{"entity":{"id":"lurbinectedin-basket-sclc","kind":"trial","name":"Lurbinectedin basket trial, small-cell lung cancer cohort","aka":["PM1183-B-005-14","Lurbinectedin SCLC basket"],"tldr":"A single-arm study of 105 patients that gave relapsed small-cell lung cancer its first new drug in decades, on a response rate rather than a survival benefit.","summary":"Small-cell lung cancer relapsing after platinum and etoposide had one approved option, topotecan, with a response rate near 15 percent and heavy myelosuppression. Lurbinectedin binds the minor groove of DNA at CG-rich promoter regions and blocks oncogenic transcription; it also depletes tumour-associated macrophages. The basket study recruited from 26 hospitals in six European countries and the United States between October 2015 and January 2019 and treated 105 patients with one previous chemotherapy line at 3.2 mg/m2 every three weeks.\n\nInvestigator-assessed objective response was 35.2 percent (95 percent confidence interval 26.2 to 45.2) at a median follow-up of 17.1 months. Grade 3 to 4 events were haematological: neutropenia 46 percent, leucopenia 29 percent, anaemia 9 percent, thrombocytopenia 7 percent. Serious treatment-related events occurred in 10 percent.\n\nThe FDA granted accelerated approval in 2020. The confirmatory trial, ATLANTIS, which tested lurbinectedin with doxorubicin against topotecan or CAV, missed its overall survival endpoint, so the approval rested on the single-arm data for years; the randomised evidence came from IMforte, on which the FDA approved lurbinectedin with atezolizumab for maintenance treatment of extensive-stage disease on 2 October 2025. Lurbinectedin has no marketing authorisation in the United Kingdom and no NICE appraisal, so it is not available on the NHS.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT02454972","url":"https://clinicaltrials.gov/study/NCT02454972"},{"label":"Lurbinectedin SCLC basket cohort (Lancet Oncology 2020)","url":"https://doi.org/10.1016/S1470-2045(20)30068-1"}],"tags":[],"related":[],"cancers":["extensive-stage-sclc","sclc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["lurbinectedin","topotecan"],"companies":["pharmamar"],"institutions":[],"pathways":[],"terms":["palliative-treatment"],"trials":["atlantis","imforte"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02454972","phase":"2","setting":"Small-cell lung cancer after one previous chemotherapy-containing line, performance status 2 or better, no brain metastases: lurbinectedin 3.2 mg/m2 as a one-hour infusion every three weeks, single arm, with investigator-assessed objective response as the primary endpoint","sponsor":"PharmaMar","result":"Objective response 35.2 percent (37 of 105); grade 3-4 neutropenia in 46 percent.","yearReported":2020,"enrolled":105,"enrolledBasis":"treated","enrolledNote":"105 patients with small-cell lung cancer were enrolled and treated in this cohort; the registry enrolment covers the whole basket study.","outcomes":[{"endpoint":"Objective response rate (investigator assessed)","primary":true,"unit":"%","arms":[{"name":"Lurbinectedin 3.2 mg/m2","n":105,"value":35.2}],"ci":[26.2,45.2],"source":"https://doi.org/10.1016/S1470-2045(20)30068-1"}],"replication":"The confirmatory ATLANTIS trial missed its primary overall survival endpoint; IMforte later provided randomised evidence for lurbinectedin in first-line maintenance with atezolizumab."},"route":"/trials/lurbinectedin-basket-sclc/","neighbours":{"cancer":[{"id":"extensive-stage-sclc","kind":"cancer","name":"Extensive-stage small-cell lung cancer","route":"/cancers/extensive-stage-sclc/"},{"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":"pharmamar","kind":"company","name":"PharmaMar","route":"/companies/pharmamar/"}],"term":[{"id":"palliative-treatment","kind":"term","name":"Palliative","route":"/terms/palliative-treatment/"}],"trial":[{"id":"nct05060016","kind":"trial","name":"A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)","route":"/trials/nct05060016/"},{"id":"atlantis","kind":"trial","name":"ATLANTIS","route":"/trials/atlantis/"},{"id":"imforte","kind":"trial","name":"IMforte","route":"/trials/imforte/"}]}}