[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Mexico\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":695},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,575,0,25,[9,46,86,115,144,171,204,232,261,283,304,326,353,379,400,422,461,486,509,539,565,586,610,632,652],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":31,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100652278","molecular-ovarian-cancer-assessment-in-latinoamerican-patients-100652278",false,"NCT07771400","Molecular Ovarian Cancer Assessment in LatiNoAmerican PAtients","MOANA","Inclusion Criteria:\n\n1. Participants ≥18 years-old.\n2. Patients diagnosed with ovarian, fallopian tube or peritoneal cancer:\n\n   1. advanced stages stage III or IV by FIGO disease stage\n   2. new diagnosis and persistent or recurrent disease\n3. Diagnosed from 2018 to 2024.\n4. Histologically confirmed diagnosis of serous (low or high grade), endometrioid, mucinous or clear cell ovarian carcinoma.\n5. Accept to participate in the project and sign the informed consent (if applicable).\n6. An archived representative formalin-fixed paraffin-embedded (FFPE) tumor specimen in tumor tissue blocks (preferred) or freshly sectioned unstained slides (at least 20) from biopsy\u002Fsurgery is mandatory.\n\nExclusion Criteria:\n\n1. Histological ambiguous diagnosis upon review.\n2. Diagnosis based on cytology and without any biopsy or surgical specimen.\n3. Patients diagnosed and staged but not receiving any treatment.\n4. Patients without medical records available (lost, empty or irretrievable clinical information).","FEMALE","18 Years",{"count":20,"type":21},320,"ESTIMATED","OBSERVATIONAL","This is a multicentric observational study conducted at selected sites across Latin America. Eligible participants will be identified through the medical records of participating institutions. The study aims to describe overlap of expression of folate receptor alpha (FRα), HER2 and PD-L1 using immunohistochemistry (IHC) and HRD and BRCA (somatic and germline) by NGS. Additionally, to describe clinical demographic and socioeconomic variables, as well as treatment patterns, pathological characteristics, outcomes, and genetic and molecular testing part of clinical practice.\n\nAll data (including patient characteristics, treatment patterns, outcomes and available tests) will be collected once, retrospectively from medical records, ensuring adherence to ethical standards and participant confidentiality. Biomarkers analysis (including FRα, HER2 and PD-L1) will be performed prospectively, a Formalin-Fixed Paraffin-Embedded (FFPE) tumor block will be collected to evaluate and describe the expression of folate receptor alpha (FRα) and HER2, using immunohistochemistry (IHC) with the Roche Ventana kit (FOLR1 and HER2 4B5) and Dako's 22C3 for PD-L1. The study will analyze samples collected between 1st January 2018 to 31 December 2024 (analysis of historically collected samples).\n\nThe study comprises a retrospective data collection from medical charts. Participants will continue to receive treatment and clinical evaluations according to what is determined by their medical team, according to the usual standards of treatment and clinical practice of each center. No intervention or prospective follow-up is proposed in this study.",[25,26,27,28,29,30],"Ovarian Cancer by FIGO Stage","Ovarian Cancer Stage III","Ovarian Cancer Stage IV","Fallopian Tube Cancer Stage III","Fallopian Tube Cancer Stage IV","Fallopian Tube Cancers",[32],"Peritonial Cancer","NOT_YET_RECRUITING","2026-08-24",{"date":36,"type":37},"2026-08-25","ACTUAL",{"date":39,"type":21},"2026-09",{"date":41,"type":21},"2027-08",{"name":43,"class":44},"Latin American Cooperative Oncology Group","OTHER",17,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":85},"100600637","phase-2-study-of-izalontamab-brengitecan-bms-986507-versus-platinum-pemetrexed-for-egfr-mutated-non-small-cell-lung-cancer-after-failure-of-egfr-tki-therapy-izabright-lung01-100600637","NCT07100080","Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)","IZABRIGHT-Lung01: A Randomized, Open-label, Phase 2\u002F3 Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-based Chemotherapy in Patients With EGFR-mutated Non-small Cell Lung Cancer and Disease Progression on EGFR Tyrosine Kinase Inhibitor Therapy","Inclusion Criteria:\n\n* Non-squamous NSCLC, not amenable to treatment in curative intent.\n* Documented evidence of EGFR mutation (exon 19 deletion, L858R mutation).\n* Progressive disease on a 3rd-generation (such as osimertinib, furmonertinib, lazertinib,...) EGFR-TKI-based mono- or combination therapy regimen as the most recent line of therapy in an adjuvant, locally advanced, or metastatic treatment setting.\n* Eligible to receive a platinum-based doublet chemotherapy regimen (either cisplatin or carboplatin in combination with pemetrexed).\n\nExclusion criteria:\n\n* Inadequate organ function and\u002For bone marrow reserve.\n* Leptomeningeal metastases or spinal cord compression.\n* Poorly controlled systemic medical conditions.\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.","ALL",{"count":55,"type":21},500,"INTERVENTIONAL",[58,59],"PHASE2","PHASE3","A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy",[62],"Non-Small Cell Lung Cancer",[64,65,66,67,68,69,70,71,72,73,74,75],"Epidermal Growth Factor Receptor","Tyrosine Kinase Inhibitors","Osimertinib","Standard of Care","Lung Neoplasms","Antineoplastic Agents","Izalontamab brengitecan","Iza-bren","BL-B01D1","Carboplatin","Cisplatin","Pemetrexed","RECRUITING",{"date":36,"type":37},{"date":79,"type":37},"2025-11-05",{"date":81,"type":21},"2030-11-15",{"name":83,"class":84},"Bristol-Myers Squibb","INDUSTRY",186,{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":56,"phases":96,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":109,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":20},"100597842","a-study-to-compare-the-combination-of-navlimetostat-bms-986504-with-pembrolizumab-and-chemotherapy-versus-placebo-plus-pembrolizumab-and-chemotherapy-in-first-line-metastatic-non-small-cell-lung-cancer-participants-with-homozygous-mtap-deletion-100597842","NCT07063745","A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","A Randomized Phase 2\u002F3 Study of Navlimetostat (BMS-986504) in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","MountainTAP-29","Inclusion Criteria\n\n* Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease.\n* Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Participants must have at least 1 measurable lesion as per RECIST v1.1.\n\nExclusion Criteria\n\n* Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy.\n* Participants must not have symptomatic brain metastases or spinal cord compression.\n* Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC).\n\nNote: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated.\n\n* Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":95,"type":21},590,[58,59],"The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (BMS-986504) (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homozygous MTAP deletion",[99],"Metastatic Non-small Cell Lung Cancer With MTAP Deletion",[101,102,103,104,105,106,107,108],"PRMT5","Lung cancer","NSCLC","MTAP","CDKN2A","MRTX1719","First-line","Navlimetostat",{"date":36,"type":37},{"date":111,"type":37},"2026-01-02",{"date":113,"type":21},"2031-08-12",{"name":83,"class":84},{"id":116,"slug":117,"hasResults":12,"nctId":118,"briefTitle":119,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":12,"sex":53,"minAge":122,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":137,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":7},"100579387","an-international-multicenter-study-on-transcatheter-device-closure-of-perimembranous-ventricular-septal-defects-100579387","NCT06823635","An International Multicenter Study on Transcatheter Device Closure of Perimembranous Ventricular Septal Defects","PERI-CLOSE","Inclusion Criteria:\n\n1. Patients with perimembranous ventricular septal defects (PmVSD) diagnosed by 2D transthoracic echocardiography according to established classification systems, who provided informed consent and underwent transcatheter closure using any commercially available occluder devices (whether specifically designed for this indication or used off-label), with follow-up according to local hospital protocols.\n2. Defect size between 3 mm and \\\u003C20 mm on the left ventricular side, as measured by 2D echocardiography.\n3. Age ≥1 month and body weight ≥5 kg.\n4. Left-to-right ventricular shunt.\n\nExclusion Criteria:\n\n1. Patients or legal guardians refusing the use of personal data for research purposes.\n2. Failure to attend any follow-up visit post-discharge.","1 Month",{"count":124,"type":21},2000,"The international multicenter registry aims to gather real-world data on patient outcomes and assess the procedural success and performance of various device occluders used in the transcatheter treatment of pediatric and adult patients with perimembranous ventricular septal defects (PmVSD).",[127],"Perimembranous Ventricular Septal Defect",[129,130,131,132,133,134,135,136],"Cardiovascular Abnormalities","Congenital Heart Disease","Device Closure","Heart Defects, Congenital","Heart Septal Defects","Heart Septal Defects, Ventricular","Transcatheter Interventions","Ventricular Septal Defects",{"date":36,"type":37},{"date":139,"type":37},"2025-01-01",{"date":141,"type":21},"2027-06-30",{"name":143,"class":44},"Fondation Hôpital Saint-Joseph",{"id":145,"slug":146,"hasResults":12,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":12,"sex":17,"minAge":152,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":56,"phases":155,"briefSummary":156,"conditions":157,"keywords":159,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":163,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":170},"100522211","phase-3-study-of-volrustomig-in-women-with-high-risk-locally-advanced-cervical-cancer-evolve-cervical-100522211","NCT06079671","Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical)","A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-centre, Global Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer Who Have Not Progressed Following Platinum-based, Concurrent Chemoradiation Therapy (eVOLVE-Cervical)","eVOLVECervical","Inclusion Criteria:\n\nFor inclusion in the study, patients should fulfill the following criteria:\n\n1. Female.\n2. Aged at least 15 years at the time of screening. Note: Participants \\\u003C 18 years of age: physical changes should be aligned with Tanner Stage III.\n3. Body weight \\> 35 kg.\n4. Histologically documented FIGO 2018 Stage IIIA to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with no evidence of metastatic disease.\n5. Initial staging procedures performed no more than 56 days prior to the first dose of CCRT.\n6. Provision of FFPE tumor sample to assess the PD-L1 expression.\n7. Must not have progressed following CCRT, participants with persistent disease after definitive CCRT must not be amenable to other available therapies with curative intent.\n8. WHO\u002FECOG performance status of 0 or 1; duration of life expectancy of ≥ 12 weeks.\n9. Adequate organ and bone marrow function.\n10. Capable of providing signed informed consent.\n\nExclusion Criteria:\n\nPatients should not enter the study if any of the following exclusion criteria are fulfilled:\n\n1. Diagnosis of small cell (neuroendocrine) or mucinous adenocarcinoma of cervical cancer.\n2. Evidence of metastatic disease.\n3. Intent to administer a fertility-sparing treatment regimen.\n4. History of organ transplant or allogenic stem cell transplant.\n5. History of active primary immunodeficiency or active or prior documented autoimmune or inflammatory disorders.\n6. Uncontrolled intercurrent illness.\n7. History of another primary malignancy except for a) Malignancy treated with curative intent with no known active disease ≥2 years before the first dose of study intervention; b) Adequately treated nonmelanoma skin cancer or lentigo maligna, or carcinoma in situ without evidence of disease.\n8. Unresolved toxicities from previous CCRT except for irreversible toxicity that is not reasonably expected to be exacerbated.\n9. Prior history or presence of vesicovaginal, colovaginal, or rectovaginal fistula.\n10. History of anaphylaxis to any biologic therapy or vaccine.\n11. Current or prior use of immunosuppressive medication within 14 days before the first dose of the study intervention is excluded. The following are exceptions to this criterion: a) Intranasal, inhaled, topical steroids, or local steroid injections (eg, intraarticular injection); b) Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication or chemotherapy premedication) or a single dose for palliative purpose (eg, pain control); c) Physiologic doses of oral corticosteroids, ie, not exceeding 10 mg\u002Fday of prednisone (or equivalent) in the preceding 14 days.\n12. Patients who have undergone a previous hysterectomy, including a supracervical hysterectomy, or will have a hysterectomy as part of their initial cervical cancer therapy.\n13. Any prior (besides prior CCRT) or concurrent treatment for cervical cancer.\n14. Major surgical procedures within 4 weeks prior to the first dose of the study intervention or still recovering from prior surgery.\n15. Exposure to immune mediated therapy prior to the study for any indication.\n16. Receipt of live attenuated vaccine within 30 days prior to the first dose of the study intervention.\n17. Participants with a known allergy or hypersensitivity to the study intervention, or any excipients of the study intervention.","15 Years",{"count":154,"type":21},800,[59],"This is a phase III, randomized, double-blind, placebo-controlled, multi-center, global study to explore the efficacy and safety of volrustomig in women with high-risk LACC (FIGO 2018 stage IIIA to IVA cervical cancer) who have not progressed following platinum-based CCRT.",[158],"Locally Advanced Cervical Cancer",[160,161,162],"Locally Advanced Cervical Cancer;","Adolescent and Young Adult;","Volrustomig",{"date":36,"type":37},{"date":165,"type":37},"2023-09-22",{"date":167,"type":21},"2030-09-30",{"name":169,"class":84},"AstraZeneca",205,{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":179,"enrollmentInfo":180,"targetDuration":4,"studyType":56,"phases":182,"briefSummary":183,"conditions":184,"keywords":186,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":196,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":203},"100502809","phase-3-phase-iiib-study-of-ribociclib--et-in-early-breast-cancer-100502809","NCT05827081","Phase IIIb Study of Ribociclib + ET in Early Breast Cancer","A Phase IIIb Study to Characterize the Efficacy and Safety of Adjuvant Ribociclib Plus Endocrine Therapy in a Close-to-clinical Practice Patient Population With HR+ HER2- Early Breast Cancer (Adjuvant WIDER)","Adjuvant WIDER","Key Inclusion criteria:\n\n* Participant is an adult, male or female ≥ 18 years of age at the time of informed consent form signature (IC).\n* Participant has a histologically and\u002For cytologically confirmed diagnosis of estrogen-receptor positive and\u002For progesterone receptor positive breast cancer (BC) based on the most recently analyzed tissue sample tested by a local laboratory prior to enrollment.\n* Participant has HER2- BC defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing based on the most recently analyzed tissue sample.\n* Participants may have already received any standard neoadjuvant and\u002For adjuvant ET, including tamoxifen or toremifene at the time of informed consent signature, but enrollment should occur within 36 months of prior ET start date and participants should have at least 3 years remaining of endocrine adjuvant therapy.\n* For participants with prior ET treatment \\> 12 months, restaging is highly recommended (unless contradictory to local regulations) to rule out disease recurrence prior to enrollment.\n* The number of participants with prior ET between 12 and 36 months will be capped at 30%. The cap will not apply to Black or African American participants.\n* Participant has no contraindication to receive adjuvant ET in the study.\n* Participant after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and belongs to one of the following categories:\n\n  * Anatomic Stage Group III, or\n  * Anatomic Stage Group IIB, or\n  * A subset of Anatomic Stage Group IIA.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.\n* Participant has adequate bone marrow and organ function.\n* ECG values assessed by KardiaMobile-6L device, or standard 12-lead ECG per local investigator where KardiaMobile-6L cannot be used, as:\n\n  * QTcF interval at Screening \\\u003C 450 msec (QT interval using Fridericia's correction).\n  * Mean resting heart rate 50-99 beats per minute (determined from the ECG).\n\nKey Exclusion criteria:\n\n* Participant with distant metastases of BC beyond regional lymph nodes (Stage IV according to AJCC 8th edition) and\u002For evidence of recurrence after curative surgery.\n* Participant is concurrently using other antineoplastic therapy with the exception of adjuvant ET.\n* Participant has any other concurrent severe and\u002For uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate participant participation in the clinical study or compromise compliance with the protocol, or limit life expectancy to ≤5 years.\n* Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality.\n* Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial.\n* Women of child-bearing potential (CBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 21 days after stopping the treatment.\n\nOther inclusion\u002Fexclusion criteria may apply","100 Years",{"count":181,"type":21},1400,[59],"The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC).",[185],"Early Breast Cancer",[187,188,189,190,191,192,193,194,195],"Hormone receptor positive (HR+)","Human epidermal growth factor receptor-2 negative (HER2-)","Early breast cancer (EBC)","premenopausal","postmenopausal","male breast cancer","ribociclib","LEE011","Endocrine therapy (ET)",{"date":36,"type":37},{"date":198,"type":37},"2024-02-28",{"date":200,"type":21},"2030-09-20",{"name":202,"class":84},"Novartis Pharmaceuticals",228,{"id":205,"slug":206,"hasResults":12,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":56,"phases":213,"briefSummary":214,"conditions":215,"keywords":218,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":224,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":231},"100409600","phase-2-phase-2-trial-of-adagrasib-monotherapy-and-in-combination-with-pembrolizumab-and-a-phase-3-trial-of-adagrasib-in-combination-in-patients-with-a-kras-g12c-mutation-krystal-7-100409600","NCT04613596","Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7","A Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation","Inclusion Criteria:\n\n* Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS\n* Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS\\>=50%\n* Phase 3: Presence of measurable disease per RECIST1.1\n* Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following:\n\n  1. No evidence of brain metastases\n  2. Untreated brain metastases not needing immediate local therapy\n  3. Previously treated brain metastases not needing immediate local therapy\n\nExclusion Criteria:\n\n* Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510).\n* Phase 2: Active brain metastases\n* Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following:\n\n  1. Any untreated brain lesions \\> 2.0 cm in size\n  2. Any brainstem lesions\n  3. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of \\> 10 mg of prednisone (or equivalent) prior to randomization.\n  4. Have poorly controlled (\\> 1\u002Fweek) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy\n* Phase 3: Radiation to the lung \\> 30 Gy within 6 months prior to the first dose of study treatment",{"count":212,"type":21},626,[58,59],"The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment.\n\nThe Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \\>=50% and who are candidates for first line treatment.",[216,217],"Advanced Non-Small Cell Lung Cancer","Metastatic Non-Small Cell Lung Cancer",[219,220,103,217,221,222,223],"KRAS G12C","Non-small cell lung cancer","Adagrasib","Krazati","TPS",{"date":36,"type":37},{"date":226,"type":37},"2020-12-02",{"date":228,"type":21},"2029-10-31",{"name":230,"class":84},"Mirati Therapeutics Inc.",770,{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":12,"sex":53,"minAge":240,"maxAge":241,"enrollmentInfo":242,"targetDuration":4,"studyType":56,"phases":244,"briefSummary":245,"conditions":246,"keywords":248,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":260},"100651359","phase-2-a-study-of-brenipatide-ly3537031-in-adult-participants-with-moderate-to-severe-chronic-obstructive-pulmonary-disease-copd-100651359","NCT07759245","A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)","A Phase 2, Multicenter, Randomized, Double-Blind, 52-week Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)","RENEW-COPD","Inclusion Criteria:\n\n* Have a physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD), at least 12 months prior to screening who meet the following criteria:\n\n  * Current or former smokers with a smoking history of greater than or equal to (≥) 10 pack-years\n  * Moderate-to-severe COPD (post-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV₁)\u002Fforced vital capacity (FVC) less than (\\\u003C) 70 percent (%)\n  * Modified Medical Research Council Dyspnea Scale (mMRC-DS) grade ≥2\n  * Exacerbation history of ≥2 moderate or ≥1 severe exacerbations within the year prior to inclusion.\n  * Background double therapy \\[long-acting β₂-agonists (LABA) + long-acting muscarinic antagonists (LAMA)\\] or triple therapy \\[inhaled corticosteroids (ICS) + LABA + LAMA)\\] for 3 months prior to randomization with a stable dose of medication for ≥1 month prior to screening.\n\nExclusion Criteria:\n\n* Have a known pre-existing, clinically important lung condition other than COPD.\n* Have a current or recent acute, active infection before screening and up to randomization.","40 Years","75 Years",{"count":243,"type":21},606,[58],"The main purpose of this study is to assess if different dose levels of Brenipatide are safe and work the way they are intended to work in participants with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), when compared with placebo. The study will last approximately one year.",[247],"Pulmonary Disease, Chronic Obstructive",[249,250,251],"Emphysema","Chronic Bronchitis","Lung Disease","2026-08-21",{"date":34,"type":37},{"date":255,"type":21},"2026-08",{"date":257,"type":21},"2028-11",{"name":259,"class":84},"Eli Lilly and Company",128,{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":241,"enrollmentInfo":269,"targetDuration":4,"studyType":56,"phases":271,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":276,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":282},"100634906","phase-2-a-study-of-brenipatide-ly3537031-in-participants-with-irritable-bowel-syndrome-constipation-ibs-c-100634906","NCT07545772","A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Brenipatide in the Treatment of Adult Participants With IBS-C","RENEW-IBS-C","Inclusion Criteria:\n\n* Meets Rome IV criteria for irritable bowel syndrome-constipation (IBS-C) including having more than 25% bowel movements with Bristol Stool Form Scale (BSFS) Types 1 or 2 and less than 25% of bowel movements with BSFS Types 6 or 7\n* Based on the daily eDiary collection during the screening period:\n\n  * Have average of worst abdominal pain score of ≥3.0 on a 0-to-10-point scale during the 14 consecutive days prior to randomization\n\nExclusion Criteria:\n\n* Have a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhea, mixed IBS, or unclassified IBS by the Rome IV criteria\n* Have a history of inflammatory or immune-mediated gastrointestinal disorders\n* Have a known clinically significant gastric emptying abnormality",{"count":270,"type":21},342,[58],"The purpose of this study is to evaluate how well brenipatide (LY3537031) is tolerated what side effects may occur, and the safety and efficacy in participants with Irritable Bowel Syndrome-Constipation (IBS-C). The study drug will be administered subcutaneously (SC) (under the skin) when compared with placebo.\n\nThe study will last approximately 35 weeks.",[274,275],"Irritable Bowel Syndrome","Constipation",{"date":34,"type":37},{"date":278,"type":37},"2026-04-29",{"date":280,"type":21},"2027-09",{"name":259,"class":84},70,{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":241,"enrollmentInfo":291,"targetDuration":4,"studyType":56,"phases":293,"briefSummary":294,"conditions":295,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":297,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":303},"100634905","phase-2-a-study-of-brenipatide-ly3537031-in-participants-with-irritable-bowel-syndrome-diarrhea-ibs-d-100634905","NCT07545759","A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Brenipatide in the Treatment of Adult Participants With IBS-D","RENEW-IBS-D","Inclusion Criteria:\n\n* Meet Rome IV criteria for IBS-D, which includes having greater than 25% of bowel movements with Bristol Stool Form Scale (BSFS) Types 6 or 7 and \\\u003C25% of bowel movements with BSFS Types 1 or 2\n* Based on the daily eDiary collection during the screening period:\n\n  * Have average of worst abdominal pain score of ≥3.0 on a 0-to-10-point scale during the 14 consecutive days prior to randomization\n  * Have at least 4 days per week with a maximum BSFS ≥5 AND with at least 2 days of the 4 days per week with a maximum BSFS ≥6 during the 14 consecutive days prior to randomization\n* Have had no major changes in diet in the 4 weeks prior to screening\n\nExclusion Criteria:\n\n* Have a diagnosis of IBS with a subtype of constipation, mixed IBS, or unclassified IBS by the Rome IV criteria\n* Have a history of inflammatory or immune-mediated gastrointestinal disorders\n* Have a known clinically significant gastric emptying abnormality",{"count":292,"type":21},531,[58],"The purpose of this study is to evaluate how well brenipatide (LY3537031) is tolerated, what side effects may occur, and the safety and efficacy in participants with Irritable Bowel Syndrome-Diarrhea (IBS-D). The study drug will be administered subcutaneously (SC) (under the skin) when compared with placebo.\n\nThe study will last approximately 35 weeks.",[274,296],"Diarrhea",{"date":34,"type":37},{"date":299,"type":37},"2026-05-06",{"date":301,"type":21},"2027-11",{"name":259,"class":84},89,{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":311,"enrollmentInfo":312,"targetDuration":4,"studyType":56,"phases":314,"briefSummary":316,"conditions":317,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":319,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":325},"100624674","phase-1-a-study-of-bms-986528-in-participants-with-refractory-rheumatoid-arthritis-100624674","NCT07412704","A Study of BMS-986528 in Participants With Refractory Rheumatoid Arthritis","A Phase 1\u002F2a, Open-label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of BMS-986528 in Participants With Refractory Rheumatoid Arthritis","Inclusion Criteria\n\n\\- Adult participants with rheumatoid arthritis (RA) who meet definition of difficult-to-treat.\n\nExclusion Criteria\n\n* Juvenile arthritis or onset of inflammatory arthritis before age 18.\n* Seronegative RA participants in whom polymyalgia rheumatica has not been ruled out.\n* Active fibromyalgia with pain symptoms or signs that would interfere with joint assessment.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","65 Years",{"count":313,"type":21},84,[315,58],"PHASE1","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and the preliminary evidence of disease-modifying effect of BMS-986528 in participants with refractory, difficult-to-treat rheumatoid arthritis (RA).",[318],"Arthritis, Rheumatoid",{"date":34,"type":37},{"date":321,"type":21},"2026-09-15",{"date":323,"type":21},"2030-09-02",{"name":83,"class":84},39,{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":12,"sex":53,"minAge":333,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":56,"phases":336,"briefSummary":337,"conditions":338,"keywords":341,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":346,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":352},"100611500","phase-3-a-study-of-orforglipron-ly3502970-on-cardiovascular-outcomes-in-adults-with-atherosclerotic-cardiovascular-disease-andor-chronic-kidney-disease-attain-outcomes-100611500","NCT07241390","A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and\u002For Chronic Kidney Disease (ATTAIN-Outcomes)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Orforglipron on the Incidence of Major Adverse Cardiovascular Events in Participants With Established Atherosclerotic Cardiovascular Disease and\u002For Chronic Kidney Disease","Inclusion Criteria:\n\n* Have established ASCVD and\u002For CKD\n\nExclusion Criteria:\n\n* Have type 1 diabetes\n* Have had a major heart condition within 60 days prior to screening\n* Have New York Heart Association Functional Classification Class IV heart failure","50 Years",{"count":335,"type":21},7140,[59],"The purpose of this study is to measure cardiovascular outcomes with orforglipron compared with placebo in participants with atherosclerotic cardiovascular disease (ASCVD) and\u002For chronic kidney disease (CKD). Participation in the study will last about 5 years.",[339,340],"Atherosclerosis Cardiovascular Disease","Chronic Kidney Disease",[342,343,344,345],"Heart Disease","Kidney Disease","Outcomes","Stroke",{"date":34,"type":37},{"date":348,"type":37},"2025-12-01",{"date":350,"type":21},"2031-08",{"name":259,"class":84},567,{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":360,"sex":53,"minAge":361,"maxAge":362,"enrollmentInfo":363,"targetDuration":4,"studyType":56,"phases":365,"briefSummary":366,"conditions":367,"keywords":369,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":371,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":378},"100605263","phase-3-beatrix-a-study-to-learn-about-a-group-b-streptococcus-vaccine-in-healthy-pregnant-women-and-their-babies-100605263","NCT07160244","BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies","A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE IN HEALTHY PREGNANT WOMEN AND THEIR INFANTS","Key Inclusion criteria- Maternal:\n\n* Healthy pregnant women ≤49 years of age who are between 24 0\u002F7 and 36 0\u002F7 weeks of gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, and who have no known increased risk of complications.\n* Had a fetal anomaly ultrasound examination with no significant fetal abnormalities observed.\n* Documented negative human immunodeficiency virus (HIV) antibody test, syphilis test, and hepatitis B virus (HBV) surface antigen test during this pregnancy and prior to randomization.\n* Capable of giving personal signed informed consent.\n* Willing to give informed consent for her infant to participate in the study.\n\nKey Exclusion criteria- Maternal:\n\n* Prepregnancy body mass index (BMI) of \\>40 kg\u002Fm2.\n* Current pregnancy complications or abnormalities that may increase the risk associated with the participation in and completion of the study.\n* Prior pregnancy complications or abnormalities that, based on the investigator's judgment, may increase the risk associated with the participation in and completion of the study.\n* History of microbiologically proven invasive disease caused by GBS in the current pregnancy.\n* A known or suspected infection during the current pregnancy that may increase the risk of complications in pregnancy (eg, active tuberculosis, syphilis, primary genital herpes simplex, malaria).\n\nKey Inclusion criteria- Infant Participants\n\n\\- Evidence of a signed and dated ICD signed by the parent(s)\u002Flegally authorized representative or legal guardian\n\nKey Exclusion Criteria - Infant Participants:\n\n\\- Children or grandchildren who are direct descendants of investigator site staff or sponsor and sponsor delegate employees directly involved in the conduct of the study.\n\nKey Exclusion Criteria - Infant immunogenicity subset Participants:\n\n\\- Children with a known or suspected contraindication to any vaccine administered in the infant vaccine immunogenicity subset.\n\nRefer to the study contact for further eligibility details",true,"1 Day","49 Years",{"count":364,"type":21},6000,[59],"BEATRIX (group B strEptococcus mATeRnal and Infant VaX study) The purpose of this study is to learn about the safety and how the group B streptococcus (GBS) vaccine works in pregnant women and their babies.\n\nThis study is seeking healthy pregnant participants:\n\n* aged 49 or younger who can join.\n* between 24 and 36 weeks of gestation (\"Gestational age\" is a medical term used to describe how far along your pregnancy is)\n* had a fetal ultrasound examination performed with no major fetal abnormalities observed\n* documented negative for HIV, syphilis and Hepatitis B All participants in this study will receive only 1 shot in an arm. This could either be a group B streptococcus 6-valent polysaccharide conjugate vaccine (GBS6) or placebo. Placebo is an inactive substance used in the study for comparison purposes; in this study, the placebo injection will be saline (saltwater). The pregnant participants may take part in this study for a maximum of 14 months (6 months after delivery) , and their babies for about 12 months after they are born. The pregnant participants will need to visit the research site at least 3 to 4 times with some visits permitted to occur over the telephone.\n\nA subset of infants will be asked to take part in the study for up to 19 months. The subset will receive diphtheria toxoid-containing vaccine and\u002For pneumococcal vaccine following each country's standard immunization plan and have blood drawn 1 month after completion of the primary and\u002For toddler (booster) doses.",[368],"Healthy",[370],"group B streptococcus, maternal immunization, vaccine",{"date":34,"type":37},{"date":373,"type":37},"2025-08-25",{"date":375,"type":21},"2029-03-02",{"name":377,"class":84},"Pfizer",206,{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":4,"eligibilityCriteria":385,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":56,"phases":388,"briefSummary":389,"conditions":390,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":392,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":399},"100603521","phase-2-a-study-to-assess-the-efficacy-and-safety-of-ro7790121-in-participants-with-moderate-to-severe-rheumatoid-arthritis-who-have-not-responded-to-or-who-cannot-tolerate-tumor-necrosis-factor-tnf-andor-janus-kinase-jak-inhibitors-100603521","NCT07137598","A Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have Not Responded to or Who Cannot Tolerate Tumor Necrosis Factor (TNF) and\u002For Janus Kinase (JAK Inhibitors)","A Phase II, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of RO7790121 in Participants With Moderate to Severe Rheumatoid Arthritis Who Have an Inadequate Response or Intolerance to TNF and\u002For JAK Inhibitors","Inclusion Criteria:\n\n* Has moderate to severe active RA defined by the presence of \\>=6 swollen joints and \\>=6 tender joints at screening and baseline (based on 66\u002F68-joint count)\n* Diagnosis of RA for \\>=3 months and also fulfills the 2010 American College of Rheumatology (ACR)\u002FEuropean Alliance of Associations for Rheumatology (EULAR) classification criteria for RA\n* Demonstrated an inadequate response or loss of response to or intolerance to \\>=1 conventional synthetic disease-modifying antirheumatic drug (csDMARD)\n\nExclusion Criteria:\n\n* Have failed more than two TNF inhibitors or JAK inhibitors\n* Class IV RA according to ACR revised response criteria (Hochberg et al. 1992)\n* Past or current use of other biologic disease-modifying antirheumatic drugs (bDMARDs) (excluding TNF inhibitors) or rituximab\n* Treatment with investigational therapy within 4 weeks or within 5 half-lives of the investigational therapy, whichever is longer, prior to initiation of study treatment.\n* History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA\n* Has been treated with intra-articular, intramuscular, intravenous, trigger point or tender point, intra-bursa, or intra-tendon sheath corticosteroids in the preceding 8 weeks prior to the first dose of study drug\n* History of a severe allergic reaction or anaphylactic reaction or known hypersensitivity to any component of the study drug (or its excipients) and\u002For other products in the same class\n* Any major surgery within 6 weeks prior to screening or a major surgery planned during the study\n* Any serious, chronic and\u002For unstable pre-existing medical, psychiatric, or other- condition\n* History of malignancy, with the exception non-metastatic basal cell or cutaneous squamous cell cancer adequately treated with electrodesiccation and curettage or resection or in situ cervical cancer adequately treated and cured\n* Participants with severe chronic or recurrent viral, bacterial, parasitic, or fungal infections\n* History of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection\n* History of organ transplant\n* Any identified confirmed congenital or acquired immunodeficiency\n* Abnormal laboratory values and liver function test",{"count":387,"type":21},160,[58],"This study will assess the efficacy and safety of Afimkibart (also known as RO7790121) compared with placebo in participants with moderate to severe rheumatoid arthritis (RA) who have an inadequate response or intolerance to TNF and\u002For JAK inhibitors.",[391],"Rheumatoid Arthritis",{"date":36,"type":37},{"date":394,"type":37},"2025-12-05",{"date":396,"type":21},"2027-10-02",{"name":398,"class":84},"Hoffmann-La Roche",63,{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":56,"phases":409,"briefSummary":410,"conditions":411,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":414,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":421},"100596280","phase-3-a-study-to-investigate-tislelizumab-administered-as-subcutaneous-injection-versus-intravenous-infusion-plus-chemotherapy-in-patients-with-unresectable-or-metastatic-gastric-or-gastroesophageal-junction-adenocarcinoma-100596280","NCT07043400","A Study to Investigate Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma","A Phase 3, Multi-Center, Randomized, Open-Label Clinical Study of Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Histologically confirmed, locally advanced unresectable or metastatic gastric\u002F gastroesophageal junction (GEJ) adenocarcinoma.\n* No previous systemic therapy for locally advanced unresectable or metastatic gastric\u002FGEJ cancer.\n* At least 1 measurable or nonmeasurable lesion per RECIST v1.1 as determined by investigator assessment.\n* Must be able to provide tumor tissues for biomarker assessment.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤ 1.\n* Adequate organ function.\n* Women of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and ≥ 120 days after the last dose of tislelizumab.\n* Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of tislelizumab.\n\nExclusion Criteria:\n\n* Squamous cell or undifferentiated or other histological type gastric cancer (GC)\n* Active leptomeningeal disease or uncontrolled brain metastasis. Patients with equivocal findings or with confirmed brain metastases are eligible for enrollment provided that they are asymptomatic and radiologically stable without the need for corticosteroid treatment for ≥ 4 weeks before randomization.\n* Diagnosis with gastric or GEJ adenocarcinoma with positive human epidermal growth factor receptor 2 (HER2).\n* Active autoimmune diseases or history of autoimmune diseases that may relapse.\n* Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (at least once a week) and\u002For diuretics within 7 days prior to randomization\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":408,"type":21},351,[59],"This study is designed to assess the levels of drug exposure following treatment with tislelizumab administered as a subcutaneous (SC) injection compared to intravenous infusion (IV) as first-line therapy in adults with gastric or gastroesophageal junction (GEJ) that is locally advanced and cannot be surgically removed or has spread from the stomach to other areas of the body. Approximately 351 patients will be participating in this study. The study is composed of a screening period, a treatment period, and a follow-up period.",[412,413],"Metastatic Gastric Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma",{"date":34,"type":37},{"date":416,"type":37},"2025-08-27",{"date":418,"type":21},"2028-04-22",{"name":420,"class":84},"BeOne Medicines",95,{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":56,"phases":431,"briefSummary":432,"conditions":433,"keywords":435,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":454,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":460},"100593979","a-study-to-learn-about-the-study-medicine-ibuzatrelvir-in-adults-with-covid-19-who-are-severely-immunocompromised-100593979","NCT07013474","A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised","AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, RANDOMIZED, DOUBLE-BLIND, 3-ARM STUDY TO INVESTIGATE IBUZATRELVIR IN ADULTS WITH SYMPTOMATIC COVID-19 WHO ARE SEVERELY IMMUNOCOMPROMISED","Inclusion Criteria:\n\n1. 18 years of age or older at screening who are non-hospitalized or hospitalized with mild to moderate COVID-19\n2. Confirmed SARS-CoV-2 infection as determined by RAT (or other locally approved test) collected within 2 days prior to randomization. Initial onset of symptoms attributable to COVID-19 within 5 days prior to the day of randomization and at least 1 of the specified symptoms attributable to COVID-19 present on the day of randomization.\n3. Severely immunocompromised due to:\n\n   * Solid organ or islet cell transplant recipient who is receiving immunosuppressive therapy;\n   * Active hematologic malignancy (eg, chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, acute leukemia);\n   * Receipt of CAR-T-cell therapy or HCT either within 2 years of transplantation or who are receiving immunosuppressive therapy;\n   * Currently receiving or recently received B-cell depleting therapies (eg, rituximab), where the immunosuppressive effect is still ongoing.\n\nExclusion Criteria:\n\n1. Severe or critical COVID-19, or current need for supplemental oxygen.\n2. Receiving dialysis or have current kidney failure (ie, eGFR consistently \\\u003C15 mL\u002Fmin)\n3. Active liver disease\n4. History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator\n5. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.\n6. Life expectancy less than 30 days at study entry due to an underlying condition, in the judgement of the investigator.\n7. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n8. Has received any other antiviral for the treatment of the current COVID-19 infection\n9. Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).\n10. Current or previous administration of an investigational product (drug or vaccine) within 30 days (or as determined by local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer). Authorized or products with conditional approval are not considered investigational.\n11. Prior participation in this trial or any clinical trial of ibuzatrelvir.\n12. Females who are pregnant, breastfeeding, or who are planning to become pregnant within the timeframe of the study.\n13. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.",{"count":430,"type":21},300,[59],"This is a Phase 3, randomized, actively controlled, double-blinded, double-dummy, superiority study to evaluate the efficacy and safety of ibuzatrelvir alone and in combination with remdesivir IV compared to remdesivir IV alone for the treatment of symptomatic COVID-19 in severely immunocompromised adult participants who are non-hospitalized or are hospitalized at baseline with mild-to-moderate COVID-19.",[434],"COVID-19 Infection",[436,437,438,439,440,441,442,443,444,445,446,447,448,449,450,451,452,453],"COVID-19 infection","pneumonia","respiratory tract infections","coronavirus infection","RNA virus infection","lung disease","pneumonia, viral","infections","virus","viral protease inhibitor","protease inhibitor","enzyme inhibitor","severe immunocompromise","anti-viral agents","anti-infectives","ibuzatrelvir","remdesivir","COVID-19",{"date":36,"type":37},{"date":456,"type":37},"2025-07-14",{"date":458,"type":21},"2028-02-25",{"name":377,"class":84},152,{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":467,"eligibilityCriteria":468,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":241,"enrollmentInfo":469,"targetDuration":4,"studyType":56,"phases":471,"briefSummary":472,"conditions":473,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":478,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":485},"100593896","phase-2-a-study-of-long-acting-antibodies-alone-and-in-combinations-for-moderate-to-severe-ulcerative-colitis-100593896","NCT07012395","A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis","Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis","SKYLINE-UC","Inclusion Criteria:\n\n* Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening\n* Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy (up to approximately 15% allowed to have only proctitis)\n* Moderately to severely active disease as defined by a modified Mayo score of 5-9, rectal bleeding subscore of ≥1, and Mayo endoscopic subscore ≥2\n\nExclusion Criteria:\n\n* Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefined\n* Confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation and\u002For other conditions that will likely require surgery during induction\n* Failed 4 or more approved or investigational advanced therapy classes",{"count":470,"type":21},645,[58],"This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.",[474,475,476,477],"Ulcerative Colitis","Inflammatory Bowel Diseases","Colitis","Colitis, Ulcerative",{"date":36,"type":37},{"date":480,"type":37},"2025-05-27",{"date":482,"type":21},"2028-03",{"name":484,"class":84},"Spyre Therapeutics, Inc.",267,{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":492,"eligibilityCriteria":493,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":494,"targetDuration":4,"studyType":56,"phases":496,"briefSummary":497,"conditions":498,"keywords":500,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":502,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":507,"locationsCount":508},"100592970","phase-3-a-phase-iii-study-of-azd0780-on-major-adverse-cv-events-in-patients-with-a-history-of-ascvd-events-or-at-high-risk-for-a-first-event-100592970","NCT07000357","A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event","A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Effect of AZD0780 on Major Adverse Cardiovascular Events in Patients With Established Atherosclerotic Cardiovascular Disease (ASCVD) or at High Risk for a First ASCVD Event","AZURE-Outcomes","Inclusion Criteria:\n\n* Meets one of the following:\n\n  1. Participants with history of an ASCVD event: Participants ≥ 18 years of age at the time of signing the ICF with a history of MI or ischaemic stroke suspected to be due to atherosclerotic vascular disease ≥ 1 month prior to randomisation (presumed lacunar or cardioembolic strokes are not qualifying events), or revascularisation for symptomatic lower limb PAD any time prior to screening\n\n     Additional risk factors based on the level of the LDL-C and timing of MI or stroke:\n\n     o Participants with an LDL-C ≥ 75 mg\u002FdL (≥ 1.9 mmol\u002FL) need to have at least one of the other additional risk factors (i to viii) below.\n\n     ii) T2DM requiring ongoing medical therapy iii) Age ≥ 65 years v) Previous above ankle amputation due to PAD vi) Previous diagnosis of non-end stage CKD\n  2. Participants at increased risk of a first ASCVD event: Male participant ≥ 50 years of age or female participant ≥ 55 years of age at the time of signing the ICF with LDL-C ≥ 100 mg\u002FdL (≥ 2.6 mmol\u002FL), with no prior history of MI, ischaemic stroke due to atherosclerotic disease, or leg revascularisation for symptomatic lower limb PAD, and with diagnostic evidence of at least one of the following disease categories (i, ii, or iii):\n\n  (i) Significant atherosclerotic artery disease (ii) High-risk Type 1 or Type 2 diabetes mellitus with manifestation of at least one of the following end-organ diseases:\n  1. Nephropathy - Persistent (≥ 2 readings) microalbuminuria (urine albumin\u002Fcreatinine ratio ≥ 30 mg\u002Fg) and\u002For persistent eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2. At least one reading must come from the medical record within the last 12 months in addition to the reading from screening\n  2. Retinopathy - Treated diabetic retinopathy (surgical intervention or injectable therapy) or prior diagnosis made by a relevant healthcare specialist\n  3. Neuropathy - Treated neuropathy (medical therapy for pain relief or symptom alleviation) or prior diagnosis made by a relevant healthcare specialist\n  4. ABI \\\u003C 0.9 or \\> 1.4 - confirmed either in study during screening or randomisation, or from the medical record within the last 5 years (iii) Documented atherosclerosis of less significance\n\n     For (ii) and (iii), participants need to have at least one of the additional risk factors below:\n\n  \u003C!-- -->\n\n  1. CKD with eGFR x mL\u002Fmin\u002F1.73 m2\n  2. Current tobacco use\n  3. Age ≥ 65\n  4. T2DM (if included on the less significant atherosclerosis criterion iii)\n* Participants should receive a background lipid lowering regimen anticipated to achieve at least a \\~50% reduction in LDL-C. Except in cases of intolerance, the regimen should include a high intensity statin therapy or lower intensity statin therapy in combination with an oral agent with proven outcome benefit (eg, ezetimibe and\u002For bempedoic acid).\n\nParticipants must achieve a stable background lipid lowering therapy \\> 28 days before screening.\n\nExclusion criteria:\n\n* Any underlying known disease, or condition including homozygous familial hypercholesterolaemia, or LDL or plasma apheresis within 12 months prior to randomisation, that, in the opinion of the investigator, might interfere with the interpretation of the clinical study results.\n* Any revascularisation procedure planned within the next 3 months.\n* Available imaging assessment within the last 3 years showing either coronary calcium score of zero, or a coronary computed tomography angiography with no atherosclerosis.\n* Calculated eGFR \\\u003C 15 mL \u002Fmin\u002F1.73 m2 at screening.\n* Any laboratory values with the following deviations at screening:\n\n  * AST or ALT \\> 3 × ULN\n  * TBL \\> 2 × ULN (except for participants with Gilbert's syndrome where TBL 3 × ULN is acceptable provided direct bilirubin \\\u003C 1.5 × ULN)\n  * Fasting triglycerides ≥ 400 mg\u002FdL (≥ 4.52 mmol\u002FL).\n  * Creatine kinase \\> 5 × ULN\n  * Urine albumin\u002Fcreatinine ratio ≥ 500 mg\u002Fg\n* Uncontrolled T2DM defined as HbA1c ≥ 9.5% at screening.\n* Inadequately treated hypothyroidism defined as TSH \\> 1.5 × ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening.\n* Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months of screening or planned use during the study.\n* Use of gemfibrozil within one week prior to the Screening Visit or planned use during the study.\n* Use of PCSK9 inhibitors: evolocumab\u002Falirocumab within 12 weeks of the Screening Visit or planned use during the study, or inclisiran within 18 months of the Screening Visit or planned use during the study, or any other approved PCSK9 inhibitor use within 5 half lives prior to the Screening Visit or planned use during the study.",{"count":495,"type":21},15100,[59],"The purpose of this phase 3, randomized, placebo controlled, event-driven study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established ASCVD or at high risk for a first ASCVD event. The effect of AZD0780 vs placebo on the risk of MACE-PLUS will be evaluated from randomisation until the primary analysis censoring date (PACD). The Study Closure Visit will be scheduled to occur after the PACD and will be the final visit for each participant in the study.",[499],"Cardiovascular Disease",[501],"Atherosclerotic Cardiovascular Disease",{"date":34,"type":37},{"date":504,"type":37},"2025-06-04",{"date":506,"type":21},"2029-10-26",{"name":169,"class":84},1452,{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":515,"eligibilityCriteria":516,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":517,"targetDuration":4,"studyType":56,"phases":519,"briefSummary":520,"conditions":521,"keywords":524,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":531,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":538},"100574886","phase-3-neladalkib-nvl-655-for-tki-naive-patients-with-advanced-alk-positive-nsclc-100574886","NCT06765109","Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC","A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)","ALKAZAR","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed locally advanced (not amenable for multimodality treatment) or metastatic Non-small Cell Lung Cancer (NSCLC)\n2. Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood\n3. No prior systemic anticancer treatment for NSCLC (adjuvant\u002Fneoadjuvant chemotherapy allowed if 12 months prior to randomization; prior ALK tyrosine kinase inhibitor \\[TKI\\] such as alectinib is not allowed in any setting)\n4. Measurable disease (1 or more target lesions per Response Evaluation Criteria in Solid Tumors \\[RECIST\\] 1.1)\n5. Pretreatment tumor tissue\n\nExclusion Criteria:\n\n1. Patient's cancer has a known oncogenic driver alteration other than ALK.\n2. Known allergy\u002Fhypersensitivity to excipients of neladalkib or alectinib.\n3. Ongoing or recent radiotherapy as per protocol-specified timeframes prior to randomization\n4. Major surgery within 4 weeks prior to randomization\n5. Uncontrolled clinically relevant infection requiring systemic therapy\n6. Known active tuberculosis, or active Hepatitis B or C\n7. QT corrected for heart rate by Fridericia's formula (QTcF) \\> 470 msec on repeated assessments\n8. Clinically significant cardiovascular disease\n9. Brain metastases associated with progressive neurological symptoms or requiring increasing doses of corticosteroids to control CNS disease\n10. Active malignancy requiring therapy within 2 years prior to randomization",{"count":518,"type":21},450,[59],"Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NSCLC).",[522,523],"Non-small Cell Lung Cancer","Anaplastic Lymphoma Kinase-positive",[103,102,525,526,527,528,529,530],"Lung neoplasms","Lung diseases","ALK positive NSCLC","TKI naive","ALK TKI naive","Treatment naive",{"date":36,"type":37},{"date":533,"type":37},"2025-07-17",{"date":535,"type":21},"2029-12",{"name":537,"class":84},"Nuvalent Inc.",158,{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":545,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":179,"enrollmentInfo":547,"targetDuration":4,"studyType":56,"phases":549,"briefSummary":550,"conditions":551,"keywords":553,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":558,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":564},"100570795","phase-3-phase-iii-extension-study-of-efficacy-and-safety-of-ianalumab-with-or-without-study-treatment-withdrawal-in-participants-with-lupus-nephritis-sirius-ln-extension-100570795","NCT06711887","Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)","An Open-label Extension Study to Assess the Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Adult Participants With Lupus Nephritis Who Have Completed Study Treatment in the CVAY736K12301 Core Study (SIRIUS-LN Extension)","SIRIUS-LN ext","Inclusion Criteria:\n\n1. Signed informed consent prior to participation in the extension study.\n2. Participants must have participated in the SIRIUS-LN core study and must have completed the entire treatment up to Week 144 on double-blind or open label study treatment.\n\nExclusion Criteria:\n\n1. Use of prohibited therapies\n2. Pregnant or nursing (lactating) women.",{"count":548,"type":21},348,[59],"The purpose of this up to 6-year extension study is the evaluation of the efficacy and safety\n\n1. after study treatment withdrawal in patients with lupus nephritis (LN) who achieved response (complete renal response \\[CRR\\] or partial renal response \\[PRR\\]) on double-blind treatment at the end of the SIRIUS-LN core study, and\n2. of open-label ianalumab 300 mg treatment in patients who, at the end of the SIRIUS-LN core study, were either already receiving ianalumab open-label treatment or did not meet CRR\u002FPRR criteria on double-blind treatment at the end of the SIRIUS-LN core study.",[552],"Lupus Nephritis",[554,555,556,557],"Lupus Nephritis (LN)","B cell depletion","ianalumab","VAY736",{"date":34,"type":37},{"date":560,"type":37},"2025-05-19",{"date":562,"type":21},"2035-08-01",{"name":202,"class":84},47,{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":4,"eligibilityCriteria":571,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":572,"targetDuration":4,"studyType":56,"phases":574,"briefSummary":575,"conditions":576,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":579,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":584,"locationsCount":585},"100569788","phase-3-a-study-to-understand-how-the-study-medicine-dazukibart-works-in-people-with-idiopathic-inflammatory-myopathies-100569788","NCT06698796","A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies","A PHASE 3, MULTI-CENTER, OPEN-LABEL EXTENSION STUDY TO INVESTIGATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF DAZUKIBART IN PARTICIPANTS WITH IDIOPATHIC INFLAMMATORY MYOPATHIES (INCLUDING PARTICIPANTS WITH DERMATOMYOSITIS OR POLYMYOSITIS)","Inclusion Criteria:\n\n* Participants that completed a qualifying study through Week 52.\n\nExclusion Criteria:\n\n* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior or laboratory abnormality that may increase the risk of study participation.\n* Previous administration with an investigational product (drug or vaccine) other than dazukibart in a qualifying study within 30 days (or as determined by the local requirement) or 5 half-lives preceding baseline in this study (whichever is longer).\n* Current use of any prohibited concomitant medication(s).\n* Active bacterial, viral, fungal, mycobacterial or other infections.\n* Ongoing adverse event in a qualifying study or the participant has met safety monitoring criteria in a qualifying study that have not resolved.\n* Investigator site staff or sponsor employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.",{"count":573,"type":21},211,[59],"The purpose of this study is to understand how the study medicine, dazukibart, works in people with active idiopathic inflammatory myopathies (dermatomyositis \\[DM\\] or polymyositis \\[PM\\]).\n\nIdiopathic inflammatory myopathies are a group of disorders that show inflammation of the muscles used for movement. There are several types of idiopathic inflammatory myopathies, including DM and PM.\n\nDM and PM involve weakness of the muscles closest to the center of the body, such as the muscles of the hips, thighs, upper arms, and neck. People with these forms of idiopathic inflammatory myopathies may find it difficult to climb stairs, get up from a seated position, or lift items above their head. People with DM can also have a skin rash.\n\nThese disorders negatively impact the quality of life and functioning of patients. In addition to the above, these disorders can affect how the lungs and heart work.\n\nThis study is seeking participants who took part in a DM and PM study with dazukibart before. Some participants will receive study medicine, and some participants will not receive study medicine and only complete safety follow-up.\n\nThe study medicine will be given as an intravenous (IV) infusion (directly into the veins). This takes about 1 hour, every 4 weeks, from Day 1 to Week 48 (about 12 months) of the study. This will be followed by a safety follow-up period that lasts about 4 months after the last infusion. Participants who receive study medicine will have about 18 study visits at the site over about 16 months.\n\nThere will also be participants enrolled in this study who will not receive study medicine. Such participants will only take part in safety follow-up visits as they do not want to or are not eligible to receive dazukibart. These participants will not receive study medicine and will have up to 4 study visits at the site every 4 weeks to complete safety follow-up.",[577,578],"Dermatomyositis","Polymyositis",{"date":36,"type":37},{"date":581,"type":37},"2025-01-22",{"date":583,"type":21},"2031-07-29",{"name":377,"class":84},26,{"id":587,"slug":588,"hasResults":12,"nctId":589,"briefTitle":590,"officialTitle":591,"acronym":592,"eligibilityCriteria":593,"healthyVolunteers":12,"sex":53,"minAge":594,"maxAge":595,"enrollmentInfo":596,"targetDuration":4,"studyType":56,"phases":598,"briefSummary":599,"conditions":600,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":603,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":608,"locationsCount":609},"100567773","phase-3-a-platform-trial-for-pediatric-participants-with-obesity-or-overweight-ly900040-100567773","NCT06672549","A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)","A Master Protocol for a Randomized, Controlled, Clinical Platform Trial to Investigate the Efficacy and Safety of Interventions for Chronic Weight Management in Pediatric Participants With Obesity or Overweight","ADVANCE","Inclusion Criteria:\n\n* Have a history of at least 1 unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification program (diet and exercise counseling for at least 3 months) prior to screening.\n* Obesity as defined by BMI equal to or above the 95th percentile for age and sex (on age- and gender-specific growth chart \\[CDC-NCHS, 2022\\]); OR\n* Applies to participant age between 12 and \\\u003C18 years old. Overweight as defined by BMI equal to or above the 85th percentile but less than the 95th percentile for age and sex, on age- and sex-specific growth chart (CDC-NCHS, 2022), and at least 1 weight-related comorbidity,\n\n  * hypertension\n  * type 2 diabetes (T2D)\n  * prediabetes\n  * dyslipidemia\n  * obstructive sleep apnea\n  * metabolic dysfunction-associated steatohepatitis (MASH) or metabolic dysfunction-associated steatotic liver disease (MASLD)\n\nExclusion Criteria:\n\n* Have undergone or plan to undergo weight reduction procedure during the study, such as, but not limited to:\n\n  * gastric bypass\n  * sleeve gastrectomy\n  * restrictive bariatric surgery, such as Lap-Band® gastric banding, or\n  * any other procedure intended to result in weight reduction.\n* Have a diagnosis that is a secondary cause of obesity or have a history of abrupt onset of obesity suggesting a secondary cause, such as hypothalamic, monogenetic, syndromic, or endocrine causes.\n* Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records\n* Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state.\n* Have HbA1c \\>9.0% (75 mmol\u002Fmol) as measured by central laboratory at screening.\n* Have a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome Type 2.","6 Years","17 Years",{"count":597,"type":21},125,[59],"The purpose of this pediatric, chronic weight management, Phase 3 Master Protocol (PWMP) is to create a framework to evaluate the safety and efficacy of pharmacologic agents for the treatment of obesity or overweight in pediatric participants.",[601,602],"Obesity","Overweight",{"date":34,"type":37},{"date":605,"type":37},"2024-11-18",{"date":607,"type":21},"2027-03",{"name":259,"class":84},117,{"id":611,"slug":612,"hasResults":12,"nctId":613,"briefTitle":614,"officialTitle":615,"acronym":616,"eligibilityCriteria":617,"healthyVolunteers":12,"sex":53,"minAge":594,"maxAge":595,"enrollmentInfo":618,"targetDuration":4,"studyType":56,"phases":620,"briefSummary":621,"conditions":622,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":625,"startDateStruct":626,"completionDateStruct":628,"leadSponsor":630,"locationsCount":631},"100555499","phase-3-a-trial-to-investigate-benralizumab-in-children-with-eosinophilic-diseases-100555499","NCT06512883","A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases","Phase 3, Open-label Trial to Evaluate Safety, Pharmacokinetics, and Efficacy of Benralizumab in Children With Eosinophilic Diseases (CLIPS)","CLIPS","Inclusion Criteria:\n\nAll Cohorts:\n\n* Male or female participants must be aged 6 to \\\u003C 18 years of age at the time of signing the assent form and their caregiver signing the informed consent form.\n* Body weight greater than (\\>=) 15 kilograms (kg).\n\nEGPA Cohort:\n\n* Therapy with corticosteroids: The prescribed dose of oral corticosteroids (OCS) (greater than \\[\\>\\] 0.1 milligrams per kilogram per day (mg\u002Fkg\u002Fday), max dose of 50 milligrams per day (mg\u002Fday) must be stable (that is, no adjustment of the dose) for at least 4 weeks prior to baseline (Visit 2).\n* Immunosuppressive therapy: If receiving immunosuppressive therapy, the dosage must be stable for at least 4 weeks prior to baseline (Visit 2).\n\nHES Cohort:\n\n* Documented HES diagnosis, defined as history of persistent eosinophilia \\>1500 cells\u002FµL without secondary cause on 2 examinations ≥1 month apart and evidence of eosinophil-mediated organ involvement.\n* Symptomatic active HES, or history of a prior flare, or considered eligible based on disease severity per investigator judgement.\n* AEC ≥1000 cells\u002FµL at screening (Visit 1).\n* Documented negative testing for Fip1-like 1 gene fused with the platelet-derived growth factor receptor alpha gene (FIP1L1-PDGFR) fusion tyrosine kinase gene translocation.\n\nExclusion Criteria:\n\nAll Cohorts:\n\n* Any current malignancy or history of malignancy.\n* History of anaphylaxis to any biologic therapy or vaccine.\n* Known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological, respiratory, or any other system abnormalities.\n* Previous receipt of benralizumab in an interventional clinical study.\n\nEGPA Cohort:\n\n* Diagnosed with granulomatosis with polyangiitis (previously known as Wegener'granulomatosis) or microscopic polyangiitis.\n* EGPA relapse: any deterioration in EGPA and\u002For organ-threatening EGPA that per Investigator judgement renders participants unstable in their EGPA within 3 months prior to screening (Visit 1) and through first administration of IP at baseline (Visit 2).\n* Life-threatening EGPA: imminently life-threatening EGPA disease within 3 months prior to screening (Visit 1) and through first administration of IP at baseline (Visit 2), as per Investigator judgement.\n\nHES Cohort:\n\n* Life-threatening HES or HES complications, as judged by the investigator.\n* Hypereosinophilia of unknown significance (HE-US).\n* Diagnosis of systemic mastocytosis.",{"count":619,"type":21},14,[59],"The main purpose of study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of benralizumab.",[623,624],"Eosinophilic Granulomatosis With Polyangiitis (EGPA)","Hypereosinophilia Syndrome (HES)",{"date":34,"type":37},{"date":627,"type":37},"2025-04-17",{"date":629,"type":21},"2029-05-14",{"name":169,"class":84},15,{"id":633,"slug":634,"hasResults":12,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":4,"eligibilityCriteria":638,"healthyVolunteers":12,"sex":53,"minAge":639,"maxAge":4,"enrollmentInfo":640,"targetDuration":4,"studyType":56,"phases":642,"briefSummary":643,"conditions":644,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":646,"startDateStruct":647,"completionDateStruct":649,"leadSponsor":650,"locationsCount":651},"100542140","phase-3-a-study-of-lebrikizumab-ly3650150-in-participants-with-chronic-rhinosinusitis-and-nasal-polyps-treated-with-intranasal-corticosteroids-contrast-np-100542140","NCT06338995","A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)","A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lebrikizumab\u002FLY3650150 in Participants With Chronic Rhinosinusitis With Nasal Polyps on Background Intranasal Corticosteroids","Inclusion Criteria:\n\n* Physician-diagnosed chronic rhinosinusitis (CRS) with bilateral nasal polyps (NP).\n* Prior treatment with systemic corticosteroids (SCS) within the last 2 years (or a medical contraindication or intolerance to SCS), prior surgery for NP, or both.\n* Endoscopic bilateral NPS score of at least 5 out of 8, with a minimum score of 2 in each nasal cavity performed at screening and baseline.\n* Ongoing symptoms for at least 8 weeks prior to study entry (screening), including:\n\n  1. Nasal congestion with moderate or severe symptom severity (score 2 or 3) at screening and a weekly average severity score of at least 1 (range 0 to 3) at randomization, and\n  2. At least one other symptom, such as partial loss of smell (hyposmia), total loss of smell (anosmia), or anterior or posterior rhinorrhea.\n* Have concomitant asthma must be stable in the 3 months prior to screening using permitted regular asthma treatment.\n* Adolescent participants ≥12 to \\\u003C18 years of age and weighing ≥40 kg at time of Visit 1.\n\nExclusion Criteria:\n\n* Have received a dose of lebrikizumab.\n* Have received treatment with any rescue medication and\u002For have the need for surgery for NP during screening and\u002For run-in period.\n* Allergen immunotherapy (subcutaneous immunotherapy \\[SCIT\\]\u002Fsublingual immunotherapy \\[SLIT\\]) initiated within 6 months prior to screening, that is not on a stable dose (3 months prior to screening).\n* Has received a biologic treatment approved for use in CRSwNP, asthma, or AD, even if administered to treat a different condition, within 4 months or 5 half-lives, whichever is longer, prior to screening.\n* Have received treatment with any biologic or systemic immunosuppressants for inflammatory disease or autoimmune disease prior to the baseline visit:\n\n  1. B cell-depleting biologics, including rituximab, within 6 months.\n  2. other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer.\n  3. Systemic immunosuppressants within 4 weeks prior to baseline.\n* Have had any sinus intranasal surgery (including nasal polypectomy) within 6 months prior to screening\n* Have had prior sino-nasal surgery or sinus surgery changing lateral wall structure of the nose making it difficult to assess endoscopic NPS\n* Have a presence of any of the following conditions that may impact the assessment of endpoints at screening or baseline:\n\n  1. Nasal septal deviation occluding at least one nostril.\n  2. Antrochoanal polyps.\n  3. Acute sinusitis, acute nasal infection, or acute upper respiratory infection.\n  4. Ongoing rhinitis medicamentosa.\n  5. Presence of another diagnosis associated with NP (ie, eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis, Young's syndrome, primary ciliary dyskinesia, cystic fibrosis). Note: for adolescents, documentation for ruling out cystic fibrosis and primary ciliary dyskinesia is required.\n  6. A nasal cavity tumor (malignant or benign).\n  7. Evidence of fungal rhinosinusitis.\n* Have anosmia from COVID or any reason other than CRSwNP.\n* Participants with forced expiratory volume in 1 second (FEV1) 50% or less (of predicted normal) at screening.\n* Female participant who is pregnant, breastfeeding, or is planning to become pregnant, or to breastfeed during the study.","12 Years",{"count":641,"type":21},510,[59],"The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in participants with chronic rhinosinusitis and nasal polyps treated with intranasal corticosteroids. The study will last about 18 months.",[645],"Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)",{"date":34,"type":37},{"date":648,"type":37},"2024-04-29",{"date":482,"type":21},{"name":259,"class":84},202,{"id":653,"slug":654,"hasResults":12,"nctId":655,"briefTitle":656,"officialTitle":657,"acronym":658,"eligibilityCriteria":659,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":660,"targetDuration":4,"studyType":56,"phases":662,"briefSummary":663,"conditions":664,"keywords":667,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":688,"startDateStruct":689,"completionDateStruct":691,"leadSponsor":693,"locationsCount":694},"100525272","phase-3-a-study-of-first-line-olomorasib-ly3537982-and-pembrolizumab-with-or-without-chemotherapy-in-patients-with-advanced-kras-g12c-mutant-non-small-cell-lung-cancer-100525272","NCT06119581","A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer","SUNRAY-01, A Global Pivotal Study in Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in Those With PD-L1 Expression ≥50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum Regardless of PD-L1 Expression","SUNRAY-01","Inclusion Criteria:\n\n* Histologically or cytologically confirmed NSCLC with Stage IIIB-IIIC or Stage IV disease, not suitable for curative intent radical surgery or radiation therapy.\n* Part B and Safety Lead-In Part B: the histology of the tumor must be predominantly non-squamous (in line with pemetrexed label).\n* Must have disease with evidence of KRAS G12C mutation.\n* Must have known programmed death-ligand 1 (PD-L1) expression\n\n  * Part A: Greater than or equal to (≥)50 percent (%).\n  * Part B: 0% to 100%.\n  * Part C: \\\u003C50%.\n* Must have measurable disease per RECIST v1.1.\n* Must have an ECOG performance status of 0 or 1.\n* Estimated life expectancy ≥12 weeks.\n* Ability to swallow capsules.\n* Must have adequate laboratory parameters.\n* Contraceptive use should be consistent with local regulations for those participating in clinical studies.\n* Women of childbearing potential must\n\n  * Have a negative pregnancy test.\n  * Not be breastfeeding during treatment\n\nExclusion Criteria:\n\n* Have a documented additional validated targetable oncogenic driver mutation or alteration in genes such as epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), BRAF (V600E), human epidermal growth factor receptor 2 (HER2), MET (exon 14), ROS1, rearranged during transfection (RET), or neurotrophic tyrosine receptor kinase (NTRK)1\u002F2\u002F3.\n* Have had any of the following prior to randomization:\n\n  \\-- Prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for advanced or metastatic NSCLC.\n\n  \\--- 1 cycle of standard-of-care treatment prior to study enrollment will be allowed for cases where immediate treatment is clinically indicated:\n* Have known active central nervous system metastases and\u002For carcinomatous meningitis.\n\nExclusion Criteria for Participants receiving Pemetrexed and Platinum (Part B and Safety Lead-In Part B)\n\n* Have predominantly squamous cell histology for NSCLC\n* Only for participants with mild to moderate renal insufficiency: Unable to avoid aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drugs (NSAIDs) two days before (5 days for long acting NSAIDs), day of, and two days after administration of pemetrexed\n* Is unable or unwilling to take folic acid or vitamin B12 supplementation.",{"count":661,"type":21},1264,[59],"The purpose of this study is to assess if adding LY3537982 (olomorasib) in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing.",[665,666],"Carcinoma, Non-Small-Cell Lung","Neoplasm Metastasis",[216,668,669,670,671,672,673,674,675,676,677,678,679,666,62,680,69,681,682,683,684,685,686,687,68],"KRAS G12 Lung Cancer","Advanced Lung Cancer","Metastatic Lung Cancer","KRAS G12C inhibitor","KRAS G12C Positive","KRAS Mutation","KRAS G12 Mutation","Lung Cancer Mutation","Olomorasib","Lung Diseases","Neoplastic Processes","Pathologic Processes","Non-Small Cell Lung Cancer (NSCLC)","Respiratory Tract Neoplasms","Thoracic Neoplasms","Neoplasms by Site","Neoplasms","Respiratory Tract Diseases","Carcinoma, Bronchogenic","Bronchial Neoplasms",{"date":34,"type":37},{"date":690,"type":37},"2023-12-21",{"date":692,"type":21},"2031-01",{"name":259,"class":84},418,""]