{"entity":{"id":"nct05671510","kind":"trial","name":"ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors","aka":["PRESERVE-003"],"tldr":"A phase 3 trial testing Gotistobart in non-small-cell lung cancer, active and no longer recruiting.","summary":"ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors is a phase 3 interventional study registered as NCT05671510, led by OncoC4 with BioNTech SE, and active but no longer recruiting on the registry. Official title: Phase 3, Two-stage, Randomised Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers That Progressed on PD-1/PD-L1 Inhibitors. Planned enrolment is 630 participants (estimated). The study started in 2023-06-28 and primary completion is expected in 2027-08-31. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05671510","url":"https://clinicaltrials.gov/study/NCT05671510"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":[],"targets":[],"drugs":["gotistobart"],"companies":["oncoc4"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct05671510-nat-med-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05671510","phase":"3","setting":"Phase 3, Two-stage, Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers That Progressed on PD-1/PD-L1 Inhibitors","sponsor":"OncoC4","started":"2023-06-28","startedType":"actual","enrolled":630,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05671510/","neighbours":{"cancer":[{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"drug":[{"id":"gotistobart","kind":"drug","name":"Gotistobart","route":"/drugs/gotistobart/"}],"company":[{"id":"oncoc4","kind":"company","name":"OncoC4","route":"/companies/oncoc4/"}],"paper":[{"id":"paper-nct05671510-nat-med-2026","kind":"paper","name":"Gotistobart or docetaxel in metastatic squamous non-small cell lung cancer: stage 1 of the randomized phase 3 PRESERVE-003 trial","route":"/key-papers/paper-nct05671510-nat-med-2026/"}]}}