Clinical trial · no report yet · Phase 3
PRESERVE-003
ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors
- NCT05671510 ↗
- Active, not recruiting
- OncoC4, Inc.
- Focused
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Preliminary discovery
Commentary in our index that names this trial so far
Podcasts, YouTube videos and X posts we have indexed. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build.
| Channel | Found | |
|---|---|---|
| X threads | 5 | |
| Podcasts | 1 |
The trial
ClinicalTrials.gov- Official title
- 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
- Phase
- Phase 3
- Status
- Active, not recruiting
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Gotistobart; Docetaxel
- Arms
- Arm 1: Gotistobart 6 mg/kg with 2 loading doses of 10 mg/kg, Q3W · Experimental
- Arm 2: Docetaxel 75 mg/m2, Q3W · Active comparator
- Enrollment
- 630 (estimated)
- Primary outcomes
- Overall Survival (OS)
- Sponsor
- OncoC4, Inc. with BioNTech SE
- Start
- Jun 28, 2023
- Primary completion
- Aug 31, 2027 (estimated)
- Results posted
- No
- Registry record
- NCT05671510 · updated Aug 13, 2026
Publications
linked from the registry- Zhang Y, Du X, Liu M, Tang F, Zhang P, Ai C, Fields JK, Sundberg EJ, Latinovic OS, Devenport M, Zheng P, Liu Y. Hijacking antibody-induced CTLA-4 lysosomal degradation for safer and more effective cancer immunotherapy. Cell Res. 2019 Aug;29(8):609-627. doi: 10.1038/s41422-019-0184-1. Epub 2019 Jul 2. PubMed 31267017
- Liu Y, Zheng P. Preserving the CTLA-4 Checkpoint for Safer and More Effective Cancer Immunotherapy. Trends Pharmacol Sci. 2020 Jan;41(1):4-12. doi: 10.1016/j.tips.2019.11.003. Epub 2019 Dec 10. PubMed 31836191
- Cho BC, Balaraman R, Chen HJ, Yu X, Fawole A, Liu ZG, Zhang J, Wu L, Yang B, Leddon JL, Hamm J, Huang Y, Wu L, Pan P, Singh P, Beardsley A, Kayali F, Davarifar A, Lee KH, Park KU, Lee Y, Li L, Wang X, Sun M, Yu Y, Jain V, Shpyro S, Wang Q, Wenger M, Sahin U, Efuni S, Song S, He K, Zheng P, Liu Y, He K, Li T, Socinski MA, Wu YL. Gotistobart or docetaxel in metastatic squamous non-small cell lung cancer: stage 1 of the randomized phase 3 PRESERVE-003 trial. Nat Med. 2026 Jun;32(6):2245-2253. doi: 10.1038/s41591-026-04323-8. Epub 2026 Mar 27. PubMed 41896648