[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"small-cell-lung-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:small-cell-lung-carcinoma":44},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,100,127,150,173,198,224,255,288,324,354,404,434,461,486,506,532,555,581,608,635,656,677,698,723],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":58,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":99},"100407463","phase-1-the-evaluation-of-pc14586-in-patients-with-advanced-solid-tumors-harboring-a-tp53-y220c-mutation-pynnacle-100407463",false,"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","ALL","12 Years",{"count":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24,25],"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.",[28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57],"Advanced Solid Tumor","Advanced Malignant Neoplasm","Metastatic Cancer","Metastatic Solid Tumor","Lung Cancer","Ovarian Cancer","Endometrial Cancer","Prostate Cancer","Colorectal Cancer","Breast Cancer","Other Cancer","Locally Advanced","Head and Neck Cancer","Gall Bladder Cancer","Small Cell Lung Cancer","Small Cell Lung Cancer ( SCLC )","Small Cell Lung Carcinoma","NSCLC","NSCLC (Non-small Cell Lung Cancer)","SCLC","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",[59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86],"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","RECRUITING","2026-06-24",{"date":90,"type":91},"2026-06-26","ACTUAL",{"date":93,"type":91},"2020-10-29",{"date":95,"type":21},"2027-12-31",{"name":97,"class":98},"PMV Pharmaceuticals, Inc","INDUSTRY",77,{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":111,"conditions":112,"keywords":113,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":126},"100377838","phase-1-petct-imaging-of-small-cell-lung-cancer-using-89zr-dfo-sc1656-100377838","NCT04199741","PET\u002FCT Imaging of Small Cell Lung Cancer Using 89Zr-DFO-SC16.56","Immuno-PET Imaging of Neuroendocrine Tumors Using 89Zr-DFO-SC16.56, a DLL3-targeting Monoclonal Antibody","Inclusion Criteria:\n\nSubject Inclusion Criteria for Adult population\n\n* Signed, informed consent\n* Age 18 or more years\n* Histologically confirmed, SCLC, (newly diagnosed or recurrent); small cell carcinoma of unknown or non-lung origin; or other types of neuroendocrine tumor OR Histologically confirmed prostate cancer, with suspected or confirmed NEPC based upon clinical assays obtained prior to the trial OR Histologically confirmed or suspected primary brain neoplasm OR Desmoplastic small round cell tumors, osteosarcoma, Ewing's sarcoma, rabdomyosarcoma, Wilms tumors, hepatoblastomas, rhabdoid tumors and neuroblastoma patients\n* At least one tumor lesion on CT2 or MRI ≥ 0.8 cm OR\n* Tumor detectable FDG PET, PSMA PET, DOTATATE PET, MIBG SPECT (or planar MIBG scan if SPECT unavailable) OR\n* MRI or bone scan that shows new osseous metastases. The scans should have been obtained in the last 12 weeks\n* ECOG performance status 0 to 2\n* Negative serum pregnancy test within 2 weeks of 89Zr-DFO-SC16.56 for women of child-bearing potential\n* Available archival tumor specimen suitable for DLL3 IHC or clinician already has plans to obtain tumor specimen as part of standard of care (unrelated to patient participation in 19-292) which will yield sufficient tumor specimen to allow for DLL3 IHC\n* For the prostate cancer patient cohort, as an alternative if archival tissue is not available, patients must be willing to undergo PET\u002FCT guided biopsy3 as described in section 9.3.\n\n  1. Patients with SCLC will be the primary study population, however patients with other types of neuroendocrine tumors may be included at the PI's discretion.\n  2. Criterion is intended to demonstrate presence of imageable disease. A low-dose CT (e.g. from a PET\u002FCT scan) may be used at PI's discretion.\n  3. While willingness to undergo the biopsy is required if archival tissue is not available, PET\u002FCT guided biopsy is not a mandatory study assessment. As described in section 9.3, the guided biopsy may be waived at the discretion of the principal investigator if the DLL3 PET\u002FCT reveals no sites of DLL3 tracer-avid tumor or if the principal investigator deems itis not in the best interest of the patient, according to best clinical judgement. The pediatric population would not be approached for an optional PET\u002FCT-guided biopsy\n\nSubject Inclusion Criteria for Pediatric population\n\n* Signed, informed consent\n* Age 4 or more years\n* High risk neuroblastoma patients\n* At least one tumor lesion on CT2 or MRI ≥ 0.8 cm OR Tumor detectable FDG PET, PSMA PET, DOTATATE PET, MIBG SPECT (or planar MIBG scan if SPECT unavailable) OR MRI or bone scan that shows new osseous metastases. The scans should have been obtained in the last 12 weeks\n* ECOG performance status 0 to 2\n* Performance Status: Subjects must have a Lansky (\\\u003C16 years) of at least 40\n* Negative serum pregnancy test within 2 weeks of 89Zr-DFO-SC16.56 for women of child-bearing potential\n\nExclusion Criteria:\n\nSubject Exclusion Criteria for the Adult population\n\n* History of anaphylactic reaction to humanized or human antibodies\n* Pregnant or breast feeding\n* Psychiatric illness that would interfere with compliance with the study procedures\n* Inability to undergo PET scan due to weight limit\n* Patients who require anesthesia or monitored sedation to tolerate PET scan procedure\n\nSubject Exclusion Criteria for the Pediatric population\n\n* History of anaphylactic reaction to humanized or human antibodies\n* Pregnant or breast feeding\n* Psychiatric illness that would interfere with compliance with the study procedures\n* Inability to undergo PET scan due to weight limit\n* Patients who require anesthesia or monitored sedation to tolerate PET scan procedure","18 Years",{"count":109,"type":21},53,[24,25],"The purpose of this study is to look at how safe 89Zr-DFO-SC16.56 is, and how it is processed by the body in people with small cell lung cancer.",[42,44],[114,44,115,116,117],"Small cell lung cancer","89Zr-DFO-SC16.56","19-292","Memorial Sloan Kettering Cancer Center",{"date":119,"type":91},"2026-06-25",{"date":121,"type":91},"2019-12-11",{"date":123,"type":21},"2027-06-11",{"name":117,"class":125},"OTHER",1,{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":12,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":149},"100507028","phase-2-dareon-5-a-study-to-test-whether-different-doses-of-bi-764532-help-people-with-small-cell-lung-cancer-or-other-neuroendocrine-cancers-100507028","NCT05882058","DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers","DAREON™-5: An Open-label, Multi-center Phase II Dose Selection Trial of Intravenous BI 764532, a DLL3-targeting T Cell Engager, in Patients With Relapsed\u002FRefractory Extensive-stage Small Cell Lung Cancer and in Patients With Other Relapsed\u002FRefractory Neuroendocrine Carcinomas","Inclusion criteria:\n\n1. Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF).\n2. Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.\n3. Part 1: Histologically or cytologically confirmed, cancer of the following histologies:\n\n   * Small cell lung cancer (SCLC)\n   * Extra-pulmonary neuroendocrine carcinoma (epNEC) (except Merkel cell carcinoma (MCC), Medullary thyroid cancer (MTC) and Neuroendocrine prostate cancer (NEPC))\n   * Large cell neuroendocrine carcinoma (LCNEC) of the lung Patients with tumours with mixed histologies for any above type are eligible only if the neuroendocrine carcinoma\u002Fsmall tumour cells component is predominant and represents at least 50% of the overall tumour tissue.\n\n   Patients must have progressed or recurred after standard of care therapy\n   * SCLC: after at least two prior lines of therapy, including at least one platinum-based regimen; in countries where standard of care in first line therapy includes PD-L1 inhibitor treatment patients should have received the combination of platinum-based regimen plus PD-L1 inhibitor unless they have been unable to receive checkpoint inhibitor treatment.\n   * Therapy includes PD-L1 inhibitor treatment; patients should have received the combination of platinum-based regimen plus PD-L1 inhibitor unless they have been unable to receive checkpoint inhibitor treatment.\n   * epNEC\u002FLCNEC: after at least one platinum-based regimen. Part 2 and part 3: Histologically or cytologically confirmed epNEC (except MCC, MTC and NEPC) with centrally assessed DLL3 high expression status. Patients must have progressed or recurred after at least one platinum-based regimen.\n4. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.,\n5. Measurable lesions as defined per Response Evaluation Criteria In Solid Tumours (RECIST) v 1.1 within 21 days prior to the first dose of BI 764532.\n6. Part 1: Availability of archival tumour tissue sample Part 2 and part 3: Availability of archival formalin-fixed paraffin-embedded (FFPE) tumour tissue sample. Following specimens are not allowed: Fine Needle Aspiration (FNA), Cytology samples, decalcified bone samples.\n7. Adequate organ function as defined in the protocol.\n8. All toxicities related to previous anti-cancer therapies have resolved = Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 prior to trial treatment administration (except for alopecia, peripheral neuropathy, fatigue and endocrinopathies controlled by replacement therapy which must be = CTCAE Grade 2 and amenorrhea\u002Fmenstrual disorders which can be any grade).\n9. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use acceptable methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the participant information\n10. Only for Part 3, at the timepoint of Screening 02:\n\n    * For Cycle 1, patients should be willing to stay within 1 hour driving distance for 48 hours after IMP administration and confirm availability of a caregiver for the same timeframe.\n    * Patients should be considered suitable by the investigator to follow instructions applicable to the reduced monitoring cohort, such as taking their temperature and administration of oral medication at home if needed.\n\nExclusion criteria:\n\n1. Untreated or symptomatic brain metastases. (Part 2 and part 3: identified during the mandatory assessment by brain MRI within 21 days before first trial drug administration.) Participants with treated, stable brain metastases are eligible provided they meet the following criteria:\n\n   * Radiotherapy or surgery for brain metastases was completed at least 2 weeks prior to the first administration of BI 764532.\n   * Patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off anti-epileptic drugs for at least 7 days or on stable doses of anti-epileptic drugs for malignant central nervous system (CNS) disease.\n2. Presence of leptomeningeal disease or, part 2 and part 3: epidural disease including spinal cord compression.\n3. Part 1: Active\u002Fprevious history of interstitial lung disease or non-infectious pneumonitis (any grade).\n\n   Part 2 and part 3: Active\u002Fprevious history of interstitial lung disease, pulmonary fibrosis, organizing pneumonia or non-infectious pneumonitis (any grade). Patients with a history of therapy-related pneumonitis that is considered clinically resolved are eligible.\n4. Participants who experienced severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.\n5. Prior anti-cancer therapy:\n\n   * Patients who have been treated with any other anti-cancer drug within 4 weeks or within 5 half-life periods (whichever is shorter) prior to first administration of BI 764532.\n   * Patients who have been treated with extensive field radiotherapy including whole brain irradiation within 2 weeks prior to first administration of BI 764532.\n6. Previous treatment with Delta-like ligand 3 (DLL3)-targeting T cell engagers or cell therapies.\n7. Diagnosis of immunodeficiency or systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of BI 764532. Physiological replacement of steroids is allowed.\n8. Unresolved toxicity from prior anti-tumour therapy, defined in the inclusion criteria.\n\nFurther exclusion criteria apply.",{"count":135,"type":21},204,[25],"This study is open to adults with small cell lung cancer and other neuroendocrine tumours. The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists.\n\nThe purpose of this study is to find a suitable dose of BI 764532 (also called obrixtamig) that people with advanced cancer can tolerate. 2 different doses of BI 764532 are tested in this study. Another purpose is to check whether BI 764532 can make tumours shrink. BI 764532 is an antibody-like molecule (DLL3\u002FCD3 bispecific) that may help the immune system fight cancer.\n\nThe study has 3 parts. In Part 1, participants are put into 2 groups randomly, which means by chance. Participants have an equal chance of being in either group. One group gets dose 1 of BI 764532 and the other group gets dose 2 of BI 764532. In Part 2 and Part 3, all participants receive the same dose of BI 764532. Part 2 and Part 3 are open to people with a certain kind of tumour called extrapulmonary neuroendocrine carcinoma.\n\nAll participants receive BI 764532 as an infusion into a vein when starting treatment. If there is benefit for the participants and if they can tolerate it, the treatment is given up to the maximum duration of the study. During this time, participants visit the study site regularly. The total number of visits depends on how they respond to and tolerate the treatment.\n\nThe first study visits include an overnight stay to monitor participants´ safety. Doctors record any unwanted effects and regularly check the general health of the participants.",[44,139,140],"Neuroendocrine Neoplasms","Extra-pulmonary Neuroendocrine Carcinoma","2026-06-23",{"date":88,"type":91},{"date":144,"type":91},"2023-10-13",{"date":146,"type":21},"2028-02-24",{"name":148,"class":98},"Boehringer Ingelheim",59,{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":12,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":22,"phases":159,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":5},"100596550","phase-1-a-study-of-ly4175408-in-participants-with-advanced-cancer-100596550","NCT07046923","A Study of LY4175408 in Participants With Advanced Cancer","A First-in-Human, Phase 1a\u002F1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4175408, an Antibody Drug Conjugate Targeting Protein Tyrosine Kinase 7-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors","Inclusion Criteria:\n\n* Have one of the following advanced or metastatic solid tumor cancers:\n\n  * Non-small cell lung cancer (NSCLC)\n  * Small cell lung cancer (SCLC)\n  * Endometrial cancer\n  * Triple negative breast cancer (TNBC) (characterized by HR-negative disease and HER2-negative expression according to American Society of Clinical Oncology (ASCO) - College of American Pathologists guidelines).\n* Received all standard therapies for which the individual was deemed to be an appropriate candidate by the treating investigator (except in Cohort B1 and B2 expansion, which require participants who are treatment naive in the advanced metastatic setting); OR the individual is refusing the remaining most appropriate standard of care treatment; OR there is no standard therapy available for the disease.\n* Eastern Cooperative Oncology Group (ECOG) performance status of greater than or equal to (≤) 1.\n* For dose optimization\u002Fdose and expansion cohorts (Cohort A2, Cohort B\u002FC): Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n* Cohorts B1\u002FB2: NSCLC with no known actionable genomic alterations. ≤2 prior lines of systemic therapy for advanced or metastatic disease in safety lead-in; no prior systemic therapy in expansion\n\nExclusion Criteria:\n\n* Prior treatment with a protein tyrosine kinase 7 (PTK7) antibody-drug conjugate (ADC) with a topoisomerase I inhibitor as payload (prior therapy with a PTK7 ADC with a non-topoisomerase I inhibitor payload OR non-PTK7 ADC with any payload is permitted). Prior topoisomerase I-based ADCs are not allowed in cohorts A2, B1 or B2.\n* Any serious unresolved toxicities from prior therapy.\n* Individual with known or suspected history of uncontrolled central nervous system (CNS) metastases.\n* Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection.\n* Significant cardiovascular disease.\n* Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) \\> 470 milliseconds (ms)\n* History of pneumonitis\u002Finterstitial lung disease.\n* Individuals who are pregnant, breastfeeding, or plan to breastfeed during the trial or within 30 days of the last dose of trial intervention.",{"count":158,"type":21},240,[24],"The purpose of this study is to measure the safety and efficacy of LY4175408 in participants with selected advanced cancer. In addition, this study will evaluate how much LY4175408 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it. Participation could last up to 4 years.",[162,44,163,164,49],"Carcinoma, Non-Small-Cell Lung","Endometrial Neoplasms","Neoplasm Metastasis","2026-06-19",{"date":141,"type":91},{"date":168,"type":91},"2025-07-28",{"date":170,"type":21},"2030-07",{"name":172,"class":98},"Eli Lilly and Company",{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":17,"minAge":107,"maxAge":181,"enrollmentInfo":182,"targetDuration":4,"studyType":22,"phases":184,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":197},"100592375","phase-3-durvalumab-after-chemoradiotherapy-in-limited-stage-small-cell-lung-cancer-100592375","NCT06992609","Durvalumab After Chemoradiotherapy in Limited Stage Small Cell Lung Cancer.","A Phase IIIb Study of Durvalumab as Consolidation Treatment for Patients Diagnosed With Limited Stage Small Cell Lung Cancer Who Have Not Progressed Following Definitive Concurrent or Sequential Platinum-based Chemoradiation Therapy in Spain (ALBORAN).","ALBORAN","Inclusion Criteria:\n\n* Female or male patients aged ≥18 years at the time of signing the Informed Consent Form (ICF).\n* Written informed consent obtained from the patient\u002Flegal representative prior to performing any protocol-related procedures. Additionally, signed and dated written genetic and\u002For biomarker informed consents, respectively, to collect baseline tissue and blood samples for future translational biomarker assessment at baseline, at the initiation of durvalumab maintenance treatment (cycles 1, 2, 3, 4, 7, 10, 13, 19, 26), and at end of treatment\u002Fprogression.\n* Patients must have histologically or cytologically documented limited stage SCLC (stage I-III SCLC \\[T any, N any, M0\\] according to the AJCC Cancer Staging Manual, \\[8th Edition\\] or the IASLC Staging Manual in Thoracic Oncology \\[2016\\]), i.e., patients whose disease can be encompassed within a radical radiation portal. Patients who are stage I or II must be medically inoperable as determined by investigator.\n* WHO\u002FECOG PS of 0, 1 or 2 at enrolment, after CRT. A maximum of 20% of patients with ECOG 2 is allowed.\n* Received an appropriate first-line concurrent or sequential chemoradiotherapy regimen as defined below, unless after consultation with the study medical team an alternative is acceptable:\n\n  * Received 3-4 cycles of platinum-based chemotherapy concurrent or sequential with radiotherapy, which must be completed within 1 to 90 days prior to the first dose of durvalumab.\n  * The chemotherapy regimen must contain platinum and IV etoposide, administered as per local SoC regimens.\n* Received a total dose of radiation of 60 to 66 Gy (±10%) over approximately 6 weeks for standard QD radiation schedules or 45 Gy (±10%) over approximately 3 weeks for hyperfractionated BID radiation schedules.\n* Patients must have achieved CR, PR, or SD and not have progressed following definitive, platinum-based chemoradiotherapy. NOTE: PCI may be delivered at the discretion of investigator and local standard of care and must be conducted after the end of CRT and completed between 1 to 90 days to first dose of IP.\n* Adequate organ and marrow function (independent of transfusion, infusion, or growth factor support for at least 14 days prior to obtaining screening labs), defined as below:\n\n  * Haemoglobin ≥9.0 g\u002FdL\n  * Absolute neutrophil count ≥1.5 x 109\u002FL\n  * Platelet count ≥100 x 109\u002FL\n  * Serum bilirubin ≤1.5 x the ULN. This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia \\[predominantly unconjugated bilirubin\\] in the absence of evidence of hemolysis or hepatic pathology), who will be allowed in consultation with their physician.\n  * ALT and AST ≤2.5 x ULN\n  * Measured creatinine clearance (CL) \\>40 mL\u002Fmin or calculated CL \\>40 mL\u002Fmin as determined by Cockcroft-Gault (using actual body weight) Males Creatinine CL (mL\u002Fmin) = (Weight (kg)×(140-Age))\u002F(72×serum creatinine (mg\u002FdL)) Females Creatinine CL (mL\u002Fmin) = (Weight (kg)×(140-Age))\u002F(72×serum creatinine (mg\u002FdL) )× 0.85\n* Must have a life expectancy of at least 12 weeks.\n* Body weight \\>30 kg.\n\nExclusion Criteria:\n\n* Mixed SCLC and NSCLC histology.\n* Extensive-stage SCLC.\n* Any history of grade ≥2 pneumonitis.\n* History of allogeneic organ transplantation.\n* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[except for diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis\\], Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc. The following are exceptions to this criterion:\n\n  * Patients with vitiligo or alopecia.\n  * Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement.\n  * Any chronic skin condition that does not require systemic therapy.\n  * Patients without active disease in the last 5 years may be included but only after consultation with the study physician.\n  * Patients with celiac disease controlled by diet alone.\n* Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active ILD, serious chronic GI conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n* History of another primary malignancy except for:\n\n  * Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of durvalumab and of low potential risk for recurrence.\n  * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\n  * Adequately treated carcinoma in situ without evidence of disease.\n* History of leptomeningeal carcinomatosis.\n* History of active primary immunodeficiency.\n* Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known positive HBsAg result), hepatitis C (HCV), or human immunodeficiency virus (positive HIV 1\u002F2 antibodies).\n\n  * NOTE: Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n* Any unresolved toxicity NCI Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 from previous CRT except for alopecia, vitiligo, and the laboratory values defined in the inclusion criteria:\n\n  * Patients with grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician.\n  * Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the study physician.\n* Brain metastases or spinal cord compression. All patients will have an MRI (preferred) or CT, preferably with IV contrast of the brain, prior to study entry, after CRT.\n* Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart).\n* Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n* Patients whose conditions have progressed while on CRT.\n* Major surgical procedure (as defined by the Investigator) within 42 days prior to the first dose of IP.\n* Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:\n\n  * Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection).\n  * Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent.\n  * Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication).\n* Participation in another clinical study with an investigational product administered in the last 4 weeks.\n* Concurrent enrolment in another clinical study unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.\n* Involvement in the planning and\u002For conduct of the study (applies to both AstraZeneca staff and\u002For staff at the study site).\n* Female patients who are pregnant or breastfeeding and male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 3 months after the last dose of durvalumab.\n* Judgment by the investigator that the patient should not participate in the study because the patient is unlikely to comply with study procedures, restrictions, and requirements.","130 Years",{"count":183,"type":21},70,[185],"PHASE3","Lung cancer is a highly prevalent disease worldwide in women and men. In 2022, lung cancer stood as the most frequently diagnosed cancer with approximately 2.48 million new cases on a global scale, followed by cancers of the female breast (11.6%), colorectum (9.6%), prostate (7.3%), and stomach (4.9%).\n\nLung cancer is the leading cause of cancer death worldwide according to data provided by the International Agency for Research on Cancer. In 2022 they estimated a 1.8 million deaths across the world. Specifically in Spain, from 1980 to 2022, lung cancer led to 745,182 deaths.\n\nHistologically, lung cancer (LC) can be classified into two major subtypes: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), accounting for 85% and 15% of LC patients, respectively. Smoking is the major risk factor for SCLC.\n\nThere are two stages of SCLC: limited-stage SCLC (LS-SCLC) and extensive-stage SCLC (ES-SCLC). Limited-stage (LS) means that the cancer is located on the ipsilateral hemithorax that can be encompassed within a radiation port while extensive-stage (ES) means that the cancer has spread widely throughout the lungs, to non-regional lymph nodes or to other organs. At present, LS is identified in \\~30% of patients, and ES is identified in \\~70% of patients with SCLC.\n\nWith a 5-year survival rate of less than 7%, SCLC is still one of the most lethal malignancies and it is also characterized by early metastatic spread. Reflecting this high metastatic capacity, two thirds of patients already have tumor cell dissemination outside the chest at the time of initial diagnosis (ES-SCLC). Therefore, the number of patients with LS-SCLC who can benefit from multimodality therapy with potentially curative intent is limited. SCLC is a highly aggressive form of LC that typically recurs and progresses rapidly despite initial response to chemotherapy and radiotherapy in patients with LS-SCLC.\n\nThe etoposide\u002Fplatinum (EP) combination was the standard of care (SoC) for patients with ES-SCLC until 2019, when the addition of immunotherapy to EP chemotherapy was shown to improve survival, with up to 17% of patients remaining alive at 3 years. On the other hand, the SoC for patients with LS-SCLC is concurrent platinum-based chemoradiotherapy (cCRT) ± prophylactic cranial irradiation (PCI) that remained unchanged for decades. Several studies have shown that concurrent chemoradiotherapy (cCRT) is more effective than sequential CRT (sCRT) in LS-SCLC. Nonetheless, subject to the lymph node regions involvement and treatment-related toxicities, some patients do not undergo concurrent CRT and instead receive sequential CRT. In a non-interventional, retrospective cohort study of limited-stage SCLC patients conducted in France, Italy and the UK, sequential chemoradiotherapy accounts for 37.6% of all treatment patterns while concurrent chemoradiotherapy accounts for 35.1% of the whole therapies used as first line.\n\nADRIATIC (NCT03703297) is a phase 3, randomized, double-blind, placebo-controlled, multicenter, global study evaluating durvalumab ± tremelimumab as consolidation therapy for patients with LS-SCLC who have not progressed after cCRT. Positive high-level results of the ADRIATIC clinical trial showed durvalumab demonstrated a statistically significant and clinically meaningful improvement in the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients with LS-SCLC who had not progressed following cCRT compared to placebo. Durvalumab was well tolerated, and AEs were consistent with the known safety profile. These data support the consolidation of durvalumab as a new SoC for patients with LS-SCLC who have not progressed after cCRT.\n\nThere is limited information on the effectiveness and safety of durvalumab in a broader patient population with LS-SCLC, including those who received sequential CRT.\n\nTherefore, there remains an unmet need for additional data to help support and inform the healthcare decisions on the use of durvalumab as consolidation treatment for patients with LS-SCLC in real-world clinical practice. In addition, ADRIATIC study did not allow to include patients with ECOG PS 2 assessed after CRT.\n\nThe present phase IIIb study will assess the safety and effectiveness of durvalumab in real world like LS-SCLC population. Furthermore, this trial will focus on patient characteristics, treatment exposure, administration, quality of life (QoL), effectiveness and safety providing insights into durvalumab use.",[44],"2026-06-15",{"date":190,"type":91},"2026-06-16",{"date":192,"type":91},"2025-09-15",{"date":194,"type":21},"2029-06-30",{"name":196,"class":98},"AstraZeneca",15,{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":22,"phases":206,"briefSummary":208,"conditions":209,"keywords":211,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":223},"100589661","a-study-of-hospital-at-home-for-people-receiving-tarlatamab-100589661","NCT06957314","A Study of Hospital-at-Home for People Receiving Tarlatamab","MATCHES-Novel: MAking Telehealth Delivery of Cancer Care at Home Effective and Safe for Novel Therapies: A Hospital-at-Home Model for Tarlatamab Delivery","Inclusion Criteria:\n\nPatient\n\n* Diagnosis of extensive stage small cell lung carcinoma (ES-SCLC)\n* Treatment plan of commercially available tarlatamab monotherapy as standard of care\n* Patients must be 18 years of age or older\n* Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C2\n* Patients must have adequate organ and bone marrow function, defined by the following laboratory results obtained within 28 days prior to the first study treatment:\n\n  * ANC ≥ 1000 cells\u002FμL (without granulocyte colony stimulating factor support within 4 weeks prior to Cycle 1, Day 1)\n  * Platelet count ≥50,000\u002FμL (without transfusion within 4 weeks prior to Cycle 1, Day 1)\n  * Hemoglobin ≥8.0 g\u002FdL (without transfusion within 4 weeks prior to Cycle 1, Day 1)\n  * Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 3 X upper limit of normal (ULN). Serum bilirubin ≤ 1.5 x ULN. Patients with known Gilbert disease who have serum bilirubin level ≤ 2 x ULN may be enrolled.\n  * Estimated Glomerular Filtration Rate (eGFR) ≥ 30mL\u002Fmin using the CKD-EPI formula.\n* The patient is willing to give and sign informed consent\n* Appropriate homebound setting as defined by one of the following:\n\n  * Lodging at MSK Residence or hotel\n  * 5 New York City boroughs, lower Westchester County (northern boundary Cross County Parkway) and Nassau County (eastern boundary Wantagh State Parkway). This is based on the community paramedic (SeniorCare) 60-minute response time catchment area. If there is any uncertainty about patient residence eligibility, the Principal Investigator will decide after discussion with SeniorCare.\n* Patients must be accompanied by a caregiver for the period of time the patient is enrolled in the HaH intervention. For cases where there is uncertainty, the Principal Investigator will make the final determination.\n\nCaregiver\n\n* Primary caregiver as identified by patient enrolled on study\n\nPhysician\n\n* Treating physician for patient(s) enrolled on study; managing treatment plan of commercially available tarlatamab as standard of care\n\nExclusion Criteria:\n\nPatient\n\n* Patients with a documented active infection prior to starting tarlatamab. This includes grade 3 or higher viral, bacterial, or fungal infection.\n* Patients with baseline dementia or cognitive barriers\n* Uncontrolled arrhythmias\n\nCaregiver\n\n* Caregiver deemed inappropriate by treating physician\n\nPhysician\n\n* No exclusion criteria",{"count":183,"type":21},[207],"NA","The purpose of this study is to find out whether a Hospital-at-Home (HaH) program is a more efficient way to monitor people's health after receiving tarlatamab than monitoring in the hospital (inpatient).",[210,44],"Small-cell Lung Cancer",[210,44,212,117,213,214],"Tarlatamab","25-077","extensive stage small cell lung cancer","2026-06-11",{"date":217,"type":91},"2026-06-12",{"date":219,"type":91},"2025-04-23",{"date":221,"type":21},"2028-04-23",{"name":117,"class":125},7,{"id":225,"slug":226,"hasResults":12,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":12,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":22,"phases":233,"briefSummary":234,"conditions":235,"keywords":239,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":223},"100471453","phase-2-a-study-of-stereotactic-radiosurgery-srs-for-people-with-lung-cancer-that-has-spread-to-the-brain-100471453","NCT05419076","A Study of Stereotactic Radiosurgery (SRS) for People With Lung Cancer That Has Spread to the Brain","A Single Arm Phase II Study Assessing Efficacy of Stereotactic Radiosurgery (SRS) for Brain Metastasis (BM) From Small Cell Lung Cancer (SCLC)","Inclusion Criteria:\n\n* Histologic diagnosis of small cell lung cancer\n* Radiographic diagnosis of up to 20 brain metastases on contrast-enhanced MRI\n* Age 18 and above\n* Performance status KPS 60-100\u002FECOG 0-2\n* Female patients must be of non-reproductive potential or have a negative serum pregnancy test at the time of enrollment\n* The patient or legally authorized representative is able to provide informed consent\n\nExclusion Criteria:\n\n* Unable to undergo contrast-enhanced MRI brain\n* Leptomeningeal disease confirmed on lumbar puncture, MRI brain, or MRI spine\n* Pregnant or lactating women\n* Prior brain-directed radiotherapy\n* Uncontrolled systemic disease without reasonable systemic therapy options felt likely to result in death as observed on CT or PET\u002FCT imaging, no more than 3 months before study enrollment",{"count":232,"type":21},62,[25],"The purpose of the study is to see if stereotactic radiosurgery\u002FSRS is an effective treatment for people with a new diagnosis of brain metastases from small cell lung cancer\u002FSCLC.",[32,236,237,238,210,44],"Lung Cancer Metastatic","Brain Metastases","Brain Metastases, Adult",[240,241,242,243,244,245,246,117],"Stereotactic Radiosurgery","small cell lung cancer","small cell lung carcinoma","lung cancer","lung cancer metastatic","brain metastases","22-133","2026-06-09",{"date":249,"type":91},"2026-06-10",{"date":251,"type":91},"2022-06-10",{"date":253,"type":21},"2027-06-10",{"name":117,"class":125},{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":17,"minAge":107,"maxAge":262,"enrollmentInfo":263,"targetDuration":4,"studyType":22,"phases":265,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":277,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":287},"100643672","phase-2-a-phase-ii-study-of-gv20-0251-in-combination-with-anti-pd-1-monoclonal-antibodies-in-patients-with-unresectable-locally-advanced-or-metastatic-solid-tumors-100643672","NCT07623642","A Phase II Study of GV20-0251 in Combination With Anti-PD-1 Monoclonal Antibodies in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors.","An Open-Label, Multicenter, Non-Randomized, Phase II Study of GV20-0251 in Combination With Anti-PD-1 Monoclonal Antibodies in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors","Inclusion Criteria\n\n1. Voluntarily signed written informed consent (ICF) prior to any study-specific procedures.\n2. Able and willing to participate in and comply with study procedures throughout the study.\n3. Age ≥ 18 and ≤ 80 years, any gender.\n4. Histologically confirmed unresectable, locally advanced, or metastatic solid tumor.\n5. Must have failed standard of care (SOC), be intolerant to SOC, or be deemed by the investigator to be unsuitable for a specific form of SOC. If SOC failure, documented progression from SOC is required.\n6. No more than 2 prior lines of systemic therapy. Subjects with more lines may be enrolled after sponsor approval. Treatment-naive subjects with locally advanced or metastatic melanoma who have not received systemic therapy may enroll.\n7. Tumor types include: endometrial cancer, cervical cancer, ovarian cancer, triple-negative breast cancer, prostate cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, hepatocellular carcinoma (HCC), biliary tract malignancies (including only intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer; excluding ampullary carcinoma), pMMR\u002FMSS colorectal adenocarcinoma, pancreatic ductal adenocarcinoma, non-small cell lung cancer (NSCLC), small cell lung cancer, and melanoma (assessed per local institutional standard practice).\n8. For certain tumor types, IGSF8 protein expression on the tumor cell membrane must be positive at pre-screening or screening.\n9. If the subject has received prior anti-PD-1\u002FPD-L1 therapy, documented disease progression during treatment with anti-PD-1\u002FPD-L1 monoclonal antibody (as monotherapy or combined with other checkpoint inhibitors\u002Ftherapies) is required.\n10. Eligible subjects of childbearing potential (female and male) must agree to use effective contraception (hormonal or barrier method) starting 28 days prior to the first dose of GV20-0251, throughout the treatment period, and for at least 4 months after the last dose.\n11. Must have at least one measurable lesion per RECIST v1.1. Previously irradiated lesions with documented progression may be considered measurable.\n12. Must provide archival tumor tissue collected within 3 years prior to signing the ICF. If archival tissue is \\>3 years old, enrollment requires medical confirmation with the sponsor.\n13. ECOG performance status of 0-1 prior to the first dose on C1D1.\n14. Expected survival ≥ 24 weeks.\n15. No history of other primary malignancies, except: (a) a curatively treated malignancy with no active disease for at least 2 years prior to consent and low risk of subsequent relapse; or (b) curatively treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the breast.\n16. Adequate organ, Hepatic, and Coagulation function at screening.\n17. All adverse events related to prior anticancer therapy have resolved to ≤ Grade 1 (per NCI CTCAE v5.0). For persistent Grade 2 toxicities deemed by the investigator unlikely to resolve, eligibility may be discussed with the sponsor.\n18. For HCC or biliary tract malignancy subjects only, as Child-Pugh Class A.\n\nExclusion Criteria\n\n1. Prior immunotherapy discontinued due to ≥ Grade 3 immune-related adverse events (irAEs) - except endocrine disorders manageable with replacement therapy or asymptomatic elevated serum amylase\u002Flipase - Grade 2 myocarditis, or recurrent Grade 2 pneumonitis.\n2. Insufficient washout period from prior systemic anticancer therapy before initiating GV20-0251 and anti-PD-1 therapy (C1D1)\n3. Received radiotherapy within 2 weeks prior to initiating GV20-0251 and anti-PD-1 therapy, or has radiation-related toxicity requiring corticosteroids. For NSCLC subjects: pulmonary radiotherapy \\> 30 Gy within 6 months prior to C1D1.\n4. Currently enrolled in a drug or device clinical trial; or received an investigational device or investigational drug within 4 weeks prior to C1D1.\n5. Diagnosed with immunodeficiency; or currently receiving chronic systemic corticosteroids (\\> 10 mg\u002Fday prednisone equivalent) or any other form of immunosuppressive therapy.\n6. History of gastrointestinal perforation and\u002For fistula within 6 months prior to consent; or active gastric\u002Fduodenal ulcer, ulcerative colitis, or other GI conditions the investigator believes may cause bleeding or perforation.\n7. Clinically significant and\u002For uncontrolled cardiac disease, including NYHA Class III or IV heart failure, uncontrolled hypertension (systolic BP \\> 160 mmHg), clinically significant arrhythmia assessed by the investigator to affect study participation safety, or myocardial infarction within 6 months prior to C1D1.\n8. Severe hypersensitivity reaction (≥ Grade 3) to anti-PD-1 monoclonal antibody and\u002For any of its excipients; or prior severe hypersensitivity to biologic therapies that the investigator considers may increase subject risk.\n9. Acute leukemia or chronic lymphocytic leukemia (CLL).\n10. QTcF \\> 470 msec, or history of congenital long QT syndrome, or clinically significant ECG abnormalities (including pericarditis) that the investigator considers may affect subject safety.\n11. Active infection requiring systemic treatment; or active, uncontrolled bacterial, viral, or fungal infection requiring systemic treatment within 7 days prior to C1D1.\n12. History of (non-infectious) pneumonitis\u002Finterstitial lung disease requiring steroid treatment, or current pneumonitis\u002Finterstitial lung disease.\n13. Active autoimmune disease requiring systemic treatment within 2 years prior to C1D1\n14. HIV infection.\n15. Active HBV or HCV infection\n16. Prior major organ transplantation\n17. Prior autologous or allogeneic bone marrow transplantation.\n18. Symptomatic primary CNS malignancy, CNS metastases, or leptomeningeal disease.\n19. Major surgery (excluding diagnostic procedures) or severe trauma within 28 days prior to the first dose of GV20-0251, or currently in recovery that the investigator deems would interfere with the study, or anticipated major surgery during the study.\n20. Received a live or attenuated vaccine within 30 days prior to the first dose.\n21. Requires treatment with interferon-α or related\u002Fsimilar agents within 3 weeks prior to C1D1 or during the entire study period.\n22. Requires more than one paracentesis per 8 weeks to manage ascites; or single ascites drainage volume \\> 1.5 liters within 8 weeks prior to C1D1.\n23. Psychiatric illness or substance abuse disorder (e.g., drug abuse, alcohol dependence) that may interfere with the subject's ability to comply with study requirements.\n24. Other serious non-malignant conditions or laboratory abnormalities that, in the opinion of the investigator and\u002For sponsor, make the subject unsuitable for the study; or other circumstances that the investigator believes may confound study results or prevent the subject from completing the study.\n25. Additional exclusion criteria that applicable to HCC or biliary tract malignancy subjects.","80 Years",{"count":264,"type":21},227,[25],"This is a Phase 2 study of GV20-0251 in combination with anti-PD-1 monoclonal antibodies (including tislelizumab and toripalimab) for the treatment of participants with unresectable, locally advanced, or metastatic solid tumors who are refractory to, intolerant of, or ineligible for standard of care.",[268,269,270,271,272,273,274,275,276,162,44],"Uterine Cervical Neoplasms","Triple Negative Breast Neoplasms","Prostatic Neoplasms","Squamous Cell Carcinoma of Head and Neck","Esophageal Squamous Cell Carcinoma","Cholangiocarcinoma","Gallbladder Neoplasms","Colorectal Neoplasms","Pancreatic Ductal Adenocarcinoma","NOT_YET_RECRUITING","2026-06-04",{"date":280,"type":91},"2026-06-08",{"date":282,"type":21},"2026-06-02",{"date":284,"type":21},"2029-08-15",{"name":286,"class":98},"GV20 Therapeutics",2,{"id":289,"slug":290,"hasResults":12,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":12,"sex":17,"minAge":107,"maxAge":295,"enrollmentInfo":296,"targetDuration":4,"studyType":22,"phases":298,"briefSummary":299,"conditions":300,"keywords":304,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":323},"100593460","phase-1-phase-i-study-of-225acac-etn029-in-patients-with-advanced-dll3-expressing-solid-tumors-100593460","NCT07006727","Phase I Study of [225Ac]Ac-ETN029 in Patients With Advanced DLL3-expressing Solid Tumors","A Phase I, Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [225Ac]Ac-ETN029 in Patients With Advanced DLL3-expressing Solid Tumors","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Patients with one of the following indications:\n* Locally advanced, unresectable, or metastatic SCLC with disease progression following, or intolerance to, at least 1 line of systemic therapy, including platinum-containing chemotherapy, unless patient was ineligible to receive such therapy. Prior DLL3-targeted therapy is allowed. For dose expansion, patients should have received no more than 2 prior lines of systemic therapy.\n* Dose escalation only: LCNEC of the lung with disease progression following, or intolerance to, at least 1 line of systemic therapy, including platinum-containing chemotherapy, unless patient was ineligible to receive such therapy.\n* Dose expansion only: Locally advanced, unresectable, or metastatic de novo or castration-resistant, treatment-emergent NEPC with neuroendocrine differentiation confirmed by local histology and NEPC marker expression (e.g., chromogranin, synaptophysin) confirmed by local IHC. Prior PSMA-targeted, Lu-177-based RLT is allowed. Patients must have at least one measurable lesion (per RECIST 1.1) that shows 111In-ETN029 uptake higher than surrounding tissues on SPECT\u002FCT as assessed by the Investigator.\n* Dose expansion only: Locally advanced, unresectable, or metastatic GEP-NEC with disease progression following, or intolerance to, at least 1 line of systemic therapy, including platinum-containing chemotherapy, unless patient was ineligible to receive such therapy. Patients must have at least one measurable lesion (per RECIST 1.1) that shows 111In-ETN029 uptake higher than surrounding tissues on SPECT\u002FCT as assessed by the Investigator.\n\nExclusion Criteria:\n\n* Absolute neutrophil count (ANC) \\\u003C 1.0 x 109\u002FL, hemoglobin \\\u003C 9 g\u002FdL, or platelet count \\\u003C 75 x 109\u002FL\n* QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec\n* eGFR \\\u003C 60 mL\u002Fmin (\\\u003C0.835 mL\u002Fs), calculated using the CKD-EPI 2021 formula or measured\n* Unmanageable urinary tract obstruction or urinary incontinence\n* Presence of leptomeningeal disease, of symptomatic CNS metastases or of CNS metastases that require local CNS-directed therapy\n* History of or current interstitial lung disease or pneumonitis ≥ Grade 2\n* Any prior DLL3-targeted therapy (except for SCLC) and any prior RLT (except for NEPC)\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","100 Years",{"count":297,"type":21},116,[24],"The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \\[225Ac\\]Ac-ETN029 and the safety and imaging properties of \\[111In\\]In-ETN029 in patients aged ≥ 18 years with locally advanced or metastatic DLL3 positive cancers.",[44,301,302,303],"Large Cell Neuroendocrine Carcinoma of the Lung","Neuroendocrine Prostate Cancer","Gastroenteropancreatic Neuroendocrine Carcinoma",[305,306,307,308,309,310,311,312,313],"Small Cell Lung Carcinoma (SCLC)","Large Cell Neuroendocrine Carcinoma of the Lung (LCNEC)","Neuroendocrine Prostate Cancer (NEPC)","Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC)","DLL3","Neuroendocrine neoplasms","Radioligand therapy (RLT)","[225Ac]Ac-ETN029","[111In]In-ETN029","2026-05-04",{"date":316,"type":91},"2026-05-05",{"date":318,"type":91},"2025-10-16",{"date":320,"type":21},"2031-08-29",{"name":322,"class":98},"Novartis Pharmaceuticals",6,{"id":325,"slug":326,"hasResults":12,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":12,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":331,"targetDuration":4,"studyType":22,"phases":333,"briefSummary":334,"conditions":335,"keywords":338,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":353},"100526215","phase-1-a-study-of-sgn-ceacam5c-in-adults-with-advanced-solid-tumors-100526215","NCT06131840","A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors","An Open-label Phase 1 Study to Investigate PF-08046050 (SGN-CEACAM5C) in Adults With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Tumor type:\n\n   * Participants in Part A (dose escalation) and Part B (dose optimization) must have histologically- or cytologically-confirmed metastatic or unresectable solid tumor malignancy. Must have relapsed, refractory, or progressive disease, and should have no appropriate standard therapy available.\n\n     * Participants in Part A must have one of the following tumor types: colorectal cancer (CRC); gastric carcinoma (GC) or gastroesophageal junction adenocarcinoma (GEJ); non-small cell lung cancer (NSCLC); or pancreatic ductal adenocarcinoma (PDAC).\n     * The tumor types to be enrolled in Part B will be identified by the sponsor from among those specified in Part A.\n   * Participants in Part C (dose expansion) must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor malignancies.\n\n     * CRC (adenocarcinoma of the colon or rectum) and must have received no more than 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer and evidence of either progressive disease or intolerance to their last regimen.\n     * PDAC with one or more metastatic lesions measurable by computed tomography\u002Fmagnetic resonance imaging according to RECIST v1.1 criteria; and must have received no more than 1 prior chemotherapy regimen for the treatment of advanced PDAC and evidence of either progressive disease or intolerance to that regimen.\n     * GC or GEJ and must have received prior platinum and fluoropyrimidine-based chemotherapy.\n     * NSCLC and must have received platinum-based therapy. If eligible and consistent with local standard of care must have received a PD-1\u002FPD-L1 inhibitor. In addition, participants with tumor genomic mutations\u002Falterations for which approved targeted therapies are available per local standard of care, must have received such therapies.\n     * Small cell lung cancer (SCLC) and must have received platinum-based therapy for extensive-stage disease and no more than 3 prior lines of therapy. If eligible and consistent with local standard of care must have received a PD 1\u002FPD-L1 inhibitor.\n   * CRC participants in Part D and Part E (bevacizumab combination therapy) must have histologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Received a maximum of 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen.\n   * CRC participants in Part D and Part E (5FU\u002FLV + bevacizumab and 5FU\u002FLV + oxaliplatin + bevacizumab combination therapy) must have histologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Must not have received a prior TOPO1 inhibitor (such as irinotecan or nanoliposomal irinotecan) in any setting. 1L cohorts: No prior chemotherapy for advanced disease. 2L cohorts (applicable to 5FU\u002FLV + bevacizumab combination only): 1 prior chemotherapy regimen for the treatment of advanced disease, which must have included a fluoropyrimidine and oxaliplatin.\n\n   \\> 2L PDAC participants in Part E (5FU\u002FLV combination therapy) must have histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma. One or more metastatic lesions measurable by computed tomography\u002Fmagnetic resonance imaging according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.\n\n   \\> 1L PDAC participants in Part E (5FU\u002FLV + oxaliplatin combination therapy) must have histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma that has not been previously treated in the metastatic setting. One or more metastatic lesions measurable by computed tomography\u002Fmagnetic resonance imaging according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. No prior chemotherapy for PDAC with the following exception: Patients who received adjuvant\u002Fneoadjuvant chemotherapy and who had recurrence more than 12 months after completion of adjuvant\u002Fneoadjuvant chemotherapy are eligible.\n2. Participants enrolled in the following study parts should have a tumor site that is accessible for biopsy(ies) and agree to biopsy(ies) and\u002For submission of archival tissue:\n\n   * Monotherapy dose optimization (Part B)\n   * Monotherapy (Part C) and combination therapy (Part E) disease-specific expansion cohorts\n3. An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1\n4. Measurable disease per Response Evaluation in Solid Tumors (RECIST) v1.1 at baseline.\n\nExclusion Criteria:\n\n1. Previous exposure to CEACAM5-targeted therapy.\n2. Prior treatment with a TOPO1-targeting ADC (CPT payload), such as Enhertu (trastuzumab deruxtecan) or Trodelvy (sacituzumab govitecan).\n3. History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.\n4. Active cerebral\u002Fmeningeal disease related to the underlying malignancy. Participants with a history of cerebral\u002Fmeningeal disease related to the underlying malignancy are allowed if prior central nervous system disease has been treated and the participant is clinically stable (defined as not having received steroid treatment for symptoms related to cerebral\u002Fmeningeal disease for at least 2 weeks prior to enrollment and with no ongoing related AEs).\n\n   \\> Criteria related to bevacizumab administration (participants in Parts D and E)\n5. History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients.\n6. History of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies.\n7. Serious non-healing wound, non-healing ulcer, or non-healing bone fracture.\n8. Deep venous thromboembolic event within 4 weeks prior to enrollment\n9. Known coagulopathy that increases risk of bleeding, bleeding diatheses.\n10. History of any life-threatening VEGF-related adverse event",{"count":332,"type":21},914,[24],"This clinical trial is studying advanced solid tumors. Solid tumors are cancers that start in a part of your body like your lungs or liver instead of your blood. Once tumors have grown bigger in one place but haven't spread, they're called locally advanced. If your cancer has spread to other parts of your body, it's called metastatic. When a cancer has gotten so big it can't easily be removed or has spread to other parts of the body, it is called unresectable. These types of cancer are harder to treat.\n\nParticipants in this study must have cancer that has come back or did not get better with treatment. Participants must have a solid tumor cancer that can't be treated with standard of care drugs.\n\nThis clinical trial uses an experimental drug called PF-08046050. PF-08046050 is a type of antibody-drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. They may also stick to some normal cells.\n\nThis study will test the safety of PF-08046050 in participants with solid tumors that are hard to treat or have spread throughout the body.\n\nThis study has 5 different study parts. Part A and Part B of the study will find out how much PF-08046050 should be given to participants. Part C will use the information from Parts A and B to see if PF-08046050 is safe and if it works to treat certain solid tumor cancers. Part D and E of the study, together with information from Parts A and B, will find out how much PF-08046050 should be given in combination with other anti-cancer agents. Part E will use the information from Parts A, B, and D to see if PF-08046050 is safe in combination with other anti-cancer agents and if it works to treat a certain solid tumor.",[275,162,336,276,337,44],"Stomach Neoplasms","Gastroesophageal Junction Adenocarcinoma",[339,45,340,341,342,47,343],"CRC","PDAC","GC","GEJ","Seattle Genetics","2026-04-17",{"date":346,"type":91},"2026-04-20",{"date":348,"type":91},"2023-11-20",{"date":350,"type":21},"2030-09-12",{"name":352,"class":98},"Seagen, a wholly owned subsidiary of Pfizer",44,{"id":355,"slug":356,"hasResults":12,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":12,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":22,"phases":363,"briefSummary":364,"conditions":365,"keywords":387,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":403},"100561192","phase-1-a-study-with-nkt3964-for-adults-with-advancedmetastatic-solid-tumors-100561192","NCT06586957","A Study With NKT3964 for Adults With Advanced\u002FMetastatic Solid Tumors","A Phase 1, First-in-human, Open-label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Oral CDK2 Degrader NKT3964 in Adults With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n\\- Must have a pathologically confirmed advanced and unresectable or metastatic solid tumor listed below with documented disease progression on last standard treatment. Part 1 only: subjects must be refractory to, or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.\n\nDose Escalation:\n\n1. Ovarian cancer\n2. Endometrial cancer (only endometrioid subtype will require CCNE1 amplification)\n3. Gastric, gastroesophageal junction (GEJ) or esophageal adenocarcinoma with CCNE1 amplification\n4. Small cell lung cancer (SCLC)\n5. Triple-negative breast cancer (TNBC; HER2, estrogen receptor and progesterone receptor negative)\n6. HR+ (includes estrogen-receptor or progesterone-receptor) and HER2- breast cancer (must have progressed following treatment with a CDK4\u002F6 inhibitor, and is not suitable for endocrine therapy \\[ET\\])\n7. Other solid tumors with CCNE1 amplification\n\nDose Expansion:\n\nPart 2A: HR+ and HER2- breast cancer that is locally advanced and unresectable (Stage III) or metastatic (Stage IV); previously treated with ≥1 line of standard of care (SOC) including CDK4\u002F6 inhibitor plus ET and not suitable for further ET. Subjects must have progressed after receiving therapy for ≥3 months in the metastatic setting or for ≥6 months in the adjuvant setting. Subjects must have received ≤2 lines of systemic cytotoxic therapy (chemotherapy or cytotoxic antibody drug conjugate \\[ADC\\]) in the metastatic setting..\n\nPart 2B: Advanced platinum-based-chemotherapy resistant or refractory epithelial ovarian\u002Ffallopian\u002Fprimary peritoneal carcinoma or clear cell ovarian cancer (defined as recurrence ≤6 months after completing platinum-based regimen) with progression on at least one platinum containing therapy and previously treated with ≤4 prior lines of systemic therapy administered for advanced\u002Fmetastatic disease and with CCNE1 amplification.\n\nPart 2C: Advanced unresectable or metastatic gastric, GEJ or esophageal adenocarcinoma with progression on at least one systemic therapy and previously treated with ≤3 prior lines of systemic therapy administered for advanced\u002Fmetastatic disease, with CCNE1 amplification as determined by NGS by local liquid or tissue test.\n\nPart 2D: Advanced endometrial adenocarcinoma or uterine papillary serous carcinoma previously treated with ≤4 prior lines of systemic therapy administered for advanced\u002Fmetastatic disease with CCNE1 amplification.\n\nPart 2E: Advanced\u002Frecurrent uterine carcinosarcoma previously treated with 1 prior platinum-based chemotherapy regimen and ≤3 prior lines of systemic therapy. Prior bevacizumab or PARP inhibitors are allowed and must be at least 3 weeks prior to the start of study drug.\n\n* Have adequate organ function\n* Subjects with female reproductive organs must be surgically sterile, post-menopausal, or must be willing to use highly effective method(s) of contraception\n* Ability to swallow oral medications.\n* Consent to provide archived tumor tissues and paired tumor biopsy at pretreatment\n\nExclusion Criteria:\n\n* Locally advanced solid tumor that is a candidate for curative treatment through radical surgery and\u002For radiotherapy, or chemotherapy.\n* History of another malignancy with exceptions\n* History of lymphohistiocytic or lymphoid hyperplasia; hemophagocytic lymphohistiocytosis.\n* Failed to recover from effects of prior anticancer treatment therapy to baseline or Grade ≤ 1 severity (per CTCAE)\n* Clinically significant cardiovascular event within 6 months prior to start of NKT3964 treatment\n* Known active CNS metastases and\u002For carcinomatous meningitis\n* Active interstitial lung disease currently requiring treatment\n* History of uveitis, retinopathy or other clinically significant retinal disease\n* Active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy, or any clinically significant corneal disease\n* Active wound healing from major surgery within 1 month or minor surgery within 10 days before the first dose of NKT3964.\n* Known human immunodeficiency virus (HIV), active hepatitis B or C infection\n* Prior investigative treatment with a selective or nonselective CDK2 inhibitor or degrader\n* Childs-Pugh class B or C cirrhosis or any other clinically significant liver disorder\n* Palliative radiation therapy within 14 days or other radiation therapy within 4 weeks prior to C1D1",{"count":362,"type":21},150,[24],"The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity to determine the preliminary recommended dose for expansion (RDE) of NKT3964 in adults with advanced or metastatic solid tumors. The goal of the Expansion phase of the study is to evaluate the preliminary anti-tumor activity of NKT3964 at the RDE based on objective response rate (ORR) and determine the preliminary recommended Phase 2 dose (RP2D).",[366,28,367,368,33,369,370,371,163,372,373,49,374,375,376,377,378,379,380,42,44,269,381,382,383,384,385,386],"Solid Tumor","Solid Tumor, Adult","Metastatic Tumor","Ovarian Neoplasms","Ovarian Carcinoma","Metastatic Ovarian Carcinoma","Endometrial Diseases","Metastatic Endometrial Cancer","Metastatic Endometrial Carcinoma","Advanced Endometrial Carcinoma","Advanced Ovarian Carcinoma","Gastric Cancer","Advanced Gastric Carcinoma","Metastatic Gastric Cancer","Metastatic Gastric Carcinoma","Platinum-resistant Ovarian Cancer","Platinum-refractory Ovarian Carcinoma","CCNE1 Amplification","Hormone Receptor Negative Breast Carcinoma","Human Epidermal Growth Factor 2 Negative Carcinoma of Breast","Progesterone-receptor-positive Breast Cancer",[388,389,390,391,392,393],"CDK 2 Inhibitor","CDK 4 Inhibitor","CDK 6 Inhibitor","CDK2 Degrader","Protein Degrader","PROTAC","2026-04-16",{"date":396,"type":91},"2026-04-21",{"date":398,"type":91},"2024-09-19",{"date":400,"type":21},"2029-05",{"name":402,"class":98},"NiKang Therapeutics, Inc.",19,{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":12,"sex":17,"minAge":411,"maxAge":412,"enrollmentInfo":413,"targetDuration":4,"studyType":22,"phases":415,"briefSummary":416,"conditions":417,"keywords":420,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":126},"100632103","mdt-based-umbrella-decision-model-for-geriatric-lung-cancer-patients-100632103","NCT07509333","MDT-Based Umbrella Decision Model for Geriatric Lung Cancer Patients","Establishment and Validation of a Multidisciplinary Team (MDT)-Based Umbrella Decision-making and Treatment Model for Geriatric Lung Cancer Patients","Inclusion Criteria:\n\n1. Age 60 to 90 years.\n2. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC).\n3. Clinical stage I-IV (according to the 9th edition of the IASLC TNM staging system).\n4. ECOG Performance Status 0-2.\n5. Estimated life expectancy ≥ 3 months.\n6. Able to tolerate baseline examinations (including CT, MRI, pulmonary function tests) and at least one planned treatment modality (surgery, ablation, SBRT, etc.) as assessed by the investigator.\n7. Patients or their legal representatives provide written informed consent and commit to completing the full follow-up schedule (including questionnaires and functional assessments).\n8. Other conditions deemed suitable by the investigator.\n\nExclusion Criteria:\n\n1. History of other primary malignancies within the past 5 years (except non-melanoma skin cancer or carcinoma in situ of the cervix).\n2. Unclear pathological diagnosis (no definite histologic or cytologic evidence) or post-enrollment pathological review excludes lung cancer.\n3. Severe psychiatric disorders (e.g., Alzheimer's disease, schizophrenia) or cognitive impairment (MMSE score \\\u003C 20) that interferes with questionnaire completion or treatment decision-making communication.\n4. Contraindications to study-related examinations or treatments:\n\n   4.1Known contraindication to iodine-based contrast agents or MRI (e.g., incompatible metallic implants).\n\n   4.2Known severe allergy to any of the essential therapeutic agents (e.g., chemotherapy, targeted drugs) involved in the study.\n5. Severe organ dysfunction (e.g., Child-Pugh class C cirrhosis, end-stage renal disease without dialysis) that precludes tolerability of baseline examinations or any treatment.\n6. No fixed residential address or effective contact information, or family members refuse to assist with follow-up, leading to an estimated follow-up dropout risk \\> 50%.\n7. Concurrent participation in another interventional clinical trial for lung cancer (observational studies are allowed).\n8. Any other condition that, in the opinion of the investigator, makes the patient unsuitable for study participation.","60 Years","70 Years",{"count":414,"type":21},2000,[207],"This is a single-center, prospective, single-arm interventional study with historical control, designed to evaluate the clinical value of a multidisciplinary team (MDT)-based decision-making umbrella decision model in elderly patients with lung cancer. A total of 2,000 patients aged 60-90 years with newly diagnosed non-small cell or small cell lung cancer will be enrolled. Each patient will undergo comprehensive geriatric assessment and receive an individualized treatment plan formulated by an MDT comprising thoracic surgeons, geriatricians, oncologists, pulmonologists, rehabilitation therapists, and radiologists. Treatment options include surgery, ablation, stereotactic body radiotherapy (SBRT), neoadjuvant immunochemotherapy, targeted therapy, and best supportive care. The primary outcome is 3-year progression-free survival (PFS). Secondary outcomes include overall survival, objective response rate, quality of life (EORTC QLQ-LC43), incidence of adverse events (CTCAE v5.0), and healthcare economics. Historical controls (2014-2024) will be extracted from hospital records and matched using propensity score matching. The study aims to establish a standardized MDT pathway to improve treatment outcomes and reduce risks in the geriatric lung cancer population.",[418,162,44,419],"Lung Neoplasms","Elderly",[421,419,422,423,424],"Lung cancer","Geriatric","Multidisciplinary team","Umbrella trial","2026-03-28",{"date":427,"type":91},"2026-04-03",{"date":429,"type":91},"2025-12-01",{"date":431,"type":21},"2030-10-31",{"name":433,"class":125},"West China Hospital",{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":440,"eligibilityCriteria":441,"healthyVolunteers":12,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":442,"targetDuration":4,"studyType":22,"phases":443,"briefSummary":444,"conditions":445,"keywords":446,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":460},"100594165","phase-3-dose-escalation-radiotherapy-in-limited-stage-small-cell-lung-cancer-a-phase-iii-randomized-trial-100594165","NCT07015892","Dose-Escalation Radiotherapy in Limited-Stage Small Cell Lung Cancer: A Phase III Randomized Trial","Phase III Randomized Clinical Trial to Evaluate the Efficacy and Safety of Twice-Daily Hyperfractionated Dose-Escalated Thoracic Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer (ESCALADOR Study)","ESCALADOR","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of small cell lung cancer (SCLC)\n* Limited-stage disease (Stage I-III; any T, any N, M0), eligible for definitive radiotherapy\n* Measurable disease according to RECIST 1.1\n* Age ≥18 years\n* ECOG performance status 0-2\n* No prior thoracic radiotherapy\n* Signed informed consent\n* Adequate hematologic function: WBC ≥3.0×10⁹\u002FL, neutrophils ≥1.5×10⁹\u002FL, platelets ≥100×10⁹\u002FL, hemoglobin ≥90 g\u002FL\n* Adequate liver and renal function: total bilirubin ≤1.5×ULN, AST\u002FALT ≤1.5×ULN, creatinine normal or CrCl ≥60 mL\u002Fmin\n* Pulmonary function: FEV1 \\>1 L or \\>30% predicted; DLCO \\>30% predicted\n\nExclusion Criteria:\n\n* Prior surgery or radiotherapy for any lung cancer (SCLC or NSCLC)\n* Presence of malignant cells in pleural or pericardial effusion\n* Serious uncontrolled systemic disorders (e.g., active infection, unstable cardiovascular disease)\n* Medical, psychological, or social conditions that could interfere with compliance\n* Active malignancy other than SCLC (except localized prostate\u002Fbreast cancer or basal cell carcinoma)\n* Refusal or inability to sign informed consent",{"count":20,"type":21},[185],"This is a phase III clinical trial that aims to evaluate whether increasing the dose of radiotherapy given twice a day can improve treatment outcomes in patients with localized small cell lung cancer (SCLC). All patients will receive standard chemotherapy with cisplatin and etoposide and will be randomly assigned to one of three radiotherapy regimens.\n\nThe main objective is to determine whether this intensified radiotherapy improves progression-free survival and overall survival. The study will also compare two different dose escalation strategies and assess treatment side effects and patients' quality of life.\n\nThis research may help identify a more effective treatment approach for patients with limited-stage SCLC and could contribute to improving long-term survival in this aggressive type of cancer",[44],[447,448,449,450],"Radiotherapy","Chemoradiotherapy","Dose-Response Relationship","Radiation","2026-03-25",{"date":453,"type":91},"2026-03-31",{"date":455,"type":91},"2026-03-01",{"date":457,"type":21},"2028-12-31",{"name":459,"class":125},"Instituto de Investigación Biomédica de Salamanca",13,{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":4,"eligibilityCriteria":467,"healthyVolunteers":12,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":468,"targetDuration":4,"studyType":22,"phases":470,"briefSummary":472,"conditions":473,"keywords":475,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":126},"100486920","early-phase-1-autologous-car-t-cells-targeting-the-gd2-antigen-for-lung-cancer-100486920","NCT05620342","Autologous CAR T-Cells Targeting the GD2 Antigen for Lung Cancer","Administration of T Cells Expressing a 2nd Generation GD2 Chimeric Antigen Receptor, IL-15, and iCaspase9 Safety Switch in Subjects With Lung Cancer","Inclusion Criteria:\n\n1. Written informed consent to undergo cell procurement explained to, understood by, and signed by the subject.\n2. Subject has a life expectancy of ≥ 12 weeks.\n3. Subject must be platinum-refractory and either currently receiving or has previously received a PD1\u002FPDL1 inhibitor\n4. Use of systemic corticosteroids at doses ≥10 mg prednisone daily or it's equivalent; those receiving \\\u003C10 mg daily may be enrolled at the discretion of the investigator.\n5. Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to cell procurement.\n6. Subject has demonstrated adequate organ function.\n\nExclusion Criteria:\n\n1 . Subject has less than 12 weeks of life expectancy.\n\n2\\. Subject did not receive platinum-based chemotherapy\n\n3\\. Subject does not have adequate organ function.",{"count":469,"type":21},24,[471],"EARLY_PHASE1","This is a phase 1, single-center, open-label study that enrolls adult subjects with extensive stage lung cancer or stage IV non-small cell lung cancer that is platinum-refractory and received PD-1 and\u002For PD-L1 therapy. The purpose of this study is to test the safety of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the GD2 antigen (iC9-GD2.CAR.IL-15 T cells) in subjects with lung cancer. How much (dose) of the iC9-GD2.CAR.IL-15 T cells are safe to use without causing too many side effects and what is the maximum dose that could be tolerated will be studied.\n\nModified immune cells as an experimental treatment that combines antibodies and T cells will be used. Antibodies are proteins that protect the body from foreign invaders like bacteria. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill viruses and other cells, including tumor cells. Although antibodies and T cells have been used to treat cancer and they both have shown promise, neither alone has been able to cure most patients. This study will combine T cells and antibodies to create a more effective treatment.\n\nThe treatment that is being researched in this study is called autologous T lymphocyte chimeric antigen receptor cells targeted against the disialoganglioside (GD2) antigen that expresses Interleukin (IL)-15, and the inducible caspase 9 safety switch (iC9). The short name for this treatment is iC9.GD2.CAR.IL-15 T cells therapy is an experimental therapy and has not been approved by the Food and Drug Administration. There are two steps. In the first step, blood will be collected from the subjects to prepare the iC9-GD2.CAR.IL-15 T cells. T cells will be isolated from the blood and modified to make iC9-GD2.CAR.IL-15. In the second step, the iC9-GD2.CAR.IL-15 T cells produced from the subject's own blood will be administered to the subject.",[32,44,474],"Non Small Cell Lung Cancer",[476],"cellular therapy","2026-02-02",{"date":479,"type":91},"2026-02-05",{"date":481,"type":91},"2023-06-21",{"date":483,"type":21},"2029-10-24",{"name":485,"class":125},"UNC Lineberger Comprehensive Cancer Center",{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":17,"minAge":107,"maxAge":262,"enrollmentInfo":493,"targetDuration":4,"studyType":22,"phases":494,"briefSummary":495,"conditions":496,"keywords":4,"overallStatus":277,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":126},"100620431","phase-2-exploration-of-treatment-strategies-after-concurrent-chemoradiotherapy-for-ls-sclc-guided-by-mrd-100620431","NCT07357532","Exploration of Treatment Strategies After Concurrent Chemoradiotherapy for LS-SCLC Guided by MRD","Exploration of Treatment Strategies After Concurrent Chemoradiotherapy for Limited-stage Small Cell Lung Cancer (LS-SCLC) Guided by Molecular Residual Disease (MRD)","Inclusion Criteria:\n\n1. Signed informed consent; age \\>18 and \\\u003C80 years;\n2. Histologically or cytologically confirmed limited-stage small cell lung cancer (LS-SCLC);\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1;\n4. Patients who have achieved disease stabilization after concurrent or sequential chemoradiotherapy;\n5. Patients who had not received previous immune checkpoint inhibitor treatment;\n6. Patients with MRD-positive status following concurrent chemoradiotherapy;\n7. Willingness to provide clinical-pathological data, imaging studies, and other required materials for research purposes; compliance with follow-up procedures, including blood sample collection at predefined efficacy evaluation timepoints; and agreement to use the collected data for subsequent research analyses.\n\nExclusion Criteria:\n\n1. Have other malignant tumors;\n2. Autoimmune disorders that are not amenable to PD-L1 inhibitor therapy;\n3. Prior exposure to other anti-angiogenic small molecule TKIs such as erlotinib or anti-angiogenic monoclonal antibodies such as bevacizumab (except locally infused bevacizumab); or participation in a clinical trial of another antineoplastic agent within 4 weeks prior to the first dose of ; or prior treatment with a paclitaxel;\n4. Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg despite optimal pharmacologic therapy);\n5. Class II or greater myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc intervals ≥450 ms in men and ≥470 ms in women). According to NYHA criteria, grade III-IV cardiac insufficiency, or cardiac color ultrasound suggests that the left ventricular ejection fraction (LVEF) is \\\u003C50% have had a myocardial infarction within 6 months prior to enrollment, New York Heart Association class II or higher heart failure, uncontrolled angina pectoris, uncontrolled severe ventricular arrhythmia, clinically significant pericardial disease, or ECG suggestive of acute ischemia or active conduction system abnormalities; (6) uncontrolled angina pectoris, uncontrolled severe ventricular arrhythmias, clinically significant pericardial disease, or ECG suggestive of acute ischemia or active conduction system abnormalities.\n6. Uncontrolled co-morbidities including, but not limited to, poorly controlled diabetes mellitus, diabetic peripheral lesions , persistent infections, or psychiatric or social conditions that may interfere with the subject's ability to comply;\n7. Abnormal coagulation (INR \\> 1.5 or Prothrombin Time (PT) \\> ULN + 4 seconds or APTT \\> 1.5 ULN), hemorrhagic symptoms, or on thrombolytic or anticoagulant therapy;\n8. Known hereditary or acquired bleeding and thrombotic disorders such as hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.;\n9. Significant coughing up of fresh blood or hemoptysis of one-half teaspoon (2.5 ml) per day or more within 2 months prior to entry into the study ;\n10. Failure to receive specified treatment or change in treatment regimen prior to disease progression;\n11. Unable to cooperate with the study in accordance with the established clinical follow-up period;\n12. Unable to accept or provide the specified means of efficacy assessment such as imaging.\n13. Pregnant or lactating women.",{"count":353,"type":21},[25],"This study plans to enroll limited-stage small cell lung cancer (LS-SCLC) patients who have achieved disease control after concurrent chemoradiotherapy (cCRT). Tissue samples collected at initial diagnosis and serial peripheral blood samples obtained at multiple post-cCRT timepoints will be analyzed using targeted next-generation sequencing to investigate the correlation between molecular residual disease (MRD) status and tumor recurrence\u002Fmetastasis. For patients with MRD-positive results, a therapeutic strategy combining immunotherapy with anti-angiogenic agents will be implemented with the aim of improving clinical outcomes.",[44],"2026-01-21",{"date":499,"type":91},"2026-01-22",{"date":501,"type":21},"2026-01-31",{"date":503,"type":21},"2028-10-30",{"name":505,"class":125},"Peking University Cancer Hospital & Institute",{"id":507,"slug":508,"hasResults":12,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":512,"eligibilityCriteria":513,"healthyVolunteers":514,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":515,"targetDuration":4,"studyType":22,"phases":517,"briefSummary":518,"conditions":519,"keywords":521,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":126},"100553109","prospective-longitudinal-biocollection-in-thoracic-oncology-including-newly-diagnosed-lung-cancer-patients-100553109","NCT06481813","Prospective, Longitudinal Biocollection in Thoracic Oncology, Including Newly Diagnosed Lung Cancer Patients","BREATHE Cohort : Prospective, Longitudinal Biocollection in Thoracic Oncology, Including Newly Diagnosed Lung Cancer Patients","BREATHE","Inclusion Criteria:\n\nPatients :\n\n* Adult\n* Patient newly diagnosed with NSCLC or CPC\n* Cared for at Nantes University Hospital\n* Affiliated or beneficiaries of a social security scheme or similar\n* Treated with a systemic therapy including chemotherapy and\u002For immunotherapy and\u002For targeted therapy and\u002For therapy as part of a clinical trial after agreement from the sponsors of the studies concerned (only in the absence of blinding).\n* Having agreed to participate in this study by signing the biocollection consent.\n\nHealthy subjects :\n\n* Adult\n* Affiliated or beneficiaries of a social security or similar scheme\n* Who have agreed to participate in this study by signing the Biocollection consent form.\n* No known infectious pathology\n* No known history of cancer\n* No known history of chronic autoimmune disease\n* No background immuno-suppressive treatment\n\nAncillary Study :\n\n-Metastatic NSCLC with a KRAS G12C mutation, receiving treatment with Sotorasib, Adagrasib, or another KRAS G12C inhibitor, either as monotherapy or in combination.\n\nExclusion Criteria:\n\nPatients :\n\n* Previous anticancer treatment for Lung cancer\n* Patients who have not consented to participate in the BREATHE collection\n* History of cancer (excluding thoracic cancer) with evidence of disease for less than 2 years\n* Inclusion in a therapeutic trial with blinded treatment\n* Patients under guardianship\n* Patients with AME.\n* Pregnant or breast-feeding women\n\nHealthy subjects :\n\n* Person under guardianship\n* Person benefiting from AME (State medical aid)\n* Pregnant or breast-feeding women\n\nAncillary Study :\n\n\\- Pregnant or breast-feeding women",true,{"count":516,"type":21},730,[207],"In clinical trials, patients are selected according to strict eligibility criteria (inclusion and exclusion criteria). These criteria aim to ensure homogeneity within the trial population, but may omit patients with specific characteristics, comorbidities or co-medications. Indeed, patients of advanced age, with comorbidities or brain metastases, who are frequently encountered in clinical practice, are often excluded from clinical trials. Real-life data in oncology play a vital role in assessing the efficacy of therapies and therapeutic strategies, complementing data from controlled clinical trials. They make it possible to analyze a larger population and take into account multiple variables such as patient history, co-medications and comorbidities, but also to analyze efficacy and toxicity data in populations not represented in clinical trials. The establishment of a prospective cohort including various stages and histologies will make it possible to set up a platform of available data, including a maximum of data linked to the patient, his tumor and his treatments, collected longitudinally until the patient's death (or the end of the study).\n\nIn parallel with this cohort, the project aims to set up a longitudinal plasmatheque (from diagnosis to death, or at the end of the study), as well as a tumorotheque (samples systematically stored as part of care by the CHU tumorotheque, and for which patient consent allows their use in research depending on the material available) for patients with available tumor samples. This will enable the construction of ancillary projects to validate research hypotheses, for example concerning the identification of mechanisms of resistance to therapies.",[32,162,44,520],"Metastatic Lung Cancer",[522,32,523],"Real-world cohort","Biobank","2026-01-19",{"date":497,"type":91},{"date":527,"type":91},"2024-12-10",{"date":529,"type":21},"2034-12-01",{"name":531,"class":125},"Nantes University Hospital",{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":536,"acronym":4,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":538,"targetDuration":4,"studyType":22,"phases":540,"briefSummary":541,"conditions":542,"keywords":543,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":546,"lastUpdatePostDateStruct":547,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":553,"locationsCount":126},"100604875","phase-1-small-cell-lung-cancer-irinotecan-and-cdc2-like-kinase-inhibition-trial-slick-trial-100604875","NCT07155200","Small Cell Lung Cancer Irinotecan and CDC2-like Kinase Inhibition Trial (SLICK Trial)","Inclusion Criteria:\n\n* Histologically or cytologically confirmed small cell lung cancer that has progressed on at least one line of prior platinum-based chemotherapy, given with or without anti-PD-(L)1 therapy.\n* Presence of measurable disease per RECIST 1.1 criteria\n* At least 18 years of age.\n* ECOG performance status ≤ 2\n* Adequate bone marrow and organ function as defined below:\n\n  * Absolute neutrophil count ≥ 1.0 K\u002Fcumm\n  * Platelets ≥ 100 K\u002Fcumm\n  * Total bilirubin ≤ 1.5 x IULN\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 x IULN (≤ 5 x IULN for patients with liver metastases)\n  * Calculated creatinine clearance \\> 35 mL\u002Fmin by Cockcroft-Gault\n* The effects of cirtuvivint on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 31 weeks after completion of study treatment (either drug). Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s\u002Fhe must inform the treating physician immediately.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Prior or concurrent malignancy whose treatment or natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition (following discussion with the PI) are eligible for this trial.\n* Previous intolerance to irinotecan. Treatment with prior irinotecan is allowed as along as treatment was not discontinued for treatment related adverse events.\n* Currently receiving any other investigational agents.\n* Patients with untreated symptomatic brain metastases or with clinically evident CNS hemorrhage. Patients with treated brain metastases are allowed if post-treatment brain imaging after CNS-directed therapy shows no evidence of progression. Patients with asymptomatic, punctate brain metastases \\\u003C 5 mm are allowed.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to cirtuvivint, irinotecan, or other agents used in the study.\n* Concurrent diarrheal illness (such as inflammatory bowel disease) that requires medical therapy.\n* Undergone major surgery within 28 days prior to Cycle 1 Day 1\n* Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis at a level of Child-Pugh B or worse, cirrhosis (any degree) with a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis (defined as ascites from cirrhosis requiring diuretics or paracentesis), fatty liver, and inherited liver disease.\n* Unresolved grade 2 or higher toxicities from previous treatment with the exception of fatigue, lymphopenia, endocrine AEs that are being managed with hormone replacement, alopecia, or dysgeusia.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to C1D1.\n* HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing is not required in the absence of known history of infection.\n* Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing is not required in the absence of known history of infection.\n* History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing is not required in the absence of known history of infection.\n* Known retinal abnormalities, including diabetic retinopathy, macular degeneration, other retinal degenerative diseases, or other retinal findings that may place the patient at risk.\n* Patients currently using or anticipating the need for food or drugs known to strongly inhibit or induce CYP3A4, such as ketoconazole, itraconazole, erythromycin, or rifampin, within 10 days prior to first dose of study medication.\n* Patients with a corrected QT interval (QTc) using Fridericia's formula (QTcF) \\> CTCAE v5.0 Grade 1 (\\>480 msec) based on the mean of triplicate evaluation at Screening. In patients with ventricular paced rhythm, a 50 msec subtraction should be applied to the QTc to calculate the QTcF, potential exceptions for patients with pacemakers should be discussed with the PI.",{"count":539,"type":21},42,[24,25],"Although small cell lung cancer (SCLC) responds dramatically to initial platinum-based chemotherapy, recurrences are nearly universal. The addition of atezolizumab, an immune checkpoint inhibitor, to front-line chemotherapy has recently demonstrated an improvement in overall survival (OS) in extensive stage SCLC (ES-SCLC). Subsequent lines of therapies are associated with modest efficacy in patients with relapsed disease, and the median overall survival is still 12 to 13 months at best.\n\nCirtuvivint is a small molecule inhibitor of the CDC2-like kinases (CLKs) and dual-specificity tyrosine-regulated kinases (DYRKs); inhibiting CLKs and DYRKs has been shown in preclinical models to cause tumor growth inhibition and sensitize cancer cells to cytotoxic chemotherapy.\n\nThis study is testing the hypothesis that adding cirtuvivint to chemotherapy in patients with relapsed SCLC will be well tolerated and improve the response rate and progression-free survival (PFS).",[210,44,42],[42,544,545],"CLK Inhibitors","Cirtuvivint","2025-12-19",{"date":548,"type":91},"2025-12-22",{"date":550,"type":91},"2025-12-18",{"date":552,"type":21},"2029-01-31",{"name":554,"class":125},"Washington University School of Medicine",{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":4,"eligibilityCriteria":561,"healthyVolunteers":12,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":562,"targetDuration":4,"studyType":22,"phases":564,"briefSummary":565,"conditions":566,"keywords":567,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":575,"completionDateStruct":577,"leadSponsor":579,"locationsCount":287},"100473905","phase-2-study-of-plk1-inhibitor-onvansertib-in-relapsed-small-cell-lung-cancer-100473905","NCT05450965","Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer","A Phase 2 Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Patients must have histologically or cytologically confirmed small cell lung cancer\n2. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \\>20 mm with conventional techniques or as \\>10 mm with spiral CT scan. See Section 8for the evaluation of measurable disease.\n3. Patient must have failed or found to be intolerant of standard frontline platinum-based regimens and not more than two lines of cytotoxic chemotherapy treatment in total for extensive stage disease. Maintenance immunotherapy counts as part of the frontline therapy, while prior chemotherapy for limited stage disease will not count toward this total if completed more than 12 months before initiation of protocol therapy. Retreatment with the original chemotherapy regimen for sensitive relapsed SCLC counts as a separate line of treatment.\n4. Adult patients with age \\>18 years. Because no dosing or adverse event data are currently available on the use of arsenic trioxide in patients \\\u003C18 years of age, children are excluded from this study but will be eligible for future pediatric single-agent trials, if applicable.\n5. Ability to tolerate oral medicine\n6. ECOG performance status ≤2\n7. Patients must have normal organ and marrow function as pre-defined\n8. Negative serum pregnancy test within 48 hours before starting study treatment in women with childbearing potential\n9. Women of child-bearing potential and men must agree to use adequate contraception.\n10. Ability to understand and the willingness to sign a written informed consent document.\n11. Both men and women and members of all races and ethnic groups are eligible for this trial.\n\nExclusion Criteria:\n\n1. Treatment with chemotherapy (within 4 weeks; 6 weeks for nitrosoureas or mitomycin C); radiotherapy or biologic agents (within 2 weeks) prior to first dose of onvansertib or those persistent, clinically significant, grade ≥2 adverse events due to agents administered more than 4 weeks earlier.\n2. Patients may not be receiving any other investigational agents (Use of conventional external beam radiation therapy will be allowed during protocol therapy solely for palliation of localized painful lesions or bone lesions at risk of fracture provided the radiation field does not encompass any selected target lesions required for assessment).\n3. Patients with uncontrolled symptomatic brain metastases. Subjects with a history of central nervous system (CNS) metastases must have documentation of stable brain imaging after completion of definitive treatment and prior to first dose of Study Drug. Patients must be off or on a stable dose of corticosteroids (not more than 10mg prednisone or equivalent). Definitive treatment may include surgical resection, whole brain irradiation, and\u002For stereotactic radiation therapy.\n4. Patients with active GI disorders likely to impair the absorption of oral medications\n5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to onvansertib.\n6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n7. Patient with untreated or active HBV, HCV and HIV are ineligible. Patients on stable doses of antiretroviral for at least six months and undetectable viral load will be enrolled with prior approval of the study sponsor. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.\n8. Patients who require ongoing treatment with any hematopoietic colony-stimulating growth factors (e.g., G-CSF, GM-CSF) ≤ 2 weeks prior to starting study drug.\n9. Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy\n10. Patient is unable or unwilling to abide by the study protocol or cooperate fully with the investigator.",{"count":563,"type":21},37,[25],"This phase II clinical trial will study the safety and efficacy of onvansertib to treat patients with small cell lung cancer (SCLC) who have either not responded to or are unable to tolerate chemotherapy. Onvansertib is a drug that inhibits polo-like kinase 1 (PLK-1), an enzyme that is over-expressed in many cancer cells and is involved in cellular repair.",[210,44],[32,568,569,570,571],"Onvansertib","Polo-like Kinase","PLK1","Salvage Therapy","2025-12-15",{"date":574,"type":91},"2025-12-17",{"date":576,"type":91},"2022-07-19",{"date":578,"type":21},"2027-11-30",{"name":580,"class":125},"University of Maryland, Baltimore",{"id":582,"slug":583,"hasResults":12,"nctId":584,"briefTitle":585,"officialTitle":585,"acronym":4,"eligibilityCriteria":586,"healthyVolunteers":12,"sex":17,"minAge":587,"maxAge":4,"enrollmentInfo":588,"targetDuration":4,"studyType":590,"phases":4,"briefSummary":591,"conditions":592,"keywords":594,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":607},"100459654","biology-of-young-lung-cancer-study-the-young-lung-study-100459654","NCT05265429","Biology of Young Lung Cancer Study: The YOUNG LUNG Study","Inclusion Criteria:\n\n* Age 45 and under at lung cancer diagnosis\n* Pathologically confirmed bronchogenic lung carcinoma (NSCLC or SCLC of any stage) at any treatment time point\n* Provision of written informed consent\n* Willingness to undergo no more than two (2) peripheral blood draws in a four (4) week period, with no more than 50 ml peripheral blood collected over eight (8) weeks\n* Individuals under age 18 are eligible for study if they meet defined criteria; in addition, consent for participation must be given by a legal guardian or parent\n\nExclusion Criteria:\n\n* Individuals who decline to sign consent\n* Individuals who are unable to give consent or assent and are without a designated healthcare proxy\n* Compromise of patient diagnosis or staging if tissue is used for research","15 Years",{"count":589,"type":21},500,"OBSERVATIONAL","The purpose of this research study is to learn more about lung cancer (NSCLC or SCLC) diagnosed in adults at ages 45 or younger.",[474,44,593],"NUT Carcinoma",[474,44,595,596,597],"Genetics","Genomics","Young lung cancer","2025-10-28",{"date":600,"type":91},"2025-10-29",{"date":602,"type":91},"2023-01-01",{"date":604,"type":21},"2027-08-01",{"name":606,"class":125},"Dana-Farber Cancer Institute",4,{"id":609,"slug":610,"hasResults":12,"nctId":611,"briefTitle":612,"officialTitle":613,"acronym":4,"eligibilityCriteria":614,"healthyVolunteers":12,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":615,"targetDuration":4,"studyType":22,"phases":617,"briefSummary":618,"conditions":619,"keywords":620,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":633,"locationsCount":287},"100556743","radiotherapy-strategies-for-use-in-combined-treatment-of-small-cell-lung-cancer-100556743","NCT06529081","Radiotherapy Strategies for Use in Combined Treatment of Small-cell Lung Cancer","Assessment of Radiotherapy Strategies for Use in Combined Treatment of Small-cell Lung Cancer at the Stage of Extensive Disease - a Research Experiment","Inclusion Criteria:\n\n* Histopathological confirmation of small cell lung cancer based on histological or cytological examination.\n* Primary clinical stage: Extensive stage of the disease according to VASLG classification or stage IV according to TNM classification.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 prior to randomization.\n* Partial response (PR) or stable disease (SD) to platinum-based doublet chemotherapy with durvalumab or atezolizumab based on restaging (positron emission tomography \\[PET\\]\u002Fcomputed tomography \\[CT\\] or CT or magnetic resonance imaging \\[MRI\\]).\n* Ability to undergo radiotherapy at a total dose of 45 Gy in 15 daily fractions of 3 Gy to the chest area and a total dose of 24 Gy administered in single fractions every 2-3 days of 8 Gy to the metastatic lesions.\n* Clinical control of brain metastases (prior whole-brain irradiation at any stage is acceptable before study entry).\n* Measurable residual disease after chemioimmunotherapy (according to RECIST 1.1 solid tumor response assessment criteria) or in case of CR\u002FPR presence of tumor lesions not classified as measurable.\n* Volume and number (up to 10) of metastatic lesions allowing for radiotherapy in doses according to the study protocol.\n* Absence of clinically significant and uncontrolled co-morbidities with pharmacological treatment.\n* Absence of active autoimmune diseases except for diabetes, hypothyroidism, psoriasis, eczema, lichen planus, and vitiligo.\n* Adequate hematopoietic function allowing treatment with atezolizumab or durvalumab, according to the current SmPC (Summary of Product Characteristics).\n* Renal and hepatic function allowing treatment according to the current SmPC for atezolizumab or durvalumab.\n\nExclusion Criteria:\n\n* Age under 18 years old.\n* Premenopausal women who do not accept the need for effective contraception during radiotherapy and\u002For chemotherapy\u002Fimmunotherapy.\n* Individuals excluded from participation in a medical experiment based on Article 23A(1) of the Act on the Profession of Physician and Pharmacist.\n* Coexistence of other uncontrolled malignant neoplasms.\n* Contraindications to the use of atezolizumab or durvalumab as specified in the SmPC.\n* Grade 2 or greater CTCAE v.5 pneumonitis secondary to immunotherapy.\n* Participation in another clinical trial during the study.\n* Prior chest radiotherapy that precludes safe administration of radiotherapy according to the study protocol. Prior palliative radiotherapy to metastatic sites is acceptable before study entry if clinically indicated as determined by the physician.\n* Contraindications to radiotherapy according to the approved protocol.",{"count":616,"type":21},165,[207],"The purpose of this study is to evaluate the efficacy of radiotherapy as part of the combined treatment approach for patients diagnosed with histopathologically confirmed small cell lung cancer (SCLC) in the advanced stage of extensive disease (ED) who are undergoing chemo-immunotherapy. The planned study aims to assess the impact of incorporating consolidative radiotherapy into the treatment strategy, focusing on residual changes following chemo-immunotherapy (during immunotherapy) and its effect on progression-free survival.\n\nThis research experiment will be conducted as a randomized multi-center study, comprising the following treatment arms:\n\n* Arm I: Continuation of standard of care - PDL1\u002FPD1 immunotherapy (durvalumab or atezolozumab) after chemo-immunotherapy based on platinum compounds;\n* Arm II: Standard of care, followed by consolidating radiotherapy of the chest area and possibly metastases (if indicated) in doses and for palliative indications (total dose of 30 Gy in 10 daily doses of 3 Gy each);\n* Arm III: Standard of care, followed by consolidating radiotherapy in the radical\u002Fablative doses (total dose of 45 Gy delivered in 15 daily fractions of 3 Gy for the chest area, and total dose of 24 Gy in single fractions of 8 Gy administered every 2-3 days for the metastatic lesions) of the chest area and all metastatic lesions.\n\nAdditionally, as part of routine weekly blood collections, an extra volume of 10 ml of blood will be collected. This additional blood sample will be obtained before starting radiotherapy, during each week of radiotherapy (maximum three collections), and at the time of disease progression (one collection), resulting in a total of five extra samples. The collected blood will be prepared, stored and used for circulating tumor DNA (ctDNA) testing, according to the protocol. The ctDNA analysis data will be utilized as a potential marker to determine the time to progression and assess the benefits derived from the administered radiotherapy.",[44],[44,621,622,447,623,624,625],"Extensive Disease","Chemo-immunotherapy","Durvalumab","Atezolizumab","Immunotherapy","2025-08-22",{"date":628,"type":91},"2025-08-28",{"date":630,"type":91},"2024-04-01",{"date":632,"type":21},"2029-12-31",{"name":634,"class":125},"Copernicus Memorial Hospital",{"id":636,"slug":637,"hasResults":12,"nctId":638,"briefTitle":639,"officialTitle":640,"acronym":4,"eligibilityCriteria":641,"healthyVolunteers":12,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":642,"targetDuration":4,"studyType":590,"phases":4,"briefSummary":643,"conditions":644,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":648,"lastUpdatePostDateStruct":649,"startDateStruct":651,"completionDateStruct":653,"leadSponsor":654,"locationsCount":126},"100511922","molecular-analysis-and-treatment-options-of-sclc-100511922","NCT05945745","Molecular Analysis and Treatment Options of SCLC","Molecular Landscape Analysis and Clinical Implications for SCLC","Inclusion Criteria:\n\n* Histologically proven diagnosis of SCLC\n* 18 years of age or older\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Histologically proven diagnosis of non-SCLC",{"count":589,"type":21},"Small cell lung cancer (SCLC) is an aggressive disease that is characterized by rapid growth and the early development of metastases. Patients typically respond to initial chemotherapy but quickly experience relapse, resulting in a poor long-term outcome. Therapeutic innovations that substantially improve survival have historically been limited, and reliable, predictive biomarkers are lacking.\n\nOngoing research has advanced the understanding of molecular categories and the immunologic microenvironment of SCLC, which in turn has helped improve disease classification and staging. Considering the role of molecular alterations has not yet fully to be defined in the treatment of SCLC, there is an urgent recognition that molecular alterations in the SCLC are important to predict response and survival for novel therapies and ongoing clinical trials. Advances in research have revealed critical information regarding biologic characteristics of the disease, which may lead to the identification of vulnerabilities and the development of new therapies. Further research focused on identifying biomarkers and evaluating innovative therapies will be paramount to improving treatment outcomes for patients with SCLC.\n\nIn summary, identification of (genetic) biomarkers in SCLC is increasingly essential to perform molecular diagnostics and individualized treatments. This project aims to create a registry of patients with SCCL to further the characterization of molecular alterations and develop (novel) treatments based on the detection.",[210,645,44,646,647],"Small Cell Lung Cancer, Combined Type","Small Cell Lung Cancer Extensive Stage","Small Cell Lung Cancer Limited Stage","2024-11-26",{"date":650,"type":91},"2024-11-29",{"date":652,"type":91},"2016-01-01",{"date":457,"type":21},{"name":655,"class":125},"Shanghai Chest Hospital",{"id":657,"slug":658,"hasResults":12,"nctId":659,"briefTitle":660,"officialTitle":661,"acronym":662,"eligibilityCriteria":663,"healthyVolunteers":12,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":664,"targetDuration":4,"studyType":590,"phases":4,"briefSummary":666,"conditions":667,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":668,"lastUpdatePostDateStruct":669,"startDateStruct":671,"completionDateStruct":673,"leadSponsor":675,"locationsCount":126},"100535079","pet-guided-radiotherapy-for-patients-with-small-cell-lung-cancer-100535079","NCT06247163","PET-guided Radiotherapy for Patients With Small Cell Lung Cancer.","Prospective PET-guided Radiotherapy for Patients With Small Cell Lung Cancer.","PET-ART","Inclusion Criteria:\n\n* Histopathologic confirmation\n* Limited disease\n\nExclusion Criteria:\n\n* Other histology than small cell lung cancer\n* Further tumor diagnosis\n* ECOG 3 or worse\n* Extensive disease\n* stage IV",{"count":665,"type":21},30,"There is a prospective risk-adapted evaluation of the optimal dose of radiotherapy for definitive radiotherapy of locally advanced small cell lung cancer within the corridor recommended as standard therapy according to the current interdisciplinary S3 guideline of the German Cancer Society\u002FCancer Aid\u002FAWMF",[44],"2024-09-25",{"date":670,"type":91},"2024-09-27",{"date":672,"type":91},"2024-02-22",{"date":674,"type":21},"2029-06-22",{"name":676,"class":125},"University Hospital, Essen",{"id":678,"slug":679,"hasResults":12,"nctId":680,"briefTitle":681,"officialTitle":682,"acronym":4,"eligibilityCriteria":683,"healthyVolunteers":12,"sex":17,"minAge":107,"maxAge":4,"enrollmentInfo":684,"targetDuration":4,"studyType":22,"phases":686,"briefSummary":687,"conditions":688,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":689,"lastUpdatePostDateStruct":690,"startDateStruct":692,"completionDateStruct":694,"leadSponsor":696,"locationsCount":126},"100535113","phase-3-a-phase-iiii-study-of-al8326-in-small-cell-lung-cancer-100535113","NCT06247605","A Phase IIII Study of AL8326 in Small Cell Lung Cancer","Phase III Clinical Study of AL8326 Tablets in Patients With Advanced or Recurrent Small Cell Lung Cancer After at Least Prior Second-line Treatment","Inclusion Criteria:\n\n1. All subjects or legal representatives must sign the informed consent form approved by the Ethics Committee in writing prior to the start of any screening procedures;\n2. Age ≥ 18 years, male or female;\n3. Histologically or cytologically confirmed small cell lung cancer patients who have recurrent or advanced disease after at least two lines of systemic regimen (including first-line platinum-based therapy, second-line monotherapy or other therapies \\*);\n4. At least one measurable tumor lesion according to RECIST 1.1 \\*\\*;\n5. Expected survival time of at least 12 weeks;\n6. ECOG (PS) score of 0 to 2;\n7. Subject has adequate organ and bone marrow function and meets the following laboratory criteria:\n\n   1. Blood routine test (without red blood cell or platelet transfusion or hematopoietic factor drug correction within 14 days before screening): absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL (1500\u002Fmm3), platelets ≥ 80 × 10\\^9\u002FL; hemoglobin ≥ 9.0 g\u002FdL;\n   2. Liver function: serum total bilirubin ≤ 1.5 × ULN (upper limit of normal), except for patients with Gilbert 's syndrome (persistent or recurrent hyperbilirubinemia, manifested as unconjugated bilirubin elevation in the absence of hemolysis or pathological evidence of liver); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN for patients without liver metastasis, and ALT and AST ≤ 5 × ULN for patients with liver metastasis;\n   3. Renal function: Serum creatinine ≤ 1.5 × ULN and estimated standard cendogenous creatinine clearance rate ≥ 60 ml\u002Fmin by Cockcroft-Gault formula, Ccr (ml\u002Fmin) = \\[(140-age) × body weight (kg)\\]\u002F\\[72 × Scr (mg\u002Fdl)\\], calculated for females × 0.85;\n   4. Coagulation function: international normalized ratio (INR) ≤ 1.5;\n   5. Left ventricular ejection fraction (LVEF) \\> 50% at screening. 8.1) Female: For female subjects of childbearing potential, they must have a negative serum pregnancy test within 7 days prior to enrollment and agree to use a medically approved method of contraception (condom, sponge, gel, diaphragm, IUD, oral or injectable contraceptive, subcutaneous implant, etc.) during and for 3 months after treatment; they must be non-pregnant and lactating. Female subjects are considered fertile if they are menopausal but have not reached post-menopausal status (menopause of 12 consecutive months or more, with no cause other than menopause) and have not undergone sterilization (removal of ovaries and\u002For uterus). Their sexual partner agrees to use a medically licensed method of contraception during the subject's treatment and for 3 months after completion; 2) Males: surgical sterilization or agreement to use medically licensed contraception during and for 3 months after the end of treatment; their sexual partners agree to use medically licensed contraception during and for 3 months after the end of the subject's treatment;\n\n9\\. Capable and willing to comply with protocol requirements during the study and subsequent procedures.\n\nExclusion Criteria:\n\n1. Known uncontrollable hypersensitivity to AL8326 similar compounds;\n2. Having previously used AL8326 tablets;\n3. Having or had a history of leptomeningeal disease or leptomeningeal metastases at screening, or confirmed CNS metastases presenting with symptoms of uncontrolled brain metastases, spinal cord compression, or cancerous meningitis within 8 weeks of first dose, except for CNS metastases or spinal cord compression that are clinically stable and do not require corticosteroids and have an interval of greater than 2 weeks between screening and previous treatment (including radiation therapy or surgery);\n4. Having or had other neoplasms unless radically treated and with no evidence of recurrence or metastasis within the past 2 years;\n5. Having significant gastrointestinal history or current illness, such as inability to swallow, severe peptic ulcer, uncontrollable nausea and vomiting, and clinical difficulty in controlling chronic diarrhea, intestinal obstruction or other chronic gastrointestinal diseases in the past 3 months, which may affect the intake, transport or absorption of drugs as judged by the investigator, or who have previously undergone total gastrectomy;\n6. Having other important primary diseases, such as single agent uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure ≥ 95 mmHg), arrhythmia requiring clinical intervention (such as long QT syndrome, QTcF \\> 470 ms), abnormally prolonged arrhythmia caused by unstable coronary artery disease, decompensated congestive heart failure (New York Heart Association(NYHA) class III or IV) or myocardial infarction, unstable angina pectoris, ascites or pleural effusion with uncontrolled within 6 months before the administration of the investigational product (CTCAE 5.0 ≥ 2), active autoimmune diseases, mental illness, symptomatic or interstitial lung disease requiring treatment, thyroid disease that may seriously affect the trial evaluation;\n7. Previously received cytotoxic chemotherapy and\u002For immunotherapy, and the end of the last dose is at least 4 weeks apart from the first dose of study drug; the end of anti- tumor herb medicine is at least 14 days apart; the end of nitroso or mitomycin was at least 6 weeks apart, and tyrosine kinase inhibitors (TKIs) class molecular targeted drugs were at least 4 weeks apart; the treatment of brain metastases\u002Fbone metastases had to be at least 2 weeks apart; and had recovered to ≤ Grade 1 from the toxicity of previous treatment \\[except for the following: a. alopecia; b. long-term toxicity caused by radiotherapy, which could not be recovered in the judgment of the investigator; c. platinum-induced Grade 2 and the following neurotoxicity such as hearing impairment (according to the Common Terminology Criteria for Adverse Events CTCAE V5.0)\\];\n8. Had arterial thrombosis or severe venous thromboembolic events within 6 months before screening, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism;\n9. Having imaging findings indicating that the tumor has invaded around important vessels at screening or the tumor is likely to invade important vessels and cause fatal massive hemorrhage during the subsequent study period as judged by the investigator;\n10. Uncontrolled infection within 14 days prior to first dose;\n11. Screening urine routine showed urine protein ≥ + +, and 24-hour urine protein \\> 1.0 g;\n12. Having active bleeding within 3 months before screening or at high risk of bleeding as judged by the investigator;\n13. Been receiving anticoagulants or vitamin K antagonists (e.g., warfarin, heparin, or their analogues) during the screening period \\[low-dose anticoagulants such as warfarin (no more than 1 mg daily orally), low-dose heparin (no more than 12,000 U daily), or low-dose aspirin (no more than 100 mg daily) were permitted for prophylactic purposes provided INR was ≤ 1.5\\];\n14. Having positive test results for hepatitis C virus (HCV) antibody, treponema pallidum antibody, or human immunodeficiency virus (HIV) antibody, or active hepatitis B (defined as hepatitis B virus HBV DNA ≥ 2000 IU\u002FmL or HBV DNA ≥ 10 \\^ 4 copies);\n15. Participated in other clinical trials (excluding observational or vitamin studies) within 4 weeks before informed consent;\n16. Having received major surgical treatment within 6 weeks prior to screening (patients must be fully recovered and stable before the start of treatment) or serious unhealed wounds, ulcers or fractures at screening;\n17. Having a history of organ transplantation or being prepared to undergo organ transplantation;\n18. Other reasons that, in the discretion of the investigator, would make participation in this study inappropriate.\n\nNotes:\n\n\\*1 new line of therapy refers to a change in treatment regimen due to disease progression rather than toxicity or other reasons; after progression on the first treatment, reuse of the same treatment regimen is also a new line of therapy;\n\n\\*\\* Lesions treated with radiotherapy or locoregional therapy must have radiographic evidence of disease progression to be considered target lesions. If there is only one measurable lesion, the lesion cannot be brain lesion.",{"count":685,"type":21},243,[185],"This is a multicenter, randomized, double-blind, placebo-controlled, phase III study to evaluate the efficacy and safety of AL8326 tablets in small cell lung cancer (SCLC) patients with disease progression or recurrence after receiving at least second-line treatment regimens.",[44],"2024-01-30",{"date":691,"type":91},"2024-02-08",{"date":693,"type":91},"2023-10-26",{"date":695,"type":21},"2029-07",{"name":697,"class":98},"Advenchen Laboratories Nanjing Ltd.",{"id":699,"slug":700,"hasResults":12,"nctId":701,"briefTitle":702,"officialTitle":702,"acronym":4,"eligibilityCriteria":703,"healthyVolunteers":12,"sex":17,"minAge":107,"maxAge":704,"enrollmentInfo":705,"targetDuration":4,"studyType":22,"phases":707,"briefSummary":708,"conditions":709,"keywords":710,"overallStatus":277,"whyStopped":4,"lastUpdateSubmitDate":714,"lastUpdatePostDateStruct":715,"startDateStruct":717,"completionDateStruct":719,"leadSponsor":720,"locationsCount":287},"100534297","phase-2-adebrelimab-and-concurrent-radiochemotherapy-as-first-line-treatment-for-extensive-stage-small-cell-lung-cancer-100534297","NCT06236997","Adebrelimab and Concurrent Radiochemotherapy as First-line Treatment for Extensive-stage Small-cell Lung Cancer","Inclusion Criteria:\n\n1. Aged 18-75 years;\n2. Histologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \\[VALG\\] staging system) ;\n3. Must sign a written informed consent form prior to any study specific procedures;\n4. No prior treatment for ES-SCLC;\n5. No more than 5 lesions (including metastases),and at least one measurable lesion that meets RECIST 1.1 evaluation criteria;\n6. Life expectancy more than 3 months;\n7. ECOG PS 0-1\n\nExclusion Criteria:\n\n1. Previous treatment with radiochemotherapy for limited-stage small cell lung cancer;\n2. Subjects who previously received systemic antitumor or Immune checkpoint inhibitor therapy ;\n3. Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment;\n4. Active brain metastases, Leptomeningeal metastasis(untreated central nervous system (CNS) metastases unless asymptomatic and lesion size\\\u003C1cm;\n5. Patients with spinal cord compression;\n6. Patients with multiple liver metastases(except isolated lesion and lesion size\\\u003C2cm);\n7. Uncontrollable third cavity effusion (e.g. a large amount of pleural effusion, ascites, or pericardial effusion, etc.) requiring repeated drainage, which was judged by the investigator to be unsuitable for study;\n8. The investigator judges that there are any patients who endanger the patient's safety, interfere with the study assessment, and have poor compliance.","75 Years",{"count":706,"type":21},48,[25],"Patients with extensive-stage small-cell lung cancer (ES-SCLC) have poor prognosis, with limited treatment options. Chemo-immunotherapy is the standard 1st-line therapy for patients with ES-SCLC.When 4 cycles of etoposide+carboplatin (EC) or etoposide+cisplatin(EP) chemotherapy combined with PD-L1 inhibitor are effective, guidelines recommend additional thoracic radiotherapy.\n\nIn this study, the investigators bring radiotherapy forward, which means that after 2 cycles of EC chemotherapy plus Adebrelimab, participants with response（PR\u002FCR\u002FSD）will receive concurrent radiotherapy and 2 cycles of EC chemotherapy plus Adebrelimab, then maintenance therapy with Adebrelimab （Q3W）.\n\nThe purpose of this study is to explore the safety and efficacy of Adebrelimab combined with concurrent chemoradiotherapy in untreated participants with extensive-stage small cell lung cancer.",[44],[711,712,713],"ES-SCLC","Concurrent Radiochemotherapy","Adebrelimab","2024-01-24",{"date":716,"type":91},"2024-02-01",{"date":718,"type":21},"2024-02-10",{"date":95,"type":21},{"name":721,"class":722},"Henan Cancer Hospital","OTHER_GOV",{"id":724,"slug":725,"hasResults":12,"nctId":726,"briefTitle":727,"officialTitle":728,"acronym":4,"eligibilityCriteria":729,"healthyVolunteers":12,"sex":17,"minAge":107,"maxAge":704,"enrollmentInfo":730,"targetDuration":4,"studyType":22,"phases":731,"briefSummary":732,"conditions":733,"keywords":742,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":746,"lastUpdatePostDateStruct":747,"startDateStruct":749,"completionDateStruct":751,"leadSponsor":753,"locationsCount":126},"100529757","phase-2-a-phase--clinical-study-of-adebrelimab-combined-with-chemotherapy-and-concurrent-radiotherapy-for-extensive-stage-oligometastatic-sclc-100529757","NCT06177925","A Phase Ⅱ Clinical Study of Adebrelimab Combined With Chemotherapy and Concurrent Radiotherapy for Extensive-Stage Oligometastatic SCLC","A Phase Ⅱ Exploratory Clinical Study of Adebrelimab Combined With Chemotherapy and Concurrent Radiotherapy as First-Line Treatment for Extensive-Stage Oligometastatic Small Cell Lung Cancer","Inclusion Criteria:\n\n* Signed inform consent form\n* Age \\>= 18 years and \\\u003C= 75 years\n* Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \\[VALG\\] staging system)，the number of metastatic lesions ≤ 5, the number of metastatic organs ≤ 3, and no previous systemic chemotherapy, radiotherapy or immune checkpoint inhibitor treatment.\n* Eastern Cooperative Oncology Group performance status of 0 or 1\n* Expected survival time ≥ 3 months\n* Patients must submit a pre-treatment tumor tissue sample during the study.\n* Adequate hematologic and end organ function\n\nExclusion Criteria:\n\n* Spinal cord compression not definitively treated with surgery and\u002For radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 1 week prior to randomization\n* Leptomeningeal disease\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures\n* Uncontrolled or symptomatic hypercalcemia\n* Malignancies other than SCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome\n* History of autoimmune disease, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease\n* Prior treatment with immune checkpoint blockade therapies\n* Subjects with a condition requiring systemic treatment with either corticosteroids (\\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid are permitted in the absence of active autoimmune disease.\n* Significant cardiovascular disease\n* Prior allogeneic bone marrow transplantation or solid organ transplant\n* Treatment with systemic immunosuppressive medications within 1 weeks prior to randomization\n* History of hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins, carboplatin or etoposide\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator",{"count":232,"type":21},[25],"This is an open-label, single arm Phase II study designed to evaluate the efficacy and safety of adebelizumab combined with carboplatin\u002FCisplatin plus (+) etoposide and concurrent radiotherapy in the first-line treatment of patients with extensive stage oligometastatic small cell lung cancer.",[734,735,736,737,738,739,740,741,418,44],"Respiratory Tract Neoplasms","Thoracic Neoplasms","Neoplasms by Site","Neoplasms","Lung Diseases","Respiratory Tract Diseases","Carcinoma, Bronchogenic","Bronchial Neoplasms",[743,744,713,745,447],"Extensive stage small cell lung cancer","Oligometastasis","Chemotherapy","2023-12-11",{"date":748,"type":91},"2023-12-20",{"date":750,"type":21},"2023-12-10",{"date":752,"type":21},"2026-09-30",{"name":754,"class":125},"Nanfang Hospital, Southern Medical University"]