{"entity":{"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","aka":[],"tldr":"Published report from the PD-L1 Inhibitors trial registered as NCT05671510, in Nature Medicine (2026), chosen as the most cited paper whose own text cites the registry id.","summary":"PRESERVE-003 is a two-stage phase 3 trial evaluating gotistobart (BNT316/ONC-392), a novel pH-sensitive anti-cytotoxic T lymphocyte-associated protein 4 (CTLA-4) antibody that selectively depletes regulatory T cells within the tumor microenvironment, in patients with metastatic squamous non-small cell lung cancer (sqNSCLC) without actionable genomic alterations who progressed on programmed cell death protein/programmed death ligand 1 inhibitor/platinum-based chemotherapy-a population with a poor prognosis. Here we report on stage 1, which aimed to confirm the dose and assess the preliminary efficacy (primary outcome: overall survival; secondary outcomes: progression‑free survival, objective response rate and duration of response) and safety of gotistobart compared to docetaxel. Patients with sqNSCLC were randomized (1:1) to gotistobart (6 mg kg -1 with two 10 mg kg -1 loading doses every 3 weeks (N = 45)) or docetaxel (75 mg m - 2 every 3 weeks (N = 42)). After a median follow-up of 14.5 months, median overall survival was not reached with gotistobart (95% confidence interval (CI) 9.3 to not evaluable) versus 10.0 months (95% CI 6.2 to 11.9 months) with docetaxel (hazard ratio 0.46, 95% CI 0.25 to 0.84, nominal two-sided P = 0.0102). Safety was manageable, with grade ≥3 treatment-related adverse events in 42% and 49% of patients receiving gotistobart and docetaxel, respectively. Stage 1 results suggest that gotistobart monotherapy can provide clinically meaningful benefit for patients with programmed cell death protein/programmed death ligand 1-resistant and chemotherapy-resistant metastatic sqNSCLC. ClinicalTrials.gov identifier: NCT05671510.\n\nIndexed on Europe PMC as PubMed record 41896648 (DOI 10.1038/s41591-026-04323-8). Its abstract cites the registry id NCT05671510, which is how it was matched to this trial; no figure has been checked by an editor.","asOf":"2026-09-22","links":[{"label":"Nat Med 2026","url":"https://doi.org/10.1038/s41591-026-04323-8"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/41896648/"},{"label":"Europe PMC","url":"https://europepmc.org/article/MED/41896648"},{"label":"ClinicalTrials.gov NCT05671510","url":"https://clinicaltrials.gov/study/NCT05671510"}],"tags":["europepmc-ingest"],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["nct05671510"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["nature-medicine"],"dependsOn":[],"notes":[],"journal":"Nature Medicine","year":2026,"doi":"10.1038/s41591-026-04323-8","pmid":"41896648","authors":"Cho BC, Balaraman R, Chen HJ, et al.","paperType":"rct","findings":[],"whatItMeans":"This is the paper Europe PMC returns for registry id NCT05671510 with the most citations, so it is the natural first reading for anyone following the PD-L1 Inhibitors trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.","caveats":["Matched to the trial by the registry id cited in the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper."]},"route":"/key-papers/paper-nct05671510-nat-med-2026/","neighbours":{"trial":[{"id":"nct05671510","kind":"trial","name":"ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors","route":"/trials/nct05671510/"}],"journal":[{"id":"nature-medicine","kind":"journal","name":"Nature Medicine","route":"/journals/nature-medicine/"}]}}