[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-small-cell-lung-cancer-squamous-or-non-squamous\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-small-cell-lung-cancer-squamous-or-non-squamous":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100621030","phase-2-a-safety-and-efficacy-study-of-eik1001-in-combination-with-pembrolizumab-and-chemotherapy-in-participants-with-stage-4-non-small-cell-lung-cancer-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":20,"type":21},750,"ESTIMATED","INTERVENTIONAL",[24,25],"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.",[28,29],"Non Small Cell Lung Cancer (Squamous or Non Squamous)","Stage 4 NSCLC",[31,32],"Non Small Cell Lung Cancer","EIK1001","RECRUITING","2026-05-18",{"date":36,"type":37},"2026-05-20","ACTUAL",{"date":34,"type":21},{"date":40,"type":21},"2040-12-31",{"name":42,"class":43},"Eikon Therapeutics","INDUSTRY",3,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100620678","phase-2-immunotherapy-without-chemotherapy-for-advanced-lung-cancer-patients-with-high-pd-l1-levels-100620678","NCT07360743","Immunotherapy Without Chemotherapy for Advanced Lung Cancer Patients With High PD-L1 Levels","Anti-PD1 Monotherapy in 1L Advanced NSCLC Patients With PD-L1 TPS > 50% and PTI=0","META-1","Inclusion Criteria:\n\nIn addition to the inclusion criteria of the METAREM master protocol, following additional criteria must be respected during patient inclusion in META-1 trial:\n\n1. Patients with age ≥18 years\n2. Patients in first-line therapy for advanced metastatic NSCLC with PD-L1 Tumor Proportion Score (TPS) \\>50%, without EGFR\u002F ALK\u002F ROS1 mutations and irrespective of their histological subtype (squamous or non-squamous).\n3. Patients with a PTI score of zero in plasma on the baseline PORTRAIT report. Note: Patients with PTI score ≥ 1 who meet all other criteria will be followed up to 36 months or death according to standard of care.\n\nExclusion Criteria:\n\nIn addition to the Exclusion criteria of the METAREM master protocol, following additional criteria must be considered during patient exclusion from META-1 trial:\n\n1. Patients who have previously received an anti-PD(L)1 or anti-CTLA4 or anti-LAG-3 or anti-TIM3 immunotherapy.\n2. Patients with any Hypersensitivity to the active ingredient or to any of the excipients of Pembrolizumab or Cemiplimab.",{"count":54,"type":21},275,[24],"Anti-PD-1 monotherapy has demonstrated significant clinical efficacy in advanced or metastatic non-small cell lung cancer (NSCLC) with high PD-L1 expression (tumor proportion score \\[TPS\\] \\>50%), outperforming platinum-based chemotherapy in terms of objective response rate (ORR) and overall survival (OS). Pivotal randomized trials such as KEYNOTE-024 and EMPOWER-Lung 1 established the superiority of PD-1 blockade in this patient population, leading to regulatory approvals by both the FDA and EMA for first-line treatment. These studies confirmed that a subset of patients can achieve deep and durable responses with immunotherapy alone, highlighting the potential of immune checkpoint inhibition to provide long-term clinical benefit without the toxicities associated with cytotoxic chemotherapy.\n\nDespite these successes, accumulating clinical evidence has revealed a clinically significant risk of hyperprogressive disease (HPD) in a subset of patients treated with anti-PD-1 monotherapy. HPD is characterized by an unexpected and rapid acceleration of tumor growth following treatment initiation and is associated with early clinical deterioration and increased mortality. This phenomenon likely contributes to the early crossover of survival curves frequently observed when comparing immunotherapy alone with chemotherapy in first-line NSCLC trials. In contrast, such early survival crossover is not observed in trials comparing chemotherapy-immunotherapy combinations with chemotherapy alone, including CheckMate-227, CheckMate-9LA, KEYNOTE-189, and KEYNOTE-407. These results have led many thoracic oncologists to favor combined chemo-immunotherapy regimens as first-line treatment, as they reduce the risk of HPD and increase initial ORR.\n\nHowever, while chemotherapy combined with immunotherapy effectively mitigates the risk of hyperprogression and improves early response rates, it also appears to compromise the durability of antitumor immune responses. Clinical data indicate that the median duration of response with chemo-immunotherapy combinations is approximately 10-11 months, compared with more than 22 months for anti-PD-1 monotherapy alone. This difference is likely attributable to the cytotoxic effects of chemotherapy on immune effector cells, which may limit the persistence and depth of immune-mediated tumor control. Consequently, there remains a strong clinical need to identify patients who could safely and effectively benefit from anti-PD-1 monotherapy while avoiding unnecessary exposure to chemotherapy.\n\nMultiple early-phase translational studies have independently identified soluble plasma biomarkers associated with response or resistance to PD-1 blockade in advanced NSCLC. Building on this body of evidence, translational analyses conducted at Gustave Roussy Cancer Center have identified a composite signature of circulating soluble factors, including interleukin-6 (IL-6), interleukin-8 (IL-8), soluble CD14 (sCD14), soluble CD25 (sCD25), and growth differentiation factor-15 (GDF-15). Together, these biomarkers define a Pro-Tumoral Inflammation (PTI) signature that is strongly associated with primary resistance to anti-PD-1 monotherapy. Elevated PTI scores reflect a systemic inflammatory state that promotes tumor progression and immune dysfunction, and have been linked to poor clinical outcomes, including non-response and hyperprogressive disease.\n\nWithin the META-1 sub-protocol of the METAREM master protocol, the investigators propose to integrate these soluble biomarkers into a single PTI score generated through baseline PORTRAIT immunoprofiling. The primary objective of this approach is to prospectively validate the predictive value of the PTI score for anti-PD-1 monotherapy efficacy in advanced NSCLC. By enabling early identification of patients at high risk of resistance or hyperprogression, this strategy aims to refine patient stratification and guide first-line treatment selection. Ultimately, the use of the PTI score could allow clinicians to identify patients most likely to benefit from anti-PD-1 monotherapy, preserving the potential for durable responses while sparing others from ineffective treatment and optimizing the overall therapeutic strategy in advanced NSCLC.",[28],[59,60,61,62,63,64,65],"anti-PD1 monotherapy","non-small cell lung cancer (NSCLC)","Tumor Proportion Score (TPS) >50%","without EGFR\u002F ALK\u002F ROS1 mutations","Pro-tumoral inflammatory score (PTI)","Advanced metastatic cancers","Personalized immunotherapy","NOT_YET_RECRUITING","2026-02-06",{"date":69,"type":37},"2026-02-10",{"date":71,"type":21},"2026-04",{"date":73,"type":21},"2032-04",{"name":75,"class":76},"UNICANCER","OTHER"]