[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053963":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":63,"centralContacts":67,"locations":73,"responsibleParty":514,"collaborators":516,"id":519,"slug":52,"hasResults":520,"nctId":521,"briefTitle":522,"officialTitle":523,"acronym":52,"eligibilityCriteria":524,"healthyVolunteers":520,"sex":525,"minAge":526,"maxAge":52,"enrollmentInfo":527,"targetDuration":52,"studyType":530,"phases":531,"briefSummary":534,"conditions":535,"keywords":52,"overallStatus":76,"whyStopped":52,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":546},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8,16,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1, Parts A and B: Gocataming + I-DXd","EXPERIMENTAL","Participants who completed standard of care (SOC) induction chemotherapy with concurrent approved anti-programmed cell death 1\u002Fligand 1 protein (anti-PD-1\u002FL1) treatment for ES-SCLC and did not have disease progression per investigator discretion, will receive gocatamig and I-DXd in the maintenance phase, until documented disease progression or meeting other study discontinuation criteria.",[13,14,15],"Drug: Gocatamig","Drug: I-DXd","Drug: Rescue Medications",{"label":17,"type":10,"description":18,"interventionNames":19},"Arm 2, Parts A and B: Gocataming + I-DXd","Participants who did not receive prior systemic treatment for ES-SCLC will receive gocatamig and I-DXd during induction and maintenance phases, until documented disease progression or meeting other study discontinuation criteria.",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"Arm 3, Part B: Gocataming + I-DXd → gocatamig + atezolizumab","Participants who did not receive prior systemic treatment for ES-SCLC will receive gocatamig and I-DXd in the induction phase, followed by gocatamig and atezolizumab in the maintenance phase, until documented disease progression or meeting other study discontinuation criteria.",[13,14,24,15],"Drug: Atezolizumab",{"label":26,"type":27,"description":28,"interventionNames":29},"Arm 4, Part B: Carboplatin + etoposide + atezolizumab → atezolizumab","ACTIVE_COMPARATOR","Participants who did not receive prior systemic treatment for ES-SCLC will receive SOC (carboplatin + etoposide + atezolizumab) in the induction phase, followed by atezolizumab in the maintenance phase, until documented disease progression or meeting other study discontinuation criteria.",[24,30,31],"Drug: Carboplatin","Drug: Etoposide",[33,42,49,53,56,59],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DRUG","Gocatamig","Intravenous (IV) administration",[9,17,21],[39,40,41],"MK-6070","HPN328","DS-3280",{"type":34,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"I-DXd","IV administration",[9,17,21],[47,48],"MK-2400","DS-7300a",{"type":34,"name":50,"description":44,"armGroupLabels":51,"otherNames":52},"Atezolizumab",[21,26],null,{"type":34,"name":54,"description":44,"armGroupLabels":55,"otherNames":52},"Carboplatin",[26],{"type":34,"name":57,"description":44,"armGroupLabels":58,"otherNames":52},"Etoposide",[26],{"type":34,"name":60,"description":61,"armGroupLabels":62,"otherNames":52},"Rescue Medications","Participants will receive rescue medications at the investigator's discretion. Recommended rescue medications include tocilizumab for treatment of cytokine release syndrome (CRS); dexamethasone, acetaminophen, and diphenhydramine for CRS\u002Finfusion-related reaction (IRR) prophylaxis; and 5-hydroxytryptamine 3 (5-HT3) receptor antagonist, neurokinin 1 (NK-1) receptor antagonist, and corticosteroid for prevention of nausea and vomiting.",[9,17,21],[64],{"name":65,"affiliation":5,"role":66},"Medical Director","STUDY_DIRECTOR",[68],{"name":69,"role":70,"phone":71,"phoneExt":52,"email":72},"Toll Free Number","CONTACT","1-888-577-8839","Trialsites@msd.com",[74,92,105,118,131,144,157,170,183,195,207,220,233,243,255,268,283,292,301,316,329,341,354,367,380,393,405,420,434,446,459,468,477,486,501],{"facility":75,"status":76,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"Providence Medical Foundation ( Site 0124)","RECRUITING","Santa Rosa","California","95403","United States","US",{"type":83,"coordinates":84},"Point",[85,86],-122.71443,38.44047,{"lat":86,"lon":85},[89],{"name":90,"role":70,"phone":91,"phoneExt":52,"email":52},"Study Coordinator","707-521-3830",{"facility":93,"status":76,"city":94,"state":95,"zip":96,"country":80,"countryCode":81,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Orlando Health Cancer Institute ( Site 0108)","Orlando","Florida","32806",{"type":83,"coordinates":98},[99,100],-81.37924,28.53834,{"lat":100,"lon":99},[103],{"name":90,"role":70,"phone":104,"phoneExt":52,"email":52},"321-841-1869",{"facility":106,"status":76,"city":107,"state":108,"zip":109,"country":80,"countryCode":81,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Saint Elizabeth Medical Center Edgewood ( Site 0112)","Edgewood","Kentucky","41017",{"type":83,"coordinates":111},[112,113],-84.58189,39.01867,{"lat":113,"lon":112},[116],{"name":90,"role":70,"phone":117,"phoneExt":52,"email":52},"859-301-4000",{"facility":119,"status":76,"city":120,"state":121,"zip":122,"country":80,"countryCode":81,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Washington University School of Medicine ( Site 0134)","St Louis","Missouri","63110",{"type":83,"coordinates":124},[125,126],-90.19789,38.62727,{"lat":126,"lon":125},[129],{"name":90,"role":70,"phone":130,"phoneExt":52,"email":52},"314-747-1171",{"facility":132,"status":76,"city":133,"state":134,"zip":135,"country":80,"countryCode":81,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"John Theurer Cancer Center at Hackensack University Medical Center ( Site 0101)","Hackensack","New Jersey","07601",{"type":83,"coordinates":137},[138,139],-74.04347,40.88593,{"lat":139,"lon":138},[142],{"name":90,"role":70,"phone":143,"phoneExt":52,"email":52},"551-996-5955",{"facility":145,"status":76,"city":146,"state":147,"zip":148,"country":80,"countryCode":81,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Providence Cancer Institute, Franz Clinic - Eastside ( Site 0107)","Portland","Oregon","97213",{"type":83,"coordinates":150},[151,152],-122.67621,45.52345,{"lat":152,"lon":151},[155],{"name":90,"role":70,"phone":156,"phoneExt":52,"email":52},"503-215-5696",{"facility":158,"status":76,"city":159,"state":160,"zip":161,"country":80,"countryCode":81,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"Avera Cancer Institute- Research ( Site 0104)","Sioux Falls","South Dakota","57105",{"type":83,"coordinates":163},[164,165],-96.72796,43.54369,{"lat":165,"lon":164},[168],{"name":90,"role":70,"phone":169,"phoneExt":52,"email":52},"605-322-6900",{"facility":171,"status":76,"city":172,"state":173,"zip":174,"country":80,"countryCode":81,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"The University of Tennessee Medical Center ( Site 0120)","Knoxville","Tennessee","37920",{"type":83,"coordinates":176},[177,178],-83.92074,35.96064,{"lat":178,"lon":177},[181],{"name":90,"role":70,"phone":182,"phoneExt":52,"email":52},"865-305-8780",{"facility":184,"status":76,"city":185,"state":173,"zip":186,"country":80,"countryCode":81,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"Lt. 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Municipality","100142","China","CN",{"type":83,"coordinates":309},[310,311],116.39723,39.9075,{"lat":311,"lon":310},[314],{"name":90,"role":70,"phone":315,"phoneExt":52,"email":52},"010-88121122",{"facility":317,"status":76,"city":318,"state":319,"zip":320,"country":306,"countryCode":307,"cosmosGeoPoint":321,"geoPoint":325,"contacts":326},"Southern Medical University Nanfang Hospital ( Site 1608)","Guangzhou","Guangdong","510515",{"type":83,"coordinates":322},[323,324],113.25,23.11667,{"lat":324,"lon":323},[327],{"name":90,"role":70,"phone":328,"phoneExt":52,"email":52},"+86 13632102245",{"facility":330,"status":76,"city":331,"state":319,"zip":332,"country":306,"countryCode":307,"cosmosGeoPoint":333,"geoPoint":337,"contacts":338},"Jiangmen Central Hospital ( Site 1611)","Jiangmen","529000",{"type":83,"coordinates":334},[335,336],113.08333,22.58333,{"lat":336,"lon":335},[339],{"name":90,"role":70,"phone":340,"phoneExt":52,"email":52},"+86 13702282382",{"facility":342,"status":76,"city":343,"state":344,"zip":345,"country":306,"countryCode":307,"cosmosGeoPoint":346,"geoPoint":350,"contacts":351},"The First Affiliated Hospital of Nanchang University ( Site 1610)","Nanchang","Jiangxi","330209",{"type":83,"coordinates":347},[348,349],115.85306,28.68396,{"lat":349,"lon":348},[352],{"name":90,"role":70,"phone":353,"phoneExt":52,"email":52},"+86079186319453",{"facility":355,"status":76,"city":356,"state":357,"zip":358,"country":306,"countryCode":307,"cosmosGeoPoint":359,"geoPoint":363,"contacts":364},"Shanghai East Hospital ( Site 1600)","Shanghai","Shanghai Municipality","200000",{"type":83,"coordinates":360},[361,362],121.45806,31.22222,{"lat":362,"lon":361},[365],{"name":90,"role":70,"phone":366,"phoneExt":52,"email":52},"021-20334534",{"facility":368,"status":76,"city":369,"state":370,"zip":371,"country":306,"countryCode":307,"cosmosGeoPoint":372,"geoPoint":376,"contacts":377},"Sichuan Cancer hospital. ( Site 1609)","Chengdu","Sichuan","610213",{"type":83,"coordinates":373},[374,375],104.06667,30.66667,{"lat":375,"lon":374},[378],{"name":90,"role":70,"phone":379,"phoneExt":52,"email":52},"18180900912",{"facility":381,"status":76,"city":382,"state":383,"zip":384,"country":306,"countryCode":307,"cosmosGeoPoint":385,"geoPoint":389,"contacts":390},"The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 1602)","Hangzhou","Zhejiang","310003",{"type":83,"coordinates":386},[387,388],120.16142,30.29365,{"lat":388,"lon":387},[391],{"name":90,"role":70,"phone":392,"phoneExt":52,"email":52},"+8657187236560",{"facility":394,"status":76,"city":395,"state":383,"zip":396,"country":306,"countryCode":307,"cosmosGeoPoint":397,"geoPoint":401,"contacts":402},"Taizhou Hospital of Zhejiang Province ( Site 1601)","Taizhou","317000",{"type":83,"coordinates":398},[399,400],121.43312,28.66266,{"lat":400,"lon":399},[403],{"name":90,"role":70,"phone":404,"phoneExt":52,"email":52},"0576-85199810",{"facility":406,"status":76,"city":407,"state":408,"zip":409,"country":410,"countryCode":411,"cosmosGeoPoint":412,"geoPoint":416,"contacts":417},"Universitaetsklinikum Jena ( Site 0403)","Jena","Thuringia","07747","Germany","DE",{"type":83,"coordinates":413},[414,415],11.5899,50.92878,{"lat":415,"lon":414},[418],{"name":90,"role":70,"phone":419,"phoneExt":52,"email":52},"+4936419324584",{"facility":421,"status":76,"city":422,"state":52,"zip":423,"country":424,"countryCode":425,"cosmosGeoPoint":426,"geoPoint":430,"contacts":431},"Rambam Health Care Campus ( Site 0602)","Haifa","3109601","Israel","IL",{"type":83,"coordinates":427},[428,429],34.99928,32.81303,{"lat":429,"lon":428},[432],{"name":90,"role":70,"phone":433,"phoneExt":52,"email":52},"+97247772688",{"facility":435,"status":76,"city":436,"state":52,"zip":437,"country":424,"countryCode":425,"cosmosGeoPoint":438,"geoPoint":442,"contacts":443},"Sheba Medical Center ( Site 0601)","Ramat Gan","5265601",{"type":83,"coordinates":439},[440,441],34.81065,32.08227,{"lat":441,"lon":440},[444],{"name":90,"role":70,"phone":445,"phoneExt":52,"email":52},"+97235303030",{"facility":447,"status":76,"city":448,"state":52,"zip":449,"country":450,"countryCode":52,"cosmosGeoPoint":451,"geoPoint":455,"contacts":456},"Seoul National University Hospital ( Site 1402)","Seoul","03080","South Korea",{"type":83,"coordinates":452},[453,454],126.9784,37.566,{"lat":454,"lon":453},[457],{"name":90,"role":70,"phone":458,"phoneExt":52,"email":52},"82-2-2072-3559",{"facility":460,"status":76,"city":448,"state":52,"zip":461,"country":450,"countryCode":52,"cosmosGeoPoint":462,"geoPoint":464,"contacts":465},"Severance Hospital Yonsei University Health System ( Site 1403)","03722",{"type":83,"coordinates":463},[453,454],{"lat":454,"lon":453},[466],{"name":90,"role":70,"phone":467,"phoneExt":52,"email":52},"+82215991004",{"facility":469,"status":76,"city":448,"state":52,"zip":470,"country":450,"countryCode":52,"cosmosGeoPoint":471,"geoPoint":473,"contacts":474},"Asan Medical Center ( Site 1404)","05505",{"type":83,"coordinates":472},[453,454],{"lat":454,"lon":453},[475],{"name":90,"role":70,"phone":476,"phoneExt":52,"email":52},"+82230103215",{"facility":478,"status":76,"city":448,"state":52,"zip":479,"country":450,"countryCode":52,"cosmosGeoPoint":480,"geoPoint":482,"contacts":483},"Samsung Medical Center ( Site 1401)","06351",{"type":83,"coordinates":481},[453,454],{"lat":454,"lon":453},[484],{"name":90,"role":70,"phone":485,"phoneExt":52,"email":52},"02-3410-1795",{"facility":487,"status":76,"city":488,"state":489,"zip":490,"country":491,"countryCode":492,"cosmosGeoPoint":493,"geoPoint":497,"contacts":498},"Hospital San Pedro ( Site 1004)","Logroño","La Rioja","26006","Spain","ES",{"type":83,"coordinates":494},[495,496],-2.45115,42.46615,{"lat":496,"lon":495},[499],{"name":90,"role":70,"phone":500,"phoneExt":52,"email":52},"941278760",{"facility":502,"status":76,"city":503,"state":504,"zip":505,"country":491,"countryCode":492,"cosmosGeoPoint":506,"geoPoint":510,"contacts":511},"Hospital Universitario Insular de Gran Canaria ( Site 1002)","Las Palmas de Gran Canaria","Las Palmas","35016",{"type":83,"coordinates":507},[508,509],-15.41573,28.10178,{"lat":509,"lon":508},[512],{"name":90,"role":70,"phone":513,"phoneExt":52,"email":52},"+34 928441738",{"type":515,"investigatorFullName":52,"investigatorTitle":52,"investigatorAffiliation":52,"oldNameTitle":52,"oldOrganization":52},"SPONSOR",[517],{"name":518,"class":6},"Daiichi Sankyo","100053963",false,"NCT07227597","A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003)","A Phase 1b\u002F2 Open-label Study Evaluating Different MK-6070 and Ifinatamab Deruxtecan (MK-2400)-Based Regimens in First-line Extensive Stage Small Cell Lung Cancer","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC)\n* For participants receiving gocatamig + ifinatamab deruxtecan (I-DXd) in maintenance only:\n\n  * Completed 3 to 4 cycles of platinum + etoposide chemotherapy with concurrent approved anti-programmed cell death 1\u002FLigand 1 (anti PD-1\u002FL1) as first line (1L) treatment of ES-SCLC within 6 weeks prior to enrollment\n  * No radiological disease progression per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)\n  * No other prior systemic ES-SCLC therapy allowed\n  * Rechallenge therapy counts as an additional line and leads to exclusion\n* For participants receiving gocatamig + I-DXd in induction and maintenance, or gocatamig + I-DXd in induction followed by gocatamig + atezolizumab in maintenance, or carboplatin + etoposide + atezolizumab in induction followed by atezolizumab in maintenance: No prior systemic ES-SCLC treatment allowed\n* Applicable to all participants: prior limited-stage small cell lung cancer (SCLC) is allowed if \\> 6 months have passed since the end of previous therapy and progression\n* Must be able to provide a pretreatment archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated\n* Measurable disease by RECIST 1.1 as assessed by the local site investigator\u002Fradiology. Lesions situated in a previously irradiated area are considered measurable if growth has been shown in such lesions since the completion of radiation\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures\n* Has any history of interstitial lung disease (ILD)\u002Fpneumonitis irrespective of steroid use, current ILD, ILD that cannot be ruled out by imaging at screening, or suspected ILD\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses\n* Has history of clinically significant intracranial bleeding or spinal cord bleeding\n* Has active neurologic paraneoplastic syndrome\n* Has history of coronary\u002Fperipheral artery bypass graft and\u002For any coronary\u002Fperipheral angioplasty or clinically significant cardiovascular disease such as myocardial infarction, symptomatic congestive heart failure (CHF), and\u002For uncontrolled cardiac arrhythmia within 6 months before the first dose of study intervention\n* Has other uncontrolled or significant protocol specified cardiovascular disease\n* Has history of arterial thrombosis within 6 months before the first dose of study intervention\n* Has chronic liver disease\n* Has history of allogeneic tissue\u002Fsolid organ transplant\n* Has history of leptomeningeal disease\n* Is infected with human immunodeficiency virus (HIV) and has a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor\n* Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Has major surgery within 4 weeks or minor surgery within 2 weeks of allocation\u002Frandomization (or first dose), or is anticipated to require a major surgical procedure during the study","ALL","18 Years",{"count":528,"type":529},170,"ESTIMATED","INTERVENTIONAL",[532,533],"PHASE1","PHASE2","Researchers are looking for new ways to treat extensive-stage small cell lung cancer (ES-SCLC). ES-SCLC is a type of lung cancer that has spread throughout the lung, to the other lung, or to other parts of the body.\n\nA standard (usual) treatment for ES-SCLC uses both chemotherapy and immunotherapy.\n\n* Chemotherapy is a treatment that works to destroy cancer cells or stop them from growing.\n* Immunotherapy is a treatment that helps the immune system fight cancer.\n\nGocatamig and I-DXd (short for ifinatamab deruxtecan) are study medicines. Researchers want to know if giving gocatamig and I-DXd together can treat ES-SCLC. Researchers will also look at giving the study medicines with standard treatment. Gocatamig is a T-cell engager therapy. I-DXd is an antibody drug conjugate.\n\n* T-cell engager therapy is a certain type of immunotherapy that uses T-cells to find and destroy cancer cells.\n* A T-cell is a type of white blood cell, which are cells that help the body fight infection.\n* An antibody drug conjugate (ADC) is a treatment that attaches to a protein on cancer cells and delivers treatment to destroy those cells.\n\nThe goals of this study are to learn:\n\n* About the safety of combining gocatamig and I-DXd and if people tolerate them together\n* If people who receive gocatamig and I-DXd have ES-SCLC respond, which means the cancer gets smaller or goes away",[536],"Small Cell Lung Cancer Extensive Stage","2026-07-10",{"date":539,"type":540},"2026-07-13","ACTUAL",{"date":542,"type":540},"2026-01-29",{"date":544,"type":529},"2030-12-30",{"name":5,"class":6},35]