{"entity":{"id":"nct02152631","kind":"trial","name":"A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer","aka":["JUNIPER"],"tldr":"A phase 3 trial of Abemaciclib, Erlotinib in non-small-cell lung cancer and small-cell lung cancer, run by Eli Lilly and Company, active and no longer recruiting.","summary":"A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer is a phase 3 interventional study registered as NCT02152631 by Eli Lilly and Company, with 453 participants enrolled, started 2014-10-03 and due to reach its primary completion in 2017-09-15. Interventions recorded: Abemaciclib, Erlotinib. Conditions listed: Non Small Cell Lung Cancer. Results were posted on ClinicalTrials.gov in 2018; the figures recorded here are the registry's, not a publication's.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02152631","url":"https://clinicaltrials.gov/study/NCT02152631"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["cdk46-inhibitor","kinase-inhibitors"],"targets":[],"drugs":["abemaciclib","erlotinib"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct02152631-front-oncol-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02152631","phase":"3","setting":"JUNIPER: A Randomized Phase 3 Study of Abemaciclib Plus Best Supportive Care Versus Erlotinib Plus Best Supportive Care in Patients With Stage IV NSCLC With a Detectable KRAS Mutation Who Have Progressed After Platinum-Based Chemotherapy","sponsor":"Eli Lilly and Company","started":"2014-10-03","startedType":"actual","yearReported":2018,"enrolled":453,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Survival (OS)","primary":true,"unit":"months","arms":[{"name":"Abemaciclib","n":270,"value":7.4,"note":"95% CI 6.5 to 8.8; Figures from the ClinicalTrials.gov results section (first posted 2018-12-12), not from a publication"},{"name":"Erlotinib","n":183,"value":7.8,"note":"95% CI 6.4 to 9.5"}],"hr":0.968,"ci":[0.768,1.219],"p":"0.771","source":"https://clinicaltrials.gov/study/NCT02152631?tab=results"},{"endpoint":"Progression Free Survival (PFS)","unit":"months","arms":[{"name":"Abemaciclib","n":270,"value":3.6,"note":"95% CI 2.8 to 3.8; Figures from the ClinicalTrials.gov results section (first posted 2018-12-12), not from a publication"},{"name":"Erlotinib","n":183,"value":1.9,"note":"95% CI 1.9 to 2.0"}],"hr":0.583,"ci":[0.47,0.723],"p":"<0.000001","source":"https://clinicaltrials.gov/study/NCT02152631?tab=results"},{"endpoint":"Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])","unit":"%","arms":[{"name":"Abemaciclib","n":270,"value":8.9,"note":"95% CI 5.5 to 12.3; Figures from the ClinicalTrials.gov results section (first posted 2018-12-12), not from a publication"},{"name":"Erlotinib","n":183,"value":2.7,"note":"95% CI 0.4 to 5.1"}],"p":"0.010","source":"https://clinicaltrials.gov/study/NCT02152631?tab=results"}]},"route":"/trials/nct02152631/","neighbours":{"cancer":[{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"sclc","kind":"cancer","name":"Small-cell lung cancer","route":"/cancers/sclc/"}],"technology":[{"id":"cdk46-inhibitor","kind":"technology","name":"CDK4/6 inhibitors","route":"/technologies/cdk46-inhibitor/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"abemaciclib","kind":"drug","name":"Abemaciclib","route":"/drugs/abemaciclib/"},{"id":"erlotinib","kind":"drug","name":"Erlotinib","route":"/drugs/erlotinib/"}],"company":[{"id":"eli-lilly","kind":"company","name":"Eli Lilly (incl. Loxo)","route":"/companies/eli-lilly/"}],"paper":[{"id":"paper-nct02152631-front-oncol-2020","kind":"paper","name":"A Randomized Phase III Study of Abemaciclib Versus Erlotinib in Patients with Stage IV Non-small Cell Lung Cancer With a Detectable KRAS Mutation Who Failed Prior Platinum-Based Therapy: JUNIPER","route":"/key-papers/paper-nct02152631-front-oncol-2020/"}]}}