# ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors

Source: https://onco.cc/trials/nct05671510/  
OnCo record `nct05671510` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-11
- Also known as: PRESERVE-003
- Tags: ctgov-ingest
- Registry id: 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
- Enrolled: 630

## Sources

- ClinicalTrials.gov NCT05671510: https://clinicaltrials.gov/study/NCT05671510

## Connected records

- cancers: [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- drugs: [Gotistobart](https://onco.cc/drugs/gotistobart/)
- companies: [OncoC4](https://onco.cc/companies/oncoc4/)
- key papers: [Gotistobart or docetaxel in metastatic squamous non-small cell lung cancer: stage 1 of the randomized phase 3 PRESERVE-003 trial](https://onco.cc/key-papers/paper-nct05671510-nat-med-2026/)

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