{"entity":{"id":"nct06345729","kind":"trial","name":"A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)","aka":["KANDLELIT-004"],"tldr":"A phase 3 trial testing Calderasib in non-small-cell lung cancer, now recruiting.","summary":"A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumour Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004) is a phase 3 interventional study registered as NCT06345729, led by Merck Sharp & Dohme, and recruiting on the registry. Official title: A Phase 3, Randomised, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic NSCLC With PD-L1 TPS ≥50% (KANDLELIT-004). Planned enrolment is 600 participants (estimated). The study started in 2024-05-24 and primary completion is expected in 2029-02-19. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06345729","url":"https://clinicaltrials.gov/study/NCT06345729"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","kras-g12c-nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["calderasib"],"companies":["merck"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06345729","phase":"3","setting":"A Phase 3, Randomized, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic NSCLC With PD-L1 TPS ≥50% (KANDLELIT-004)","sponsor":"Merck Sharp & Dohme","participation":[{"nct":"NCT06345729","source":"https://clinicaltrials.gov/study/NCT06345729","fetchedAt":"2026-10-07T16:54:34.595Z","studySha256":"e5d205a7a8c3cc3605a8decba141f2c7ec343f51047c6b3b8ba162fc74e5a20a","overallStatus":"RECRUITING","lastUpdatePosted":"2026-10-07","leadSponsor":"Merck Sharp & Dohme LLC","collaboratorCount":0,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":348,"enrolmentType":"ESTIMATED","siteCount":241,"recruitingSiteCount":183,"countries":["Argentina","Australia","Austria","Brazil","Bulgaria","Canada","Chile","China","Colombia","Costa Rica","France","Georgia","Germany","Greece","India","Italy","Japan","Mexico","Netherlands","New Zealand","Peru","Philippines","Poland","Romania","South Korea","Spain","Turkey (Türkiye)","Ukraine","United Kingdom","United States"]}],"started":"2024-05-24","startedType":"actual","enrolled":600,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct06345729/","neighbours":{"cancer":[{"id":"kras-g12c-nsclc","kind":"cancer","name":"KRAS G12C-mutant non-small-cell lung cancer","route":"/cancers/kras-g12c-nsclc/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"drug":[{"id":"calderasib","kind":"drug","name":"Calderasib","route":"/drugs/calderasib/"}],"company":[{"id":"merck","kind":"company","name":"Merck & Co. (MSD)","route":"/companies/merck/"}]}}