{"entity":{"id":"imforte","kind":"trial","name":"IMforte","aka":[],"tldr":"IMforte produced the first maintenance treatment ever approved for extensive-stage small-cell lung cancer, adding lurbinectedin to the immunotherapy that continues after chemotherapy.","summary":"IMforte, trial NCT05091567 sponsored by Roche, Jazz and PharmaMar and reported at the ASCO 2025 plenary and in the Lancet in 2025, produced the first maintenance treatment ever approved for extensive-stage small-cell lung cancer, adding lurbinectedin to the atezolizumab that continues after chemotherapy. It randomised 483 patients without progression after four cycles of carboplatin, etoposide and atezolizumab to lurbinectedin plus atezolizumab or atezolizumab alone, met both primary endpoints of overall and progression-free survival, and led to FDA approval on 2 October 2025, at the cost of added myelosuppression and fatigue. The maintenance concept is now being tested with tarlatamab in DeLLphi-305, so which agent wins the maintenance slot is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT05091567","url":"https://clinicaltrials.gov/study/NCT05091567"},{"label":"FDA approval (Oct 2025)","url":"https://www.roche.com/media/releases/med-cor-2025-10-03b"}],"tags":[],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["lurbinectedin","atezolizumab"],"companies":["jazz","pharmamar"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-imforte-lancet-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05091567","phase":"3","setting":"First-line maintenance after induction chemo-immunotherapy in ES-SCLC: lurbinectedin + atezolizumab vs atezolizumab","sponsor":"Roche / Jazz / PharmaMar","result":"OS 13.2 vs 10.6 months (HR 0.73); PFS HR 0.54.","started":"2021-11-18","startedType":"actual","yearReported":2025,"enrolled":483,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Lurbinectedin + atezolizumab","n":242,"value":13.2},{"name":"Atezolizumab","n":241,"value":10.6}],"hr":0.73,"ci":[0.57,0.95],"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01011-6/abstract"},{"endpoint":"Progression-free survival (IRF)","primary":true,"unit":"months","arms":[{"name":"Lurbinectedin + atezolizumab","value":5.4},{"name":"Atezolizumab","value":2.1}],"hr":0.54,"ci":[0.43,0.67],"source":"https://doi.org/10.1016/S0140-6736(25)01011-6"}],"replication":"Single phase 3; the maintenance concept is being tested with tarlatamab (DeLLphi-305) and I-DXd."},"route":"/trials/imforte/","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":"atezolizumab","kind":"drug","name":"Atezolizumab","route":"/drugs/atezolizumab/"},{"id":"lurbinectedin","kind":"drug","name":"Lurbinectedin","route":"/drugs/lurbinectedin/"}],"company":[{"id":"jazz","kind":"company","name":"Jazz Pharmaceuticals","route":"/companies/jazz/"},{"id":"pharmamar","kind":"company","name":"PharmaMar","route":"/companies/pharmamar/"}],"paper":[{"id":"paper-imforte-lancet-2025","kind":"paper","name":"Efficacy and safety of first-line maintenance therapy with lurbinectedin plus atezolizumab in extensive-stage small-cell lung cancer (IMforte): a randomised, multicentre, open-label, phase 3 trial","route":"/key-papers/paper-imforte-lancet-2025/"}],"pairing":[{"id":"chemo-io-then-maintenance-sclc","kind":"pairing","name":"Chemo-immunotherapy induction → maintenance intensification (SCLC)","route":"/pairings/chemo-io-then-maintenance-sclc/"}],"trial":[{"id":"lurbinectedin-basket-sclc","kind":"trial","name":"Lurbinectedin basket trial, small-cell lung cancer cohort","route":"/trials/lurbinectedin-basket-sclc/"}]}}