive, regardless of gender.\n2. Histologically or cytologically confirmed small-cell carcinoma of the lung or cervix that is not curable by surgery or radiochemotherapy.\n3. Have received at least two prior systemic treatment regimens, including etoposide and platinum-based chemotherapy, and have experienced disease progression.\n4. No receipt of investigational or approved cytotoxic chemotherapy within 28 days before enrollment; no receipt of alkylating agents within 42 days before enrollment; no receipt of investigational or approved targeted therapy within 28 days or 5 half-lives before enrollment (whichever is shorter, but not less than 14 days); no radiotherapy within 14 days before enrollment.\n5. Presence of measurable disease according to RECIST 1.1 criteria; measurable lesions are defined as lesions that can be accurately measured in at least one dimension (longest diameter ≥10 mm on CT or MRI scans, and lymph nodes with short-axis diameter ≥15 mm).\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Expected survival of ≥12 weeks.\n8. Recovery of prior anticancer treatment toxicities to ≤Grade 1 (except for alopecia, pigmentation, or other toxicities deemed non-safety risks by the investigator); for irreversible toxicities that are not expected to worsen with study drug administration (e.g., hearing loss), inclusion may be considered after consultation with the medical monitor. Recovery of peripheral neuropathy to ≤Grade 2 after prior use of cisplatin or etoposide may be considered for inclusion after consultation with the medical monitor. For late toxicities caused by radiotherapy that cannot be recovered, inclusion may be considered after consultation with the medical monitor.\n9. Laboratory tests: Absolute neutrophil count ≥1.5×10⁹\u002FL; platelets ≥75×10⁹\u002FL; hemoglobin ≥90 g\u002FL; serum creatinine ≤1.5 times the upper limit of normal (ULN); urine protein \\\u003C2+ or 24-hour urine protein \\\u003C1.0 g; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times ULN (or ≤5 times ULN in the presence of liver metastasis); total bilirubin ≤1.5 times ULN; albumin ≥28 g\u002FL; coagulation function: prothrombin time (PT) and international normalized ratio (INR) ≤1.5×ULN.\n10. Female subjects with negative urine or blood HCG (except for menopausal and hysterectomy cases); sexually active female subjects and their partners must agree to use effective contraception (e.g., combined hormonal contraception, intrauterine device, bilateral tubal ligation, vasectomy, abstinence) during the study and for 6 months after the last dose.\n11. Availability of tumor specimens (paraffin-embedded blocks or frozen tissue) from prior resection or biopsy sufficient for pharmacodynamic assays (≥3 slides for immunohistochemistry IHC) (mandatory for dose-expansion cohort patients only).\n12. Ability to understand the study and voluntary consent to participate in the trial by the patient or their legal representative, with signed informed consent.\n\nExclusion Criteria:\n\n1. Histological diagnosis of squamous cell carcinoma, adenocarcinoma, or other non-small-cell types of lung or cervical cancer.\n2. Concurrent enrollment in another clinical trial, unless it is an observational, non-interventional study or the follow-up period of an interventional study.\n3. Known hypersensitivity to any component of penfluridol or similar compounds with comparable chemical or biological properties.\n4. Prior exposure to penfluridol.\n5. Known presence of leptomeningeal metastasis, spinal cord compression, leptomeningeal disease, or active brain metastases. However, patients with asymptomatic brain metastases (no neurological deficits, seizures, or other typical symptoms and signs of central nervous system metastasis; no requirement for corticosteroids) or those who have been treated and are stable on imaging for at least 4 weeks before study treatment (with no new or enlarged brain metastases) and have discontinued systemic corticosteroids and anticonvulsant medications for at least 2 weeks may be included.\n6. Uncontrolled comorbid conditions, including but not limited to persistent or active infections or psychiatric\u002Fsocial conditions that would limit compliance with study requirements.\n7. Positive for human immunodeficiency virus (HIV) on combination antiretroviral therapy.\n8. Cardiovascular history or comorbidities: Known history of arrhythmias (including atrial fibrillation, tachycardia, or bradycardia), except for benign ventricular premature beats; history of CHF, MI, or stroke within the past 3 months.\n9. History of seizure within the past 3 months.\n10. Gastrointestinal dysfunction or disease that may significantly alter the absorption of penfluridol (e.g., uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).\n11. Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant.\n12. Uncontrolled severe medical conditions that, in the opinion of the investigator, would affect the patient's ability to receive the study treatment, such as severe internal medicine conditions, including hepatic or renal insufficiency, severe cardiovascular disease, cerebrovascular disease, uncontrolled diabetes, or uncontrolled infections.\n13. Pregnant or breastfeeding women; sexually active female subjects unwilling to use contraception.\n14. Presence of symptomatic or unstable pleural effusion, ascites, or pericardial effusion requiring repeated drainage.\n15. Patients deemed unsuitable for the study by the investigator.",{"count":447,"type":21},33,[59,60],"Penfluridol for Relapsed\u002FRefractory Small-Cell Carcinoma of the Lung or Cervix: A Multicenter, Open-Label, Single-Arm Phase Ib\u002FII Trial This study evaluates the safety and anti-tumor activity of oral penfluridol, a first-generation antipsychotic that pre-clinically inhibits small-cell carcinoma (SCC) growth via DRD2 blockade, metabolic reprogramming and apoptosis induction. After ≥2 prior systemic regimens, 33 adult patients (18-75 y) with measurable, metastatic or recurrent lung or cervical SCC will be enrolled across five Chinese centers. A 3+3 dose-escalation (Ib) will establish the recommended Phase II dose (RP2D); an expansion cohort (II) will examine objective response rate (ORR, RECIST 1.1). Secondary end-points include duration of response, progression-free survival, overall survival, safety and exploratory biomarkers. Key inclusion: ECOG 0-1, adequate organ function, no active brain metastases. Penfluridol is administered once weekly, dose-escalated from 20 mg to RP2D, continued until progression or intolerance. Patients receive free study drug, PET imaging and laboratory monitoring.",[451,452,28,453],"Small Cell Carcinoma","Small Cell Carcinoma of Lung","Small Cell Cervical Carcinoma",[455,456,457,458,459],"Small cell cervical carcinoma","small cell lung carcinoma","Relapsed\u002Frefractory","Phase Ib\u002FII","DRD2 targeting","2025-09-25",{"date":462,"type":39},"2025-10-03",{"date":464,"type":21},"2025-10-01",{"date":466,"type":21},"2028-10-01",{"name":468,"class":46},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":470,"slug":471,"hasResults":11,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":4,"eligibilityCriteria":475,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":476,"targetDuration":4,"studyType":22,"phases":478,"briefSummary":480,"conditions":481,"keywords":4,"overallStatus":279,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":485,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":491,"locationsCount":4},"100601133","phase-2-organoid-guided-vs-topotecan-therapy-in-relapsed-extensive-stage-small-cell-lung-cancer-100601133","NCT07106528","Organoid-guided vs Topotecan Therapy in Relapsed Extensive-Stage Small Cell Lung Cancer","Organoid-Based Drug Sensitivity Model Guided Personalized Precision Treatment for Extensive-Stage Small Cell Lung Cancer: A Prospective, Multicenter, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Aged 18 years or older.\n2. Pathologically confirmed extensive-stage small cell lung cancer (ES-SCLC) (AJCC 9th edition, Stage IV).\n3. Previously received first-line platinum-based systemic chemotherapy and experienced recurrence or progression during first-line treatment or within ≤ 6 months after completion of first-line treatment.\n4. Availability of sufficient tumor tissue or malignant serous effusion for organoid culture.\n5. Presence of measurable lesions based on RECIST 1.1.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Adequate bone marrow and organ function, confirmed by baseline blood count, blood biochemistry, and urine biochemistry tests.\n8. Asymptomatic and stable central nervous system (CNS) metastases are allowed.\n9. Expected survival of at least 3 months.\n10. For male participants: Agreement to use effective contraception during treatment and for at least 180 days after the last dose of study treatment; prohibition of sperm donation during this period.\n11. For female participants: Not pregnant or breastfeeding, and meeting at least one of the following:\n\n    Women of non-childbearing potential; or Agreement to use effective contraception during treatment and for at least 180 days after the last dose of study treatment; or Women of childbearing potential must have a negative serum or urine pregnancy test (with a minimum sensitivity of 25 IU\u002FL or HCG equivalent units) within 72 hours before initiating treatment.\n12. Voluntary participation with signed informed consent and willingness to comply with study follow-up procedures.\n\nExclusion Criteria:\n\n1. Mixed tumor pathology or lack of histological confirmation.\n2. Previous receipt of second-line or higher systemic anti-tumor therapy for ES-SCLC.\n3. Symptomatic or progressive brain metastases, or meningeal metastases.\n4. History of other malignant tumors that are progressive or require active treatment within the past 5 years.\n5. Presence of active infections, severe organ dysfunction, or other contraindications to anti-tumor treatment.\n6. Inability to obtain tumor tissue or insufficient malignant serous effusion for collection.\n7. Expected survival of less than 3 months.\n8. Inability to complete standardized clinical diagnosis\u002Ftreatment or regular follow-up.",{"count":477,"type":21},128,[60,479],"PHASE3","This study aims to provide personalized treatment options for patients with extensive-stage small cell lung cancer (SCLC) whose disease has worsened after initial chemotherapy.\n\nResearchers will use a novel approach called \"tumor organoid drug sensitivity testing\":\n\nA small sample of the patient's tumor (from biopsy or fluid) is grown into miniature 3D tumor models (\"organoids\") in the lab.\n\nThese organoids are exposed to various FDA-approved second-line drugs (including chemotherapy and newer targeted\u002Fimmunotherapy drugs if available).\n\nThe most effective drug for each patient's organoids will be recommended for their treatment.\n\n128 participants will be randomly assigned to one of two groups:Experimental Group: Receive organoid-guided personalized therapy; Control Group: Receive standard second-line chemotherapy (Topotecan).\n\nThe study will compare: How long the cancer remains controlled (Progression-Free Survival); Overall survival time; Treatment response rates and side effects.\n\nPotential benefits: May identify more effective treatments for individual patients; Could extend time without cancer progression.\n\nRisks: Organoid testing requires an additional tumor biopsy\u002Ffluid collection; Possible side effects from second-line drugs.",[482,483,28],"Extensive-stage Small Cell Lung Cancer (ES-SCLC)","Extensive-stage Small Cell Lung Cancer (SCLC)","2025-08-05",{"date":486,"type":39},"2025-08-06",{"date":488,"type":21},"2025-08",{"date":490,"type":21},"2028-12",{"name":492,"class":46},"Peking Union Medical College Hospital",{"id":494,"slug":495,"hasResults":11,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":4,"eligibilityCriteria":499,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":500,"targetDuration":4,"studyType":217,"phases":4,"briefSummary":502,"conditions":503,"keywords":505,"overallStatus":279,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":47},"100598756","a-study-to-evaluate-the-incidence-of-clinically-suspicious-lambert-eaton-myasthenic-syndrome-lems-in-subjects-diagnosed-with-small-cell-lung-cancer-sclc-100598756","NCT07075627","A Study to Evaluate the Incidence of Clinically Suspicious Lambert-Eaton Myasthenic Syndrome (LEMS) in Subjects Diagnosed With Small Cell Lung Cancer (SCLC)","An Observational Study to Evaluate the Incidence of Clinically Suspicious Lambert-Eaton Myasthenic Syndrome (LEMS) in Subjects Diagnosed With Small Cell Lung Cancer (SCLC)","Inclusion Criteria:\n\n1. Adult men or women meeting Age of Majority (AOM) at the time of consent\n2. Provide voluntary consent to participate in this study, documented via a signed informed Consent Form (ICF)\n3. Any diagnosis of SCLC\n4. Willing to provide clinical and medical information related to his\u002Fher cancer diagnoses to the study team as required\n5. Willing to comply with the requirements of the study\n\nExclusion Criteria:\n\n1. Has been diagnosed with non-tumor Lamber-Eaton Myasthenic syndrome (LEMS) \\> 1 year prior to the SCLC diagnosis.\n2. Known existence of an uncontrolled intercurrent illness including, but not limited to, psychiatric illness or social situations that would impair compliance with study requirements",{"count":501,"type":21},400,"This is a multi-center observational study in subjects with a diagnosis of small cell lung cancer. Screening and\u002For medical record review for symptoms associated with Lambert Eaton Myasthenic Syndrome (LEMS) will be conducted.",[28,504],"Lambert Eaton Myasthenic Syndrome (LEMS)",[33,506,145,507],"LEMS","lambert eaton myasthenic syndrome","2025-07-30",{"date":510,"type":39},"2025-08-01",{"date":512,"type":21},"2025-09",{"date":514,"type":21},"2026-12",{"name":516,"class":46},"Addario Lung Cancer Medical Institute",{"id":518,"slug":519,"hasResults":11,"nctId":520,"briefTitle":521,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":523,"targetDuration":4,"studyType":22,"phases":525,"briefSummary":526,"conditions":527,"keywords":531,"overallStatus":279,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":47},"100598849","zusanli-st36-electroacupuncture-treatment-for-neoadjuvant-immunotherapy-in-non-small-cell-lung-cancer-100598849","NCT07076836","Zusanli (ST36) Electroacupuncture Treatment for Neoadjuvant Immunotherapy in Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Age ≥18 and ≤80 years at the time of written informed consent, of either sex;\n2. Histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer (SCLC) or non-small cell lung cancer (NSCLC) receiving neoadjuvant immunotherapy;\n3. Undergoing standard first-line treatment with chemotherapy plus immunotherapy\n4. ECOG performance status score of 0-2;\n5. Life expectancy \\>3 months;\n6. At least one measurable target lesion per RECIST 1.1 criteria:\n7. Tumor lesions with a long axis ≥10 mm on CT scan (slice thickness ≤5 mm);\n8. Lymph node lesions with a short axis ≥10 mm on CT scan;\n9. Previously irradiated or locally treated lesions may be designated as target lesions if documented tumor progression post-treatment.\n10. Adequate major organ function within 14 days prior to randomization, defined by the following laboratory parameters without blood transfusions, growth factors, albumin, or blood products:\n11. Hematological tests: Hemoglobin ≥80 g\u002FL; Absolute neutrophil count \\>1.5×10⁹\u002FL; Platelet count ≥90×10⁹\u002FL;\n12. Biochemical tests: Total bilirubin ≤1.5×ULN (upper limit of normal); ALT\u002FAST ≤2.5×ULN; Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault formula);\n13. Coagulation tests: Prothrombin time (PT) and INR ≤1.5×ULN (unless on warfarin anticoagulation);\n14. Cardiac evaluation: Left ventricular ejection fraction (LVEF) ≥50% by Doppler echocardiography.\n15. Voluntary participation with signed informed consent, good compliance, and willingness of the patient and their family to cooperate with survival follow-up.\n\nExclusion Criteria:\n\n1. Pregnant participants;\n2. Post-organ transplant patients;\n3. Patients with uncontrolled diabetes mellitus, severe cardiac, central nervous system, psychiatric disorders, or coagulopathy;\n4. Patients with severe malnutrition;\n5. Patients with implanted cardiac pacemakers;\n6. Patients with bleeding disorders;\n7. Patients with a history of severe allergies or anaphylaxis;\n8. Patients with skin infections, lesions, ulcers, or scars at the ST36 (Zusanli) acupoint site;\n9. Patients with metal allergy, severe needle phobia, or intolerance to electroacupuncture therapy.",{"count":524,"type":21},82,[24],"This study aims to investigate the potential synergistic effects of acupuncture combined with immune checkpoint inhibitors in cancer therapy. Over the past decade, significant progress in cancer immunotherapy has been driven by breakthroughs in understanding immune checkpoint molecules; however, monotherapy with immune checkpoint inhibitors still faces challenges due to low response rates. As a traditional Chinese medical intervention, acupuncture modulates neuro-immune pathways to achieve remote regulation of organ functions, with particular anti-tumor potential observed at the Zusanli (ST36) acupoint-a site located 2 cm below the knee that can be stimulated via electroacupuncture (EA) to improve gastrointestinal function and alleviate inflammation. Preclinical evidence demonstrates that EA suppresses tumor growth in breast cancer models, reduces levels of pro-inflammatory cytokines such as IL-1β and TNF-α, enhances anti-tumor activity of CD8+ T cells and NK cells, and decreases accumulation of immunosuppressive myeloid-derived suppressor cells (MDSCs). Animal studies show that ST36 EA increases key immunomodulatory factors like serum IFN-γ, IL-2, and IL-17, thereby potentiating the efficacy of anti-tumor drugs. Guided by the traditional TCM principle of \"reinforcing healthy qi to consolidate the body's resistance,\" modern clinical applications of EA combined with specific acupoint regimens (e.g., ST36, Sanyinjiao) have effectively alleviated cancer-related pain, chemotherapy-induced side effects, and fatigue. This study will evaluate the safety and immunosensitization effects of ST36 EA combined with PD-1 inhibitors in non-small cell lung cancer patients, employing 1 mA electroacupuncture for 3 consecutive days to activate immune responses. By leveraging acupuncture-induced immune remodeling, this approach aims to provide a novel integrative medicine strategy to overcome resistance to immunotherapy.",[528,28,529,530],"Lung Cancer (NSCLC)","Immune Checkpoint Blockade","Electroacupuncture",[532,533,534,535],"lung cancer (NSCLC)","small cell lung cancer (SCLC)","immune checkpoint blockade","electroacupuncture","2025-07-11",{"date":538,"type":39},"2025-07-22",{"date":540,"type":21},"2025-07-31",{"date":542,"type":21},"2026-06-30",{"name":544,"class":46},"West China Hospital"]