# Gotistobart or docetaxel in metastatic squamous non-small cell lung cancer: stage 1 of the randomized phase 3 PRESERVE-003 trial

Source: https://onco.cc/key-papers/paper-nct05671510-nat-med-2026/  
OnCo record `paper-nct05671510-nat-med-2026` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

Indexed 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.

## Fields

- Kind: Key paper
- Last checked: 2026-09-22
- Tags: europepmc-ingest
- Journal: Nature Medicine
- Year: 2026
- DOI: 10.1038/s41591-026-04323-8
- Authors: Cho BC, Balaraman R, Chen HJ, et al.
- What it means: 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.

## Sources

- Nat Med 2026: https://doi.org/10.1038/s41591-026-04323-8
- PubMed: https://pubmed.ncbi.nlm.nih.gov/41896648/
- Europe PMC: https://europepmc.org/article/MED/41896648
- ClinicalTrials.gov NCT05671510: https://clinicaltrials.gov/study/NCT05671510

## Connected records

- trials: [ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors](https://onco.cc/trials/nct05671510/)
- journals: [Nature Medicine](https://onco.cc/journals/nature-medicine/)

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