{"entity":{"id":"atlantis","kind":"trial","name":"ATLANTIS","aka":[],"tldr":"Lurbinectedin's confirmatory trial missed its survival goal, but the drug stayed on the market because the combination tested was not the approved monotherapy dose.","summary":"ATLANTIS, trial NCT02566993 sponsored by PharmaMar and Jazz and reported in 2021, was lurbinectedin's confirmatory trial in relapsed small-cell lung cancer after one platinum line, and it missed its survival goal, though the drug stayed on the market because the combination tested was not the approved monotherapy dose. It randomised 613 patients to lurbinectedin plus doxorubicin or topotecan or CAV chemotherapy, found no difference in overall survival despite better tolerability, and the 2020 accelerated monotherapy approval, based on a basket cohort response rate, was maintained with the FDA later accepting IMforte and the LAGOON trial as confirmatory routes. OnCo links it to small-cell lung cancer, lurbinectedin and topotecan. Head-to-head second-line superiority of lurbinectedin over older chemotherapy remains unproven, which is the open question.","status":"negative","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02566993","url":"https://clinicaltrials.gov/study/NCT02566993"}],"tags":["lesson:combination-dose"],"related":[],"cancers":["sclc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["lurbinectedin","topotecan"],"companies":["pharmamar","jazz"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-atlantis-lancet-respir-med-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02566993","phase":"3","setting":"Relapsed SCLC after one platinum line: lurbinectedin + doxorubicin vs topotecan or CAV","sponsor":"PharmaMar / Jazz","result":"OS HR 0.97, not significant.","started":"2016-08-30","startedType":"actual","yearReported":2021,"enrolled":613,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Lurbinectedin + doxorubicin","n":307,"value":8.6},{"name":"Topotecan or CAV","n":306,"value":7.6}],"hr":0.97,"ci":[0.82,1.15],"source":"https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(22)00309-5/abstract"}],"replication":"Monotherapy activity supported by single-arm data and by IMforte in maintenance; head-to-head second-line superiority unproven."},"route":"/trials/atlantis/","neighbours":{"cancer":[{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"id":"sclc","kind":"cancer","name":"Small-cell lung cancer","route":"/cancers/sclc/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"drug":[{"id":"lurbinectedin","kind":"drug","name":"Lurbinectedin","route":"/drugs/lurbinectedin/"},{"id":"topotecan","kind":"drug","name":"Topotecan","route":"/drugs/topotecan/"}],"company":[{"id":"jazz","kind":"company","name":"Jazz Pharmaceuticals","route":"/companies/jazz/"},{"id":"pharmamar","kind":"company","name":"PharmaMar","route":"/companies/pharmamar/"}],"paper":[{"id":"paper-atlantis-lancet-respir-med-2023","kind":"paper","name":"Combination lurbinectedin and doxorubicin versus physician's choice of chemotherapy in patients with relapsed small-cell lung cancer (ATLANTIS): a multicentre, randomised, open-label, phase 3 trial","route":"/key-papers/paper-atlantis-lancet-respir-med-2023/"}],"term":[{"id":"confirmatory-trial","kind":"term","name":"Confirmatory trial","route":"/terms/confirmatory-trial/"},{"id":"lung-failed-programmes","kind":"term","name":"Lung cancer: the failed and stopped programmes, and why","route":"/terms/lung-failed-programmes/"},{"id":"orr","kind":"term","name":"Objective response rate (ORR)","route":"/terms/orr/"},{"id":"surrogate-validation","kind":"term","name":"Surrogate endpoint validation: which stand-ins have earned trust","route":"/terms/surrogate-validation/"},{"id":"trial-lifecycle","kind":"term","name":"Trial lifecycle: from protocol to label","route":"/terms/trial-lifecycle/"},{"id":"trial-failure-modes","kind":"term","name":"Why trials fail: underpowered, wrong endpoint, control arm drift, subgroup fishing, crossover","route":"/terms/trial-failure-modes/"}],"trial":[{"id":"lurbinectedin-basket-sclc","kind":"trial","name":"Lurbinectedin basket trial, small-cell lung cancer cohort","route":"/trials/lurbinectedin-basket-sclc/"}]}}