[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621030":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":53,"studyPopulation":41,"armGroups":54,"interventions":75,"overallOfficials":100,"centralContacts":104,"locations":110,"responsibleParty":142,"collaborators":144,"id":147,"slug":41,"hasResults":148,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":148,"sex":154,"minAge":155,"maxAge":41,"enrollmentInfo":156,"targetDuration":41,"studyType":159,"phases":160,"briefSummary":163,"conditions":164,"keywords":167,"overallStatus":113,"whyStopped":41,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":173,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},{"fullName":5,"class":6},"Eikon Therapeutics","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":41},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Progression-free survival (PFS)","Progression-free survival (PFS) is defined as the time from the first dose of the study medication to the first documented disease progression according to RECIST 1.1 by BICR, or death due to any cause, whichever occurs first","Through study completion, up to 6 years",{"measure":14,"description":15,"timeFrame":16},"Overall survival (OS)","OS defined as the time from the first dose of study medication to death due to any cause","Through study completion, up to 10 years",{"measure":18,"description":19,"timeFrame":12},"Objective Response (OR)","Objective response (OR) is defined as participants who demonstrate complete response (CR) or partial response (PR) by RECIST 1.1 as assessed by the Investigator, adverse events (AEs), and discontinuation of study intervention due to an AE (Dose Optimization Only).",[21,25,28,31,34,37],{"measure":22,"description":23,"timeFrame":24},"Objective response (OR)","Objective response (OR) is defined as participants who have a confirmed complete response (CR) or partial response (PR) according to RECIST 1.1 by BICR","Up to 6 years",{"measure":26,"description":27,"timeFrame":24},"Duration of response (DOR)","DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first, in participants demonstrating CR or PR, according to RECIST 1.1 by BICR.",{"measure":29,"description":30,"timeFrame":24},"Progression-free survival (PFS) by Investigator","Progression-free survival (PFS) is defined as the time from the first dose of the study medication to the first documented disease progression according to RECIST 1.1 by Investigator, or death due to any cause, whichever occurs first.",{"measure":32,"description":33,"timeFrame":24},"Overall Response Rate (ORR) by Investigator","Objective Response as defined by participants who demonstrate confirmed CR or PR according to RECIST 1.1 by Investigator.",{"measure":35,"description":36,"timeFrame":24},"Duration of Response (DOR) by Investigator","DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first, in participants demonstrating CR or PR, according to RECIST 1.1 by Investigator.",{"measure":38,"description":39,"timeFrame":40},"Incidence of Adverse Events (AEs)","Adverse Events (AEs) and discontinuation of study treatment due to any AE.","Up to 2.5 years",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":41,"primaryPurpose":45,"observationalModel":41,"timePerspective":41,"maskingInfo":46},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":47,"maskingDescription":41,"whoMasked":48},"QUADRUPLE",[49,50,51,52],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This is a global, multicenter, double-blind, placebo-controlled, randomized adaptive Phase 2\u002F3 study to evaluate the clinical activity and safety of EIK1001 administered IV in combination with pembrolizumab and histologically appropriate chemotherapy (pemetrexed plus either carboplatin or cisplatin) to participants with Stage 4 non-squamous or (carboplatin plus either paclitaxel or nab-paclitaxel) for participants with squamous NSCLC who have not received prior systemic therapy. The study is conducted in 2 phases (Phase 2 and Phase 3) and analyzed in 3 parts (dose optimization, dose expansion and confirmatory hypothesis testing).",[55,65,71],{"label":56,"type":57,"description":58,"interventionNames":59},"Arm 1 (Placebo in Combination with SOC)","PLACEBO_COMPARATOR","Participants in this arm will receive EIK1001 Placebo + Standard of Care (SOC).",[60,61,62,63,64],"Drug: Pembrolizumab (KEYTRUDA®)","Drug: Placebo","Drug: Paclitaxel + Carboplatin","Drug: Nab-paclitaxel + Carboplatin","Drug: Pemetrexed + Cisplatin \u002FCarboplatin",{"label":66,"type":67,"description":68,"interventionNames":69},"Arm 2 (EIK1001 in Combination with SOC)","EXPERIMENTAL","Participants in this arm will receive EIK1001 (Selected Dose 1) + Standard of Care (SOC).",[70,60,62,63,64],"Drug: EIK1001",{"label":72,"type":67,"description":73,"interventionNames":74},"Arm 3 (EIK1001 in Combination with SOC)","Participants in this arm will receive EIK1001 (Selected Dose 2) + Standard of Care (SOC).",[70,60,62,63,64],[76,81,85,89,93,96],{"type":77,"name":78,"description":79,"armGroupLabels":80,"otherNames":41},"DRUG","EIK1001","EIK1001 is a Toll like receptor 7\u002F8 (TLR 7\u002F8) dual agonist",[66,72],{"type":77,"name":82,"description":83,"armGroupLabels":84,"otherNames":41},"Pembrolizumab (KEYTRUDA®)","PD-1 inhibitor",[56,66,72],{"type":77,"name":86,"description":87,"armGroupLabels":88,"otherNames":41},"Placebo","Placebo control",[56],{"type":77,"name":90,"description":91,"armGroupLabels":92,"otherNames":41},"Paclitaxel + Carboplatin","SOC Chemotherapy for squamous NSCLC",[56,66,72],{"type":77,"name":94,"description":91,"armGroupLabels":95,"otherNames":41},"Nab-paclitaxel + Carboplatin",[56,66,72],{"type":77,"name":97,"description":98,"armGroupLabels":99,"otherNames":41},"Pemetrexed + Cisplatin \u002FCarboplatin","SOC Chemotherapy for non-squamous NSCLC",[56,66,72],[101],{"name":102,"affiliation":5,"role":103},"Nishitha Reddy","STUDY_DIRECTOR",[105],{"name":106,"role":107,"phone":108,"phoneExt":41,"email":109},"Elelta Shiferraw","CONTACT","314-209-3659","shiferrawe@eikontx.com",[111,125,133],{"facility":112,"status":113,"city":114,"state":115,"zip":116,"country":117,"countryCode":118,"cosmosGeoPoint":119,"geoPoint":124,"contacts":41},"NYU Langone Hospital Long Island","RECRUITING","Mineola","New York","11501","United States","US",{"type":120,"coordinates":121},"Point",[122,123],-73.64068,40.74927,{"lat":123,"lon":122},{"facility":126,"status":113,"city":115,"state":115,"zip":127,"country":117,"countryCode":118,"cosmosGeoPoint":128,"geoPoint":132,"contacts":41},"NYU Langone Hospital Manhattan","10016",{"type":120,"coordinates":129},[130,131],-74.00597,40.71427,{"lat":131,"lon":130},{"facility":134,"status":113,"city":135,"state":115,"zip":136,"country":117,"countryCode":118,"cosmosGeoPoint":137,"geoPoint":141,"contacts":41},"White Plains Hospital","White Plains","10601",{"type":120,"coordinates":138},[139,140],-73.76291,41.03399,{"lat":140,"lon":139},{"type":143,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[145],{"name":146,"class":6},"Merck Sharp & Dohme LLC","100621030",false,"NCT07365319","A Safety and Efficacy Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer.","A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2\u002F3 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer (TeLuRide-008).","TeLuRide-008","Key Inclusion Criteria:\n\n1. Participant must be ≥ 18 years old at the time of signing the informed consent.\n2. Participant has a life expectancy of at least 3 months.\n3. Participant has histologically or cytologically confirmed Stage 4 NSCLC predominately squamous or non-squamous) and is considered a candidate for standard therapy with pembrolizumab and chemotherapy. Participants with NSCLC-NOS (not otherwise specified) will be considered as non-squamous NSCLC.\n4. Participant must have documented evidence that mutation-directed therapy is not indicated, based on the absence of tumor-activating mutations or fusions (e.g., but not limited to EGFR, ALK, RET, ROS1, BRAF) for which approved first-line targeted therapies are available to the participant in their respective country.\n5. Participant has at least 1 lesion with measurable disease at Baseline according to RECIST 1.1 as determined locally. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.\n6. Participant has not received prior systemic therapy for advanced\u002Fmetastatic NSCLC.\n\n   Note: Participants who received adjuvant or neoadjuvant treatment (after surgery and\u002For radiation therapy) and developed recurrent or metastatic disease more than 1 year after completing therapy are eligible.\n7. Participant has an ECOG Performance Status of 0 to 1 assessed no more than 10 days before start of the treatment.\n8. Participant has tumor tissue available for PD-L1 testing from a site that was not radiated prior to biopsy, and was obtained, ideally, after diagnosis of metastatic disease. Biopsies obtained prior to receipt of adjuvant\u002Fneoadjuvant chemotherapy will be permitted if recent biopsy is not feasible (provided the specimen is \\\u003C 3yrs old).\n\nKey Exclusion Criteria:\n\n1. has small cell elements present histologically and\u002For the tumors are not predominantly non-squamous or squamous NSCLC.\n2. is currently actively enrolled in or has recently participated in a study of an investigational agent and received investigational therapy within 4 weeks or 5 half-lives (whichever is longer) of administration of EIK1001 or placebo.\n3. has had major surgery (\\\u003C 3 weeks prior to the first dose of study intervention administration).\n4. has received a live-virus vaccination within 30 days of the start of study intervention initiation.\n5. has received radiation therapy within 7 days of the first dose of study intervention administration.\n6. has completed palliative radiotherapy within 7 days of the first dose of study intervention administration.","ALL","18 Years",{"count":157,"type":158},750,"ESTIMATED","INTERVENTIONAL",[161,162],"PHASE2","PHASE3","This is a study to evaluate the safety and efficacy of EIK1001 administered intravenously in combination with pembrolizumab and histologically appropriate chemotherapy for patients with stage 4 NSCLC.",[165,166],"Non Small Cell Lung Cancer (Squamous or Non Squamous)","Stage 4 NSCLC",[168,78],"Non Small Cell Lung Cancer","2026-05-18",{"date":171,"type":172},"2026-05-20","ACTUAL",{"date":169,"type":158},{"date":175,"type":158},"2040-12-31",{"name":5,"class":6},3]